Annual Report 2012

2011-12
Annual Report 2011-12
Government of India Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals
Annual Report | 2011-12
Contents
1. Introduction 2. An Overview of Pharmaceuticals Industry 3. Pharmaceuticals Industry 4. National Pharmaceuticals Pricing Authority 5. Public Sector Undertakings 6. National Institute of Pharmaceutical Education & Research (NIPER) 7. New Initiatives 8. Implementation of Rajbhasha 9. General Administration 10. Performance Evaluation and Management System 11. Citizen Centric Governance 12. Information and Technology 13. Annexure
Brief Contents
1. Introduction 1.1 Mandate of Department of Pharmaceuticals 1.2 Vision and Mission of the Department 2. An Overview of Pharmaceuticals Industry 2.1 Financial Performance of the Drugs and Pharmaceuticals Industry 2.2 Imports 2.3 Exports 2.4 Share in National Trade 2.5 Pharma Export Promotion Council (Pharmexcil) 2.6 International Cooperation/Export Promotion of Pharmaceuticals 2.7 Proposed Major areas of International Conference 2.8 India Pharma Summit - 2011 2.9 Growth in Indian Pharmaceutical Industry 3. Pharmaceuticals Industry 3.1 Product Patent 3.2 Creation of IPR Facilitation Centers in Phamexcil 3.3 Data Protection as per Article 39.3 of TRIPS Agreement 3.4 Pharmaceutical Policy 3.5 Pharmaceutical Advisory Forum 4. National Pharmaceuticals Pricing Authority 4.1 NPPA 4.2 Drug Price Equalization Account (DPEA) 5. Public Sector Undertakings 5.1 Central Public Sector Undertakings 5.2 Joint Sector Undertakings 5.3 Wholly Owned Subsidiaries 5.4 Status of Annual Accounts 5.5 Generic Drugs Campaign The Jan Aushadhi Campaign 7 7 8 11 11 12 12 13 13 14 14 14 16 23 23 23 24 24 25 29 29 32 35 35 44 45 46 46
6. National Institute of Pharmaceutical Education & Research (NIPER) 51 7. New Initiatives 8. Implementation of Rajbhasha 69 73
9. General Administration 9.1 Organisation Set Up 9.2 Record Management 9.3 Grievance Cell 10. Performance Evaluation and Management System 10.1 Our Vision 10.2 Our Mission 10.3 Our Objective 10.4 Functions 11. Citizen Centric Governance 11.1 Our Vision 11.2 Our Mission 11.3 Our Clients 11.4 Our Commitment 11.5 Our Services 11.6 Our Activities 11.7 RTI-2005 11.8 CPGRAMS 12. Information and Technology 12.1 Local Area Network (LAN) 12.2 IT Infrastructure 12.3 Website 12.4 Video Conferencing 12.5 File Tracking System 12.6 Voice Mail Facility 12.7 E. Governance 13. Annexure Annexure I Annexure II Annexure III Annexure III (A) Annexure III (B) Annexure - IV
77 77 79 79 83 83 83 83 83 87 87 87 87 87 87 87 87 88 91 91 91 91 91 91 92 92 95 95 99 101 103 105 107
Chapter
Introduction 1.1 Mandate of Department of Pharmaceuticals 1.2 Vision and Mission of the Department
CHAPTER 1 Introduction
1.1 Mandate of Department of Pharmaceuticals
The Department of Pharmaceuticals in the Ministry of Chemicals & Fertilizers was created on 01.07.2008 to provide greater focus for the growth of the Pharmaceuticals industry. Following work has been allocated to the Department of Pharmaceuticals: 1) Drugs and Pharmaceuticals, excluding those specifically allotted to other departments. 2) Promotion and co-ordination of basic, applied and other research in areas related to the Pharmaceuticals sector. 3) Development of infrastructure, manpower and skills for the Pharmaceuticals sector and management of related information. 4) Education and training including high end research and grant of fellowships in India and abroad, exchange of information and technical guidance on all matters relating to pharmaceutical sector. 5) Promotion of public private partnership in pharmaceutical related areas. 6) International cooperation in pharmaceutical research, including work related to international conferences in related areas in India and abroad. 7) Inter-sectoral coordination including coordination between organizations and institutes under the Central and State Governments in areas related to the subjects entrusted to the Department. 8) Technical support for dealing with national hazards in pharmaceutical sector. 9) All matters relating to National Pharmaceuticals Pricing Authority including related functions of price control/monitoring. 10) All matters relating to National Institutes for Pharmaceuticals Education and Research (NIPERs). 11) Planning, development and control of; and assistance to, all industries dealt with by the Department. 12) Bengal Chemicals and Pharmaceuticals Limited. 13) Hindustan Antibiotics Limited & its subsidiaries as & JVs. 14) Indian Drugs and Pharmaceuticals Limited & its subsidiaries. 15) Karnataka Limited. Antibiotics and Pharmaceuticals
16) Rajasthan Drugs and Pharmaceuticals Limited. 17) Bengal Immunity Limited. 18) Smith Stanistreet Pharmaceuticals Limited. The work of the Department has been organized into three Divisions viz. Pharmaceuticals Industry Division, Public Sector Undertakings Division and R&D Division comprising National Institute of Pharmaceutical Education & Research, (NIPER) and Research & Development. The National Pharmaceuticals Pricing Authority (NPPA), an attached office of this Department, is entrusted with fixation and revision of prices of Pharmaceuticals products under Drug Price Control Order, 1995 (DPCO, 1995). There are five Central Public Sector Undertakings (CPSUs) viz Indian Drugs and Pharmaceuticals Limited (IDPL), Hindustan Antibiotics Limited (HAL), Bengal Chemicals and Pharmaceuticals Limited (BCPL), Bengal Immunity Limited (BIL) and Smith Stanistreet Pharmaceuticals Limited(SSPL). Earlier Karnataka Antibiotics & Pharmaceuticals Limited. (KAPL) was a joint venture between Hindustan Antibiotics Limited (HAL) and State Government of Karnataka and Rajasthan Drugs and Pharmaceuticals Limited (RDPL) was a joint venture of Indian Drugs and Pharmaceuticals Limited (IDPL) and the State Government of Rajasthan. But in order to sustain the growth & development of KAPL & RDPL, Government has approved de-linking of both these companies from HAL & IDPL respectively. The shares of KAPL held by HAL has now been transferred to the President of India w.e.f 1st October, 2009 and similarly shares of RDPL held by IDPL has been transferred to the President of India w.e.f 17th August, 2010. The shareholding of respective States in these joint ventures would continue to remain unaffected. National Institutes of Pharmaceuticals Education & Research (NIPERs) are autonomous institutions under this Department.
Shri M.K. Alagiri is the Minister of Chemicals and Fertilizers and Shri Shrikant Kumar Jena is the Minister of State, Independent Charge in the Ministry of Statistics and Programme implementation and Minister of State in the Ministry of Chemicals and Fertilizers. Shri Dilsher Singh Kalha, is Secretary in the Department of Pharmaceuticals w.e.f 25.01.2012 Shri K. Jose Cyriac, Secretary (Chemicals & Petrochemicals) had been entrusted additional charge as Secretary (Pharmaceuticals) w.e.f 1st November, 2011 to 24Th January, 2012.
vision has been fixed in concurrence with the Cabinet Secretariat, which is as follows: India : The largest global provider of quality medicines at reasonable prices. Mission: Ensure availability of drugs at reasonable prices as per provisions of the Drug Prices Control Order, 1995 Develop Human Resources for Pharmaceutical Industry and Drug Research and Development Formulate Scheme/ Project for promoting Public-Private Partnership for development of pharmaceuticals Industry Formulate Scheme/ Project for promoting Pharma Brand India through International Cooperation Formulate Scheme/ Project for promoting environmentally sustainable development of Pharmaceutical Industry
1.2 VISION AND MISSION OF THE DEPARTMENT

Vision: Based on the mandate given to the Department of Pharmaceuticals through the allocated functions a
Chapter
An Overview of Pharmaceuticals Industry 2.1 Financial Performance of the Drugs and Pharmaceuticals Industry 2.2 Imports 2.3 Export of Drugs and Pharmaceuticals Industry 2.4 Share in National Trade 2.5 Pharma Export Promotion Council (Pharmexcil) 2.6 International Cooperation/Export Promotion of Pharmaceuticals 2.7 Proposed Major areas of International Conference 2.8 India Pharma Summit - 2011 2.9 Growth in Indian Pharmaceutical Industry
CHAPTER -2 An Overview of Pharmaceuticals Industry

2.1 Financial performance of the Drugs and Pharmaceutical Industry
The financial performance of the Drugs and Pharmaceutical industry for the year 2009-10, 2010-11 and the forecast for the year 2011-12 are given in Table below:-
Drugs and Pharmaceuticals: Growth and Profitability in the year 2010-11 (%age Change over year ago)
S. No. Particulars June11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Income Net sales Total expenses Raw materials Salaries & wages Power & fuel Selling & marketing Other expenses Depreciation Interest expenses Tax provision PBDIT PAT PBDIT/Net Sales (%) PBDIT/Income (%) PAT/Income (%) 10.9 9.2 11.6 13.6 15.5 10.2 9.0 2.8 9.1 15.6 37.5 17.3 15.7 18.8 22.8 13.7 Quarterly Sept.11 Estimates 10.0 11.0 -1.8 14.0 13.0 24.0 15.1 28.0 13.0 20.0 -78.6 -4.3 17.2 20.8 11.4 Dec.11 Forcast 17.9 17.1 18.8 19.0 13.3 24.0 10.0 11.1 11.5 25.0 90.6 19.9 7.1 21.5 24.9 14.5 March12 Forcast 17.4 16.3 14.8 16.8 13.6 10.0 9.0 12.1 12.0 18.0 75.9 18.9 25.8 17.1 20.9 10.9 2009-10 15.0 11.9 3.1 8.0 18.2 2.5 0.1 -19.3 14.3 -0.3 108.8 105.7 210.8 21.4 25.4 15.0 10.9 12.4 19.2 14.8 21.1 20.1 11.9 15.9 12.4 6.6 73.6 -1.1 -31.6 19.0 22.7 9.2 Annual 2010-11 2011-12 Forcast 14.1 13.5 10.3 15.9 13.8 17.1 10.7 13.7 11.4 19.4 -37.2 12.6 55.6 18.7 22.4 12.6
Source: Center for Monitoring Indian Economy (CMIE) Report November 2011.
Net sales of the Drugs & Pharmaceuticals sector are expected to grow by 17.1 percent y-o-y in the December 2011 quarter as against an estimated 11 per cent growth in the September 2011 quarter. The improvement in sales growth will be largely driven by higher realization of export oriented Pharma companies. The sector generates around 40 percent of its sales from exports. A sharp depreciation in the rupees is expected to result in higher export realisations, which will enhance the over all growth of the sector. The sectors profitability is expected to remain under pressure. A sharp rise in expenses like raw materials, power & fuel and interest cost is expected to restrict
the growth in profits. Raw material expenses are expected to rise by 19 percent in the December 2011 quarter. The Pharma sector imports raw materials like chemicals intermediates and active pharmaceuticals ingredients (APIs). Imports accounts for 38 percent of the overall raw material cost. A weak rupee will make imports costlier, resulting in a higher rise in raw material cost. Power & fuel cost is expected to increase by 24 percent. With this the PBDIT margin is expected to remain flats at 24.9 percent y-o-y. The net profit of the sector is expected to grow by a modest seven percent as interest cost is expected to rise by 25 percent & the net profit margin is expected to be around 14.5 percent in the December 2011 quarter.
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Commercial Intelligence and Statistics (D.G.C.I.S.) Kolkata, value of imports of Medicinal and Pharmaceuticals Products for the period 2002-03 to 2010-11 is as under:
(Rs. in Crore)
2.2 IMPORTS: As per the Directorate General of
Year
Value of Import of Medicinal and Pharmaceuticals Products 2,865 2,956 3,139 4,515 5,866 6,734 8,649 9,959 10,937
Growth (%) 3.18 6.19 43.84 29.92 14.79 28.43 15.15 9.82
Import of Drugs & Pharmaceuticals is regulated as per the Foreign Trade Policy of Government of India. Import of some drugs and drug intermediates are restricted under current Foreign Trade Policy. These restrictions are basically due to common HS codes assigned to some narcotic substances or similarity to some Ozone Depleting Substances (ODS) with pharmaceutical products.
2.3 EXPORTS
As Per DGCIS, Kolkata Exports of Drugs and Pharmaceuticals and Fine Chemicals for the period 2002-03 to 2010-11 are below:(Rs. in crore)
2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11
Year
Value of Exports of Drugs and Pharmaceuticals and Fine Chemicals 12,826 15,213 17,228 21,230 25,666 29,354 39,821 42,456 47,551
Growth (%) 18.61 13.25 23.23 20.89 14.37 35.66 6.62 12.00
2002-03 2003-04 2004-05 2005-06 2006-07
(Source : Directorate General of Commercial Intelligence and Statistics (DGCIS), Kolkata)

VALUE OF IMPORT OF "MEDICINAL & PHARMACEUTICALS PRODUCTS"
12,000
Rs. in Crores
10,000 8,000 6,000 4,000 2,865 2,000 2,956 3,139 4,515 5,866 6,734
8,649
9,959
10,937
2007-08 2008-092009-10 2010-11

(DGCIS), Kolkata)
12
0 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11
Years
It may be observed that the imports shown declined in growth in the year 2010-11 compared to previous year. The country is almost self-sufficient in production of most of formulations/ pharmaceuticals products. As such imports are being resorted to on quality & economic considerations and not necessarily due to non-availability from domestic sources. Manufacturers of Drugs & Pharmaceuticals are free to produce any drugs approved by the Drug control authorities.
Value of Export of "Drugs Pharmaceuticals and Fine chemicals"

50,000 45,000 40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000 0 39,821 25,666 29,354 42,456 47,551
Rs. in Crores
12,826
15,213
17,228
21,230
2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11 Years
Growth of Import "Medicinal and Pharmaceuticals Products" & "Export Drugs Pharmaceuticals and Fine chemicals"
80 70 60
Indices
10,937
23 21
Total National Imports Medicinal and Pharmaceuticals Products
36
50 40 30 20 10 0 Export Import 19 13
44
30
14 15
28
7 15
12 10
6 3 0 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11 19 3 13 6 23 44 21 30 14 15 36 28 7 15 12 10
1,683,467
(Source : DGCIS, Kolkata)
2.4 Share in National Trade

Items/Years A: Total National Exports (a) Drugs Pharmaceuticals and Fine chemicals Share in Total Export % B: Total National Imports (b) Medicinal and Pharmaceuticals Products Share in Total Import % (c) Trade Balance (a)-(b) 2006-07 571779 25666 4.5 840506 5866 0.7 19800 2007-08 655864 29354 4.5 1012312 6734 0.7 22620 2008-09 840755 39821 4.7 1374436 8649 0.6 31172 2009-10 845534 42456 5.0 1363736 9959 0.7 32497
(Rs. in Crore) 2010-11 1142649 47551 4.2 1683467 10937 0.6 36614
47,551.00
Total National Exports Drugs and Pharmaceuticals and Fine Chemicals
The share of Exports of the Drugs Pharmaceuticals and Fine Chemicals in the total National Exports declined from 4.50% to 4.20% during the period 200607 to 2010-11, However in the absolute terms there is growth in Exports. The share of imports is declined 0.7% to 0.6% in the corresponding period.
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2.5 PHARMA EXPORT PROMOTION COUNCIL (Pharmexcil)

The Department had played a pivotal role in the formation of Pharmexcil consequent to the recommendation from 9th Five Year Plan Working Group Report on Drugs and Pharmaceuticals. In the light of this, the Department constantly interacts with Pharmexcil in their work areas. The role of Pharmexcil
1,142,649.00
is for facilitation of exports of Drugs, Pharmaceuticals, Biotechnology products, Herbal medicines and Diagnostics, to name a few. It is authorised to issue Registration-cum-Membership Certificate (RCMC) which is one of the requirements for the importers and exporters of commodities. In addition to this, Pharmexcil is concerned with giving export thrust to the various products through visits of delegations to various markets abroad, organizing of seminars, workshops and exhibitions. As a major area of work, Pharmexcil also holds Buyers/Sellers meets and compiles detailed data base on pharma exports and problems in exporting pharma products.
Consultants for developing India as a Global Innovation Hub by 2020. 2. Assistance to Institute of Economic Growth for conducting a study on Growth of Pharmaceutical Industry in India
2.7 Proposed Major areas of International Conference.

The Department proposes to leverage Inter-Country partnership through MoUs for formulating greater market access to Indian Pharma in key markets like Russia, Ukraine, Kazakhstan etc amongst the CIS, Mexico, Brazil, Venezuela, etc in LAC region, Japan, ASEAN, etc in the East, South Africa, Nigeria, Kenya, etc in Africa and some key Gulf Countries like Saudi Arabia, UAE, etc. It is also targeting focus on European countries like Spain, Greece, Germany, France and Italy for APIs and niche formulations.
2.6 International Cooperation/ Export Promotion of Pharmaceuticals

An important focus area for the Department of Pharmaceuticals is promotion of Indian pharma exports. The Department participated in the following International Cooperation events during 2011-2012 :1. Participation in 9th Session of India-Uzbek InterGovernmental Commission on Trade, Economic, Scientific & Technological Cooperation held on 4-5 May, 2011 in Tashkent. 2. Participation in the Meeting of Biotechnology and Life Sciences Working Group under India-US High Technology Cooperation Group held in July, 2011 in New Delhi. 3. Participation in India Russia Forum on Trade and Investment held in November, 2011 in Moscow and the Roundtable on Pharmaceuticals. 4. Participation in Seminars organized by the Embassy of India, Jakarta in cooperation with PT. Strategic Asia held in Jakarta, Indonesia. The Department of Pharmaceuticals also provided financial assistance for the following activities/events for promotion and development of the Pharma sector: 1. Preparing detailed scope of work, preparation of Expression of Interest for selection of Global
2.8 INDIA PHARMA SUMMIT-2011

The Department of Pharmaceuticals in collaboration with Federation of Indian Chamber of Commerce and Industry (FICCI) and WHO India organized India Pharma Summit 2011, on 29th November, 2011 in New Delhi. The theme of India Pharma Summit 2011 was Indian Pharma Road Map for Global Leadership in Generic Medicines. The India Pharma Summit was a one day event to showcase Indias capability in the Pharma Sector before all the stakeholders as well as to provide the networking opportunities to the Indian Pharma Industry for having a meaningful interaction with various stakeholders. It provided a platform that brings all the stakeholders such as policy makers from Government of India, State Governments, Indian Pharma Industry, Regulatory Authorities from focus countries, Academia, Global Pharma Leaders/ Experts on one platform and facilitate a meaningful interaction so as to generate a healthy debate as well as to come up with the solutions to issues of the problems being faced by Pharma Sector. India Pharma Summit 2011 was the 3rd event in successful series after the Department of Pharmaceuticals was carved out of Department of Chemicals & Petrochemicals in July 2008.
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2.9 Growth in Indian Pharmaceutical Industry

Table-1: Export and Domestic Growth
Year Mar 2006 Mar 2007 Mar 2008 Mar 2009 Mar 2010 Exports 21230 25666 29354 39821 42154* Growth% 23.23 20.89 14.37 35.66 5.86 Domestic 39989 45367 50946 55454 62055 Growth% 17.17 13.45 12.30 8.85 11.90 Total 61219 71033 80300 95275 104209
(Rs. in crore)
Growth%% 19.21 16.03 13.04 18.65 9.38
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Table 2: International sales on consolidated basis

Consolidated net sales Ranbaxy Labs Dr Reddys Labs Lupin Cipla Sun Pharma Wockhardt Jubilant Lifescience 8960.77 7236.80 5706.82 6130.31 5721.43 3751.24 3433.40 International sales 6771.74 5940.70 3983.08 3361.49 2898.20 2709.91 2369.11 Exports as % of net sales 2010-11 75.6 82.1 69.8 54.8 50.7 72.2 69.0
Consolidated net sales Cadila Healthcare Biocon Glenmark Pharma Stride Arcolab Plethico Pharma Piramal Healthcare Divis Labs Aurobindo Pharma Torrent Pharma Ipca Laboratories Dishman Pharma Orchid Chemicals Shasun Chemicals Panacea Biotec 4464.70 2300.52 3089.59 1695.84 1535.20 2509.86 1307.11 4381.48 2121.97 1882.54 990.84 1781.79 799.42 1143.78
International sales 2288.70 1956.79 1955.83 1637.67 1367.22 1280.58 1204.95 1112.06 1101.57 1025.18 911.56 725.85 676.78 610.44
Exports as % of net sales 2010-11 51.3 85.1 63.3 96.6 89.1 51.0 92.2 25.4 51.9 54.5 92.0 40.7 84.7 53.4
Table-3: Geographical Distribution of Pharma Companies

S.No. 1. 2. 3. 4. 5. 6. State Maharashtra Gujarat West Bengal Andhra Pradesh Tamil Nadu Others Total Number of Manufacturing Units Formulation Bulk Drugs 1928 1211 1129 397 694 62 528 199 472 98 3423 422 8174 2389 Total 3139 1526 756 727 570 3845 10563
Table-4: Market Turnover of Major Therapeutic Segments

Major Therapies Anti-infectives Cardiac Gastro Intestinal Respiratory Pain / Analgesics Vitamins/ Minerals/ Nutrients Anti Diabetic Gynaecology Neuro / CNS Derma MAT DEC05 (Val in Crs) 4,056 2,378 2,537 2,170 2,059 2,105 998 1,261 1,231 1,255 % Contribution 17.6 10.3 11.0 9.4 8.9 9.1 4.3 5.5 5.3 5.4 MAT DEC10 (Val in Crs) 8,060 5,318 5,099 4,080 4,038 3,625 2,743 2,658 2,633 2,554 % Contribution 17.2 11.4 10.9 8.7 8.6 7.7 5.9 5.7 5.6 5.5
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Table-5: Bulk Industry Growth

(Rs. in Crores)
Table-10: Export Growth

Year Mar 2007 Mar 2008 Mar 2009 Mar 2010 Mar 2011 Exports (Rs. crores) 25666 29354 39821 42154 45745 Growth % 20.89 14.37 35.66 6.6 7.7
2007-08 12,647.51
2008-09 16,360.71
2009-10 17,307.02
CAGR 16.98%
Table-6: The Global Market for Biologics in 2009

Country US Europe Japan Asia/Africa/Australasia Latin America Total Biologic Drugs Market 2009 Sales ($ bn) 69.02 41.68 10.29 14.4.0 1.20 136.59
Table-11: Human resource position in India

Sl Item No of Universities No of colleges No of science colleges Annual student output at degree level in science 5 Annual student output at degree level in engineering 6 Total no of pharmacy colleges 7 Number of B Pharm colleges 8 Number of Masters in pharmaceuticals area and PhD offering colleges 9 No of B Pharm students in pharma 10 No of Masters and Phd students output in pharma 1 2 3 4 Total numbers 409 25990 4696 2000374 1663619 1162 848 191 51716 5648
Table-7: The 10 Top Selling Biologics in 2009

Brand Avastin Rituxan Humira Herceptin Lantus Enbrele Remicade Drug Name bevacizumab rituximab adalimumab trastuzumab insulin glarine tanercept infliximab 2009 Sales ($ bn) 5.74 5.62 5.48 4.86 4.29 3.87 3.51
Table-8: The Global Market for Biosimilars in 2009

Country US Europe Other Countries (incl. China and India) Total Biosimilars Market 2009 Sales ($ bn) 0.06 0.14 1.03 1.23 Market Share of Biosimilars (%) 4.9 11.4 83.7 100
Table-12: Global Phama market growth rate

Year 2004 2005 2006 2007 2008 Market in Billion US$ 620 664 710 756 801 %growth rate 7.9 7.2 6.9 6.4 4.9
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Table-9: Projected Growth

(Value in Rs crs / Growth in %)
Year Value 2016-17 2019-20 130,000 233,000 Domestic Growth 21% 22% Value 158,000 248,000 Exports Growth 16% 17% Value 288,000 481,000 Total Growth 18% 19%
Table-13: Top Global Generic Players

Rank 1 2 3 4 5 Company Teva Sandoz Mylan/Merck GX Watson Andrx Barr Rank 6 7 8 9 10 Company Actavis Ratiopharm Stada Ranbaxy Perrigo
Table 14: Research and Development Expenditure

Year Mar 1995 Mar 1996 Mar 1997 Mar 1998 Mar 1999 Mar 2000 Mar 2001 Mar 2002 Mar 2003 Mar 2004 Mar 2005 Mar 2006 Mar 2007 Mar 2008 Mar 2009 Mar 2010 Growth in R&D Expenditure Rs Cr Domestic Companies 80.61 142.50 148.12 154.15 218.66 256.80 435.07 597.91 686.74 1084.26 1527.24 1850.97 2371.79 2772.63 3316.14 3342.32 Foreign Companies 64.13 83.37 89.41 90.65 79.78 90.17 109.81 110.04 232.73 346.69 510.50 816.02 695.62 700.18 846.05 934.40 R&D Expenditure As % of Sales Domestic Foreign Companies Companies 1.34 1.71 1.55 1.43 1.56 1.56 2.30 2.64 2.93 3.81 4.98 5.35 5.01 4.78 4.89 4.50 0.77 0.91 0.95 0.88 0.70 0.66 0.72 0.65 0.71 1.10 1.63 2.39 2.67 2.86 3.84 4.01
Table-15: R&D spending of leading Indian and Global pharmaceutical MNEs, FY 2009
Indian Pharmaceutical Companies Rank in R&D spending 1 2 3 4 5 Company R&D exp. FY 2008/09, million US$ 99 89 67 51 50 Global Pharmaceutical Companies Rank in R&D spending 1 5 10 25 50 Company R&D exp. 2009, million US$ 8,570 6,286 4,300 615 197
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Ranbaxy* Dr. Reddys Sun Pharma Cipla Lupin Labs
Roche, CH GlaxoSmithKlin, UK Elli Lilly, USA Lundbeck, DNK Watson, USA
Table 16: Employment Data for Pharmaceutical Sector

Year Mar 1995 Mar 1996 Mar 1997 Mar 1998 Mar 1999 Mar 2000 Mar 2001 Mar 2002 Mar 2003 Mar 2004 Mar 2005 Mar 2006 Mar2007 Mar 2008 No of Employees 1,81,497 2,04,609 2,11,614 1,89,295 2,13,999 2,43,410 2,33,704 2,26,416 2,23,556 2,40,791 2,65,396 2,90,021 3,36,211 3,53,692
Table 18: Qualifications of personnel employed in the Chemicals and Pharmaceuticals Segment
Qualification Ph. D / MTech / MSc etc. Graduate Engineers Diploma Engineers ITI and other vocational courses Graduates (BA/BSc/BCom/others) 12th standard or below Distribution 5-8% 15-25% 10% 15-20% 15-25% 20-25%
Table-19: Turnover-wise distribution

Turnover 0-10 Cr. 10-50 Cr. 50-100 Cr. 100-500 Cr. 500 + Cr. % Distribution 70 20 5 3 2
Table 17: Percentage distribution of Manpower in Pharma Industry

Function Distribution Production & Quality Control 50% 50% Research/Lab/Testing 20% Sales, Marketing, Medical assistance 5-10% Purchase, Logistics, Supply Chain 5-10% Support functions (HR, Finance, 10-12% etc.)
Table-20: Performance of CPSUs

Parameter Sales (08-09) TO/Employees Rs lacs TO/Sales employees Rs lacs PAT Rs cr Total Employees Sales Strength Sales (08-09) Year 2012-13 2013-14 2014-15 2015-16 2016-17 KAPL 225.01 30 65 5.88 739 345 225.01 RDPL 80.75 52 304 0.01 181 31 80.75 BCPL 77.63 10 134 -5.35 742 58 77.63 HAL 147.39 11 134 -22.08 1224 105 147.39 IDPL 56.70 23 236 -37900.9 243 24 56.70 TOTAL 594.37 19 106 3129 563 594.37
(Rs in Crores)
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Table-21: Sales Projection of CPSUs

IDPL 51.7 70 80 92 125.4 HAL 189 215 264 290 319 BCPL 153.37 176.57 204.73 237.6 275.83 KAPL 320 360 425 490 560
RDPL 108 122 135 150 165
Chapter
Pharmaceuticals Industry 3.1 Product Patent 3.2 Creation of IPR Facilitation Centers in Phamexcil 3.3 Data Protection as per Article 39.3 of TRIPS Agreement 3.4 Pharmaceutical Policy 3.5 Pharmaceutical Advisory Forum
CHAPTER 3 PHARMACEUTICAL INDUSTRY

The annual turnover of the Indian Pharmaceutical Industry is estimated to be about Rs. 1,04,944.351 Crores during the year 2010-11. The share of export of Drugs, Pharmaceuticals and Fine Chemicals is more than Rs. 47551.26 crore. This segment of Industry has shown tremendous progress in terms of infrastructure development, technology base and wide range of products. The industry has developed excellent GMP (Good Manufacturing Practices) compliant facilities for the production of different dosage forms. The strength of the industry is in developing cost effective technologies in the shortest possible time for drug intermediates and bulk activities without compromising on quality. This is realized through the countrys strengths in organic chemicals synthesis and process engineering. The domestic Pharma Industry has recently achieved some historic milestones through a leadership position and global presence as a world class cost effective generic drugs manufacturer of AIDS medicines. Many Indian companies are part of an agreement where major AIDS drugs based on Lamivudine, Stavudine, Zidovudine, Nevirapine are supplied to Mozambique, Rwanda, South Africa and Tanzania which have about 33% of all people living with AIDS in Africa. Many US Schemes are sourcing Anti Retrovirals from Indian companies whose products are already US FDA approved. Many Indian companies maintain highest standards in Purity, Stability and International Safety, Health and Environmental(SHE) protection in production and supply of bulk drugs even to some innovator companies. This speaks of the high quality standards maintained by a large number of Indian Pharma companies as these bulk actives are used by the buyer companies in manufacture of dosage forms which are again subjected to stringent assessment by various regulatory authorities in the importing countries. More of Indian companies are now seeking regulatory approvals in USA in specialized segments like Antiinfectives, Cardiovasculars, CNS group. Along with Brazil & PR China, India has carved a niche for itself by being a top generic Pharma player.
1 Source CMIE
Many Indian companies have got various international regulatory approvals for their plants, from agencies like USFDA, MHRA-UK, TGA-Australia, MCC-South Africa etc. Outside USA India is the only country having the highest number of USFDA approved plants for generic drugs manufacture outside USA. Major share of Indian Pharma exports is going to developed western countries and it speaks not only about excellent quality of Indian pharmaceuticals but also about the reasonableness of the prices. Some of the leading Indian Pharma companies derive 50% of their turnover from International business.
3.1 PRODUCT PATENT- Impact on medicine prices

With the enactment of Patents (Amendment) Act 2005, the process of bringing Patents Act in line with the TRIPS Agreement has been completed. The new patent regime is not expected to have much impact on prices/availability of medicines for the following reasons: (a) At any given points of time, globally only 5-10 percent of the drugs would be under patent protection. (b) The price competition among different drugs in the same therapeutic group should keep the prices under control. (c) Since majority of the patients in India pay from their pocket, the limited purchasing power will act as a check on very high price. (d) Govt. continues to have powers to regulate the prices of medicines. (e) Safe-guards like compulsory licensing, parallel imports etc. exists. (f) The drugs covered in the list of Essential Medicines are not likely to be covered by patent these would continue to be abundantly available at reasonable prices.
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3.2 CREATION OF IPR FACILITATION CENTRES IN PHARMEXCIL

The Working Group on Drugs and Pharmaceuticals for the 11th Five Year Plan (2007-2012) recommended
setting up of 3 IPR Facilitation Centres at 3 offices of Pharmexcil in order to disseminate information on IPRs and related issues to the Pharma Industry in an effective manner. For this purpose, a fund Rs. 5 crores was proposed by the Working Group for the 11th Five Year Plan. The first centre was opened at Hyderabad on 11th July, 2008. Subsequently, centre at Mohali was opened. These centres are offering various services to the members like General Information on Patents, Patent status of pharmaceutical products in India and other countries, Interpretation of search information etc. Keeping in view the importance of this scheme, it has been recommended to Planning Commission to continue and further strengthen this scheme in the 12th Five Year Plan.
(a) In order to follow-up on the recommendations made by the Committee in respect of AgroChemicals, the Department of Agriculture & Cooperation would draft necessary amendments to the Insecticides Act 1968 and process the matter further to obtain Cabinet approval; (b) As regards Traditional Medicines, AYUSH would process for acceptance of the recommendations of the Committee by the Government; (c) The Department of Health & Family Welfare would give wide publicity to the recommendations in the Report and carry out consultations with stakeholders before proposing appropriate amendments to Drugs & Cosmetics Act 1940 and its Rules. As India has been put on priority watch list 2009 by US, the issue of data protection has gained importance. US Special 301 Report mentions US concerns about weak IPR protection and enforcement in India and it urges India to improve the same. The report especially mentions about effective protection against unfair commercial use of undisclosed test and other data generated to obtain marketing approvals for pharmaceuticals and agrochemical products. The pressure on India has mounted as China has already enacted a law which gives six years data exclusivity. Keeping in view the importance of the subject, inter-Departmental meetings are being held to sort the issue out. It has been noted that Ministry of Health are still examining the recommendation of the Committee. The Department of AYUSH has informed the Department of Commerce that they strongly endorses the recommendation of Satwant Reddy Committee for data protection for ASU Drugs for a period of five years from the date of registration in India, however data protection of ASU Drugs should be considered independently of pharmaceuticals. Ministry of Agriculture and Cooperation has initiated the action on data protection for three years with the introduction of the Pesticides Management Bill 2008 in Parliament.
3.3 DATA PROTECTION as per ARTICLE 39.3 OF TRIPS AGREEMENT

The TRIPS Agreement expects WTO member countries to adopt minimum standards on the patent laws as stipulated therein. Article 39.3 of the TRIPs Agreement reads: Members when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.
24
On the request of Department of Commerce the Department of Chemicals and Petrochemicals set up a high level Inter-Ministerial Consultative Committee in February 2004 under the Chairmanship of Secretary (C&PC) to examine whether the provisions applicable under common laws of India and existing IPR laws are adequate and sufficient to address the issues and concerns of Article 39.3 of TRIPs Agreement. The Committee submitted its report to the Department of Commerce on 31.5.2007. The same is also available on the Website of the Department of Chemicals and Petrochemicals (www.chemicals.gov.in). A meeting was convened by Department of Commerce on 6th August 2007 and decisions taken are as follows:
3.4 PHARMACEUTICAL POLICY

This Department has been exercising Drug Price Control on the basis of criteria mentioned in
Modifications in Drug Policy, 1986 announced in September, 1994, which is based on production data of 1990. The Government announced the Pharmaceutical Policy 2002 in February 2002. However, a public interest litigation filed in the High Court of Karnataka at Bangalore resulted in an Order dated 12-11-02, which stopped the Government from implementing the price control regime of the Pharmaceutical Policy 2002. This Department filed a Special Leave Petition (SLP) before the Supreme Court of India against the Order of the Karnataka High Court. The Supreme Court vide its order dated 10.3.2003 directed the Government to consider and formulate appropriate criteria for ensuring essential and life saving drugs not to fall out of price control. Accordingly, a draft National Pharmaceuticals Policy was prepared by this Department after extensive discussions with various stakeholders, and in line with the declared objective of the Government in the National Common Minimum Programme(NCMP). This Policy was submitted to the Cabinet for its approval. The Cabinet considered the Policy in its meeting held on 11th January, 2007 decided that in the first instance be considered by a Group of Ministers(GoM). The GoM Chaired by Shri Sharad Pawar, Minister of Agriculture and Minister of Consumer Affairs, Food and Public Distribution held for meetings. Following the formations of the new Government, the Department with the approval of the Minister of Chemicals and Fertilizers recommended continuation of GoM. The GoM has been accordingly constituted with the ministers of the notified Departments in the earlier GoM. The new GoM is yet to give its recommendation on the draft of National Pharmaceuticals Policy, 2006. Further the Department of Pharmaceuticals prepared a draft National Pharmaceutical Pricing Policy, 2011[NPPP-2011] based on the criteria of essentiality
and requirements as stipulated by Ministry of Health & Family Welfare. The draft National Pharmaceutical Pricing Policy, 2011[NPPP-2011] was circulated among the concerned Ministries/Stakeholders. The draft Policy is also available on the Departments website www.pharmaceuticals.gov.in for comments by 30.11.2011 of any other interested person. In the draft policy it is proposed to bring the NLEM-2011 & associated medicines under price control.
3.5 Pharmaceutical Advisory Forum

Through Drug policies announced from time to time, Government of India has been trying to ensure abundant availability of good quality essential Pharmaceuticals of mass consumption at reasonable prices. At the same time strengthening the indigenous capability for cost effective quality production of medicines has been an important objective. To help realize his and in order to provide a Forum for a meaningful dialogue amongst all the stakeholders on various issues concerning the drug, policy it was decided to constitute a Pharmaceuticals Advisory Forum in the Department of Chemicals and Petrochemicals(now Department of Pharmaceuticals). A Pharmaceuticals Advisory Forum was constituted in July 2004 under the Chairmanship of Honble Minister of Chemicals & Fertilizers having Honble Minister of Sate of Chemicals & Fertilizers, Health Ministers of All States/UTs, Secretary, Department of Chemicals & Petrochemicals(now Department of Pharmaceuticals), Secretary(Health), Chairman, NPPA, Drugs Controller General of India, other concerned senior Center and State Government Officers and representatives of other stakeholders as its Members. After the formation of the new Government the Pharma Advisory Forum has been reconstituted vide OM No. 5/12/2004-PI-I dated 27th July, 2009 which is also available on the Departments website www. pharmaceuticals.gov.in.
25
Chapter
National Pharmaceuticals Pricing Authority 4.1 NPPA 4.2 Drug Price Equalization Account (DPEA)
CHAPTER - 4 NATIONAL PHARMACEUTICAL PRICING AUTHORITY (NPPA)

4.1 NPPA
The National Pharmaceutical Pricing Authority (NPPA) was established as an independent body of experts under the Ministry of Chemicals and Fertilizers by Gazette notification dated 29.08.1997. The Authority is entrusted with the task of price fixation / revision of the 74 scheduled bulk drugs and formulation containing any of the scheduled drugs under the Drugs (Prices Control) Order, 1995 as well as monitoring and enforcement of prices. NPPA also provides inputs to the Government for policy formulation and on other specific issues concerning affordable medicines to the consumer. The functions of the National Pharmaceutical Pricing Authority (NPPA) are: (1) To implement and enforce the provisions of the Drugs (Price Control) Order (DPCO), 1995 in accordance with the power delegated to it. (2) To undertake and/or sponsor relevant studies in respect of pricing of drugs/formulations. (3) To monitor the availability of drugs, identify shortages, if any, and to take remedial steps. (4) To collect/maintain data on production, exports and imports, market share of individual companies, profitability of companies etc. for bulk drugs and formulations. (5) To deal with all legal matters arising out of the decisions of the Authority. (6) To render advice to the Central Government of changes/revisions in the drug policy. (7) To render assistance to the Central Government in parliamentary matters relating to drug pricing. The organizational structure of NPPA is given at Annexure IV. The performance of NPPA since its inception (up to 15.01.2012) is as under: The National Pharmaceutical Pricing Authority (NPPA) since its inception has fixed / revised the prices of scheduled bulk drugs in 522 cases, which includes 334 bulk drugs and 188 derivatives of scheduled bulk drugs. Of these, the prices of 15 scheduled bulk drugs and 6 derivative and 607 formulations were fixed / revised during the period from 01.04.2011 to 15.01.2012. The NPPA compiles the annual data on production of selected monitored bulk drugs. The data on production for the years 2008-09, 2009-10, 20102011 and 2011-2012 (upto September, 2011) is give in the Annexure - I. The price of scheduled bulk drugs fixed during the last four years & since inception are given in Annexure II and summarized below:
BULK DRUGS PRICES

Particulars No. of Bulk Drugs Where Price Increased No. of Bulk Drugs Where Price decreased No. of Bulk Drugs Where price fixed For First Time No change In Price Total 2008-09 22 9 0 0 31 2009-10 15 10 02 01 28 2010-11 10 07 01 03 21 2011-12 (upto 15th Jan., 2012 19 01 0 01 21 Since inception of NPPA 152 343 17 10 522
29
FORMULATION PACKS
Particulars No. of Packs Approved Price Increased Price Decreased Price fixed for first time No change in prices Total 2008-09 1577 190 89 1256 42 1577 2009-10 1824 184 450 1155 35 1824 2010-11 713 223 60 371 59 713 2011-12 (upto 15th Jan., 12) 607 257 50 239 61 607 Since Inception of NPPA 11660 1789 3409 6062 400 11660
MONITORING OF PRICES
The NPPA monitors and analyses month-wise price movements of non-scheduled formulations based on the reports of ORG-IMS now renamed as IMS Health. The prices of these formulations are fixed / determined by manufacturers themselves depending on various factors like the cost of production, market competition, companys profitability status etc. NPPA monitors the prices of non-scheduled formulations through various methods like (a) scrutiny of price lists submitted by manufacturers (b) analysis of monthly Stockiest Secondary Audit Reports published by IMS Health, and (c) complaints / references received from official and non-official sources. Wherever price increase beyond 10% is noticed, manufacturers of such formulations are asked to clarify the reasons for such price increases.
The manufacturers are impressed upon to bring down the prices voluntarily and to maintain the price level. So far 33 companies have reduced prices of 65 non-scheduled formulation packs voluntarily after intervention of NPPA. This is an on-going process. Further, NPPA has fixed the price of 30 non-scheduled formulations under para 10(b) of DPCO, 1995. Thus prices of 95 non-scheduled formulation packs have been reduced through the intervention of NPPA till 15th January, 2012.
CREATION OF ENFORCEMENT DIVISION & ITS PERFORMANCE

A separate Enforcement Division was created in NPPA in June, 2007 to facilitate suo-motu detection of violation of DPCO 1995. Since inception 3208 samples were analysed leading to prima facie detection of 1169 cases of overcharging and 547 cases of selling of scheduled medicines without price approval.
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Year 2007-08 2008-09 2009-10 2010-11 2011-12 (upto Dec. 2011)*
* 29 cases are under process
Performance of Enforcement Division

No. of Samples Collected 1450 520 464 533 307 Prima Facie Violations detected 840 284 246 225 121 Referred for Overcharging 456 172 208 216 117 Identified for Price fixation 384 112 38 9 4
RECOVERY OF OVERCHARGED AMOUNT

There are a total no. of 810 cases wherein demand notices have been issued (including cases suo-moto recovery) involving total overcharged amount of Rs. 2318.54 crores since inception of NPPA till December, 2011. An amount of Rs. 217.42 crores has been recovered till 31.12.2011 which also includes recovery through Court orders. During the year 2011-12 (upto 31.12.11) Demand Notice for an amount of Rs. 21.23 crores have been issued and Rs. 8.71 crores has been recovered. As on 31.12.11 out of 78 cases referred to Collectors of various States for recovery under land and revenue arrears, 25 cases are under litigation, 48 cases are pending for recovery with Collectors of various States and in the balance 5 cases amount
has been recovered. The recovery of the overcharged amount is affected due to various Court orders passed by various High Court and also Supreme Court in various cases filed by Pharmaceuticals Companies challenging the price fixation / notification issued by NPPA / Government and complaints filed by various drug control authorities against Pharma companies for not following the notified price. Inclusion of some bulk drugs under price control (scheduled-I of DPCO95) has also been challenged by the Pharma companies in different courts of India. NPPA / Government is defending such cases through SG, ASGs and Senior Government Counsels. Whenever necessary NPPA files urgent application in the Courts for vacation of interim orders and also for early hearing / disposal of the case.
(Rs. in Crores)
The Status of cases of overcharging since inception till 31st December, 2011
SI Particulars No.
Aug, 2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 Cummulative 1997 to (upto (Aug, 97 to March Dec, Dec., 2011) 2006 11) 335 700.22 67 38.01 118 820.31 135 435.62 89 156.22 42* 146.93 24 21.23 810 2318.54
1. 2.
No. of Cases Overcharged amount demanded alongwith interest Amount Realized Amount Outstanding Amount still under litigation including cases referred to collector and contested by the companies in the court of law Cases referred to collector & amount still to be recovered Amount pending relating to the overcharging cases under process
3. 4. 5.
99.16 601.06 --
0.96 37.05 --
4.51 815.80 --
51.41 384.21 --
35.41 120.81 --
17.26 129.67 --
8.71 12.52 --
217.42 2101.12 1933.90
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-------44.16
6.
7.
--
--
--
--
--
--
--
123.06
*Note : Demand issued in the year 2010-11 withdrawn in 7 cases during the year 2011-12 with the approval of Department of Legal Affairs/Department of Revenue (TRU)/Competent Authority.
4.2 Drug Prices Equalisation Account (DPEA)

Drug Prices Equalisation Account (DPEA) has been maintained by Government under the provisions of Drugs (prices Control) Order, 1979. Under the Drugs (Prices Control) order, 1979 (DPCO, 1979), there were 345 bulk drugs under price control. The Department computed tentative liabilities in respect of 47 bulk drugs only on suo-motu basis covering 172 cases till the Interim stay dated 30.6.1997 was granted by the Honble Bombay High court in the Writ petition No. 2368/1996 filed by the Indian Drugs Manufacturers Association (IDMA) and Organisation of pharmaceutical producers of India (OPPI) restraining the Department and its committees etc., from issuing fresh notices to the drug companies calling for information required for determining liabilities. Out of these 172 cases where the liabilities have already been determined tentatively and communicated to the companies, only 72 such cases during the period 1994-97 could be referred to the Drugs Prices Liabilities Review Committee (DPLRC) constituted on 21.3.1994 under the Chairmanship of a judge of Honble Delhi High Court retired in October, 1994) alongwith two members to review/ determine the liability in such cases. Out of these 72 cases, the Committee after deliberation in each case and giving adequate opportunity of hearing to
the drug companies to present their point of view gave reports in 47 cases. In view of the stay granted by the Honble Bombay High Court the Committee had not taken up the other 25 cases and also any fresh case. On the basis of the recommendations of the DPLRC, Department issued demand notices in 45 cases (no liability in one cases and one case inked with another case). Most of these companies filed Writ petition in the different High Courts against the demand notices. The total amount of liability on the basis of the recommendations of the DPLRC is to the tune of Rs. 228.47 crore (appx) till November, 2011 Rs. 1,62,90,23,696/- have been collected and deposited in DPEA. Since, no new cases could be taken up by DPLRC for determination of the DPEA liability because of the stay granted by the Honble Bombay High Court, there was no work with the DPLRC. Hence a conscious decision was taken by the Government to keep the DPLRC under suspended animation w.e.f. 31 December, 2005 vide Resolution dated 16th December, 2005. At that time 25 cases were pending with the DPLRC because of stay, where no quantification could be done. In addition to these 25 cases, there may be a large number of DPEA liability cases in respect of 298 bulk drugs where information from the companies concerned are to be gathered for determination of the DPEA liability.
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Chapter
Public Sector Undertakings 5.1 Central Public Sector Undertakings 5.2 Joint Sector Undertakings 5.3 Wholly Owned Subsidiaries 5.4 Status of Annual Accounts 5.5 Generic Drugs Campaign The Jan Aushadhi Campaign
CHAPTER 5 PUBLIC SECTOR UNDERTAKINGS

5.1 CENTRAL PUBLIC SECTOR UNDERTAKINGS
The total production and sales of five Pharma Central Public Sector Undertakings (CPSUs) under the control of this Department for the last four years are as under:(` in crore)
* Provisional
I) KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LIMITED (KAPL), BANGALORE.

Karnataka Antibiotics & Pharmaceuticals Limited (KAPL) is a profit making Mini Ratna Central PSU having 59% of the equity shares of GoI and 41% of equity shares of Karnataka State Industrial and Investment Development Corporation (KSIIDC).
The paid up share capital of the company as on date is `7.49 crores. The Company was incorporated on 13th March, 1981 and the commercial production started from August, 1984. The manufacturing units and the registered office of the company is located at Bangalore (Karnataka). The main products are Pharmaceuticals formulations like tablets, capsules, injectables, etc. It is an MOU signing company.
35
Earlier it was a Joint Sector Undertaking of HAL in collaboration with KSIIDC. But in the interest of continued growth and development of the company, Government has implemented the delinking of KAPL from HAL and transferred the shareholding of HAL in KAPL to Government of India. Government of India had also invested Rs. 7.10 crore in KAPL for upgrading its manufacturing facilities conforming to WHO-GMP standards and setting up a new WHOGMP compliant Cephalosporin plant. Other joint venture partner, viz. Karnataka State Industrial and Investment Development Corporation (KSIIDC) would bring in additional investment of ` 4.90 crore in KAPL. The company has also ISO-9001 and ISO 14001 accreditation. It has been continuously generating profits for the last 11 years and the performance of the company has further improved and gone up especially on account of Purchase Preference Policy announced by the Department in August, 2006 for a period of five years.
product at an estimated cost of Rs.22.23 crores. The Project is likely to be completed by end of the financial year 2011-12. When the project is completed, it will be possible for the Company to increase its exports, as new range of products can be added to export.
II) RAJASTHAN DRUGS & PHARMACEUTICALS LIMITED (RDPL), JAIPUR.

Rajasthan Drugs and Pharmaceuticals Limited (RDPL) is a consistently profit making Central Public Sector Unit in Joint Sector with a total paid-up equity capital of ` 4.98 crores where Government of India (GoI) and Rajasthan State Industrial Development & Investment Corporation Limited (RIICO) hold 51% and 49% respectively. It was incorporated in 1978 and commercial production started in 1981. The Company has its manufacturing facilities & registered office at Road no. 12, VKI Industrial Area, Jaipur (Rajasthan).
Production & Sales
(` In crore)
36
* Provisional
Product range of the company includes Antibiotics, Anti-diabetic, cardiovasculars, pain management, general medicines and animal health products. Presently the Company is undertaking creation of separate manufacturing facilities for Cephalosporin
This is a formulation unit engaged in production of Tablets, Capsules, Liquid Orals, ORS Powder & Opthalmic medicines in a Schedule M compliant facility. The company, under the quality management, has a existence of a well-equipped laboratory with modern equipments like HPLC, FTIR, etc., for ensuring high quality parameters.
In the interest of continued growth and development of the company, Government has delinked RDPL from IDPL (the original promoter representing GOI) and transferred the shareholding of IDPL in RDPL to Government of India in August 2010. The Company has since then enhanced its manufacturing capacities by installing new machines and at the same time the workers have also acquired skills and expertise for attaining high productivity. The Company has changed its outlook and entered in the arena of select Public Sector Companies showing consistent profits amidst stiff competition. It is now fairly on the path of growth.
Production & Sales
(` In crore)
* Provisional
Projects undertaken & Future Projects

The Company has almost completed the Phase-I (Schedule M) of the expansion and modernization plan has embarked upon Phase-II programme to qualify for WHO (GMP) requirements to become eligible for exploring International Markets as well as for participating in the Internationally Funded Projects of GOI and other Governments.
The company has carved for itself a name in the institutional market in India as a reputed manufacturer of high quality life saving drugs and other specialized medicines, with its marketing activities spread throughout the country. The company is engaged in manufacture and selling of medicines of high quality at reasonable rates to the Govt. of Rajasthan, Central Government Institutions, viz ESIC, Defence, Railways, other PSUs and also to other State Govt. Institutions. The company is further diversifying its marketing activities into Pharma Prescription Markets (Open Trade Sales), Veterinary Markets, Marketing of Ayurvedic and other Indian system of medicines in order to enhance its market share and also in its endeavour to improve the profitability of the organization.
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III) HINDUSTAN ANTIBIOTICS LIMITED (HAL), PIMPRI, PUNE

Hindustan Antibiotics Ltd. (HAL), Pimpri, Pune was incorporated on 30th March, 1954. This was the first Public Sector Company in drugs and Pharmaceuticals. HAL has its plant located at Pimpri. The company produces a wide range of Pharmaceutical formulations including agro-vet products. There are two joint sector units promoted by HAL in collaboration with the respective State Governments. These are Maharashtra Antibiotics & Pharmaceuticals Ltd. (MAPL) at Nagpur (Maharashtra-since closed) and Manipur State Drugs & Pharmaceuticals Ltd. (MSDPL) at Imphal (Manipur-since closed). Karnataka Antibiotics & Pharmaceuticals Limited (KAPL), Bangalore, which was earlier a Joint Sector Undertaking of HAL in collaboration with Karnataka Government, has since been de-linked from HAL after approval of the Government.
Based on the Scheme, the Government approved the Rehabilitation of the company on 9th March 2006 followed by BIFR approval on 5th June 2007. The Rehabilitation Scheme inter alia involved the following:S. No. 1. 2. Particulars Cash infusion Write off/ exemptions from Government of India Sacrifices by Banks, financial institutions and PSUs Total Amount (` in crores) 137.59* 267.57
3.
103.34
508.50
(* This includes interest free loan of ` 56.96 crores to be repaid by HAL by sale of land within a period of two years.)
The entire cash infusion of ` 137.59 crores has been released to the company. Parliament has approved writing off of loan and waiver of interest to the extent of ` 259.43 crores. As regards generation of ` 56.96 crore as part of Cash Infusion, BIFR issued guidelines for sale of land as per the Rehabilitation Scheme through an Assets Sale Committee. Action is under progress by HAL in this regard.
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After establishment, the company made profits for several years. However, as the company started incurring continuous losses since 1993-94, it was referred to the BIFR in January, 1997. BIFR declared the company formally sick on 31.3.1997 and appointed Industrial Development Bank of India (IDBI), Mumbai as the Operating Agency for a TechnoEconomic Viability Study and Report. Accordingly, a Rehabilitation Scheme was prepared by HAL which was later revised on the directions of the BIFR and the Government.
Further, Government has additionally approved proposals of ` 30.17 crore received from HAL for setting up new powder injectable facilities for Cephalosporin and upgradation of existing vialling facilities for Betalactum (Penicillin) Antibiotics complying to WHO-GMP standards at an estimated cost of ` 20.17 crores and for upgradation of manufacturing facilities of Tablet, Capsule and Liquid Sections complying to WHO-GMP standards at an estimated cost of ` 10.00 crore in order to make the company further viable.
Production & Sales

Details of Production & Sales of HAL from 2008-09 onwards are as under:
(` In crore)
HAL has completed the work on Cephalosporin in record time of 9 months. It has commissioned commercial production in February, 2009 and also obtained WHO-Certification for the same. Work relating to upgradation of existing vialling facilities for Betalactum Antibiotics has also been completed and production will start by the end of the year 2011-12.
* Provisional
IV) BENGAL CHEMICALS & PHARMACEUTICALS LIMITED (BCPL), KOLKATA

BCPL was a chemicals manufacturing company set up in the private sector in 1901 by Dr. Acharya P.C. Roy, the great visionary and scientist. Later on being sick, it was taken over by the Government and nationalized on 15th December, 1980. A new public sector company in the name and style of Bengal Chemicals & Pharmaceuticals Limited (BCPL) was incorporated on the 17th March, 1981. The company has four manufacturing units one each at Maniktala (Kolkata), Panihati at North 24 Parganas (West Bengal), one at Mumbai (Maharashtra) and one at Kanpur (UP). Besides, the company is having nine sales outlets and three C&F agencies spread all over India. The company manufactures and markets a wide range of industrial chemicals, drugs and Pharmaceuticals besides cosmetics and home products. In the home products, the well known products include Cantharidine Hair Oil and Lamp Brand Phenol are quite popular. Post 1980, company continued its operations. However, due to continued losses, the company was declared sick by the Board for Industrial and Financial Reconstruction (BIFR) on 14th January, 1993. A Revival Package was accordingly prepared & approved by the BIFR on 4th April, 1995. The package was reviewed by BIFR from time to time, based on which a Modified Revised Rehabilitation Scheme was
New Cephalosporin Plant Building of Hindustan Antibiotics Ltd. Pimpri, Pune.
FUTURE PROJECTS
Sl.No. Project Estimated Cost (` in crore) Multi Product Sterile facilities 20.76 for Betalactum Antibiotics complying to WHO-GMP Upgradation of Large Volum 40.00 Parenteral with facilities complying to WHO-GMP Total 60.76
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1.
2.
then prepared. BIFR approved this Modified Scheme on 14.1.2004. Finally, based on the requirements for modernization of plants & machinery and taking into account the earlier schemes, the Board for Reconstruction of Public Sector Enterprises (BRPSE) at its meeting held on 25.8.2006 recommended a modified revival plan for revival of BCPL. The recommendations of BRPSE were confirmed by the Cabinet Committee on Economic Affairs (CCEA) which approved the BRPSE Scheme in its meeting held on 21st December 2006. The Revival Scheme which include interalia: (i) Cash infusion by GOI - ` 207.19 crore (ii) Write off/Waiver of Loans/Interest - ` 233.41 crore Parliament has approved writing off of GOI loans & interest of ` 233.41 crore and cash infusion component of ` 207.19 crore. The components as approved by the Government have been released. The company
has appointed Consultants for undertaking the work of upgradation & modernization of plant & machinery including compliance with Schedule M/WHO-GMP standard.
Production & Sales

Details of Production & Sales of BCPL from 2008-09 onwards are as under: (` In crore)
* Provisional
UNITS, PRODUCT PROFILE & MANPOWER

Unit Products Maniktala Tablets, Capsules, Ointment, Spirituous preparations, Non-spirituous preparations, Antiseptic preparations, Injectables, Anti snake venom serum (ASVS), Syrup, Hair oil etc. 296 Panihati Alumina ferric, Phenol, Naphthalene balls, Bleaching powder, Floor Cleanser, Liquid soap. Mumbai Hair oil Kanpur Tablet, Nonspirituous preparations, Hair oil
40
Manpower as on 01.11.2011
158
15
21
Total Manpower as on 01.11.2011: 656, Officers: 119 Non-Officers: 537
The Upgradation & Modernization of Tablet, ORS Powder, Liquid and Home Product Sections at Kanpur are in progress. It is expected to complete the modernization work by June, 2012. Setting up of GLP Compliant Laboratory, Product Development Laboratory is on the verge of completion.
STEPS TAKEN FOR UPGRADATION & MODERNIZATION

Upgradation & Modernization Projects including capacity augmentation for Chemical Plants at Panihati(West Bengal) and in Pharmaceutical Plants at Maniktala (Kolkata) and Kanpur have been undertaken. In addition, Greenfield Projects for Cephalosporin and Betalactum range of products (in dosage forms of Capsule, Tablet, Dry Powder Injectables & Dry Syrup) at Maniktala, upgradation of Ointment, Liquid antiseptic, Liquid Orals and ASVS are in progress and expected to be completed during 2011-12. Upgraded Phenol Manufacturing and filling, Composite Production Block, Renovated Alum Plant, QC Block, Finished Goods Stores, Administrative Block and other allied services are in operation at Panihati.
FUTURE PROJECTS
A project for manufacture of Anti-Rabies and other vaccines and a Biological Park at Panihati under Joint Venture/PPP mode have been considered.
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V) INDIAN DRUGS & PHARMACEUTICALS LIMITED (IDPL), GURGAON

Indian Drugs and Pharmaceuticals Ltd (IDPL) was incorporated on 5th April, 1961 for achieving Indias march towards self-sufficiency and self-reliance in the field of drugs and pharmaceuticals, particularly with the primary objective of creating self sufficiency in essential life saving drugs and medicines.
IDPL is the largest Central Pharma Public Sector Undertaking in India with plants at Rishikesh (Uttarakhand), Hyderabad (Andhra Pradesh) and Gurgaon (Haryana) and wholly owned subsidiaries, namely, IDPL (Tamil Nadu) Ltd., Chennai (Tamil Nadu) and Bihar Drugs & Organic Chemicals Ltd. (BDOCL) at Muzaffarpur (Bihar). In addition, IDPL has one joint sector undertaking, promoted in collaboration with the Orissa State Government, namely, Orissa Drugs & Chemicals Ltd. (ODCL) Bhubaneswar.
Consequently, an Expert Committee was appointed in September, 2004, to study the Techno-Financial Feasibility of rehabilitating IDPL. In this connection, a Technical Audit of various plants of IDPL was also assigned to National Institute of Pharmaceutical Education and Research (NIPER). NIPER in its report submitted to the Department on 31.8.2005, recommended revival of all plants of IDPL and its subsidiaries in phases for production of existing and new products. IDBI, the Monitoring Agency on behalf of BIFR, supported the recommendations for revival of IDPL subject to certain conditions. Accordingly, in a meeting held under the Chairmanship of the then Minister (C&F&S), it was decided to revive all the five units of IDPL in a phased manner. Honble AAIFR at its hearing on 13.9.2005 set aside the impugned order of BIFR dated 4.12.2003 and remanded the matter back to BIFR for taking further action for rehabilitation of IDPL.
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IDPL was formally declared sick by the Board for Industrial & Financial Reconstruction (BIFR) on 12th August, 1992. A revival package for the company was formulated and approved by BIFR on 10th February, 1994. However, after taking into account the performance of the company which fell short of the targets, the BIFR on 23.1.1996 treated the sanctioned package as failure, and thereafter in its meeting held on 4.12.2003 BIFR confirmed its prima-facie opinion about winding up of IDPL in terms of Section 20(1) of the Sick Industrial Companies (Special Provisions) Act, 1985. However, given the possibility of revival of the company, Department of Chemicals & Petrochemicals (Now Department of Pharmaceuticals) filed an appeal against the opinion of BIFR in Appellate Authority for Industrial & Financial Reconstruction (AAIFR) on 10.2.2004.
A Draft Rehabilitation Scheme for revival of Indian Drugs & Pharmaceuticals Limited (IDPL) was considered by the Board for Reconstruction of Public Sector Enterprises (BRPSE) at its meeting held on 9.3.2007 and recommended for approval. The scheme was placed before the Cabinet for approval. Cabinet considered the proposal at its meeting held on 17.5.2007 and referred it to GoM for consideration at the first instance. GoM was constituted on 1.6.2007. The first meeting of the GoM was held on 11.10.2007. Based on the recommendation of GoM and Draft scheme prepared earlier, a Pre-feasibility Report was prepared by an expert agency, Ernst & Young. Now the revival scheme of the company is under the consideration of Central Government. Despite being a sick company, during the countrys calamity of outbreak of Plague in 1994, IDPL was the only company which played the sheet anchor
role in supplying Tetracycline for the entire Nation. Similarly, company had made uninterrupted supply of Chloroquine to combat Malaria epidemic in different parts of the country. In 2005 to combat national emergency (Leptospirosis) arising due to floods in Maharastra, IDPL had supplied required Doxycycline Caps within no time.
Cephalosporin Plant at an estimated cost of ` 13 Cr. at its premises in Gurgaon.
VI)
BENGAL IMMUNITY LIMITED (BIL)
Production and Sales Progress

Details of Production & Sales figures of IDPL from 2008-09 onwards are as under:
(` In crore)
BIL was a sick company in the private sector in the name and style of Bengal Immunity Company Limited. The management of the company was taken over by the Central Government with effect from the 18th May, 1978. It was nationalized w.e.f. 1st October, 1984 and a new public sector company in the name and style of Bengal Immunity Limited was incorporated on the 1st October, 1984. The company has two manufacturing units, one each at Baranagar at Kolkata (West Bengal) and at Dehradun (Uttrakhand). The Board for Industrial and Financial Reconstruction (BIFR) formally declared the company sick on 9th March, 1993. BIFR heard the case from time to time. In the hearing held on 13th September, 2002, BIFR formed its prima-facie opinion to wind up the company. The opinion was confirmed by BIFR in the hearing held on 25th February, 2003. With the approval of the Cabinet, VSS was introduced in the company. The company has since relieved all employees under VSS as on 30th September, 2003. The company is closed. The Official Liquidator has already been appointed by the Kolkata High Court. However, on a Writ Petition filed by the BIL Employees Union, the appointment of Liquidator in respect of BIL has been stayed by High Court of Kolkata by its order dated 08.08.2005. High court of Kolkata also directed that AAIFR shall hear and dispose of the application
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* Provisional
Presently, under different Class of Therapeutic Medicines, around 87 generic/branded drugs covering tablets, capsules, injections, vitamins, ORS pouches etc. are being manufactured in various plants of IDPL. The implementation of schedule-M at Rishikesh and Gurgaon Plants has been partly completed and the balance work is in progress. IDPL is engaged in setting up of a new
of BIL Employees Unions. AAIFR in its order dated 9.11.2005 directed that possibility of revival through some other alternative Pharmaceuticals company or some firm producing some other goods using the available assets should be considered. Thereafter a Committee was constituted in this Department to look into the issue of revival of BIL looking to the order passed by AAIFR. The Committee, constituted to explore the possibility of revival of Bengal Immunity Limited (BIL), recommended revival of BIL through Public Private Partnership (PPP) mode. Bids were then called on revival proposals and in continuation of orders of AAIFR dated 03.03.2008, 5 short listed companies were asked to give their proposals. Meanwhile, SBI Caps have also been appointed for preparation of Bid/ RFP document for subsequent bidding by the 5 short listed companies. SBI Caps has since submitted its report which is under examination.
VSS was introduced in the company. The company has since relieved all the employees under VSS as on 30th September, 2003. The company is closed. The Official Liquidator has been appointed by the Honble High Court of Kolkata Order dated 12.1.2006. The Registered Office, Plant & Machinery and other assets have since been taken over by the Official Liquidator.
5.2 JOINT SECTOR UNDERTAKINGS I) MAHARASHTRA ANTIBIOTICS & PHARMACEUTICALS LTD (MAPL)
This is a Joint Sector Undertaking promoted by Hindustan Antibiotics Limited (HAL) and State Industrial & Investment Corporation of Maharashtra (SIICOM) based at Nagpur (Maharashtra). HAL holds 52% of the equity shares, 38% is with SIICOM and 10% with IDBI. The company was incorporated in November, 1979, and the commercial production started in May, 1981. After initial operations, the company could not be run profitably and had to incur continuous losses. Accordingly, BIFR formally declared MAPL as sick on 14.1.1997. BIFR has since heard the case from time to time. In the hearing held on 04.07.2000, BIFR formed opinion for winding up of the company under Section 20(1) of the SICA, 1985. Appeals filed in AAIFR by M/s Environmental Engineers Inc. and a group of employees were also dismissed. At present, the company is closed and is before the High Court of Mumbai, Nagpur Bench for appointing a Liquidator. However, Writ Petitions have been filed by M/s Environmental Engineers Inc. in the Nagpur Bench of the Mumbai High Court against the liquidation proceedings of MAPL. No further order has been issued by the Bench in this connection. Meanwhile, as winding up requirements and additionally in accordance with the direction of the Nagpur Bench of the High Court of Mumbai, Government introduced VSS in MAPL. Accordingly all employees were released under VSS.
VII) SMITH STANISTREET PHARMACEUTICALS LIMITED (SSPL)

It was a sick company in the private sector in the name and style of Smith Stanistreet Company Limited set up in 1821 and its management was taken over by the Government of India with effect from 4th May, 1972. The company was nationalized on 1st October, 1977, and a new public sector company in the name and style of Smith Stanistreet Pharmaceuticals Limited (SSPL) was incorporated on 19th July, 1978. The company has its registered office at 18, Convent Road, Kolkata (West Bengal)
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The company was formally declared sick by the Board for Industrial and Financial Reconstruction (BIFR) on 21st December, 1992. The BIFR approved a revival package for the company on 31st August, 1994. The revival package was for a period of ten years beginning from 1994-95. The same was declared as having failed during the hearing on October, 17, 2000. The BIFR heard the case on 3rd December, 2001 and confirmed its prima facie opinion that it was just, equitable and in public interest that the company should be wound up. With the approval of the Cabinet,
II) MANIPUR STATE DRUGS & PHARMACEUTICALS LIMITED (MSDPL)

This is a joint sector undertaking promoted by Hindustan Antibiotics Limited (HAL) in collaboration with Manipur Industrial Development Corporation (MANIDO). HAL holds 51% of the equity shares and 49% is with MANIDO. The company was incorporated on the 18th July, 1989. The manufacturing unit and the registered office is at Imphal (Manipur). After initial operations, there were losses on account of law & order and connected reasons. The Company has since been closed as per recommendations of the State Govt. of Manipur. Consequently, there has been separation of employees with retrenchment benefits under the Industrial Disputes Act/Worksmens Compensation Act. At present, the company is closed.
fully tied up proposal for revival. In the hearing held on 8.7.2002, the BIFR, inter-alia, directed the O.A. to issue advertisement inviting offers for sale of the assets of the company under Section18(2) (i) without any liability or under Section 18(ii). Later on, BIFR in its order dated 8th April, 2003 has finally passed orders for winding up of the company under the provisions of Sick Industrial Companies (Special Provisions) Act, 1985. The appeal filed by ODCL employees against the winding up order of BIFR has been dismissed by the AAIFR vide its order dated 23.6.2005. High Court of Odisha had appointed a provisional Liquidator. This has since been stayed by a larger Bench of the Odisha High Court. After intervention of IDPL in the day to day activities of ODCL from March 2007 the production and sales have visibly gone up in comparison since the inception of the unit. The unit has generated profit in 2010-11. The target for production in 2011-12 is ` 11 crores. The Ministry has sanctioned ` 1.21 cr. for implementation of Schedule-M .
III) ORISSA DRUGS & CHEMICALS LTD. (ODCL)

This is a joint sector undertaking promoted by Indian Drugs & Pharmaceuticals Limited (IDPL) and the Industrial Promotion and Investment Corporation of Odisha (IPICOL). IDPL holds 51% of the equity shares and 49% is with IPICOL. The company was incorporated in 1979 and commissioned fully for production from September, 1983. The company has its manufacturing unit and its registered Office in Mancheshwar Industrial Area, Bhubaneshwar in the State of Odisha. The company is engaged in the manufacture of Pharmaceutical formulations in the form of Tablets, Capsules, Powders, Ointments etc. After initial profitable operations, ODCL was formally declared sick by the Board of Industrial and Financial Reconstruction (BIFR) on 26th October, 1992. On the basis of the report of the Operating Agency, appointed by the BIFR and the support extended by the promoters, the BIFR approved a revival package for ODCL on the 18th August, 1994. However the package could not be implemented due to lack of support from the State Government. Accordingly, BIFR in the hearing on 18.12.2000, declared this scheme as failure and issued a show cause notice for winding up of the company in the absence of a
5.3 WHOLLY OWNED SUBSIDIARIES a) IDPL (TAMIL NADU) LIMITED, CHENNAI.

IDPL (Tamil Nadu) Ltd, Chennai was incorporated in September 1965 is a sick unit of IDPL. In terms of the revival package approved by BIFR in 1994 in the case of IDPL, the Surgical and Formulation Unit of IDPL at Chennai was converted into a wholly owned subsidiary in the name and style of IDPL (Tamil Nadu) Limited, Chennai with effect from 1st April, 1994. IDPL holds the entire equity capital of this unit. At present, it is engaged in the manufacture of pharmaceutical formulations. Most of the work of Schedule M has been completed at the plant. The production for the year 2010-11 was ` 553.45 Lakhs and for the year 2011-12 (until Nov. 11 provisionally) amounted to ` 392.09 Lakhs. The implementation of Schedule-M has been partly completed and the balance work is in progress.
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b) BIHAR DRUGS & ORGANIC CHEMICALS LTD (BDOCL), MUZAFFARPUR

Bihar Drugs & Organic Chemicals Ltd (BDOCL), Muzaffarpur was earlier a Organic Chemicals and
Drug Manufacturing unit of IDPL at Muzaffarpur (Bihar). It was incorporated in November 1979. In terms of the revival package approved by the Board for Industrial & Financial Reconstruction (BIFR), the Organic Chemicals and Drug Manufacturing unit of IDPL at Muzaffarpur (Bihar), was converted into a wholly owned subsidiary in the name and style of Bihar Drugs & Organic Chemicals Limited, Muzaffarpur with effect from 1st April, 1994. IDPL holds the entire equity capital of this Unit. The past long-term liabilities amounting to ` 36 crore as on 31.3.1994 were taken over by IDPL. At present there is no production activity in the unit and is closed since November 1996.
poor and the disadvantaged. Under this campaign, less priced quality unbranded generic medicines will be made available through Jan Aushadhi Stores which inherently are less priced but are of same and equivalent quality, efficacy and safety as compared to branded generic medicines. Under this Scheme, the State Government has to provide space in Government Hospital premises for the running of the Jan Aushadhi Stores (JAS). Government hospitals, NGOs, Charitable Organizations and public societies like Red Cross Society, Rogi Kalyan Samitis typically constituted for the purpose can be operating agencies for the JAS. The operating agency for JAS is nominated on the basis of the recommendations of the State government. Operational expenditure is met from trade margins admissible for the medicines. The State Government has to ensure prescription of unbranded generic medicines by the Government doctors. The Bureau of Pharma Public Sector Undertakings of India (BPPI), comprising of all the Central Pharma PSUs (CPSUs), namely, IDPL, RDPL, KAPL, HAL and BCPL, was set up on 1st December 2008 with the major objective to have a focused & empowered structure to implement the Jan Aushadhi Campaign initiated by the Department of Pharmaceuticals. Initially it was as an independent, unincorporated body but subsequently, it was registered as a Society under the Societies Registration Act, 1860 by the Govt. of NCT of Delhi on 21st April, 2010. BPPI is monitoring the opening of Jan Aushadhi Stores. It is also involved in promotion of the unbranded generic drugs and the Generic Drug Campaign. The first Jan Aushadhi Generic Drug Store was opened in Civil Hospital, Amritsar on 25th November, 2008 and with the active support and cooperation of the State Government of Punjab, the stores were opened not only in all districts of Punjab but also being opened at block levels too. The campaign has now been spread besides in Punjab, also in the States of Haryana, Uttrakhand, Rajasthan, Andhra Pradesh, Odisha, West Bengal, Jammu & Kashmir, Himachal
5.4 STATUS OF ANNUAL ACCOUNTS

Details of Annual Accounts finalized till date are as under:Karnataka Antibiotics & Pharmaceuticals 2010-11 Limited Rajasthan Drugs & Pharmaceuticals Limited Hindustan Antibiotics Limited Indian Drugs & Pharmaceuticals Limited Bengal Chemicals & Pharmaceuticals Limited Bengal Immunity Limited Smith Stani-Street Pharmaceuticals Limited 2008-09 2009-10 2008-09 2007-08 2005-06 2004-05
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5.5 GENERIC DRUGS CAMPAIGN THE JAN AUSHADHI CAMPAIGN

Access to quality medicines at affordable prices is a key challenge for the Government. The prices of branded medicines are generally higher than generic medicines due to various reasons as having patent protection and having limited regulation through the Drug Prices Control Order, 1995 etc. For fulfilling this goal, a Campaign in the name of Jan Aushadhi Campaign has been launched. The purpose of this campaign is to make available medicines at affordable prices for all, especially the
Pradesh & UT of Delhi and Chandigarh by having opened 117 Jan Aushadhi Generic Drug Stores so far (till 29.02.2012). Efforts are on to open more number of stores. The Jan Aushadhi Campaign will help: i) Improve access to healthcare in as much as cost of treatment would come down substantially. This would enable the Public Health System to increase the coverage.
these retail outlets. iv) Ensure successful implementation of the Jan Aushadhi campaign would dispel the myth that quality of medicines is linked to price and demonstrate that quality medicines can be sold at substantially lower prices. v) Educate doctors that unbranded generic medicines provide a better option than branded products since quality of generic medicines can be equally efficacious and safe at much lower prices. vi) Create Consumer awareness & involve private & charitable bodies & NGOs by making them part of the campaign. vii) Reduce promotional cost and profits for the benefit of patients etc.
ii) Secure a socio- economically viable mechanism / institutional arrangement for efficacious sales of Pharma CPSU products, thereby improving their viability. iii) Promote & encourage private industry to sell their quality unbranded generic products through
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Chapter
National Institute of Pharmaceutical Education & Research (NIPER)
CHAPTER - 6 NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION & RESEARCH (NIPER), S.A.S. NAGAR
NIPER, SAS Nagar, Mohali was initially registered as a society under the Societies Act. The faculty for the institute was appointed in 1994. In 1998, Parliament enacted National Institute of Pharmaceutical Education Act, 1998. NIPER was declared as an Institute of National Importance under the Act of Parliament on 26th June 1998. NIPER is a member of Association of Indian Universities.
Disciplines:
The first batch of students was admitted in 1998. NIPER offers Masters and Ph.D. degrees in 15 streams and caters to the various needs of pharmaceutical industry: 1. Medicinal Chemistry 2. Natural Products 3. Traditional Medicine 4. Pharmaceutical Analysis 5. Pharmacology & Toxicology 6. Regulatory Toxicology 7. Pharmaceutical Technology (Biotechnology) 8. Pharmaceutical Technology (Formulations) 9. Pharmaceutical Technology (Process Chemistry) 10. Pharmaceutics 11. Biotechnology 12. Pharmacy Practice 13. Clinical Research 14. Pharmacoinformatics 15. Pharmaceutical Management
The main objectives of the Institute:

1. Nurture and promote quality and excellence in pharmaceutical education & research. 2. Toning up the level of pharmaceutical education and research by training the future teachers, research scientists and managers for the industry and profession. 3. Creation of National Centers to cater to the needs of the pharmaceutical industryand other research and teaching institutes. 4. Collaboration with Indian industry to help it meet global challenges. 5. National/International collaborative research. 6. Study of sociological aspects of drug use and abuse and rural pharmacy etc. 7. Running programmes in drug surveillance, community pharmacy and pharmaceutical management.
Infrastructure:
NIPER conducts regular education programmes for academia and industry in various disciplines and helps the Indian Pharmaceutical Industry in solving their R&D related requirements. NIPER has upgraded facilities for achieving the highest level of efficiency in imparting education and events. There are state-of-art classrooms with installation of TV panels and laptop systems. NIPER laboratories are fully equipped with modern equipments that are equivalent to other state-of-the-art laboratories in the world. All the available facilities are of international level and standards. A Technology Development Centre has also been set up. In addition, there has been significant improvement in research infrastructure as several high value sophisticated instruments have been added which has helped in increased thrust in R&D activities.
NIPER has nine Departments and one Centre:

1. Medicinal Chemistry 2. Pharmaceutics 3. Natural Products 4. Pharmacology & Toxicology 5. Pharmaceutical Analysis 6. Biotechnology 7. Pharmaceutical Technology 8. Pharmacy Practice 9. Pharmaceutical Management 10. Pharmacoinformatics
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Central Research Facilities:

Following central facilities provide support to the research groups within the Institute as well as from outside: 1. Central Instrument Laboratory 2. Computer Centre 3. Library and Information Centre 4. Central Animal facility 5. National Toxicology Centre (GLP compliant) 6. Technology Development Centre 7. National Bioavailability Centre (WHO accredited) 8. Impurity Profiling & Stability Testing Laboratory 9. Pharmacological & Toxicological (GLP compliant) Screening Facilities
Seats for admission to P.G. Courses, Ph. D in NIPER, S.A.S. Nagar:

Since 2010, NIPER, S.A.S. Nagar, has increased seats for admission to postgraduate courses and Ph.D. programme Courses Students admitted in year 2010 46 250 61 357 Students admitted in year 2011 34 239 58 331
International collaborations: The Institute entered into several International collaborations and a number of visitors from abroad and within the country visited the Institute, thus highlighting the ever-rising status of the Institute. NIPER started conducting training programs at the newly established Small and Medium Pharmaceuticals Industry Centre (SMPIC) for Small and Medium Pharmaceuticals industry on the aspects of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), Instrumental analysis and manufacturing of APIs and Formulations. The centre will also provide a focal point to industry academia interaction. Round Six of the Indo-Australian Biotechnology Fund, NIPER, S.A.S. Nagar, and Nutritional Physiology Research Centre, University of South Australia, Australia resulted in joint submission of applications to their respective national focal points for a collaborative Workshop under the priority area of Functional Foods and Nutraceuticals.
Recent Developments at NIPER, S.A.S. Nagar (General)

1. The Institute has played mother role to all the new NIPERs started in different parts of the country by helping them in variety of ways including centralized admissions. 2. A Technology Development Centre has been set up in the NIPER, S.A.S. Nagar. 3. The WHO accredited National Bioavailability Centre has been established with support of Deptt. of Science & Technology, Govt. of India, which is one of the two centers of the world to conduct the bioavailability studies for oral fixeddose combination of anti-tubercular drugs. 4. The Institute has also set up the Good Laboratory Practices (GLP) compliant National Toxicology Centre, National Centre of Pharmacoinformatics, National Centre for Safety Pharmacology and Centre for Nanotechnology with the support of Department of Science & Technology (DST) under Pharmaceutical Research & Development Support Fund (PRDSF programme).
PhD. M.S. M.B.A. Total
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In July 2011, 147 Masters students [including M.S. (Pharm.), M. Pharm. and M.Tech. (Pharm.)], 43 M.B.A. (Pharm.) and 24 Ph.D. candidates graduated from the Institute. Academic excellence: A new course leading to M. Pharm. in Clinical Research has been started in 2011 with an initial intake of 9 students. During 2011 (till date), the Institute has published 61 articles in journals of repute. As on date, NIPER has filed 142 patents, out of which 29 patents have been granted. Since the inception of academic programme, 1,262 students have passed out (Masters-897, MBA-247 & Ph.D.-118). Presently, 834 students are studying in NIPER, S.A.S. Nagar.
5. NIPER, S.A.S. Nagar, has now started training programmes for Small and Medium Pharmaceutical industry on the aspects of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), Instrumental analysis and manufacturing of APIs and Formulations. An important aspect of the training programs is the demonstration in the Technology Development Center (TDC), Central Instrument Laboratory (CIL), and Central Animal Facility (CAF), etc. Separate hands-on training modules are available for High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Atomic Absorption Spectroscopy (AAS). 6. NIPER has more than 1400 publications, most of them in reputed, peer-reviewed, international journals. In 2011, NIPER has filed 27 patents and 8 patents have been granted till date. 7. The Plan budget proposal for Rs. 25.58 cr for the year 2011-12 has been submitted to Deptt. of Chemicals & Petrochemicals, Ministry of Chemicals & Fertilizers, Govt. of India out of which Rs. 17.84 cr has already been released. 8. Non-Plan budget proposal of Rs. 34.61 cr has been submitted out of which Rs. 17.30 has already released by the Ministry for meeting the expenses for the first quarter for the year 201112. 9. New projects, worth Rs. 0.78 cr were sanctioned by various funding agencies to NIPER.
the most potent analogues in in vivo evaluation is under progress. Synergistic activity of 3, 3 diindolylmethane and miltefosine was observed at low doses of 3, 3 diindolylmethane. Antagonistic activity at higher doses. The combination groups were found to have higher activity than single doses as well as control groups. Around 78 semisynthetic derivatives based on berberine, curcumin, carboline and tryptanthrin templates have been synthesized and are currently being evaluated for in vitro antileishmanial activity. Using DOS (diversity-oriented synthesis) approach, various small molecules have been designed to target the FtSZ (bacterial cell division protein) and protein synthesis in Mycobacteria. 162 such compounds have been synthesized and evaluated for anti-TB activity at AstraZeneca, Bangalore. Eight compounds have shown promising anti-TB activity (MIC = 16 g/mL).
2. Other diseases
Biological evaluation of the anti isomers formed after aldol reactions of 5-methyl-3-(substituted phenyl)-4-oxo-2-thioxoimidazolidines in PC-3 and LNCaP prostate cancer cells demonstrated inhibition of cell growth. The highly potent compounds demonstrated cytotoxicity better than doxorubicin and flutamide on PC-3 and LNCaP cells, respectively. Screening of 18 compounds from four medicinal plants, viz. Ajuga bracteosa, Dysophylla stellata, Inula cuspidata and Rumex nepalensis for in vitro COX-1, COX-2 and anti-inflammatory activity in vivo showed five compounds to be highly active and provided stellatin as a lead molecule. Semi-synthetic modification of stellatin resulted in 18 compounds of which three exhibited better in vivo anti-inflammatory activity than positive control indomethacin. Neuroprotective effect of GW1929, a PPAR-g agonist in cerebral ischemia/reperfusion
(Research) 1. Neglected diseases

Two of the most active dihydroartemisinin derivatives synthesized in the Institute, which were proven to be strongly more active (blood schizontocidal activity) than artemisinin against P. berghei in mice, are being studied for their toxicity. Derivatives of 8-aminoquinoline have been synthesized which exhibit activity in the range of 15-20 ng/mL against drug-sensitive and resistant strains of malaria parasite. Dose optimization of
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injury induced brain damage and associated neurobehavioral deficits, has been shown. Melatonin and nicotinamide alone as well as in combination were shown to ameliorate the functional deficits along with improvement in pain parameters in diabetic neuropathy. Investigation of insulin treatment under high glucose condition leading to the generation of reactive oxygen species has been shown to alter multiple histone H3 modifications in L6 myoblasts. Genotoxicity testing using different end points (CA, MN, COMET, NRF2, p53, NF-kB, H2AX etc.) has been developed to screen New Chemical Entities (NCEs) as well as for the existing drugs in the market. Direct role of the neurotoxin MPTP in the aggregation of a-synuclein, the protein implicated in Parkinsons disease, has been demonstrated. Some synthetic peptides, derived from full-length apolipoproteins, have been shown to exhibit unique binding specificity towards particular oxidized phospholipid species without binding to normal, non-oxidized phospholipids. This indicates their potential to be developed as drug candidates in cardiovascular and other chronic inflammatory diseases.
Oral bioavailability of poorly water soluble/ poorly permeable drugs (e.g. anticancer drugs like tamoxifen, paclitaxel and doxorubicin; antifungal drugs like amphotericin B and cyclosporine A; antioxidants, etc.) and acid-labile drugs using different types of nano formulations has been carried out.
4. Other areas
3-[5-(4-Fluorophenyl)-5(S)-hydroxypentanoyl]4(S)-4-phenyl-1,3-oxazolidin-2-one, a crucial intermediate for ezetimibe synthesis, was prepared by lipase-mediated transesterification and ester hydrolysis of the corresponding precursors Biocatalytic synthesis of silver and selenium nanoparticles has been carried out for evaluation of antimicrobial and anticancer activities, respectively. Both areas have shown positive results. Overexpression of recombinant proteins in bacterial systems has been achieved without formation of inclusion bodies, resulting in higher yields of functional target proteins. A database of Adverse Drug Reactions (ADRs) spotted in different settings over a long period of time has been developed.
3. Drug development and formulation

LDPE packs have been demonstrated to exhibit higher sorption of preservatives, as compared to polypropylene packs. An excipient has been identified that retarded the loss of parabens in LDPE containers. Novel role of antimicrobial preservatives, viz. benzalkonium chloride, benzyl alcohol and m-cresol, as inhibitors of protein aggregation, has been reported. Biomimetic polymeric particulate scaffolds for tissue engineering have been developed. These have been for osteoblasts for bone tissue engineering.
(Events and Activities)

1. The following awards have been granted to the Institute: a. Thomson Reuters Innovation Award 2011 in PharmaAcademic & Government Institute. b. OPPI Scientist Award in pharmacology and toxicology c. Ranbaxy Science Scholar Pharmaceutical Sciences. Award for
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d. In addition, students have received awards at various national and international symposia, in recognition of the work carried out by them. 2. The following events were conducted by the Institute:
a. National Seminar on Common Technical Document (Jan. 21, 2011) b. Special course on Educational programme for drug regulatory/industry representatives and labs under ITEC programme for participants from Nigeria (Feb. 7-25, 2011) c. 3rd International Symposium on Drug Metabolism and Pharmacokinetics (DMPK) Application towards Drug Discovery and Development (Feb. 11-13, 2011) d. Workshop on Improving Use of Medicines (Feb. 21-23, 2011) NIPER, Mohali
e. 4th Winter School on Nanotechnology in Advance Drug Delivery (Feb. 28-Mar. 4, 2011) f. Visit of a delegation from Nutritional Physiology Research Centre, University of South Australia, to prepare a joint proposal for submission to the IndoAustralian Biotechnology Fund Australia for a collaborative Workshop under the priority area of Functional Foods and Nutraceuticals (Sept. 16, 2011)
g. Fifth Convocation (Oct. 22, 2011)
Inauguration of Academic Session 2011-2012 by Dr. V. M. Katoch, Chairman, BoG, NIPER
Students being awarded degrees during fifth Convocation (Oct. 22, 2011)
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Prof. K. K. Bhutani receiving the Thomson Reuters Innovation Award 2011 in the category of PharmaAcademic & Govt. Institute (Nov. 17, 2011)
Dr. K. B. Tikoo receiving the OPPI Scientist Award (Sept. 27, 2011)
Establishment of New NIPERs:

In terms of the amended National Institute of Pharmaceutical Education and Research (NIPER) Act, 1998, the Government of India has set up six new NIPERs at Hajipur, Hyderabad, Ahmedabad, Rae Bareli, Guwahati and Kolkata. These New NIPERs will cater to the growing demand of the pharmaceutical industry for highly trained man power for continuous growth of the pharmaceuticals sector with increased focus on R&D, particularly after the amendment of Indian Patent Act. At present, new NIPERs are functioning with the assistance of the Mentor Institutes.
Participants in the workshop on Advanced Analytical Techniques, organized under ITEC/SCAAP programme (Oct. 3-14, 2011) S.N. New NIPERs 1. 2. 3. 4. 5. 6. NIPER, Ahmedabad NIPER, Hajipur NIPER, Hyderabad NIPER, Guwahati NIPER, Kolkata NIPER, Rae Bareli Mentor Institute
B.V. Patel Pharmaceutical Education and Research Development (PERD) Centre, Ahmedabad. Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna. Indian Institute of Chemical Technology (IICT), Hyderabad. Guwahati Medical College and Hospital, Guwahati. Indian Institute of Chemical Biology (IICB), Kolkata. Central Drug Research Institute (CDRI), Lucknow. Mohali in association with these new NIPERs. An Apex Committee under the chairmanship of Secretary (Pharma) has been formed to oversee the smooth functioning of new NIPERs till the Board of Governors of each new NIPER is formed. Likewise, State level Coordination Committee under the Chairmanship of an officer of the level of Principal Secretary of the concerned State Government has been formed for each NIPER to oversee the functioning of the new NIPERs.
Starting of Classes at New NIPERs:

Pursuant to the approval of the Cabinet to the setting up of six new NIPERs, classes were started from the academic Session 2007-08 with the help of Mentor Institutes at Ahmedabad, Hyderabad, Kolkata and Hajipur. The classes were started at NIPER, Guwahati and Rae Bareli in 2008-09.
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The students are selected through Common Admission Test conducted by NIPER, SAS Nagar,
MS (Pharma) course: Stream wise details:

SN Name of Existing Disciplines Institute 1 Ahmedabad Natural Products, Pharmaceutics, Biotechnology, Pharmaceutical Analysis, Medicinal Chemistry, Pharmacology and Toxicology. 2 Guwahati Pharmacology & Toxicology, Pharmacy Practice, Biotechnology. 3 Hajipur Biotechnology, Pharmacy Practice, Pharmacoinformatics. 4 Hyderabad Medicinal Chemistry, Pharmaceutical Analysis, Pharmacology & Toxicology, Pharmaceutics. 5 Kolkata Medicinal Chemistry, Natural Products, Phamacoinformatics. 6 Raibareli Medicinal Chemistry, Pharmaceutics.
NIPER JEE Admissioin for 2011 : Category wise detail

Centre Ahmedabad Guwahati Hajipur Hyderabad Kolkata Raibareli SAS Nagar (Science) SAS Nagar (MBA) Genernal 23 (23) 19 (19) 23 (23) 38 (38) 24 (24) 18 (18) 123 (123) 29 (29) OBC 13 (13) 11 (11) 12 (12) 20 (20) 14 (14) 9 (9) 66 (65) 16 (16) PH 1 (1) 1(1) 1 (1) 2 (2) 2 (0) 1 (1) 7 (7) 2 (2) SC 7 (7) 6 (6) 7 (7) 10 (10) 8 (8) 5 (5) 36 (36) 9 (9) ST 4 (3) 3 (1) 3 (0) 5 (5) 4 (1) 3 (1) 18 (13) 4 (2) Total 48 (47) 40 (38) 46 (43) 75 (75) 52 (47) 36 (34) 250 (244) 60 (58) 607 (586)
Note: Actual Intake is bracketed figure.
NIPER, RAE BARELI ACADEMIC ACTIVITIES

NIPER, Raebareli offers P.G. Courses in two disciplines viz. Medicinal Chemistry and Pharmaceutics. It is a matter of great satisfaction and pride that NIPER, Raebareli stepped into fourth academic year. The 4th batch was started on 1st of August 2011 with 17 students in MS (Pharm.) Medicinal Chemistry and 16 in Pharmacetics stream. The 3rd batch students have completed their 1st and 2nd Semester here in Raebareli and are now doing lab work under the able supervision of different scientists of CDRI for the 3rd and 4th semester. The present status is given below. Courses No. of students in Ist Year (2011) 17 16 33 No. of Students in Second year (2011) 15 15 30
on Medicinal Chemistry and Pharmaceutical Sciences was organized during 3 - 5 March, 2011 at CDRI, Lucknow.
Exposure of students to Industry

To provide an industrial exposure to Pharma Industry a visit of students of third semester was organized on 7th July, 2011 to Zydus Research Centre, Ahmedabad. Mr. Anuj Garg, Lecturer in Pharmaceutics, NIPER, Raebareli accompanied the students.
Pharmacy Day
This year Pharmacy Day Rx was successfully organized at NIPER on 24th October 2011, with the support of all the faculty and staff members. The programmes included a scientific session that included a very informative lecture Targeted gene delivery to liver cells using engineered Sendai viral envelopes: A Preclinical Experience by Prof. Debi P. Sarkar, University of Delhi and Role of partition coefficient in drug delivery and discovery by Prof. Ambikanandan Misra, The Maharaja Sayajirao University of Baroda.
M.S. (Med. Chem.) M.S. (Pharmaceutics) Total
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EVENTS AND ACTIVITIES 3rd NIPER (RBL)-CDRI Symposium on Medicinal Chemistry and Pharmaceutical Sciences (3-5 March, 2011)
To enable students in updating their knowledge and awareness about recent scientific developments, a symposium 3rd CDRI-NIPER (RBL) Symposium
Annual Day
NIPER, Raebareli also celebrated its 3nd Annual Day on 14th November, 2011. The Annual Day lecture Art and Science of New Drug Development was delivered by Dr. V. P. Kamboj, Former Director, Central Drug Research Institute, Lucknow. Dr. D. K. Dikshit, Project Director presented the Annual Report and Dr. T. K. Chakraborti, Director addressed
the staff members and students of NIPER and the scientists of CDRI. The function was attended by eminent scientists, technologists and academia of Uttar Pradesh. Students were also given awards for their participation in various extracurricular activities during the year.
selected our students with attractive pay packages. Students have joined various pharma industries and academic institutions after selections through campus interviews.
PUBLICATIONS
The students were inspired for scientific publication and presentation to bring NIPER, Raebareli on scientific research platform which led to publications in reputed journals with inputs from project work and presentation of papers in conferences. A total of 37 publications in research Journal and conferences were carried out.
PLACEMENT
In addition to providing quality education as its priority, NIPER, Raebareli has organised campus interviews for the placement of its students. Renowned industries including Zydus Cadila, Curadev Pharma Pvt. Ltd., Jubilant Chemsys Ltd., Vyome Biosciences etc. came forward for campus recruitment and
Pharmaceutics Lab NIPER Raebareli
Library, NIPER, Raebareli
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Students, NIPER, Raebareli
Annual Day 2011, NIPER, Raebareli disciplines viz. Pharmaceutical Analysis Medicinal Chemistry and Pharmacology & Toxicology. The present status of courses is given below.
NIPER HYDERABAD ACADEMIC ACTIVITIES

NIPER, Hyderabad offers P.G. Courses in three
Courses Pharmaceutical Analysis Pharmacology & Toxicology Medicinal Chemistry Pharmaceutics
No. of students admitted (2010-11) 14 15 30 16
Summer Workshop on Computer Aided Drug Design & Discovery (CAD3), 2011, NIPERHyderabad, 15.4.11 to 17.4.11.
AWARDS AND HONOURS OPPI Young Scientist Award- 2010

Dr. N. Shankaraiah, Assistant Professor, Department of Medicinal Chemistry at National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad received the prestigious Organization of Pharmaceutical Producers of India- Young Scientist Award- 2010 from Shri Prithviraj Chavan Honourable Minister of Science & Technology Govt. of India in Mumbai on 24th September 2010.
EVENTS AND ACTIVITIES

Industrial visit to USP India was organized on 13.1.11. 2011 IPC- USP 10th Science & Standards Symposium was held at ITC Kakatiya Hotel, Hyderabad, 17.2.11 to 18.2.11. MedChem Congress, 2011 Symposium was jointly organized by Royal Society of Chemistry, NIPER-Hyderabad and IICT- Hyderabad, NIPER, Hyderabad, 25.2.11 to 26.2.11. Workshop in Chemistry workshop was jointly organized by Royal Society of Chemistry, Deccan Section, London and NIPER- Hyderabad, 8.4.11 to 9.4.11.
Associate Ship Award

Dr. M.V.N. Kumar Talluri, Lecturer, Department of Pharmaceutical Analysis, NIPER- Hyderabad, Elected as an Associate & Received Associate Ship Award from the Institute of Chemist for the high quality research contributions in the area of Drugs and Pharmaceutical Analysis.
Computer Aided Drug Design & Discovery 2011
Students of NIPER, Hyderabad
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Workshop NIPER, Hyderabad
Students Farewell Celebration
Students interaction with Guest lectures at NIPER, Hyderabad
MEDCHEM Congress 2011
NIPER, KOLKATA
Counseling for admission of students took place in NIPER-Mohali in the month of July, 2011. Details of courses taught and students admitted in 2011-2012 are as follows: Discipline Medicinal Chemistry Natural Products Pharmacoinformatics No. of students 17 16 14
The fourth batch of 49 students has completed
their 2nd semester in June, 2011 and will be completing the third semester in January, 2011. At present they are engaged in their respective project work under the supervision of Faculties/ Scientists of Universities, Research institutes and Industries. Their final examination is scheduled to be held in the month of June, 2012. completing their 1st semester examination in December, 2011.The 2nd semester examination for them is scheduled to be held in May- June, 2012.
The fifth batch of 47 students will be
The orientation programme for the students took place on 1st August, 2011 and the first year first semester classes commenced from 2nd August, 2011.
Placement activities:
Academic Programme
The placement for the first two batches of
Twenty nine Masters Students of the first 60
batch graduated in June, 2009. The first annual convocation of National Institute of Pharmaceutical Education and Research (NIPER), Kolkata was held at 10 AM on Friday the 11th June, 2010. 27 students received their M.S. (Pharm.) degrees. Two students were awarded their degrees in absentia. batch graduated in June, 2010. June, 2011.
students was quite good and most of them have been absorbed in the Industries, Colleges and Research institutes. Placement was achieved for these students according to their options for employment in companies as well as in centres for teaching and higher studies. students have been not up to expectation as only five students got placement through campus interview. Subsequently a number of the students have secured openings in colleges, research institutes and industries.
The placement for the third batch of
Thirty two Masters Students of the second The third batch of 40 students graduated in
The placement activities for the fourth batch

of students have been initiated and on 7 December, 2011 a company has conducted campus interview and the results are awaited.
th
delegates from all over the country participated in the symposium. b) Each second year student is allowed to attend one scientific conference.
Events & activities:

a) A symposium on carbohydrates at the interface of chemistry and biology was jointly organized by NIPER-Kolkata and IICB, the mentor institute, during November 23-25, 2011. Apart from the NIPER-Kolkata students, 300
Games & Sports activities

Facilities have been provided in the Hostel campus for out-door games like Cricket, Badminton and Volleyball and indoor games like carom and chess. The annual sports and games of NIPER-Kolkata are held in January every year.
Library, NIPER, Kolkata
Hostel, NIPER, Kolkata inception, Niper, Hajipur is slowly growing into a truly professional centre of higher learning and research in pharmaceutical sciences.
Departments
From the beginning NIPER, Hajipur has been entrusted with the responsibility of teaching and research in three disciplines: Biotechnology Pharmacy Practice Pharmacoinformatics Outdoor Sports Activities at NIPER, Kolkata
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Intake of students:
Following is position of admission during 2009 to 2012 Year 2009-11 2010-12 2011-13 Admitted 34 42 43 Passed 32 Continuing Continuing Left NIPER 2
NIPER, HAJIPUR
Niper, Hajipur was established under the Act of Parliament in the year 2007 under the mentorship of Rajendra Memorial Research Institute of Medical Sciences (an ICMR institution). Patna. Since its
Examinations
Examinations are being conducted as per the declared academic calendar. No backlog of examination. Students of session 2009-11 has already left after successfully completing the course and almost 80% of them are either employed (academia + industry +administration) or pursuing higher studies.
of Jamia Milia, Prof. R.N. Mishra of BHU,Varanasi, Prof. K. Sairam of IT, BHU Varanasi., Prof. PRP Verma of BIT, Ranchi, Prof. Bishwajit Mukherjee of Kolkata, Pr. Amit Ghosh of NICED visited NIPER, Hajipur and helped us in our education programme by interacting with students.
Guest Lectures
During this period a number of prominent scientists visited Niper, Hajipur and delivered lectures on the various topics of modern pharmaceutical research. Some of the prominent ones were Dr. Ashok Prasad of Delhi University, Dr. Sonal Shruti of Carnegi Melon University of USA, Dr. Shubhadeep Sinha. MD of Vimta Lab. Hyderabad, Prof. S.I. Ahson, Pro VC, Patna University, Dr. Satish Kumar of Munich, Germany, Prof. R.N. Mishra of BHU, Varanasi, Prof. Amit Ghosh, NICED, Kolkata, Dr. Ashish Ganguly of IMTECH, Chandigarh and Dr. Chandan Roy Chaudhary of Bengaluru.
Introduction of Ph. D programme

As per the decision of Department of Pharmaceuticals, GOI, New Delhi that the Ph.D. courses should be introduced in all new NIPERS from the session 2011 onward, Niper, Hajjipur has successful initiated the Ph.D. programme in subjects like pharma biotechnology and pharmacoinformatics from the academic session of 2011-12 itself. Altogether five students (3 in Biotechnology and 2 in Pharmacoinformatics) have been admitted in Ph. D programme. They have been assigned to experts and the required course work for these programmes have been initiated and is in progress.
Infra-structure
Being in its infancy, infra structure is being developed a little slowely due to some unavoidable factors. Currently Niper, Hajipur has four well appointed class rooms accommodating a maximum of sixty students, a fully air conditioned seminar cum examination hall having a capacity of 200 persons, a fully airconditioned and networked computer lab, a well equipped wet lab for biotechnology, an air conditioned well stocked library with net connectivity and facilities for indoor as well as outdoor games.
Foundation Day Celebration

NIPER, Hajipur celebrated its 4th and 5th Foundation Day. A number of scientific and cultural events were organized. Padma Bhushan Dr. Nirmal Kumar Ganguly, former DG, ICMR and currently the Chairman of JIPMER, Pondicherry delivered the 5th foundation Day Oration Lecture on the Role of Modern Technologies in Eradication of Leishmaniasis (Kalazar). This function was inaugurated by Sri P. K. Shahi, Honble Minister, Human Resource Development, Bihar. The function was presided over by Sri Devendra Choudhary, IAS, sr. joint secretary, DOP, GOI. A lively cultural programme was also presented on the occasion by the students of NIPER, Hajipur. A sports week was also organized on the occasion and the winners of different events were awarded prizes and certificates.
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New Soft-ware and Equipments

During the period, NIPER, Hajipur has procured new Soft-wares like SPSS, Micromedix and Schordinger suite. These soft-wares are internationally approved and helping our students in gaining experience of international bioinformatics platform. Some costly equipments like Nano Drop and HPLC have also been added to our wet lab.
Guest Faculty
A number of eminent academic personalities like Prof. S.P.gupta of MIT, Muzaffarnagar, Dr. Imtiyaz Hassan
Academics
The teaching and examinations are being held as per the academic calendar of Niper, Hajipur. Our
faculty members also performed creditably during the period as they participated in a number of seminars representing NIPER, Hajipur. Our students also participated in many workshops and two of our students also won the prizes at national level.
Shri Prashant Kumar Sahi, Honble Minister Education, Bihar being felicitated Discipline Prof. Nirmal Kumar Ganguly on foundation day ceremony 2011 at NIPER, Hajipur Natural Products Pharmaceutics Biotechnology Pharmaceutical Analysis Medicinal Chemistry Pharmacology and Toxicology Total No. of Students admitted (2011-12) 09 12 10 06 05 05 47 (2010-11) 15 17 12 06 03 05 58
Teaching schedule for the Academic Year 2011-12 1st Semester

Teaching started with the orientation week on the 4th week of July 2011. Regular teaching schedule followed the week after. Four seminars were scheduled for the First semester students. The Mid-term exams were scheduled from 10th to 19th October 2011 and the Final Exams are scheduled in December 2011.
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Invocation by the Students of NIPER Hajipur
NIPER, AHMEDABAD ACADEMIC ACTIVITIES

Admission of Students in 2011-2012: NIPER Ahmedabad stepped into fifth academic year from July 2011. In the fifth academic year, 47 students were admitted to six streams.
3rd Semester
Third Semester started form the third week of July 2011. The students submitted their Project proposals in the First week of August 2011 followed by the
Project Proposal Defense. The Project Progress Evaluation is scheduled in December 2011.
NIPER-PH. D. Program
NIPER-Ph. D. program has been started at NIPERAhmedabad during the academic year 2011-2012. Six Ph. D. fellows were enrolled on the basis of common NIPER-Ph. D. entrance test. Three Ph. D. fellows were taken up in the Natural products stream and three Ph. D. were recruited in the Biotechnology. The fellows have been assigned their Ph.D. mentors and are pursuing their doctoral degree.
the faculty members as well as the students of NIPER-A) has been created which is responsible for publishing a placement brochure and sending it to various Pharma companies. An Industry Academia meet is also organized at NIPER-Ahmedabad as a part of the placement activity. Distinguished personalities from various Pharma companies including HR people attend the function. Various companies have been visiting our organization for Campus Interviews. About 80 % of the students have been placed from the third that recently passed out in June 2011.
Industrial Visit to Vasu Health Care Pvt. Ltd., Baroda

Natural Products department planned one day visit in Vasu Healthcare for growing up their knowledge in various departments. Students were introduced to Vasu Healthcare and Vasu Research Centre through a corporate video followed by a visit to various departments. Finally, an interactive session was organized with eminent scientists of the company with the students.
List of Companies who recruited NIPER-A Students

Sun pharma, Baroda Intas Biopharmaceuticals, Ahmedabad Matrix Labs, Hyderabad Alembic Labs, Baroda Eris Lifesciences Ahmedabad Biocon Ltd, Bangalore Piramal Pharamceutical Development Services Private Ltd, Ahmedabad Troika Labs, Ahmedabad Cadilla Pharma, Ahmedabad Zydus Cadilla, Ahmedabad INDOCO Research Centre, Mumbai Jindal Drugs Pvt. Ltd. Mumbai Oxygen Health Care, Ahmedabad Piramal Life Sciences, Mumbai Private Limited,
CONFERENCE/WORKSHOPS ORGANIZED
1. 4th Indo-Australian Conference on Innovations in Biomaterials, Tissue Engineering and Drug Delivery Systems, Organized at Sardar Patel University, Vallabh Vidyanagar, Gujarat, from February 10 February 12, 2011. 2. Mammalian Cell Culture: Hands-On Training Programme, Organized at B. V. Patel PERD Centre, from June 27 June 2, 2011 3. Molecular Biology: A Laboratory Training Course, Organized at B. V. Patel PERD Centre, from July 11 July 15, 2011
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PLACEMENT ACTIVITIES
To provide placement to student at reputed Pharma companies, a placement Cell (including
PROJECT ON TUBERCULOSIS
Development and Clinical Evaluation of Novel fixed dose combination of Rifampicin and Isoniazid to improve Bioavailability of Rifampicin for the
treatment of Tuberculosis in collaboration with AIIMS- New Delhi. Clinical Trials are going on at AIIMS with 50 TB Patients.
reduce the treatment duration from 6-9 months to 3-4 months.
HONOURS/AWARDS First Prize:

Kalavadia Samir, Patel Sandip, Pathak Rudree. Nanodisks: Redefining drug delivery targeting. A Model presented at MYRIAD The Cluster of Events (Nanotechnology based Drug Designing). Organized by Institute of Research and Development, Gujarat Forensic Science University, Gandhinagar on 14 November 2011. First Prize Special Award by Royal Society of Chemistry-Process Technology Group (RSC-PTG, London) in Process Chemistry Hitesh B. Jalani, Amit N. Pandya, Arshi B. Baraiya, Brianna Jill Williams, V. Sudarsanam, Kamala K. Vasu. Synthesis of quinazolinon-2yl-tetrasubstituted thiophenes as modulator of NFkB and AP-1 transcription factor. Presented at 15th ISCB International Conference, Rajkot, Gujarat, 4th -7th February 2011.
Objectives of the Project:

To compare the safety and efficacy of Novel FDC of Rifampicin and Isoniazid developed at NIPER, Ahmedabad against Conventional FDC of Rifampicin and Isoniazid which are available in the market in pulmonary tuberculosis patients. Pharmacokinetics study to analyze the levels of rifampicin from novel FDC and market FDC in pulmonary tuberculosis patients enrolled in the study. To check and record the cases for the relapse of TB. To check the potentially of novel FDC to
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Experimental Session at NIPER, Gandhinagar
Workshop on Mammalian Cell Culture
Sports activity NIPER, Gandhinagar
Students of NIPER, Gandhinagar Presenting Model 1) Pharmacology & Toxicology 2) Pharmacy Practice. 3) Biotechnology 4) Ph.D (Pharmacology & Toxicology) -- -- -- -- 20 09 09 04
NIPER, GUWAHATI Academic Programme:

NIPER, Guwahati started functioning from the academic year 2008-09 with the help of Guwahati Medical College and Hospital as its Mentor Institute. It is providing PG education in the following three disciplines: 1) Pharmacology & Toxicology. 2) Pharmacy Practice. 3) Biotechnology. NIPER, Guwahati is also imparting Ph D in Pharmacology and Toxicology. The student strength in the Institute in respect of the 2011-13 batch is as follows:
EVENTS AND PLACEMENTS

Annual Day was celebrated on 16th September. Campus Recruitment was attended by BIOCON from Bangalore on 19th May, 2011. The following candidates were selected 1. Arvind Kataria. 2. Ambrish Singh. 3. Srinivas Rao M. 4. Rajkumar Johny Singh.
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Chapter
New Initiatives
CHAPTER 7 NEW INITATIVES

Setting up Good Laboratory Practices (GLP) Compliant Chemical, Biological Laboratories and Large Animal House
The Department plans to set up Good Laboratory Practices (GLP) Compliant Chemical, Biological Laboratories and Large Animal House in PPP Mode. Though with the approval of Planning Commission, the applications were invited for setting up these facilities in PPP Mode, yet these could not be sanctioned finally due to technical problems. Despite repeated advertisements and extensions of time for submission of proposals, adequate number of proposals for consultancy of the project was not received. Another attempt is being made to elicit adequate number of proposals. evaluation of novel fixed dose combination of Rifampicin and isoniazid designed to improve stability and bioavailability of Rifampicin for the treatment of tuberculosis. The project is in collaboration with All India Institute of Medical Sciences (AIIMS), New Delhi. The project is presently under implementation.
National Centre for Research & Development in Drugs at NIPER, Hyderabad

It is proposed to set up a National Centre for R&D in bulk drugs at Hyderabad NIPER. The Centre would aim at development of technologies and process for cost competiveness, environmental impact management, risk management and development of safety in manufacturing operations, knowledge transfer platform between industry and academia. The research avenues for bulk drugs are: Drugs process innovation, Drug discovery and development, Analytical chemistry, Process engineering, cleaner technology, Polymorphism, Nanotechnology etc. The proposal is being processed.
Collaborative TB Research Project Proposal of NIPER, Ahmedabad

The Department has sanctioned the project for collaborative TB Research at NIPER Ahmedabad. The project aims at Development and Clinical
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Chapter
Implementation of Rajbhasha
CHAPTER 8 Implementation of Rajbhasha

Use of Hindi in Official work
All out efforts were made for implementation of the various provisions of the Official Language Policy of the Union of India including those of Official Language Act, 1963 as well as of Official Languages (Use for Official Purposes of the Union) Rules, 1976. All the documents mentioned in Sub Section (3) of Section 3 of the Official Languages Act, 1963 were issued bilingually i.e. in Hindi as well as in English. Letters received in Hindi and representations etc. signed in Hindi were replied to in Hindi as per provisions of the rule 5 and Rule 7 (2) of the Official Languages (Use for Official Purposes of the Union) Rules, 1976 (as amended in 1987).
Hindi Prayog Protsahan Pakhwara

Hindi Prayog Protsahan Pakhwara was observed in the Department during 14th to 29th September 2011 with the objective to encourage the officers and members of the staff of the Department to progressively increase the use of Hindi in their official work. In addition to various Hindi competitions held during the Pakhwara Hindi Vyavhar Pratiyogita was organized and winners were awarded with cash prizes. As a part of the Pakhwara three Hindi workshops on different topics were also organized to train the personnel of the Department and also remove their hesitation to work in Hindi. Third Committee of Committee of Parliament on Official Language inspected National Pharmaceutical Pricing Authority, an attached office under the control of the Department on 5-5-2011. Based on the deliberations in the inspection meeting suitable instructions were issued to NPPA for improving the use of Hindi in their official work. The first meeting of the reconstituted Hindi Advisory Committee of the Ministry of Chemicals and Fertilizers held on 10-10-2011 in Port Blair was attended by the Department at Joint Secretary level and almost all the Heads of the PSUs under the Department were present in the meeting.
Official Language Implementation Committee

Department is having Official Language Implementation Committee working under the Chairmanship of the Joint Secretary to periodically review the progressive use of Hindi in the official work and suggest the suitable measures to increase the use of Hindi in the official work. Its meetings were held on regular intervals and implementation status of the various targets set in the Annual Programme for transaction of the official work of the Union in Hindi for the year 2011-12 issued by the Department of Official Language, Ministry of Home Affairs was reviewed.
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Chapter
General Administration 9.1 Organisation Set Up 9.2 Record Management 9.3 Grievance Cell
CHAPTER 9 General Administration

9.1 ORGANISATION SET UP OF THE DEPARTMENT
The main activities of the Department are policy making, sectoral planning promotion and Development of Pharmaceutical industries. The administrative and managerial control of the public sector undertakings engaged in the manufacture of various, pharmaceutical items and some other organization is a major function of the Department. 2. The Department is headed by Secretary to the Government of India who is assisted by two Joint Secretaries, one Economic Adviser and one Deputy Director General. 3. There is an attached office namely National Pharmaceutical Pricing Authority which looks Group A B C D Total Total No. Of Posts 21 35 6 14 76 Scheduled Castes 3 7 1 6 17 after Price fixation/revision of pharmaceuticals and other related matters. It also monitors the prices of decontrolled drugs and formulation and oversees the implementation of the provisions of the Drug (Price Control) Order. In addition, there are 7 public sector undertaking and 1 other organization under the administrative control of the Department. The names of these are given in Annexure III. EMPLOYMENT OF SCHEDULED CASTES / SCHEDULED TRIBES / PHYSICALLY HANDICAPPED IN THE MAIN SCERETARIAT OF THE DEPARTMENT OF PHARMACEUTICALS The status of employment of Scheduled Castes / Scheduled / Tribes / Physically handicapped in the main Secretariat of the Department of Pharmaceuticals, as on 14.03.2012 is as under: Other Backward Castes 2 3 1 6 Physically Handicapped 2 2
Scheduled Tribes 3 3
4. Officers in Group A include officers belonging to Central Secretariat Service besides officers on deputation from All India Services, Central Services and other Departments/ Undertakings. Appointment to posts in Group B and C is mostly done on the basis of nominations made by the Department of Personnel & Training.
5. The Department also monitors the progress of filling up of the posts reserved for the members of Scheduled Castes, Scheduled Tribes and other Backward Classes in the Public Sector Undertaking under the administration control of the Department.
LIST OF PERSONNEL IN THE DEPARTMENT OF PHARMACEUTICALS

Sl. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. Name Shri D.S. Kalha Dr Raja Sekhar Vundru Shri A.N. Bhattacharya Shri Binay Kumar Singh Shri S.C. Sharma Ms. Monika Verma Shri Ravinder Mathur Shri Rakesh Kumar Maggo Shri M.L.Sidana Designation Secretary Joint Secretary Economic Advisor Director Director Director Director (Cost) Deputy Secretary Deputy Secretary
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Sl. No. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29.
Name Shri S.D. Maurya Shri A.K. Karn Shri Ram Chander Shri Roshan Lal Shri A.K. Sah Shri Seeta Ram Meena Shri Anil Jain Shri Raj Kumar Shri V.K. Tyagi Shri Brij Lal Sharma Shri R. K. Ahlawat Shri M.R. Sankla Shri Shah Faiz Ahmed Shri Sanjay Gupta Shri P.K. Singh Smt. Veena Smt Seema Agrawall Shri T.K. Munshi Shri N.N. Ahuja Smt. Bhuwaneshwari Chauhan
Designation Joint Director (Cost) Under Secretary Under Secretary Under Secretary Under Secretary Under Secretary Under Secretary Under Secretary Deputy industrial Advisor Assistant Director (OL) Section Officer Section Officer Section Officer Section Officer Section Officer Section Officer Section Officer Section Officer Section Officer Section Officer
ORGANISATIONAL CHART OF DEPARTMENT OF PHARMACEUTICALS
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* As one post of Joint Secretary is vacant, all the works in the Department at present is being looked after by Dr. Raja Sekhar Vundru, Joint Secretary.
9.2 Record Management

The Parliament had enacted The Public Records Act 1993 to regulate the management, administration and Preservation of Public Records of the Central Government, Union Territory Administrations, Public Sector Undertakings, statutory bodies and corporations etc. The Central Government has also made the rules to carry out the provisions of the Act. In terms of the provisions and terms contained in Section 5(1) of the Act, the Under Secretary Incharge of General Administration has been nominated as Records Officer in the Department. The requisite reports and returns are being sent to National Archives of India (NAI) regularly.
Publicity about the setting up of this Grievances Cell was given through the National daily newspapers of Hindi, English and Regional Languages. The on line Grievance Redressel Mechanism, Public Grievances Redressal and Monitoring System (PGRAMS) has been brought into operation w.e.f. 1st August, 2005. Recently an online Centralized Public Grievance Redressal and Monitoring System (CPGRAMS) has also been introduced by Department of Administrative Reforms and Public Grievances (DARPG). For giving wide publicity to the Grievance Cell, information has been uploaded on the websites of Department of Pharmaceuticals and also on the websites of the Institutions/Organizations falling under their purview. Links are given with the home pages of Department of Chemicals and Petrochemicals and Department of Pharmaceuticals to access CPGRAMS with the websites of the Institutions/Organizations under Department of Chemicals & Petrochemicals and Department of Pharmaceuticals. Grievance Cell plays a vital role in the redressal of grievances of common man.
9.3 Grievances Cell.

The Grievance Cell is monitoring grievances related to all Pharmaceuticals viz. their availability, quality, pricing, policy matters etc. One of the main objectives for opening of this cell was to make available medicines to common man at affordable prices.
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Chapter
10
Performance Evaluation and Management System 10.1 Our Vision 10.2 Our Mission 10.3 Our Objective 10.4 Functions
CHAPTER 10 PERFORMANCE EVALUATION AND MANAGEMENT SYSTEM

The Department of Pharmaceuticals has developed its Result Framework Document for the year 2011-2012 on the basis of the guidelines of Cabinet Secretariat and as revised from time to time. Based on the mandate given to the Department of Pharmaceuticals through the allocated functions a Vision, Mission, Objectives and Functions have been fixed in concurrence with the Cabinet Secretariat. 4. Ensure proper management of M Pharma and PhD programs in NIPERs 5. Develop Human Resources, Infrastructure for Pharma R&D and Industry including PublicPrivate-Partnerships (PPP) 6. Formulate Scheme/ Project for promoting Pharma Brand India 7. Formulate Scheme/ Project for promoting environmentally sustainable development of Pharmaceutical Industry 8. Formulation of Annual Plan, Budget Monitoring of Budget Expenditure and
10.1

Our Vision:
India: The largest global provider of quality medicines at reasonable prices.
10.2

Our Mission:
Ensure availability of drugs at reasonable prices as per provisions of the Drug Prices Control Order 1995 Develop Human Resources for Pharmaceutical Industry and Drug Research and Development Formulate Scheme/ Project for promoting Public-Private Partnership for development of pharmaceuticals Industry Formulate Scheme/ Project for promoting Pharma Brand India through International Cooperation Formulate Scheme/ Project for promoting environmentally sustainable development of Pharmaceutical Industry
9. Start preparation of Strategy Paper for the Department
10.4
Functions:
The Functions of the Department of Pharmaceuticals arise from the following work allocated to it as per The Allocation of Business Rules, 1961 vide Notification of Cabinet Secretariat dated 1st July 2008: 1) Drugs and Pharmaceuticals, excluding those specifically allotted to other departments. 2) Promotion and co-ordination of basic, applied and other research in areas related to the Pharmaceuticals sector. 3) Development of infrastructure, manpower and skills for the Pharmaceuticals sector and management of related information. 4) Education and training including high end research and grant of fellowships in India and abroad, exchange of information and technical guidance on all matters relating to pharmaceutical sector. 5) Promotion of public private partnership in pharmaceutical related areas. 6) International cooperation in pharmaceutical research, including work related to international conferences in related areas in India and abroad. 7) Inter-sectoral coordination including coordination between organizations and institutes under the
10.3
Our Objectives:
The objectives are based on the functions allocated to the Department as per The Allocation of Business Rules, 1961 vide Notification of Cabinet Secretariat dated 1st July 2008: 1. Ensure availability of drugs at reasonable prices as per provisions of the Drug Prices Control Order 1995 2. Ensure proper functioning of the Central Pharma Undertakings in control of the Department. 3. Project Based Support and Revival Schemes for CPSUs
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Central and State Governments in areas related to the subjects entrusted to the Department. 8) Technical support for dealing with national hazards in pharmaceutical sector. 9) All matters relating to National Pharmaceuticals Pricing Authority including related functions of price control/monitoring. 10) All matters relating to National Institutes for Pharmaceutical Education and Research.
11) Planning, development and control of; and assistance to, all industries dealt with by the Department. 12) Bengal Chemicals and Pharmaceuticals Limited. 13) Hindustan Antibiotics Limited. 14) Indian Drugs and Pharmaceuticals Limited. 15) Karnataka Limited. Antibiotics and Pharmaceuticals
16) Rajasthan Drugs and Pharmaceuticals Limited
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Chapter
Citizen Centric Governance 11.1 Our Vision 11.2 Our Mission 11.3 Our Clients 11.4 Our Commitment 11.5 Our Services 11.6 Our Activities 11.7 RTI-2005 11.8 CPGRAMS
11
CHAPTER 11 Citizen Centric Governance

Based on the mandate given to the Department of Pharmaceuticals through the allocated functions a vision has been fixed in concurrence with the Cabinet Secretariat, which is as follows: India: The largest global provider of quality medicines at reasonable prices. Our commitment is to formulate policies and initiate consulations with all Industry Associations/stakeholders and to amend them whenever so required.
11.5 Our Services

We formulate and implement policies relating to drugs and pharmaceuticals, dyestuff and dye intermediates.
11.2

Our Mission:
Ensure availability of drugs at reasonable prices as per provisions of the Drug Prices Control Order 1995 Develop Human Resources for Pharmaceutical Industry and Drug Research and Development Formulate Scheme/ Project for promoting Public-Private Partnership for development of pharmaceuticals Industry Formulate Scheme/ Project for promoting Pharma Brand India through International Cooperation Formulate Scheme/ Project for promoting environmentally sustainable development of Pharmaceutical Industry
11.6 Our Activities

The key activities of the Department focus on:
1. Ensure availability of drugs at reasonable prices

as per provisions of the Drug Prices Control Order 1995 2. Ensure proper functioning of the Central Pharma Undertakings in control of the Department. 3. Project Based Support and Revival Schemes for CPSUs 4. Ensure proper management of M Pharma and PhD programs in NIPERs 5. Develop Human Resources, Infrastructure for Pharma R&D and Industry including PublicPrivate-Partnerships (PPP) 6. Formulate Scheme/ Project for promoting Pharma Brand India 7. Formulate Scheme/ Project for promoting environmentally sustainable development of Pharmaceutical Industry 8. Formulation of Annual Plan, Budget Monitoring of Budget Expenditure and
11.3

Our Clients
Consumers and users of the products and by-products of the Pharma Industry Entrepreneurs of pharmaceuticals sectors Industry Associations Central government ministries/departments/ organizations
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11.4 Our Commitment

We are committed to provide impartial, sympathetic and prompt services to the public in matters relating to the pharmaceuticals industries. Our commitment is to take prompt steps to provide quick redressal of the grievances of our personnel and public at large.
The Citizen Charter of the Department has been placed on the website of the Department.
11.7
Right to Information Act 2005
As per the provisions of the RTI Act 2005, All the relevant information relating to Department of Pharmaceuticals has been available on the web site in a manner, which is easily accessible and comprehensible to the public.
Central Public Information Officers have been nominated in the department to provide information to the public.
11.8 CPGRAMS (Centralized Public Grievances and Monitoring System)
A portal of CPGRAMS has been uploaded on the website of the Department. Public Grievances received on CPGRAMS are monitor and disposed regularly. Name of Public Grievances Officer is Sh. M L Sidana, Deputy Secretary.
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Chapter
Information and Technology 12.1 Local Area Network (LAN) 12.2 IT Infrastructure 12.3 Website 12.4 Video Conferencing 12.5 File Tracking System 12.6 Voice Mail Facility 12.7 E. Governance
12
CHAPTER 12 Information and Technology

Ever since internet made its entry into the world of Information and Communication Technologies (ICT), the concept of good governance has assumed a whole new dimension coupled with an increased awareness and desire amongst citizens and other stake holders to have a much more enriching and convenient interaction with the rules, policies and their implementations by the Government. Taking advantage of latest information technology enabled tools, Department of Pharmaceuticals has taken sincere initiatives towards adoption of best practices and integrated delivery of useful information not only to improve administrative operations but also to enhance the efficiency of Department. Simplify dissemination of information to public and make it interactive. Train all personnel in making most of this technology.
12.3
Website:
12.1
Local Area Network (LAN):
A local Area Network (LAN) is functioning in the Department inter-connecting all the Windows based computers of officers, personal staff and sections. All computers are equipped with the facility of Internet and easy accessibility of applications from the server. An IT based Computer Centre, set up by National Informatics Centre (NIC) is operational in the Department and is equipped with latest Servers, Client machines for providing Internet and E-mail facilities for local and global connectivity. LAN of Department is being upgraded as per IPv6 guidelines.
As Website is an electronic medium to provide information and enhance government citizen interaction, a Web Site in English and in Hindi has been launched by the Department (http:// pharmaceuticals.gov.in) and is hosted at NIC to ensure maximum reach of information and services to the citizens. It provides details of organizational set up of the department, its functions, subordinate offices, policies, publications, statistical data/information on functional parameters. Another website for Jan Aushadhi Scheme of the Department is also launched (http://janaushadhi.gov.in). It provides details of the scheme, list of generic medicines (unbranded) which are being dispensed through the Jan Aushadhi Stores (JAS) being setup in various districts of India. It facilitates the visitors to know the locations of the JAS already opened. It also provides comparative prices of Generic Medicines sold at Jan Aushadhi Stores and Branded Products.
12.4
Video Conferencing:
12.2
IT Infrastructure:
Department of Pharmaceuticals in close association with NIC has focused on building up the IT infrastructure within the Ministry with the following objectives: Improve workflow, work management and monitoring. Assist in analyzing, decision making and scheduling through Management Information Systems (MIS). Storage of data, analysis and handling of databases. Provide Graphical User Interface (GUI) based environment. LAN for sharing the resources among users.
Video Conferencing facility is operational for Joint Secretary and above level Officers. PSUs of the department and Educational Institutes (NIPERs) have also initiated installation of the Video Conferencing facility. With the facility already implemented at a few of the PSUs and NIPERs, Department is able to interact with them frequently to monitor their performance and communicate the decisions.
91
12.5
File Tracking System:
Department has implemented a web based File Tracking system (FTS) to keep record of its receipts being received at various locations in the department and to maintain a consistent watch over the movement of various important Files and Receipts at different levels in the process of decision-making. The system is used as a tool to curb down pendency at all levels in the Department.
12.6
Voice Mail Facility:

implemented. Intra portal for Department of Pharma:- An intranet portal Intrapharma with electronic Notice Board is available to officials of the Department for ready reference of various circulars, office orders, letters etc. It is also a gateway of application like digital library for Parliament Questions and presentation material etc. Centralized Public Grievance Redress Monitoring System (CPGRAMS): CPGRAMS is implemented in the Department and all the attached office to address Public grievances received online with minimum delay. Other e-Governance applications like RTI Request & Appeal Management Information System, Composite Payroll System (Comp DDO), Result Framework Management System are functional in the Department to facilitate various sections.
Voice Mail facility is successfully implemented in the Dept. through the landline telephone system at all levels to ensure high availability, enhance accountability and efficiency of the officials of the department at work.
12.7
E. Governance:

Taking advantage of latest ICT enabled tools, Department of Pharmaceuticals with the support of NIC has taken sincere initiatives towards adoption of best practices. Various applications have been developed and implemented by NIC to strengthen, monitor and decision making and high availability of right information at right time. Activity Monitoring System- A web based MIS has been developed and implemented to monitor time bound important activities and tasks assigned to officials/sections of Department. Project Implementation Monitoring SystemTo monitor the status of progress in projects being implemented by PSUs under the Department, Web based online monitoring system MIS has been developed and
To enhance e-Governance further various applications in various domains such as G2C, G2B, G2G & G2E have been envisaged to be developed & implemented with assistance of NIC.
92
Chapter
Annexure Annexure I Annexure II Annexure III Annexure - IV
13
Annexure I
(Ref: Chapter 4) DATA OF PRODUCTION OF SELECTED BULK DRUGS ON THE PRODUCTION RETURN RECEIVED FROM CAMPANIES FOR THE YEAR 2008-09, 2009-10, 2010-11, 2011-12 (PROVISINAL) S.No I 1 2 II 3 4 5 6 7 8 9 10 III 11 12 13 14 15 IV 16 17 18 19 20 21 22 23 24 25 26 27 Name of the Therapeutic Group and Bulk Drugs ANAESTHETICS Lignocaine / Xylocaine / Lidocaine Procaine ANALGESICS & ANTIPYRETICE Analgin / Metamizole (s) Aspirins (s) Ibuprofen (s) Oxyphenylbutazone Paracetamol Pethidine Phenylbutazone Piroxicam ANTI-ASTHAMATICS Aminophylline (s) Ephedrine (s) Salbutamol (s) Terbutaline Theophylline (s) ANTI-BIOTICS Amoxycilline Ampicilline Cephalexin Chloramphenicol Palmitate Chloramphenicol Powder Cloxacillin (s) Doxycycline (s) Erythromycin (s) Framycetin (s) Gentamycin (s) Griseofulvin (s) Oxytetracycline (s) MT MT MT MT MT MT MT MT 176.653 1095.224 N.A. N.A 13421.549 N.A 32.950 N.A 186.708 1018.737 4687.000 N.A 11209.612 N.A 42.242 N.A 243.757 1151.436 4822.000 N.A 13669.802 N.A 33.255 N.A 98.042 696.879 0.000 N.A 4028.000 N.A 0.000 N.A Unit 2008-09 2009-10 2010-11 2011-12 till sept (prov.) 36.150 N.A.
MT MT
72.253 N.A.
85.760 N.A.
106.750 N.A.
MT MT MT MT MT
2.075 883.515 5.056 1.064 69.182
5.445 413.716 7.115 0.576 80.980
8.035 472.803 9.543 0.602 N.A
2.775 180.033 3.902 0.343 N.A
MT MT MT MT MT MT MT MT MT MT MT MT
1402.152 77.530 1129.036 38.900 34.717 20.370 0.500 620.430 N.A. N.A. N.A. N.A.
1545.670 90.260 1088.787 42.943 24.554 29.920 1.929 480.457 N.A N.A N.A N.A
1219.608 64.410 1259.667 34.509 31.113 3.000 6.248 492.853 N.A N.A N.A N.A
556.351 43.910 559.935 7.167 12.491 5.090 3.276 277.272 N.A N.A N.A N.A
95
S.No 28
Name of the Therapeutic Group and Bulk Drugs Penicillin (s) a. Penicillin G 1st Crystal b. Penicillin G Procaine c. Penicillin G Sodium d. Penicillin G Benzathine
Unit
2008-09
2009-10
2010-11
2011-12 till sept (prov.) 876.043 N.A. N.A. N.A 131.725 N.A. N.A.
MMU MMU MMU MMU MT MT MT
1831.415 N.A. N.A. 6.790 343.126 N.A. N.A.
1789.000 N.A. N.A. 4.170 369.735 N.A. N.A.
2000.000 N.A. N.A. 0.000 407.714 N.A. N.A.
29 30 31 V 32 33 34 35 VI 36 37 38 39 VII 40
Rifampicin (s) Streptomycin (s) Tetracycline (s) ANTI-DIABETICS Chlorpropamide (s) Glibenclamide Insulin (s) Tolbutamide ANTI-DYSENTRY DRUGS Diloxanide Furoate Iodo Chloro Hydroxy Quinoline (s) Metronidazole (s) Tinidazole ANTI-FILARIALS Diethyl Carbamazine (DEC Citrate) ANTI-HELMENTICS Mebandazole Piperazine and Salts Pyrantel Pamoate (s) Tetramisole / Levamisole ANTI-HISTAMINS Diphenhydramine Pheniramine Maleate (s) ANTI-LEPROTICS Clofuzamine Dapsone
MT MT KG MT
25.700 3.989 N.A. 18.850
4.100 2.421 N.A. 44.800
8.525 1.686 N.A. 52.135
2.200 0.968 N.A. 45.900
MT MT MT MT
N.A 138.254 393.353 N.A
48.750 185.427 374.122 76.501
38.647 220.242 326.094 73.500
33.804 69.414 42.316 23.000
MT
20.125
24.800
9.015
11.655
96
VIII 41 42 43 44 IX 45 46 X 47 48
MT MT MT MT
N.A N.A N.A N.A
N.A N.A N.A N.A
N.A N.A N.A N.A
N.A N.A N.A N.A
MT MT
37.218 56.360
52.415 35.429
51.946 53.430
35.640 27.808
MT MT
N.A N.A
N.A N.A
N.A N.A
N.A N.A
S.No
Name of the Therapeutic Group and Bulk Drugs ANTI-MALARIALS Amodiaquin (s) Chloroquine (s) ANTI-T.B. DRUGS Ethambutol INH Pas & its Salts Pyrazinamide Thiacetazone CARDIOVASCULAR DRUGS Digoxin Methyl Dopa (s) Propranolol Xanthinol Nicotinate CNS STIMULANTS Caffeine Nikethamide CORTICOSTEROIDS Betamethasone (s) Dexamethasone (s) Hydrocortisone Prednisolone (s) DIURETICS Acetazolamide Frusemide (s) Hydrochlorothiazide Spironolactone GASTRO INTESTINAL Ranitidine (s)
Unit
2008-09
2009-10
2010-11
2011-12 till sept (prov.)
XI 49 50 XII 51 52 53 54 55 XIII 56 57 58 59 XIV 60 61 XV 62 63 64 65 XVI 66 67 68 69 XVII 70
MT MT
3.200 84.814
17.400 168.194
0.587 119.888
2.387 32.995
MT MT MT MT MT
851.423 N.A 21.680 260.160 0.000
931.401 N.A 37.687 299.186 N.A
935.192 N.A 51.578 339.248 N.A
473.031 97.500 140.074 N.A
MT MT MT MT
N.A N.A N.A N.A
N.A N.A N.A N.A
N.A N.A N.A N.A
N.A N.A N.A N.A
MT MT
N.A N.A
N.A N.A
N.A N.A
N.A N.A
MT MT MT MT
4.823 N.A N.A N.A
5.101 N.A N.A N.A
4.886 N.A N.A N.A
2.583 N.A N.A N.A
97
MT MT MT MT
N.A N.A 51.134 2.558
N.A N.A 44.564 3.550
N.A 2.433 65.723 2.246
N.A 4.086 13.967 1.584
MT
1132.391
1254.709
1686.114
651.122
S.No
Name of the Therapeutic Group and Bulk Drugs OTHER ANTI-BACTERIALS Nalidixic Acid (s) Trimethoprim (s) Sulpha Drugs Sulphacetamide Sulphadiazine (s) Sulphadimidine (s) Sulphaguanidine Sulphamethoxazole (s) Sulphamoxole (s) Sulphaphenazole Sulphasomidine TRANQUILIZERS & SEDATIVES Diazepam Imipramine Nitrazepam Phenobarbitone Trifluperazine VITAMINS Folic Acid Nicotinamide Niacotinic Acid Vitamin A (s) Vitamin A (s) Vitamin B1 / Thiamine(s) Vitamin B12 Vitamin B12 Vitamin B2 (s) Vitamin B6 Vitamin C/Ascorbic Acid(s) Vitamin D3 Vitamin E (s)
Unit
2008-09
2009-10
2010-11
2011-12 till sept (prov.)
XVIII 71 72 XIX 73 74 75 76 77 78 79 80 XX 81 82 83 84 85 XXI 86 87 88 89 89 90 91 91 92 93 94 95 96
MT MT
132.930 231.924
182.299 275.699
174.411 299.557
54.851 139.472
MT MT MT MT MT MT MT MT
N.A N.A N.A N.A N.A N.A N.A N.A
MT MT MT MT MT
6.697 N.A. 0.229 25.390 N.A.
6.155 N.A. 0.259 31.194 N.A.
6.956 N.A. 0.076 22.092 N.A.
5.863 N.A. 0.165 0.000 N.A.
98
MT MT MT MMU MT MT MT MT MT MT MT MT MT
N.A. N.A. N.A. 82.656 N.A N.A N.A N.A N.A N.A N.A 256.498
81.120 N.A. N.A. 38.268 N.A N.A N.A N.A N.A N.A N.A 354.000
Annexure II
(Ref: Chapter 4) PRICES OF SCHEDULED BULK DRUG/DERIVATIVES FIXED /REVISED BY NPPA SINCE ITS INCEPTION Existing Revised S.NO. NAME OF THE DRUG % 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Metronidazole Metronidazole Benzoate Cefadroxyl Monohydrate Vitamin E Acetate Trimethoprim Analgin ICHQ Ibuprophen Rifampicin Erythromycin Estolate Ex-Fermentation Erythromycin Estolate TIOC Erythromycin Stearate Erythromycin Base Erythromycin Ethyl Succinate Erythromycin Propionate Carbamazapine, ExONT Carbamazapine, ExIntermediate Silver Sulphadiazine Frusemide Pentazocine Famotidine First Time No Change Increases Decreases
1944(E) 1944(E) 539 (E) 526 447 2758 04.08.2008 04.08.2008 20.03.2008 22.01.2009 27.03.2006 16.04.2010 24.04.2009 11.10.2010 24.04.2009 20.03.2008 20.03.2008 20.03.2008 514 450 2951 1207 1021 575 1158 498 4111 3584 2896 2484 3674 4249 4030 3400 2583 19376 1225 29467 1897 01.07.2011 01.07.2011 01.07.2011 25.07.2011 25.07.2011 25.07.2011 20.09.2011 20.09.2011 20.09.2011 25.11.2011 25.11.2011 25.11.2011 25.11.2011 25.11.2011 25.11.2011 25.11.2011 25.11.2011 25.11.2011 25.11.2011 25.11.2011 25.11.2011 -2.28 0.67 7.00 4.41 23.31 9.94 24.12 9.93 9.86 75.43 41.75 94.98 77.66 58.13 99.21 56.32 18.76 442.90 0.00 31.97 41.25
Remarks Decrease Increase Increase Increase Increase Increase Increase Increase Increase Increase Increase Increase Increase Increase Increase Increase Increase Increase No Change Increase Increase
253(E)
418(E) 857(E) 1047(E) 2483(E) 1049(E) 536(E) 536(E) 536(E)
1156
828 523 933 453 3742 2043 2043 1274
536(E)
536(E)
2068
2687 2023 2175 2175 3569 1225 22329 1343 17 10 152 343 522
20.03.2008
20.03.2008 20.03.2008 20.03.2008 20.03.2008 18.11.1992 05.06.2008 20.03.2008 20.01.2010 cases* cases cases cases cases
536(E)
536(E) 536(E) 846(E) 1388(E) 536(E) 128(E)
99
Since Inception of NPPA Bulk Drug Derivative Total 334 188 522
* Notification of Oxcarbazapine is withdrawn
Annexure-III
(Ref: Chapter 9) List of Public Sector Undertaking and other Organisation under the administrative Control of the Department of Pharmaceuticals
ATTACHED OFFICE
NATIONAL PHARMACEUTICAL PRICING AUTHORITY.
PUBLIC SECTOR UNDERTAKINGS

1. Karnataka Antibiotics & Pharmaceuticals ltd (KAPL), Bangalore. 2. Rajasthan Drugs & Pharmaceuticals ltd. (RDPL), Jaipur 3. Hindustan Antibiotics Ltd, Pimpri, Pune, Maharahstra. 4. Bengal Chemicals & Pharmaceuticals Ltd, Kolkata, West Bengal. 5. Indian Drugs & Pharmaceuticals Ltd, Dundahera Industrial Complex, Dundahera, Gurgaon, Haryana. 6. Bengal Immunity Limited, Kolkata, West Bengal. - since closed 7. Smith Stanistreet Pharmaceuticals Ltd, Kolkata, West Bengal - since closed
OTHER ORGANISATIONS
National Institute of Pharmaceuticals Education and Research (NIPER) at 7 places namely Mohali, SAS Nagar (Punjab), Hyderabad (AP), Kolkata (WB), Rai Bareli (UP), Hajipur (Bihar), Ahmedabad (Gujarat), Guwhati (Assam).
101
Annexure III(a).
(Ref. Chapter 9) Address and Name of Head of PSUs under the Department of Pharmaceuticals
Sl No. 1.
Address and Organizations Karnataka Antibiotics & Pharmaceuticals Limited. (KAPL) Bangalore 560 010. Rajasthan Drugs and Pharmaceuticals Limited (RDPL) Road No. 12 V.K.I Area Jaipur 302 013 Hindustan Antibiotics Limited (HAL), Pune 411010. Bengal Chemicals and Pharmaceuticals Limited (BCPL), Kolkata 700 013 Indian Drugs and Pharmaceuticals Limited (IDPL), Gurgaon. Bengal Immunity Limited(BIL) Kolkata (Since closed) Smith Stanistreet Pharmaceuticals Limited (SSPL), Kolkata (Since Closed, under liquidation)
Name Shri S L Phadke
Designation Managing Director
2.
Shri M K Nagendra
Managing Director
3.
Shri Praveen Kumar
Managing Director I/C
4.
Shri S Kundu
Managing Director
5.
Shri Praveen Kumar
Chairperson & Managing Director
6.
Shri S. Kundu
Managing Director
103
7.
Annexure III(b)
(Ref. Chapter 9) List of Responsibility Centers and Subordinate Organizations for : Year: 2011-2012.
S.No
Order
Responsibility Centers and Subordinate Organizations Description Dr K K Bhutani, Officiating Director
Landline Number
Email
Mobile Number
Address
1722214692
bhupindersingh@ niper.ac.in
9417203802
National Institute of Pharmaceuticals Education & Research (NIPERS) Sector -67, SAS Nagar, Punjab 160062 NIPER Ahmedabad, B.V. Patel Pharmaceutical, Education and Research Development (PERD) Center ThaltejGandinagar Highway, Thaltej, Ahmedabad380054 NIPER Hydrabad IDPL Township, Balangar, Hyderabad- 500007 NIPER Hajipur Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) Agam Kuan, Patna 800 007 NIPER Kolkata Indian Institute of Chemical Biology 4, Raja S.C. Mullick Road, Jadavpur, Kolkata 700032
Dr. Neeta 7927450449 Shrivastava, Project Director
perd@perdcentre. com
9824250226
Dr Ahmed Kamal, Project Director
4023073751
niperhyd@yahoo. com
9440802784
Dr. Pradeep Das, Project Director
612263437
Drpradeep.das@ gmail.com
9431012380
105
Dr. Asish Kumar Banerjee, Project Director
3324735197
asishbanerjeeiich@ 9830141666 gmail.com
S.No
Order
Responsibility Centers and Subordinate Organizations Description Dr K C Saikia , Project Director
Landline Number
Email
Mobile Number
Address
3612132751
Gmch-ash@nic.in
NIPER Guwahati, Guwahati Medical College and Hospital (Guwahati) - 781032 9415021749 NIPER Rai Bareli, Central Drug Research Institute Chatter Manzil P.O Box 173, Lucknow 226001 NPPA, YMCA Cultural Centre Building 3rd Floor, 1, Jai Singh Road, New Delhi 110001
Dr D K Dikshit, Project Director
5222620713
dk_dikshit@cdri. res.in
National Pharmaceuticals Pricing Authority (NPPA)
23389866
nppa@nic.in
9812345678
106
Chairman NPPA Member Secretary Advisor Director
Annexure IV
Director (Bulk & Enforcement)
Director Legal-II
Director (Monitoring)
Director Legal-I (Overcharging) / (Admin) / Estt.
1. Bulk Drug Pricing. 2. Form-I, II & VI Examination 3. Policy Matters 4. IEM & Customs/Excise issues. 5. Statistics relating to production, Import/Export of drugs & formulations 6. Quarter monitoring of bulkd drugs prices.
1. sample collection form Mkt. and analysis. 2 Examination of Trade Journals & other Secondary information 1. Monitoring of prices of scheduled and nonschedueld formulations. 2. General Market Survelliance. 3. Form V examination 4. SSI related issues. 5. Inclusions / Exclusion of drugs under DPCO, 1995. 6. Policy related matters
1. Formulation Pricing (Form III & IV) 2. Availability / Shortage of bulk drug . 3. Standing Committee 4. Parliament Question / Assurance & VIP ref.
1. Legal matters & follow up of pending court cases
1. Overcharging on bulk drugs & formulations and related issues. 2. Price fixation under para 10(b) and related issues. 3. Any other references on the above.
1. General Admn. 2. Co-ordination 3. V igilance 4. Hindi Advisory Committee and work relating to promotions of Hindi in NPPA 5. Pharma Index 6. Establishment 7. VIP Reference.
One post of Director is lying vacant as on date.
(Ref. Chapter 4)
107

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2011-12

Annual Report 2011-12

Government of India Ministry of Chemicals & Fertilizers

Annual Report | 2011-12

Annual Report | 2011-12

Annual Report | 2011-12

77 77 79 79 83 83 83 83 83 87 87 87 87 87 87 87 87 88 91 91 91 91 91 91 92 92 95 95 99 101 103 105 107

Annual Report | 2011-12

Annual Report | 2011-12

1.2 VISION AND MISSION OF THE DEPARTMENT

Annual Report | 2011-12

CHAPTER -2 An Overview of Pharmaceuticals Industry

Annual Report | 2011-12

2.2 IMPORTS: As per the Directorate General of

2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11

2002-03 2003-04 2004-05 2005-06 2006-07

(Source : Directorate General of Commercial Intelligence and Statistics (DGCIS), Kolkata)

2007-08 2008-092009-10 2010-11

0 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11

Value of Export of "Drugs Pharmaceuticals and Fine chemicals"

Annual Report | 2011-12

Total National Imports Medicinal and Pharmaceuticals Products

6 3 0 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11 19 3 13 6 23 44 21 30 14 15 36 28 7 15 12 10

(Source : DGCIS, Kolkata)

2.4 Share in National Trade

Total National Exports Drugs and Pharmaceuticals and Fine Chemicals

2.5 PHARMA EXPORT PROMOTION COUNCIL (Pharmexcil)

Annual Report | 2011-12

2.7 Proposed Major areas of International Conference.

2.6 International Cooperation/ Export Promotion of Pharmaceuticals

2.8 INDIA PHARMA SUMMIT-2011

Annual Report | 2011-12

Annual Report | 2011-12

2.9 Growth in Indian Pharmaceutical Industry

Growth%% 19.21 16.03 13.04 18.65 9.38

Table 2: International sales on consolidated basis

Annual Report | 2011-12

Table-3: Geographical Distribution of Pharma Companies

Table-4: Market Turnover of Major Therapeutic Segments

Annual Report | 2011-12

Table-5: Bulk Industry Growth

Table-10: Export Growth

Table-6: The Global Market for Biologics in 2009

Table-11: Human resource position in India

Table-7: The 10 Top Selling Biologics in 2009

Table-8: The Global Market for Biosimilars in 2009

Table-12: Global Phama market growth rate

Table-9: Projected Growth

Annual Report | 2011-12

Table-13: Top Global Generic Players

Table 14: Research and Development Expenditure

Ranbaxy* Dr. Reddys Sun Pharma Cipla Lupin Labs

Roche, CH GlaxoSmithKlin, UK Elli Lilly, USA Lundbeck, DNK Watson, USA

Annual Report | 2011-12

Table 16: Employment Data for Pharmaceutical Sector

Table-19: Turnover-wise distribution

Table 17: Percentage distribution of Manpower in Pharma Industry

Table-20: Performance of CPSUs

Table-21: Sales Projection of CPSUs

RDPL 108 122 135 150 165

Annual Report | 2011-12

CHAPTER 3 PHARMACEUTICAL INDUSTRY

3.1 PRODUCT PATENT- Impact on medicine prices

3.2 CREATION OF IPR FACILITATION CENTRES IN PHARMEXCIL