Global Pharma

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VOL. 2 | NO. 2 | APRIL 2013
www.iglobalpharma.com
April 2013
GLOBAL PHARMA
GLOBAL PHARMA
April 2013
CONTENTS
Cover Story
VOL. 2. NO. 2 APRIL 2013 Editor Asif Baba* asif@iglobalpharma.com Editor online Maserath Jehan BUREAUS Hyderabad G.V.Ramu B.Venkat Reddy A.Sudhakar Reddy Bangalore G.Eshwar Pratap Reddy Chennai Narayan Reddy Mumbai E.Srinivas Reddy MARKETING Head Palla Praveen Reddy Manager Ameed Baba PRODUCTION Head K.Narasa Reddy Manager Satya Sagar Rao Photo Editor Deepak Designer Muthallib. S.M Programmer Abdul CIRCULATION Amarnath Reddy Global Pharma RNI No. APENG/2012/40690 Printed, Published and Edited by ASIF BABA SHAKE Published from: # 1-7-500/11, Hari nagar, Zamistanpur, Musheerabad, Hyderabad, Andhra Pradesh, INDIA. Pin: 500020 Printed from: Hi-tech Printers # 1-3-183/40/81, Near Axis Bank ATM, SBI Colony, Gandhi Nagar, Hyderabad, Andhra Pradesh Editor: Asif Baba Shake*
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Research & Development
SCHOTT KAISHA inaugurates pharma packaging plant in Jambusar
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10
Pharma Market
22
Pharma Management
6
Adverse drug reaction cases going unnoticed in state ?
25
Pharma Education
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37
Kallam Anji Reddy, pioneer of Indian pharma industry, passes away
Health
37
Pharma Life
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* Responsible for selection of news under the PRB Act

The publisher endeavors to collect and include complete, correct and current information in Global Pharma but does not warrant that any or all such information is complete, correct or current. The publisher does not assume, and hereby disclaims, any liability to any person or entity for any loss or damage caused by errors or omissions of any kind, whether resulting from negligence, accident or any other cause. Global Pharma does not verify any claims or other information appearing in any of the advertisements contained in the publication, and cannot take any responsibility for any losses or other damages incurred by readers in reliance on such content. Copyright 2012, Global Pharma All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording or information storage and retrieval System, without permission in writing from the publisher.
April 2013
GLOBAL PHARMA
EDITORS NOTE
India demonstrated in producing low-cost and high quality products and services resulted in rapidly making it the chosen destination for manufacturing, R&D and medical tourism
The pharmaceutical industry has billions of dollars at stake in India and analysts estimate the size of the opportunity to accommodate tens of billions more as diseases and disorders threaten human life with pain, discomfort and death. From this springs the bewilderment of what the Pharma Future will hold for the industry in the days, weeks and years ahead. Conclaves are one way to assemble the more knowledgeable executives of the industry and pool their wisdom of the past and understand how they see the future unfold. Disappointingly, most executives believed the future would not be too different from the present especially since nothing much changed over the last two decades. The pharmaceutical industry in India is considered a slow adopter of new technology, new media and simply put new ways of doing things. The inertia is more obvious on the commercial front given the dynamism of its customer-facing nature. On the more strait-jacketed back-end, the industry has been fast to adopt best practices in functions such as managing the supply chain and formulation R&D etc. After all, reverse engineering and the expertise that India demonstrated in producing low-cost and high quality products and services resulted in rapidly making it the chosen destination for manufacturing, R&D and medical tourism. Does this mean that while the Indian industry is quick to improve on existing processes, it is not so quick to establish new ones? Despite this, little progress is seen to leverage the uniqueness. Emerging markets is a buzzword at global headquarters of every MNC. Yet, every business model developed by every company looks and feels the same. Foray into branded generics, expand into the rural hinterlands and expand sales forces to increase reach. Hardly anything novel here, excepting that novelty will lie in execution. Companies, when faced with the same environment, challenges and opportunities chose to react to it in almost the same way. The actual execution of those plans will set the grain apart from the chaff. The focus lay too much on discussing the adoption of technology rather than on what new processes would evolve from path-breaking technology. It is widely accepted that chronic diseases are associated with behavioral, socio-economic, and genetic factors that are not within the control of todays medical delivery system. There is a lot that the pharmaceutical industry can do in this relevant area considering that one of the ways in which the Indian market is unique is that it is a self-pay market. The pharmaceutical industry can explore robust value creation and revenue generating opportunities in areas that will help prevent onset of chronic diseases or assist chronically ill patients manage their disease in cost efficient ways. What is happening to healthcare is no different from other industriesthe power of the individual is increasingly influencing how healthcare is directed and delivered, enabled by the technological and the virtual world we live in. And this is by no means a Western phenomenon. This is the future of the pharmaceutical industry in India. The Pharma Future. ASIF BABA SHAIK asif@iglobalpharma.com
GLOBAL PHARMA
April 2013

LONDON, 19 MARCH, 2013: erbal medicines are causing millions in India to develop kidney failure and bladder cancer. In a warning that is bound to cause a fresh row over the quality of Asian herbal medicines, British scientists were due to announce on Tuesday that millions of people in Asia specially in India and China might be exposed to the risk of kidney failure and bladder cancer from taking herbal medicines widely available in the continent. Scientists from Kings College London have found that many herbal medicines used for a wide range of conditions including slimming, asthma and arthritis are derived from a botanical compound containing aristolochic acids. These products are now banned in the US and many European countries, but herbs containing these toxic acids can still be bought in China and other countries in Asia, and are also available worldwide over the internet. The scientists reviewed worldwide cases of aristolochic acid nephropathy (AAN), a type of kidney failure caused by the intake of these acids. They suggest there may be many thousands of cases across Asia that are undiagnosed or misdiagnosed. With the outcome of their study, the researchers hope to raise awareness of the risks of aristolochic acids and reduce the global disease burden from this severe condition. We do know that preparations containing aristolochic acid (AA) are widely used in India and that this is April 2013
Herbal medicines causing kidney failure, bladder cancer in India

associated with chronic kidney disease and kidney cancer if a sufficient dose is taken, lead author Professor Graham Lord told this reporter. Ethnopharmacological analyses suggest that aristolochia is widely used in India. India must start better monitoring of medicines containing herbal remedies and also assessment of patients with chronic kidney disease and kidney cancer for the presence of AA.
publications that are about or refer to aristolochic acids and Chinese herbal nephropathy, and identified 42 different case studies and one trial relating to the management of the disease. While explaining the origin and development of the disease, they propose a protocol that should make it easier to diagnose AAN. In addition, they suggest a new disease classification to help international clinicians better identify AAN patients and draft guidelines for the treatment of these patients. The research team consisted of an international collaboration of scientists from Belgium, Czech Republic,
Lord said at the moment they did not how widespread the problem was in India. We have found evidence that many millions of people continue to be exposed to significant health risk due to these herbal medicines, widely used in China and India, he said. There is also a striking lack of good quality evidence that might help guide the diagnosis and management of AAN. Their paper, published in Annals of Internal Medicine, indicates that the regulatory measures that have been adopted by national and international agencies so far may be inadequate in preventing harmful exposure to aristolochic acids. The compound is linked to many cases of kidney diseases and urothelial cancer, a form of cancer of which bladder cancer is the most known variant. The authors reviewed the latest data on the epidemiology of AAN. They used several search engines to include all
Germany and the UK. This research is a great demonstration of how international scientific collaboration is vital in helping to describe how a toxin used in widely available products can lead to cancer, said Dr Refik Gokmen, co-author from Kings College London. GLOBAL PHARMA
Adverse drug reaction cases going unnoticed in state ?

INDORE, 17 MARCH, 2013:
lame it on the poor state of pharmacovigilance centres in state or lack of awareness among healthcare staff, the state, on an average, reported only 49 adverse drug reaction (ADR) cases per month between July 2011 and February 2013.
Related figures, which were reported to Central Drug Standard Control Organisation (CDSCO) by the state, were revealed by Union Minister of Health and Family Welfare Ghulam Nabi Azad in the Rajya Sabha while replying to a question raised by Dr T Subbarami Reddy on March 12. During the period, the state reported only 980 adverse drug reaction cases while the less populated union territories like Chandigarh, Puducherry and Delhi reported 3,123, 1,781 and 4,222 cases respectively. Apathy towards monitoring of adverse reaction reporting can be gauged by the fact that the state government is doing little to improve the condition of pharmacovigilance centres set up in the state. Under the Centres ambitious project three pharmacovigilance centres were set up in state but are dying a slow death. Answering a question raised by MLA Pratap Grewal in state assembly, health minister Narottam Mishra could not provide information about the centres and their functioning. The centres have contributed minimally to National Coordinating Centre in New Delhi so far. Indore centre coordinator Dr Chhaya Goyal said, The programme failed to kick off properly as doctors fear that this might affect their practice. However, this is a good project on which U S Food and Drug Administration (USFDA) bans drugs. We have been informing hospitals and doctors to report adverse drug reaction as and when they come to notice but to no avail. We also wrote to Maharaja Yeshwantrao Hospital in this regard but in vain. The centres hold importance as new drug is generally tested on no more than a few thousand patients at the time of granting marketing authorization. However, soon after the grant, it is extensively marketed and used by a much larger population. Many adverse reactions to new drugs as well as to those already in the market, which might not have been observed in the limited population, could clinically manifest in a larger population. According to the sources, the centres can help modify usage and labeling of the drug and in some cases drugs can be withdrawn and banned. Unfortunately, in India drugs are banned only on the basis of action taken by USFDA.
GLOBAL PHARMA
April 2013
US FDA reviews pancreas risks from new diabetes drugs
Maryland, 15 March, 2013: he US Food and Drug Administration is investigating reports of possible increased risk to the pancreas from using a class of diabetes drugs that includes blockbusters like Merck & Cos Januvia and Novo Nordisks Victoza. The agency is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients treated with incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes, the FDA states, adding that it has asked the researchers to provide the methodology used to collect and study these specimens and tissue samples. April 2013
Drugs in the incretin mimetic class include Victoza (liraglutide), Januvia (sitagliptin), AstraZeneca/BristolMyers Squibbs Byetta (exenatide) and Onglyza (saxagliptin), Takedas Nesina (alogliptin) and Boehringer Ingelheims Trajenta (linagliptin). The meeds work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. The FDA went on to say it has not reached any new conclusions about safety risks with incretin mimetic drugs and thisearly communication is intended only to inform the public and healthcare professionals. However, it has previously warned the public about postmarketing reports of acute pancreatitis, including fatal and serious nonfatal cases, associated with the use of Byetta and Januvia. GLOBAL PHARMA
hanging the label on opioid pain medications to limit their continuous use to 90 days would do little to stop drug abuse while depriving millions of Americans of the medication they need to live a reasonable life, according to a leading professional organization representing pain specialists.
Pain Group Says Simple Dosing Change Wont Fix Prescription Drug Abuse Problem
with few treatment options, given the on-label restrictions imposed by many insurers, including Medicare/ Medicaid, AAPM leadership wrote. In light of the complexities surrounding this and other proposed labeling changes, the FDA held a public hearing in March to consider the science otherwise suffer terribly, according to the AAPM. Other proposals under consideration by the FDA include limiting longterm opioid therapy to severe pain (excluding moderate pain) and setting a daily dosage limit of 100 mg morphine equivalents. The AAPM
In written comments to the FDA, the American Academy of Pain Medicine (AAPM) renewed its commitment to fighting prescription drug abuse but warned that adopting the proposal could effectively eliminate the use of opioids for chronic noncancer pain, usually defined as pain lasting longer than 90 days. This position could potentially leave an untold number of pain sufferers
behind the safety and effectiveness of administering opioids for chronic noncancer pain. A decision on labeling has yet to be made. The Institute of Medicine (IOM) reports that 100 million Americans live with chronic pain. Chronic opioid therapy may not be a first choice for the control of pain but can effective for some patients who dont respond to other therapies and who would
stated that there is evidence supporting that patients vary widely in their experience of pain and their response to medications, in part because of genetic differences. The group called the 100-mg limit unsubstantiated and expressed fear that a sole focus on dose could lull prescribers into a false sense of security by allowing them to ignore important risk factors.(Based on a press release from the American Academy of Pain Medicine) April 2013
GLOBAL PHARMA
State AGs Pressure FDA for Abuse-Resistant Generic Pain Drugs

In our states, nonmedical users are shifting away from the new tamperresistant formulations to nontamperresistant formulations of other opioids as well as to illegal drugs, the attorneys general wrote in their letter to the FDA. There is great concern in our law enforcement community that many nontamper-resistant products are available for abuse when only a few products have been formulated with tamper-resistant features. injury death in the United States. Motor vehicle deaths are second. In February 2012, the FDA issued a draft directive outlining requirements for tamper-proof opioid development; among them were conducting randomized controlled, double-blind trials showing the ease with which the potentially abuse-deterrent properties of a formulation can be defeated or compromised.
tate attorneys general have joined forces to urge the FDA to mandate more difficult-toabuse versions of prescription pain medicationsspecifically, generic opioid analgesics. In a letter dated March 11 to the FDA, the group of 48 state attorneys general asked the agency to adopt drug development standards outlining how manufacturers of generic prescription painkillers should develop abuseand tamper-resistant versions of the analgesics. The FDA has issued a draft directive defining the requirements for developing tamper-resistant opioids that does not make it mandatory. The directive is expected to be finalized sometime in March. The attorneys general noted that brand-named versions of opioids such as OxyContin (Purdue; oxycodone) and Opana ER (Endo; oxymorphone) have taken steps to make it more difficult to abuse their drugs, such as making it harder to crush pills, which is often done by abusers to make the drug easier to inject or snort. Yet, the FDA is faced with the contentious issue of generic opioids. Purdue and Endo have filed Citizen Petitions separately with the FDA over the past year in an effort to force generic opioid formulations to prove they are tamper-resistant in order to stay on the market. The concern is that prescription drug abusers will simply avoid the new tamper-resistant formulations as long as standard agents in the class are available; in many cases, that means generic versions of opioids.
By making prescription opioids tamper-resistant, we can further safeguard people from deadly prescription drug abuse, stated Floridas attorney general Pam Bondi. Ms. Bondi sent a similar letter to the FDA in October 2012, asking that all manufacturers of prescription opioids develop tamper-resistant formulations. Alabama attorney general Luther Strange, Kentucky attorney general Jack Conway, North Carolina attorney general Roy Cooper, and Ms. Bondi led the current effort. The Centers for Disease Control and Prevention cites fatal drug overdose as the leading cause of unintentional
The letter was signed by attorneys general from Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, West Virginia, Wisconsin and Wyoming. The letter also was signed by attorneys general from Guam and Puerto Rico.
April 2013
GLOBAL PHARMA
Pharma Market
Centre finds SLAs granted 23 licenses for FDCs without DCGI approval
New Delhi, 20 March, 2013: many as 23 instances of state licensing authorities (SLAs) granting permissions to fixed dose combinations (FDCs) without prior mandatory approval of the Drugs Controller General of India (DCGI) have come to its notice, according to the Health Ministry. The Health Ministry also said that the State Drug Controllers were asked to take action under the Drugs and Cosmetics (D&C) Act 1940 in all these 23 cases where licences were granted without the approval of the DCGI. The D&C Act, 1940 empowers the state licensing authorities (SLAs) to issue licenses for manufacture and sale of drugs in the country. However, the drugs falling under the category of new drugs require prior approval from the Licensing Authority defined under Rule 21(B) of the Drugs & Cosmetics Rules, 1945 i.e. the Drugs Controller General (India) [DCG(I)] before grant of a licence by the State Licensing Authority, revealed Union Health Minister Ghulam Nabi Azad in the Parliament recently.
As
Further, on 1st October 2012, the Central Government issued directions under sections 33P of the D&C Act, 1940 to all State/UT Governments to instruct their respective drug licensing authorities to abide by the provisions prescribed under the Drugs and Cosmetics Rules in respect of grant of manufacturing licenses for the drugs falling under the definition of the term New Drug and not to grant licenses for manufacture for sale or for distribution or for export of such new
Act and Rules made thereunder. The Drugs and Cosmetics (Amendment) Bill, 2007 introduced in the Rajya Sabha on the 21st August, 2007 already contains the provisions for inter alia creation of a Central Drugs Authority and Centralised Licensing of Drugs, the Minister said. Recently, the DCGI also issued orders asking the manufacturers to prove the safety and efficacy of the FDCs approved before October 1, 2012 and made it clear that those FDCs approved
drugs, except in accordance with the procedure laid down under the said Rules i.e. without prior approval of the DCGI, he added. The statutory mechanism of Drugs Consultative Committee provided for in the D&C Act, 1940 ensures regular interaction among the State Drug Control Authorities and the Central drug regulator for uniform implementation of the provisions of the
by the State licencing authorities from October without the permission of the DCGI will be considered for ban. Fixing October 1 as the cut-of-date on the vexed issue of FDCs which is still sub-judice, the DCGI directed the state drug controllers to ask the concerned manufacturers to prove the safety and efficacy within 18 months. April 2013
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GLOBAL PHARMA
Pharma Market
New Delhi, 12 March, 2013 (PIB):
Curbing of Sub-Standard Drugs

about the details of the manufacturers are, therefore, not maintained centrally. Further, the Central Drugs Standard Control Organisation (CDSCO) does not regulate the quantum of production of drugs by the drug companies.
To
minimize the manufacture of sub-standard drugs in the country and making the regulatory control more effective, the 12th Five Year Plan contains substantial provision for further strengthening the drug regulatory system both at central and state level. The licensing and regulatory control of manufacture of drugs are the subject matter of the State Licensing Authorities and State Drugs Control Departments. The information
As per the available information, the value of all finished medicines imported during 2010-11 is Rs. 2591.23 crores, 2011-12 is Rs. 3893.83 crores and 2012-13 is Rs. 3820.40 crores. The Department of Pharmaceuticals in the Ministry of Chemicals & Fertilisers had constituted a High Powered Interministerial Coordination Committee (HPIMCC) under the Chairmanship of the Secretary of that Department to implement the Governments commitment to provide quality medicines at affordable prices to the
public. As per the available information, the first meeting of the Committee was held on 29.3.2010. Based on the decision taken in that meeting, two Working Groups, viz., Working Group for Quality of Medicines and Working Group for Pricing of Medicines were formed. In its second meeting held on 26.6.2012, the HPIMCC considered the suggestions made in the reports of the two Working Groups. Thereafter, the minutes of that meeting and the Reports of the two Working Groups were conveyed to the Ministry of Health & Family Welfare on 14.9.2013. The suggestions are broadly agreeable. This information was given by Minister for Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Rajya Sabha.
DCGI issues revised draft guidelines for issue of WC certificate for export of APIs to EU
to be submitted for application of WC certificate for active substances exported to the EU for medicinal products for human use in accordance with Article 46(2)(b) of Directives No. 2001/83/EC. The major documents mentioned in the checklist included the covering letter clearly specifying the intent of the application; an authorization letter in original issued by the Director/ Company Secretary/ Partner of the firm revealing the name and designation of the person authorized to sign; copy of GMP certificate issued as per WHO GMP, US FDA, EDQM, etc. if any; copy of Manufacturing License issued by SLA; list of all APIs approved by SLA; list of products applied for issue of WC; and list of SOPs and STPs. The checklist also include master formula record and batch manufacturing record; summary of stability data (three batches) accelerated/ real time (as prescribed); list of equipment and instruments; list of technical staff, their qualification, experience and their approval by SLA; manufacturing layout plan as approved by SLA; validation master plan; summary of process
Mumbai, 11 March, 2013: ven as the European Union (EU) is all set to implement its Directive on Falsified Medicines from July 2 this year, under which the APIs meant for medicinal products for human use would require written confirmation (WC) for each API unit by the enforcement authorities of the exporting countries, the drugs controller general of India (DCGI) has issued the revised draft guidelines for issue of WC certificate for export of active pharmaceutical ingredients (APIs) to EU. The EU Directive is aimed at preventing falsified medicinal products from entering EU from other countries. As per the directive, the APIs meant for medicinal products for human use would require written confirmation for each API unit by the enforcement authorities of the exporting countries confirming complaints with GMP standards or rules equivalent to the rules applied in the EU, such as WHO GMP, International Conference for Harmonization Q7 (ICH Q7), etc. In the revised draft guidelines, the DCGI has listed the checklist for documents April 2013
validation data for three batches of each product; schematic diagram of water system specifying circulation loop and MOC; schematic diagram of HVAC system specifying terminal filter configuration; export data of last three years; good distribution practices followed by the firm; summary of annual product review; summary of market complaint review; summary data of impurity profiling; summary data of OVI; summary data of analytical method validation; schematic diagram of ETP; NSQ reports; legal undertaking stating that inspection/ investigation reports of any regulatory inspection by Indian regulatory authority including show cause notices/ suspensions/ cancellations if any shall be communicated to competent authority i.e. DCG(I), CDSCO within 15 working days; and site master file (as specified under WHO TRS 823). Earlier in November last year, the union health ministry had made the CDSCO (DCGI office) as the competent authority for issuing WC certificate for each of its consignments ensuring compliance of the product with the good manufacturing practices (GMP) requirements of EU. GLOBAL PHARMA
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Pharma Market
Drug Controller General of India to inspect bulk drug plants exporting to EU

NEW DELHI, 20 MARCH, 2013:
he Drug Controller General of India is readying a plan to check if domestic bulk drug facilities that export to the European Union comply with WHO-prescribed norms, according to an official. As per the proposed plan, the zonal offices of the drug regulator will inspect the manufacturing practices of API (active pharma ingredient) plants across the country for compliance and forward the details to the EU drug regulator. The audit team would comprise one or two inspectors from the zonal offices, of which one trained and qualified inspector shall be designated as the team leader, the official said, adding that a quality-control expert from either the central drug testing lab or a regional drug testing lab may be included. A case for special inspections for EUbound exports had to be made after the region tightened its import norms. India exports API worth a little over $1 billion to the EU every year. The EU-focused inspection will be different from the regular checks
conducted in the country wherein plants are monitored for compliance with Schedule M of the Drugs and Cosmetics Act, the set of laws that regulate the quality of drugs in India. Once a plant is found compliant with WHOs good manufacturing practices (GMP), the DCGI issues a written permission to the drug maker that works as a stamp of quality for three years. However, the drug regulator may also conduct unannounced inspection. The deficiencies, if found, are proposed to be classified as critical, major and minor. According to the official, cases involving contamination and falsification of data will be billed as critical violation while failure to carry out proper procedures for release of drug batches will be termed major violation. Any other departure from the prescribed GMP that does not fall under the above two categories, will constitute minor deficiency. Critical and major deficiencies among other persistent problems will be reported to the EU drug regulator, the official added. In July 2011, the European Commission had introduced the Falsified Medicines Directive as a measure to prevent the entry of spurious drugs into its legal supply chain. Under the new rule, starting July 2013, API imports must bear a written confirmation issued by the competent authority of the exporting country. Indias annual pharma exports of over $13.4 billion include formulations, bulk drugs and Ayurvedic preparations. API accounts for roughly 40% of this.
BSF seizes Phensedyl

Shillong, 13 March, 2013:
the official said. The driver and his assistant have been arrested. The driver has been identified as 25-year-old Tapal Nama Das from Ambassa village in Dhalai district of Tripura. The BSF recovered Rs 1,900, a mobile phone and a SIM card from the duo. frisking the vehicle, BSF personnel recovered 37 cartons containing 5,550 bottles of Phensedyl. The troops also seized 1,100 tins of palmolein oil. The total value of the seized items is around Rs 38.16 lakh,
he BSF today recovered 5,550 bottles of Phensedyl cough syrup from a truck in Meghalayas East Jaintia Hills district. It was one of the biggest hauls of the codeine-containing cough syrup, which is used to manufacture narcotic drugs. According to an official, the BSF intercepted a Tripura-bound truck (TR-1T-1625) at a mobile checkpost while carrying out checking at Sonapur bridge in East Jaintia Hills. The truck was said to have been carrying palmolein oil. But, after
According to the driver, the owner of the truck loaded Phensedyl in Guwahati and it was being taken to Agartala, the BSF official said. The recovered items have been handed over to East Jaintia Hills district police for further action. April 2013
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GLOBAL PHARMA
Ghanian firms marketing fake drugs from India?

Accra/Lagos, 13 March 2013: a time the Indian pharmaceutical industry is attempting to brand itself to counter allegations of exporting counterfeit drugs, Ghanas Food and Drugs Authority (FDA) has accused three local companies of distributing fake drugs from India. The clampdown on the three companies came just days after 62 companies, under the umbrella of Indias Pharmaceuticals Export Promotion Council (Pharmexcil), ended an exhibition in neighbouring Nigeria. The exhibition, Pharmexcil said in a statement, was intended to live up to the challenges of increasing market share in existing and new markets and countering the negative publicity in some countries by vested interests. In addition to increasing its market share, Pharmexcil is also engaged in a Brand India Pharma Campaign with the key objective to raise the awareness of Indian pharmas success story and to create awareness that Indian generics are not counterfeits and are bonafide. Additionally, the campaign is meant to shield the industry from dubious allegations by vested interests to pave way to position India as the global pharmacy of the world. It was in line with this that the exhibition was held in Nigeria March 7-8. Pharmexcil said the exhibition, the third to be held, provided Indian companies the opportunity to showcase Indias latest range of pharmaceuticals products including bulk drugs, formulations, biotech products and herbals. The also event, provided Pharmexcil said, an opportunity to
Pharma Market
At
pharmaceutical stake-holders in Nigeria and in the neighbouring West African region to meet their Indian counterparts to discuss procurement, joint ventures, technology transfer and marketing tie-ups. The FDA accusation has thus come to destroy the clean image that Pharmexcil is trying to build. FDA said it had uncovered the widespread fraud by the three companies that has put the lives of millions at the risk of fatality by distributing fake and substandard medicines. Samples of the Ergometrine injection from Indias Ciron Drugs were found to be substandard as they contained
Drug Administration and Control (NAFDAC) and other agencies to protect, promote and diversify the Nigerian pharmaceutical market. In line with this, the two countries signed a Memorandum of Understanding on cooperation in the pharmaceutical sector in March 2011 which have helped to intensify collaboration to prevent anti-counterfeiting of Indian pharmaceuticals. Indian medicines have long been present in Nigeria and India has traditionally been the largest source of medicines to this country, supplying over a third of the market. Indian pharma products popularity is based on their efficacy and competitive prices, Pharmexcil added. It said there are more than 30 Indian pharma companies located in Lagos alone and engaged in manufacturing and/or importing Indian products. By the end of March last year, India exported drugs, pharmaceuticals and fine chemicals to Nigeria worth $307.60 million, a significant growth of 37 percent over the previous year. Pharmexcil says India is the worlds third largest producer of pharmaceuticals by volume with an annual turnover estimated at over $20 billion in domestic prices, which are significantly lower than global prices. With the industry growing at 13 percent annually, the turnover is expected to grow fivefold by 2020, it added. It said Indias global pharma exports are expected to be around $14 billion in the year ending March 31 2013, up nearly 25 percent over last year, adding: While the Indian pharmaceutical industry is famous for generics, it is also making fast inroads into branded products, especially in biotechnology. GLOBAL PHARMA
no active pharmaceutical ingredients, FDA said. Fake, substandard and contaminated imported Ergometrine injections when given to women will fail to control bleeding after child delivery and could result in death, it said. Though hospitals were not able to provide any information on the number of women and perhaps deaths this has caused, health workers told IANS that this is a real problem that has affected the countrys health delivery system. In the case of Nigeria, Pharmexcil said, it is working with the countrys National Agency for Food and
April 2013
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Cover Story
M
arking a significant milestone in its expansion, SCHOTT KAISHA inaugurated its new pharmaceutical packaging plant in Jambusar, Gujarat. This greenfield investment of 20 million Euros increases the companys production capacity in India by 50 per cent to around 2.0 billion ampoules and vials per year. Indias first fully automated pharmaceutical packaging plant complements an existing production facility in Daman and enhances SCHOTT KAISHAs competitive advantage substantially. We see a steadily rising demand for locally manufactured primary packaging that meets the rising quality demands, says Kairus Dadachanji, Managing Director of SCHOTT KAISHA, adding: Our new state-of-the-art factory sets new standards in India. This investment will result in better quality opportunities for our customers. In other words, we will be helping the Indian pharmaceutical industry to achieve its own growth objectives. The new plant in Jambusar has 20 production lines for ampoules and 16 for vials, with scope for further expansion. Its fully automated production process uses high-end robotic feeding technology for tubeloading as well as high-precision camera inspection systems. World market leading SCHOTT FIOLAX tubes are used as base material. The facility is
SCHOTT KAISHA inaugurates pharma packaging plant in Jambusar
Managing Director, SCHOTT KAISHA
Kairus Dadachanji
Indias first pharmaceutical packaging plant meeting global standards with an ISO 15378 certification. This
This greenfield investment of 20 million Euros increases the companys production capacity in India by 50 per cent to around 2.0 billion ampoules and vials per year.
underlines the companys commitment to the international GMP (Good Manufacturing Practice) standard. KAISHAs deep market knowledge about India and SCHOTTs world class technology create a perfect partnership, emphasizes Prof. Udo Ungeheuer, Chairman of the Board of Management of SCHOTT AG. The SCHOTT group is highly committed to its pharmaceutical business. Our continuous investments in India demonstrate our ambition. More than one hundred years of experience in setting the worlds highest technology standards turn us into the ideal partner for Indias ambitious and fast growing pharmaceutical industry, he adds.
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GLOBAL PHARMA
April 2013
Schott Kaisha to invest Rs 100 cr more for expansion in Gujarat

BIS in improving glass manufacturing standards in India, says Sundeep Prabhu, Vice President Marketing and Sales for Pharmaceutical Tubing at SCHOTT Glass India. This milestone is another illustration of the outstanding standardization of product quality and manufacturing processes SCHOTT has achieved in India. Together with BIS, our efforts will benefit Indian consumers as well as industry by ensuring that glass products are safe, reliable and of highest quality.
Cover Story
ndo-German joint venture Schott Kaisha today said it was looking at additional investment of around Rs 100 crore towards expanding pharma packaging products capacity at its Jambusar unit in Gujarat. The company has already invested Rs 136 crore ( 20 million) in first module at Jambusar producing about two billion ampules and vials per year. We are committed to investing even further in supporting the growth of the Indian pharma sector. Our investment may increase by another Rs 100 crore in the near future to set up second production module, Kairus Dadachanji, Managing Director, Schott Kaisha said here. The company will finalise details of expansion and investment plans after the completion of its first module by end of this year, he said. Schott Kaisha achieved a turnover of Rs 160 crore in FY-12 and targeted turnover of Rs 240 crore in FY-13 and Rs 300 crore in FY-14, Dadachanji said. Meanwhile, Schott has been appointed to Indias national standard body. As a new member of Bureau of Indian Standards (BIS), the company will advise a sub-committee of the Chemicals Department on specifications and guidelines for various kinds of glass manufacturing in India. The international technology group SCHOTT has been appointed to Indias national standards body. As a new Bureau of Indian Standards (BIS) member, the company will advise CHD10, a subcommittee of the Chemicals Department, on specifications and guidelines for various kinds of glass manufacturing in India mainly for pharmaceutical tubing but also for other applications such as fire-safe glass, household appliances, and fiber optics. This allows BIS to tap into SCHOTTs vast experience in the areas of specialty glasses, materials and advanced technologies. It is a tremendous privilege to support April 2013
BIS decision underlines SCHOTTs position as a global leader in high quality glass manufacturing.Working closely with Indias national standards body, SCHOTT will share its decades of expertise with the aim of enhancing production and testing standards of Indias glass manufacturing industry. For more than 125 years, SCHOTT has constantly improved its quality standards to accommodate evolving market demands and deliver maximum benefits to its customers. A key global success factor for SCHOTT has been its strong focus on maintaining the highest quality standards. Company data released recently proves that SCHOTT managed to maintain stringent quality standards in the area of pharmaceutical tubing consistently over the last 25 years (1988-2013). At SCHOTT, we have been setting standards for manufacturing glass tubing with our technical terms of supply. This means we are committed to constantly improve our production process and offer our customers the highest possible transparency and quality assurance, says Jrgen Achatz, Global Sales Director for Pharmaceutical Tubing at SCHOTT. SCHOTT offers pharmaceutical glass tubing products & services to customers world-wide from its five production sites in Europe, South America and
Bureau of Indian Standards (BIS) recognizes SCHOTTs expertise in pharmaceutical glass manufacturing Decision rewards companys strong commitment to international Good Manufacturing Practice (GMP) standard One of only two international companies invited as members of the Committee for Chemicals SCHOTT achieves uniform quality standards over last 25 years
Asia, including the one in Jambusar, Gujarat which serves the Asia region. Well positioned in Indias growing pharma market According to several studies, the pharmaceutical market in India is expanding by approximately 14 to 17 percent per year. Expansion will continue to be driven by demand from Indias prospering middle class. The government also supports this development financially: It plans to set up a 639 million US$ venture capital fund to boost drug discovery and strengthen the pharmaceutical infrastructure. The packaging market is expected to grow in line with the overall pharma market by about 11 percent annually. SCHOTT KAISHA is confident of exceeding overall market growth also in the future. The Indo-German company offers a complete range of primary tubular glass packaging: Products comprise ampoules, vials, cartridges for pen and auto injectors as well as sterile pre-fillable glass syringes. Since its formation in 2008, SCHOTT KAISHA has achieved steady, profitable growth. As a result, the 50:50 joint venture today employs about 1,600 people in its plants in Daman and Jambusar and its Mumbai office. GLOBAL PHARMA
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The company was established in 1997 as a premium manufacturer of pharmaceutical containers made of neutral glass in India under the name KAISHA Manufacturers Pvt. Ltd. In 2008, it started a cooperation with SCHOTT, an international technology group and one of the worldwide leading manufacturers of pharmaceutical packaging with headquarters in Mainz, Germany. SCHOTT Pharmaceutical Packaging operates under the brandname SCHOTT forma vitrum. Today, SCHOTT KAISHA is a leading supplier for pharmaceutical industry offering a one stop shop solution for the entire range of small volume tubular glass parenteral packaging including ampoules, vials, cartridges and sterile prefillable syringes. At SCHOTT KAISHA, we dont for a moment forget the sanctity of the business we are in: The business of packaging healthcare, and of carrying precious medicines to millions, spreading hope and often, saving lives. Our responsibility becomes that much larger because we have over 5 million ampoules, vials, cartridges and syringes leaving our factory daily each on its own mission of healthcare. Naturally, if we have been given this responsibility by some of the most discerning pharmaceutical companies in the world, it is because they realize that we have adopted the most advanced concepts of manufacturing in India. We have systems and quality norms that fall in line with international guidelines (ISO 9001) and technologies that can keep pace with their demands. And a spirit of innovation that constantly looks at newer forms of value addition and higher forms of customer delight. No wonder then, that our clients see us for what we really are: a partner committed to their own standards of healthcare. Further, in co-operation with SCHOTT Pharmaceutical Packaging we offer innovative solutions like SCHOTT Type I plus - Coated vials for sensitive drugs SCHOTT TopLyo - Pharma Packaging for Freeze-Dried Drugs SCHOTT TopPac - COC prefillable syringes
About SCHOTT KAISHA

With a single promise we would like to begin our association: The way you make your products is the way we make the packaging. SCHOTT Forms Pharmaceutical Packaging Joint Venture in India - 01Dec-2008 SCHOTT Forms Pharmaceutical Joint Venture in India SCHOTT AG and KAISHA Manufacturers Private Ltd., an Indian company, announce the formation of a joint venture, SCHOTT KAISHA Private Ltd. SCHOTT AG and KAISHA Manufacturers Private Ltd., an Indian company, announce the formation of a joint venture, SCHOTT KAISHA Private Ltd. The new joint venture will manufacture primary pharmaceutical packaging made of glass for the Indian market. The joint enterprise will have operations in Mumbai and Daman. With this double-digit million euro investment, SCHOTT continues on its course to growth and quality leadership. Additionally, we are securing our access to a very promising market, says Professor Udo Ungeheuer, Chairman of the Board of Management of SCHOTT AG. SCHOTT, the technology group based in Mainz, Germany, will hold a 50 percent share in the company and contribute its technological expertise in manufacturing high quality ampoules, vials, syringes and cartridges in a global environment. KAISHA will bring in its existing sites and manufacturing capacities. SCHOTT and KAISHA have worked successfully for many years in a buyer-supplier relationship. SCHOTT supplied the pharmaceutical glass tubing to Kaisha for converting them into primary pharmaceutical packaging products. KAISHA is considered to be a quality leader in the Indian market with sales of 11 million euros in 2007. For independent converters that have been supplied with SCHOTT glass tubing for pharmaceutical primary packaging by the SCHOTT Tubing division, the well established supplier relationships will not be compromised.
SCHOTT Tubing has proven in other regions of the world that fair supply and support can be made available simultaneously for SCHOTT owned and independent converters to the mutual benefit of all involved parties. There is no reason why this should not be possible in India, underlines Mohan Joshi, president of SCHOTT India. The pharmaceutical packaging market in India is growing by approximately 10 to 15 percent per year, particularly in the higher quality segments, according to industry analysis. India has the largest number of U.S. Food and Drug Administration approved plants outside of the United States, for example. The joint venture will support Indian pharmaceutical companies in upgrading products for international markets by supplying pharmaceutical packaging at an international quality level from the Indian production site. For this purpose, SCHOTT KAISHA will build production capacity for StandardLine ampoules and vials, which will be in production in the fourth quarter 2009. The joint venture combines KAISHAs local market expertise and access to customers with the technological know-how of SCHOTT, explains Kairus Dadachanji, Managing Director
SCHOTT Forms Pharmaceutical Packaging Joint Venture in India - 01Dec-2008

of SCHOTT KAISHA. The company expects to see a quick increase in manufacturing capacity. The number of employees will grow in line with the companys growth. Over the next 15 to 18 months, our Indian customers and the market will begin to experience the positive effects of this cooperation, Dadachanji says. Thanks to the close proximity to our customers and our high standards for quality, SCHOTT KAISHA will support the Indian pharmaceutical industry on the way towards reaching international quality standards as a strong partner. April 2013
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Ampoules
Cover Story
Delivering total customization
SCHOTT KAISHAs after-forming line has some excellent capabilities for customization. We are equipped with the technology and infrastructure to offer you FBCN Ampoules, Ceramic Snap-break Ampoules, Colour Identification Band, Flame Cut Ampoules, and Marzocchi Ampoules. By feeding in your requirements, we can give your ampoules a colour identification band, a colour break band, or both. We can also give you the option of a one-point cut (OPC); the difference being, we can control the depth of the cut into the glass surface. For clients who want the ampoules in a ready-to-use condition, we can provide closed ampoules under the rota system (Form D).
30 station ampoule forming machines help achieve a production capacity of 3 million ampoules per day
One-point cut ampoules Ceramic printed ampoules FBCN ampoules (Flat Based and Constricted Neck) Flame cut ampoules Closed ampoules (Rota / Marzocchi Ampoules) Ampoules with colour break band and identification bands
Moreover, our online ceramic printing will ensure the fine reproduction of your logo. Our online annealing imparts uniform distribution of heat to each ampoule individually, thereby relieving the ampoule from all stress. At the end of the after-forming line, you have sophisticated robotics calibrating and arranging the ampoules into batches, as per their specifications.
Manufacturing technology
30 station ampoule forming machines imported from France State-of-the-art production lines from Italy and electronically-led after-forming line for ampoules All cutting, glazing, checking, annealing and packing of the ampoules is done in a continuous process Computerized controls and in-built camera ensures close monitoring of the production process and strict adherence to specifications Powered with a unique selfcorrecting system (Electronic sensor picks up variants and adjusts the flame accordingly) Tailor-made ampoules as per your specifications Fully integrated, fully automated ampoule production
Robotic batch sorting April 2013
The modern ampoule forming machines at SCHOTT KAISHA are equipped with a unique self-correcting facility, whereby should the thickness of glass vary from one station to another, an electronic sensor immediately picks up the variant and adjusts the flame automatically. This ensures a high degree of uniformity and strict adherence to the specifications desired.
GLOBAL PHARMA
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Cover Story
High quality ceramic printing for a lasting impression
Range of ampoules from 1 ml to 25 ml
An electronically led stem control system ensures the perfect consistency of the stem, thereby enabling smooth filling and sealing
Electronically controlled after-forming-line
From plain necks to screw necks to lyophilized to siliconised vials

At SCHOTT KAISHA, the whole mindset is geared towards producing flawless quality. We live by that old axiom: if you dont look good, we dont look good. This explains why we bring the same quality norms to the manufacture of vials. And why, after manufacture, we check and recheck the vials on all counts from internal and external diameter, to lip height and length. Despite in-built checks in the manufacturing process, we also check the vials manually, in air-conditioned rooms, for optimum efficiency. Due to our strong focus on quality, we retain a highly skilled workforce dedicated to quality control and inspection. And, we are amongst the only pharmaceutical vendors in India to provide an analytical certificate, as a mark of confidence in our packaging.
Tubular Vials
Installed capacity for more than 700 000 vials per day
Tubular vials: plain and screw necks In-built checks in the manufacturing process Stringent checks: internal and external diameter, lip height and length
Camera inspection for vials
Broad range of vials from plain neck to screw neck

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GLOBAL PHARMA
April 2013
SCHOTT KAISHA offers prefillable syringes in sterile tub packs under the brand name of Safepac and non-sterile bulk syringes in rondo trays. They range from 0.5 ml to 5.0 ml with a variety of options and customizations as per your product and marketing requirements.
Glass Prefillable Syringes
Cover Story
Syringe Systems
0.5 ml with Luercone / Luer Lock or Staked Needle 1.0 ml Long with Luercone / Luer Lock or Staked Needle 1.0 ml Std, 1.25 ml with Luercone / Luer Lock or Staked Needle 2.25 ml with Luercone / Luer Lock or Staked Needle only 3.5 ml & 5.0 ml with Luercone / Luer Lock
Syringes are available in sterile and non-sterile form
Options
0.5 ml & 1.0 ml Long offered in 100 & 160 nest pack Bulk Pack and nested rubber plungers Flexible and Rigid Needle shields (L-1/2/5/8/1) Needles offered in Lancet point and Five cut point Custom printing on syringes as per your requirement Compliance with international standards Clean room technology State of the art equipment
Safepac sterile syringe systems
SCHOTT KAISHA offers you flexibility and customization as per your needs.
April 2013
GLOBAL PHARMA
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SCHOTT in India
About SCHOTT India

In 2008, SCHOTT formed a 50:50 Joint Venture with Kaisha Manufacturers Pvt. Ltd. for the manufacturing of pharmaceutical ampoules and vials. SCHOTT Pharmaceutical Tubing in India
SCHOTT Glass India Pvt. Ltd. has been present in India since 1998 when SCHOTT took over a company producing pharmaceutical tubing
tubing at the highest international standards directly in India. This plant in Gujarat is SCHOTTs only FIOLAX manufacturing site in Asia. It functions as a production hub for the entire region, underpinning SCHOTTs role as Asias leading supplier of special glass tubing. SCHOTTs Indian facility supplies pharmaceutical tubing to all major pharmaceutical packaging manufacturers in India and Asia. They then transform FIOLAX into end products such as ampoules, vials or pre-fillable syringes.
in Jambusar district in the State of Gujarat. This plant now functions as a production hub for SCHOTT pharmaceutical tubing for Asia. In the same year, SCHOTT set up a sales office in Mumbai to offer specialized products for other markets such as Electronics, Consumer Appliances, Optics and Speciality Tubings. Today, SCHOTT through its 100% subsidiary in India has one manufacturing site in Gujarat and two sales offices in Mumbai and Pune. The main businesses for the sales office come from Solar Photovoltaic, Electronic Packaging, Optics and Speciality Technical Tubing. The sales office is actively working with customers in other growing areas such as kitchen appliances, refrigeration displays for super markets and receiver tubes for solar thermal applications. About 350 people work on the production site and intwo sales offices. To provide the Indian pharmaceutical industry with high quality tubing, SCHOTT has completely modernized the production technology to SCHOTT standards and also expanded its production capacity. In 2006, SCHOTT installed a new tank to produce SCHOTT FIOLAX tubing on site. Two years later, a further high technology tank was set up for additional production of pharmaceutical tubing.
SCHOTT has been a strong supporter to Indias rapidly growing pharmaceutical
industry since the onset of economic reforms. In 1998, the company entered the Indian market by an acquisition in Jambusar district (Gujarat) and developed this plant to a model manufacturing site for pharmaceutical tubing. Responding to the extraordinary demand of the Indian market, in 2006, SCHOTT installed a new high technology tank to produce FIOLAX tubing. Two years later, a second tank was set up to boost production further. SCHOTT is the only supplier to produce premium customized glass
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April 2013
SCHOTTs Assurance of Reliability and Quality

FIOLAX glass tubing for pharmaceutical packaging
FIOLAX
Cover Story
With a proven track record of more than 100 years, FIOLAX today is the worlds most frequently used glass tubing for manufacturing primary pharmaceutical packaging. Pharmaceutical containers made of FIOLAX are characterized by outstanding chemical resistance, neutrality and impermeability. Ampoules, vials, cartridges, or syringes, made of FIOLAX provide safety to all kinds of sensitive pharmaceuticals, generic drugs and modern biotech medicines. Manufactured on the basis of over 125 years of experience in working with special glass materials and production technology, FIOLAX is known for its extremely high cosmetic and geometric quality. FIOLAX is very durable and resistant to mechanical effects, resulting in the lowest possible glass defect rates and geometric tolerances. This quality gives SCHOTTs customers the benefit of cost-effective, stable, automated processing with high production speed, high yield and a very low reject rate. SCHOTTs FIOLAX is a borosilicate glass, known for its high chemical resistance and optimized specifically for use in pharmaceutical packaging. It April 2013
can be sterilized rather easily and features excellent barrier properties for sensitive drugs. Because of its low alkali content and optional UV protection, it preserves a medicines effectiveness for the required time duration. To meet the quality requirements, SCHOTT developed an information and tracking system for FIOLAX that offers customers precise information on important manufacturing, material and quality parameters for every ordered batch. All details of the production process are tracked from the very start of production and are available for a period of ten years from the date of manufacturing. SCHOTT FIOLAX is more than a top product and a premium brand. With its FIOLAX Academy, SCHOTT also offers its trade partners a complete technical and scientific customer advisory service for the entire value creation chain. In special training programs, conducted regularly in
India, experts provide information on the composition, properties and production of pharmaceutical glass tubing. Special topics such as drugcontainer interaction, adsorption, chemical resistance and the stability of packaging and freeze-drying of certain pharmaceutical agents are also covered. Similarly, international regulations and standards for the pharmaceutical industry are discussed at the FIOLAX Academy. SCHOTT manufactures FIOLAX in Germany, Spain, Brazil and India. Due to its uniform worldwide quality standards the products delivered to customers are always of the same quality, irrespective of the production site. Each year, SCHOTT manufactures around one million kilometers of pharmaceutical tubing that is 25 times the circumference of the earth. GLOBAL PHARMA
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Pharma Management
Pharmaceutical companies boosting support for Interpols fight against fake prescription drugs
Washington, 12 March, 2013: ore than two dozen of the worlds largest pharmaceutical companies have agreed to provide funding and other support to Interpols battle against counterfeit prescription drugs, the international police agency said Tuesday. Interpols newly created Pharmaceutical Crime Program aims to help health agencies, police and customs bureaus in countries around the globe stem the supply of bogus brand-name and generic medicines, as well as identify and dismantle the organized crime rings distributing them. Those rings, which operate across borders, are raking in billions of dollars every year, costing legitimate drugmakers a small fortune in lost sales. Meanwhile patients who unknowingly take counterfeit drugs often are poisoned or get sicker because theyre not receiving what the doctor prescribed. Experts estimate hundreds of thousands of people around the world die because of counterfeit medicines each year. The pharmaceutical companies have pledged a total of (EURO)4.5 million, or nearly $5.9 million, over three years to help Interpol with efforts including training local law enforcement officials on investigative procedures, evidence handling and how to better work with partners outside their countries. GLOBAL PHARMA 22
Interpol also will help those authorities build up their infrastructure and target enforcement actions against crime rings that make and sell fake drugs, and also divert medication illegally to countries where its not approved. We will develop a program according to what is best for the international community and what will save lives, Aline Plancon, head of Interpols counterfeiting and pharmaceutical crime program, told The Associated Press in an exclusive interview. Its been difficult for us as Interpol to sustain our activities against counterfeiting over the years, she said, because the agencys limited resources also are needed for areas the international community sees as more serious crimes. Those include human trafficking, narcotics dealing, terrorism and money laundering. Besides the financial support, the pharmaceutical companies, most of which spend millions on their own investigations to fight counterfeiting of their medicines, will step up sharing with Interpol the intelligence they uncover.
Plancon said her agency, based in Lyon, France, plans to better coordinate its work and collaborate with its member countries. Interpol also will run pilot projects, experimenting with new strategies to find ways to be more effective. The industry support forms a bridge between the public and private sectors and will assist Interpol and
each of its 190 member countries to more effectively tackle the problem of medical product counterfeiting, Interpol Secretary General Ronald K. Noble said in a statement. The World Health Organization estimates sales of medicines that are counterfeit, contaminated or otherwise illegal total $430 billion a year. In developing countries, up to 50 percent of the drug supply may be fake. Thats many times more than in developed countries, where most April 2013
Pharma Management
potentially dangerous fake drugs are sold through rogue Internet pharmacies, but counterfeit drugs increasingly are getting into the supply of pharmacies and hospitals. In the U.S., for example, three times in the last year counterfeit versions of the Roche Group cancer drug Avastin have infiltrated the wholesale supply and been sold to cancer clinics and hospitals. An unknown amount of those fakes was administered to patients. And in Pakistan last year, 109 heart patients died after taking counterfeit medicine. The 29 companies supporting the effort include Amgen Inc., AstraZeneca PLC, Eisai Co., GlaxoSmithKline PLC, Johnson & Johnson, Eli Lilly and Co., Merck & Co., Novartis,AG, Pfizer Inc., Roche Group and Sanofi SA. John Lechleiter, chairman of the trade group Pharmaceutical Research and Manufacturers of America and CEO of Lilly, said Monday that the new program will supplement Interpols existing efforts. Counterfeiting activity is evolving so rapidly and becoming more common, he said. As a result, one thrust of the program will be to try to more quickly spot new trends in which drugs are being counterfeited, where the crime rings are based and where they are distributing fake medicines, Lechleiter said. This is really meant to cement some of these efforts together, he said. After the initial (three-year) period, depending on the results, we can certainly extend that out.
European Union bans cosmetics with animal-tested ingredients
No
Brussels, 11 March, 2013 new cosmetic product sold in Europe can contain ingredients tested on animals, thanks to a European Union (EU) ban introduced on Monday.
decided four years ago but initially left loopholes for certain tests following resistance from cosmetics companies. Animal rights groups such as Humane
at odds with its own goal of fostering a knowledge- and science-driven economy.
This is a great opportunity for Europe to set an example of responsible innovation in cosmetics without any compromise on consumer safety, said Tonio Borg, the top official on health and consumer issues for the 27-country of EU. Animal rights groups were quick to cheer the measure, but Cosmetics Europe, a trade body representing the EUs (EURO) 71 billion ($93 billion) industry, said the ban acts as a brake on innovation. While the industrys rabbits, mice or guinea pigs used in testing will now be spared, consumers are unlikely to notice immediate changes because products containing ingredients that were tested on animals before the ban can remain on the shelves. The 27-country blocs executive arm, the European Commission, claimed the decision is in line with what many European citizens believe firmly: that the development of cosmetics does not warrant animal testing. The EU has banned animal testing of finished cosmetic products since 2004. The ban on cosmetics containing animal-tested ingredients was first Society International cheered the EUs decision on the full ban as a major step in stopping animals suffering, saying the bloc has now become the worlds largest cruelty-free cosmetics market. The group also said it hopes the course taken by the EU - whose nations combine form the worlds biggest economy - will soon be replicated by the global cosmetics industry. The industrys European trade body, however, maintained the ban threatens the industrys competitiveness and comes too early because there is still no alternative for several specific animal tests to ensure all the ingredients safety. Cosmetics Europe chief Bertil Heerink said by implementing the ban at this time, the European Union is jeopardizing the industrys ability to innovate, putting the 27-country bloc
The sectors European cosmetic companies had 2010 revenues of (EURO) 71 billion, directly employing some 180,000 people, according to the EU Commission. The Commission stressed it will engage with its trading partners - for example the United States or China to explain and promote the European model and to work towards the international acceptance of the ban. The Commission will make this an integral part of the Unions trade agenda and international cooperation, it said. The EU and the U.S. are currently launching negotiations aiming at reaching a free-trade agreement. New cosmetic products manufactured outside the EU containing ingredients that were tested on animals could still be sold in Europe, but only if producers are able to document their safety to EU regulators without using data gathered through animal tests, said EU health official Sabine Lecrenier. Cosmetic products that contain pharmaceutical ingredients that have been tested on animals because of the EUs rules governing pharmaceutical products can also still be marketed in Europe.
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Pharma Management
NEW DELHI, 12 MARCH, 2013: The Supreme Court has set aside a Delhi High Court order asking the government to amend the rules to classify allnon life-saving drugs and cosmetics as vegetarian and nonvegetarian with V and NV labels, respectively. The High Court had in November last directed the central government to amend its rules to mark drugs and cosmetics with V and NV labels in spite of the Centres contention that it was not desirable to do so in public interest. The court had asked the Centre to exempt lifesaving drugs from carrying these labels. It was acting on a PIL that sought to press upon the right of a citizen to know the ingredients of all drugs and cosmetics. A Supreme Court bench last week set aside the High Court order, saying the rules do not envisage this. It also noted
No need for non-veg, veg labels on drugs and cosmetics: SC
that an expert body had advised against it. Justices GS Singhvi and SJ Mukhpadhaya, in their order in Civil Appeal No. 5644 of 2003, Indian Soaps and Toiletries Makers Association vs Ozair Husain and others decided on 7th March, 2013, said it was not an area that was left uncovered by the law and hence the High Court could not have directed the executive to exercise its power to change a law. Opposing the labels, the Centre had said that if you accept that a citizen has the right to know the origins of a drug or cosmetic, a vegetarian could also claim information about the origin of a vegetarian ingredient, depending upon his food habit. Food habit in India varies from person to person and place to place. Religion also plays a vital role.... Those who follow Jainism are vegetarian but many of them dont eat some vegetarian food such as potato, carrot, onion, garlic, etc, grown below the earth. Majority treat honey and lactose as vegetarian but scientists treat them as non-vegetarian products, it said. Also, there are egg-etarian who eat egg but no meat or fish. Even amongst non-vegetarians, a large number of persons do not take beef or ham/pork because of religious belief-...many nonvegetarians do not eat snakes, insects, frog or bird, the Centre said. It will be difficult to specify the origin of a vegetarian or non-vegetarian ingredient, if a person wants to know its definite origin to suit his food habit.
Poor growth of anti-infective segment remains a concern for pharmaceutical sector

New Delhi, 13 March, 2013:
he latest growth numbers released for the month of February 2013 do not hold good news for the Indian pharma industry. According to data compiled by PharmaTrac, the anti-infective segment, which has been growing at a poor single digits rate since the last couple of quarters, has grown by 5% during February. This is worse than the 6.9% growth reported by the segment in the preceding month of January. As a result, the industry growth slowed down to over 7% in February from 9.8% in January. The growth rates this year while being lower, are still better than no growth seen in the month of December 2012 that greatly pulled down the segment growth for the year 2012 to 11.7%.
Most industry players considered the performance of the segment during the month of December to be an aberration - which seems to be the case, given the fact that growth rates did pick up after D e c e m b e r. However, the current growth rates of the segment are still lower than the historical growth rates of 12-14%. Anti-infective is the largest category in the Indian pharmaceutical market, constituting nearly 18% of the industry
revenues. The slowdown in this segment has impacted the growth
rates of most pharma companies earning significant revenues from the domestic pharma. April 2013
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GLOBAL PHARMA
Pharma Education
US Prescribing Information & Safety Labeling
Course Overview
Participants will analyze the structure and main intricacies of US Prescribing Information and US Safety Labeling in particular. Special focus is on the understanding of the underlying principles that shape US Prescribing Information and should drive decision making by the sponsor and FDA but are not always readily visible in 201.57 and FDAs labeling Guidances. Learn key aspects of FDAs actions and reactions Course Director Dr. med. A. Leander Fontaine President Pharmaceuticals LLC
Who Should Attend

Managers and Professionals involved in creation and maintenance of US Prescribing Information Professionals involved in Core Labeling and US implementation Regulatory Affairs Professionals Pharmacovilance Professionals Medical/Clinical Professionals Lawyers
Educational Objectives:
Explain which criteria govern the inclusion of information into the various sections in the hierarchy of safety sections Describe the FDAs guiding principles for identifying adverse reactions for the purpose of labeling Restate FDAs guidance for selecting risks for inclusion in Warnings and Precautions and when to contraindicate Assess when to accept safety information based on experience with similar products Explain necessary deviations from Company Core Safety Information (CCSI), if elements of CCSI are not compatible with US labeling expectations Compose an informative highlights section
Practical exercises, performed in small groups, will deepen the understanding of these principles in order to draft more compliant labeling and better understand FDAs actions and reactions. The workshop includes several detailed presentations by the instructor.
For more info contact,
Benefits of Attendance
Identify the structure and main intricacies of US Prescribing Information Gain hands on experience through development workshops Understand principles in order to draft more compliant labeling April 2013
The Pharmaceutical Education and Research Institute

1616 North Fort Myer Drive Suite 1430 Arlington, Virginia 22209 USA (703) 276 0178 1 (703) 276 0069 registrar@peri.org http://www.peri.org GLOBAL PHARMA
25
Pharma Education
Pharmaceutical training in India in Drug Regulatory Affairs, Pharma Quality Management, Patents and Clinical research-IPM
ICH Quality guidelines - Q1,Q2,Q3, Q6 and Q7. Dossier preparation in CTD format. Regulatory Systems in US, ANDA submissions, handling post approval changes. Regulatory Systems in Europe, filing procedures, handling variations. Drug Registration with semiregulated countries. Handling deficiencies from Drug Regulatory Authorities. eCTD submissions GMP audits Patents from regulatory perspective. Post-graduate Diploma in Drug Regulatory Affairs - API Introduction to RA profession. ICH Quality guidelines - Q1,Q2,Q3, Q6 and Q7. DMF preparation in CTD format. API-Regulatory submissions to USFDA, changes to DMF. API-Regulatory submissions to EDQM & EMEA, revisions and renewals. API-Regulatory submissions to WHO, Brazil, Canada and Japan. Handling deficiencies from Drug Regulatory Authorities. eCTD submissions GMP audits. Patents from regulatory perspective. Quality Management Pharmaceutical Quality system Chromatographic techniques ICH quality guidelines Q1,Q2,Q3, Q6 and Q7 Material Management Documentation control Production and Laboratory Controls Qualification and Validation Change Management system Market Complaints and recalls GMP audits Patent laws These courses are specially designed for M.Sc/ B. Pharm and working professionals. Introduction to IPR and Patents International treaties Definitions and content of Patent systems Indian Patent laws US and Europe Patent regime Enforcement, Exploitation and Abuse of Patents
nstitute of Pharmaceutical Management (IPM) is a pioneering institution for pharmaceutical training in India in Drug Regulatory Affairs, Pharma Quality Management, Patents and Clinical research. Escalating efficiency of Pharma Aspirants by: Offering Classroom, On-site and Distance participation programmes. Providing education in Regulatory Affairs, Patent Laws, Quality management, Clinical Research. Fostering exchange of information and experience. Regulatory Affairs courses for working professionals These courses are specially designed for working professionals. Freshers may also enroll. 1. Post Graduate Diploma in Drug Regulatory Affairs (API & Formulation) 2. Post-graduate Diploma in Drug Regulatory Affairs - Formulation 3. Post-graduate Diploma in Drug Regulatory Affairs - API Post Graduate Diploma in Drug Regulatory Affairs (API & Formulation) Introduction to RA profession. ICH Quality guidelines - Q1,Q2,Q3, Q6 and Q7. DMF preparation in CTD format. API-Regulatory submissions to USFDA, changes to DMF. API-Regulatory submissions to EDQM & EMEA, revisions and renewals. API-Regulatory submissions to WHO, Canada and Japan. Dossier preparation in CTD format. Regulatory Systems in US, ANDA submissions, handling post approval changes. Regulatory Systems in Europe, filing procedures, handling variations. Drug Registration with semiregulated countries Handling deficiencies from Drug Regulatory Authorities. eCTD submissions GMP audits. Patents from regulatory perspective. Post-graduate Diploma in Drug Regulatory Affairs - Formulation Introduction to RA profession.
Patent drafting, Litigation and Enforcement with case-laws discussion Commercialization and licensing Search for prior art for various Patent systems Patent opposition with examples Quality Operations and Regulatory Affairs This course is specially designed for Pharmacy undergraduates and graduates. It gives an overview of QC, QA and RA departments and bridges the gap between Academics and Industry. An overview of pharma industry Quality Operations and relevant documentation Analytical instruments and applications in Pharma industry ICH Quality guidelines an overview Production controls Research and development of API and Formulation Validation Studies- concept and types Regulatory submissions to USFDA DMF and Dossier submissions Clinical Research Introduction to clinical research & Phases in Clinical Research ICH-GCP Schedule Y Fundamentals of clinical operations Basics of pharmacy Drug discovery & development Statistics Preclinical studies Clinical data management Clinical studies: pharmacokinetics, bioavailability & bioequivalence GMP as per ICH Q7 or EU guidelines Preparation of various documents like SOPs, site master file, validation protocols, batch manufacturing records, specifications, analytical methods etc. ICH quality guidelines Q1, Q2, Q3, Q6 & Q7 Qualifications of vendor, equipments, instruments etc. Validations of analytical, Process, Cleaning methods, water system Calibrations Analytical instruments, equipments Change controls, deviations, CAPA Production and laboratory controls April 2013
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Pharma Education
OOS, OOT Annual Product Review Market complaints, recalls Preparing for regulatory inspections Preparing response of inspectional observations, FDA 483s etc. Compliance by Process Design As you plan for Regulatory submissions in 2012 and beyond, you need to retool R&D with current techniques. The need of fresh approach to Product & Process Development is underlined by ICH Regulatory Guidelines Q8, Q9, Q10 & Q11. The current thinking brings in new concepts like Statistical Process Control, Design Space, Failure Mode & Effects Analysis in R&D portfolio. An improved approach to the process and product development envisages that quality can be planned and built into product. The concept also makes business sense! I offer onsite training and support on implementation of these concepts. FDAs Centre for Drug Evaluation & Research (CDER) has been encouraging use of this Quality by Design principle in manufacturing. The desired state for pharmaceutical manufacturing in the 21st century is expected to have emphasis on knowledge on design and understanding of product & processes involved. Thus, manufacturing has to evolve from Quality by Inspection to Quality by Design. FDAs recent guideline on Process Validation (Jan 2011) clearly underlines this paradigm shift and mandates its implementation. Though the new concept has taken a decade to come to a head, it has benefits to offer as all functions from Procurement to Marketing need to be integrated right from development phase. Some of the benefits : Reduced time to market speed of implementation. Ease of process validation. Smooth commercialisation of the process. Robust cGMP compliance. Reduction in manufacturing cost. With QBD becoming mandatory for regulatory filings, only those complying with it will survive. However, the focus of QbD implementation has mainly been Drug Product and issues related to API development and manufacturing are rarely addressed. It will need a complete understanding of the workings of interconnecting functions, process chemistry and unit process operations to assemble a working QbD approach into API process development. It necessitates a change in work style of team members. Training needs money & time but if you dont you are likely to spend more time and money. Together, we can develop a platform as a foundation for future development. For More Info Contact, Institute of Pharmaceutical Management, A2, 4th Floor, Room no 409, Kasturi Plaza, Manpada Road, Near Railway Station, Dombivli (East), Dist. Thane, Maharashtra, India. Office Landline: +91251-2860207 Mobile :+91 9320049805 / 9619301401
Established in 1927, FICCI is the largest and oldest apex business organisation in India. Its history is closely interwoven with Indias struggle for independence and its subsequent emergence as one of the most rapidly growing economies globally. FICCI plays a leading role in policy debates that are at the forefront of social, economic and political change. Through its 400 professionals, FICCI is active in 44 sectors of the economy. FICCIs stand on policy issues is sought out by think tanks, governments and academia. Its publications are widely read for their in-depth research and policy prescriptions. FICCI has joint business councils with 79 countries around the world. A non-government, not-for-profit organisation, FICCI is the voice of Indias business and industry. FICCI has direct membership from the private as well as public sectors, including SMEs and MNCs, and an indirect membership of around 2,50,000 companies from regional chambers of commerce. About Course Federation of Indian Chambers of Commerce and Industry (FICCI) is conducting an Online Certificate Course on IPR and Pharmaceutical R&D. April 2013
Opportunity to join Online Certification Course on IPR and Pharmaceutical R&D (CCIPR) by FICCI
Objective: To provide the platform to understand the working of pharmaceutical industry, its business models, research, regulatory aspects and its relevance with respect to intellectual property rights. Importance Of The Course: Pharmaceutical industry is a research based industry and requires scientists in huge numbers every year. The growing pharmaceutical R&D operations fuel the need for understanding IPR (Intellectual property rights) for pharmacy graduates and those in research. IPR is important in this era of globalization and competition. The current academic syllabus of pharmacy courses do not provide adequate knowledge about the research activities in the pharmaceutical industry, the business models, intellectual property rights and their relevance in research (Pharma R & D) and business environment which is global and highly competitive. This course is aimed to fulfill these requirements and is designed for pharmacy students and junior level scientists in the pharmaceutical industry. Eligibility/ Who Should Register Any student in pharmacy/
pharmaceutical sciences faculty doing (B.Pharm, M. Pharm, PhD). Pharmaceutical industry persons (junior levels). Those interested in career in pharmaceutical research from the faculty of Medicine, Biotechnology, Chemistry, Biosciences, Sciences, Life sciences and others. Those willing to enter Pharmaceutical R & D, Formulations, Generics, NDDS, Regulatory affairs, Drug discovery, Clinical research, Toxicology, International Business, Business strategy and the like. Online Examination: The applicants will be required to give an online examination at the end of the 6 months duration, which will consist of Multiple Choice Questions (MCQs). The Online Examination will be of 150 marks. The dates will be notified by FICCI.
Federation of Indian Chambers of Commerce and Industry (FICCI) Federation House, Tansen Marg, New Delhi - 110 001 E-mail: ipcourse@ficci.com Contact Numbers: 011-23487477, 23766930 GLOBAL PHARMA
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Health
If
Mamata Banerjee battles for generic drugs
items from us. Else we wont sell the item you need, an employee of a shop in the vicinity of SSKM was quoted as saying by a patient who went there to buy a medicine that was not available in the fair price outlet. There have been reports of patients relatives having been forced to buy all the items afresh from private shops to save their near outlet and asked the health officials to initiate action. Despite repeated orders, some of the doctors are not prescribing generic drugs. They have been given a list of drugs available at such outlets. But they are deliberately prescribing other branded medicines. We have collected all evidences against such doctors. We will take proper action, said the chief minister before walking down to five private medicine shops close by to warn them not to trouble patients who have purchased drugs from the fair price outlet at the SSKM Hospital. As Banerjee confronted private shop owners and their employees with queries about their noncooperation with patients and sought explanation, they turned clearly nervous and promised not to repeat their mistakes. Later, she told reporters: I have told them loud and clear whatever I had to say. I hope this will produce results. Otherwise, we have to take strong action. Following the state governments push for generic drugs to replace expensive branded medicines and bring down the prices of essential drugs, the Bengal Chemists and Druggist Association an umbrella body of chemists with 35,000 members hit the streets in January. They held a rally by closing their shops and gave a deputation to the chief minister protesting against the opening of fair price shops. April 2013 Kolkata, 16 March, 2013: you dont cooperate with patients, we wont tolerate that. We will cancel your licence, the stern warning from West Bengal Chief Minister Mamata Banerjee left the middle-aged chemist trembling on the other side of the sales counter. Turning up unannounced at a private pharmacy close to the state-run SSKM (Seth Sukhlal Karnani Memorial) Hospital, Banerjee said she had received specific complaints that the shop was turning away patients who had purchased medicines from the fair price outlet in the premises of the hospital. The Banerjee government has initiated the process of introducing generic medicines in state-run hospitals by opening 32 fair price pharmacies through public-private partnership (PPP). These outlets are selling generic drugs at highly rebated price. However, people have been complaining that several private medicine shops are flatly refusing to sell medicines to those who have bought some of the drugs from the fair price outlets. Although the fair price pharmacies are supposed to keep stocks of 142 generic medicines, some of the prescribed drugs are seldom found there forcing people to buy them from private shops. Forget about the fair price shop. Throw away the medicines you have purchased from it. Buy all the
ones. Such complaints also reached Banerjee, who decided to make a surprise visit accompanied by senior officials and city Police Commissioner Surojit Kar Purkayastha. Her first stop was the fair price outlet at the SSKM Hospital. She spoke to some of the customers, and was told that even after standing in queues for hours, they did not get all the drugs. The chief minister then asked the outlet officials whether all the 142 generic drugs were available. Another complaint was that some doctors in state-run hospitals were not prescribing generic medicines. Banerjee took photocopies of such prescriptions from the fair price
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JAIPUR, 11 MARCH, 2013: he range of free medicines, especially for cancer and heart patients, provided under the chief ministers free medicine scheme will be increased at government hospitals to benefit a large number of patients.
Number of free drugs set to increase

there are medicines which are costly if bought from the market. These medicines will be free for patients of government hospitals. It will benefit especially the underprivileged people who find it difficult to buy costly but life saving medicines, RMSC managing director Dr Samit Sharma said. The RMSC has started the tender process to procure the medicines. Chief minister
Health
Costly life saving drugs, urokinase injections and surfactant for
Moreover, while preparing the list, the RMSC has focused on infants too. The surfactant for intrarecheal instillation (natural bovine lung surfactant), will be made available free for infants. It reduces mortality among low birth weight and immature infants. RMSC officials said infants with low birth weight mostly die of respiratory failure. Also drugs including domperidone oral drops and lactic acid bacillus tablets will be made available free for treatment of gastrointestinal problems among children. There is also a long list of costly anti-cancer medicines which will be available free. Among the medicines (injections) are alpha interferone, carboplatin, cisplatin, dacarbazine, filgrastim, gemcitabine, ifosfamide, imatinib tablets and some other drugs. The imatinib tablets are one of the important drugs for blood cancer treatment. The official said 10 tablets of the medicine costs Rs 2,000 to Rs 3,000 in the market. It is used in treatment of chronic mycloidleukaemia, acute lymphoblastic leukaemia and mastocytosis. Alpha interferon injection is also an important drug for cancer like myelogenous leukemia, multiple myeloma, and hairy cell leukaemia. For dental care, chlorhexidine mouthwash, dental gel, eesensitizing tooth gel with sod mono fluoro phosphate, gum paint containing tannic acid and metronidazole have been included in the free drugs list. For respiratory problems, rotocaps including combination of formoterol and budesonide rotocaps, budesonide rotocaps and Ipratropium rotocaps, are included. GLOBAL PHARMA
intratracheal instillation are also in the list of 200 medicines which has been prepared by the Rajasthan Medical Services Corporation (RMSC) to be included in the existing list of 400 free drugs under the free medicine scheme. Urokinase injection is administered to a patient within few hours of the first symptoms of a heart attack, a RMSC official said. The price of the injection is quite high in the market. The RMSC also claimed that majority of the medicines listed are very costly in market. Among the 200 medicines, April 2013
Ashok Gehlot in his budget speech had announced to increase the number of free medicines from 400 to 600. Since, hearts diseases are considered life style diseases, the RMSC has included 11 more medicines in free medicine for their treatment in the list which include adenosine injections, atorvastatin tablets, combination tablets of clopidogrel and asprin, fenofibrate capsules, isoprenaline injections, metoprolal tablets, noradrenaline injections, telmisartan tablets and prazasin tablets.
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Price of Cancer Drugs

Pharma Ltd in March, 2012. However, M/s Bayer Ltd filed an appeal before IPAB (Intellectual Property Appellate Board) against the said orders of the CGPDTM. There is no classification of Life Saving Drugs in DPCO, 1995. Recently, the Government has notified New Pharmaceutical Pricing Policy, 2012 (NPPP-2012) on 7th Dec, 2012. NPPP2012 provides for price fixation of cancer drugs specified in the National List of Essential Medicines2011 (NLEM-2011) of the prescribed strengths and dosage forms. As envisaged in the NPPP-2012, prices of these specified anti-cancer drugs would be fixed after promulgation of the new DPCO by the Government. Further, to bring down the prices, Ministry of Health & Family Welfare has recommended three cancer drugs, namely, Trastuzumab, Ixabepilone and Dasatinib to the Department of Industrial Policy & Promotion to put them under Compulsory Licensing under the provisions of the Indian Patents Act, 1970.
New Delhi, 7 March, 2013(PIB): per IMS Health data available with National Pharmaceutical Pricing Authority (NPPA), the details of Nexavar which is an anti-cancer drug are not reported. In respect of drugs not covered under the Drugs (Prices Control) Order, 1995 (DPCO, 1995) i.e. non-scheduled drugs, manufacturers fix the launch prices by themselves without seeking the approval of Government/ NPPA. Anti-cancer medicines are nonscheduled drugs. Under the present framework of price fixation, there are no controls on the launch price of nonscheduled medicines. It has been informed by Department of Industrial policy and Promotion that M/s Natco Pharma Ltd. Had applied to the Controller General of Patents Design & Trade Marks (CGPDTM) in July, 2011 for grant of Compulsory License for the drug Sorafenibtosylate patented by M/s Bayer Ltd under Section 84 of the Patents Act, 1970. The Controller General Patents Design & Trade Marks, after examining the application, granted the Compulcory License to M/s Natco
As
This information was given by the Minister of State for Chemicals and Fertilisers, Shri Srikant Kumar Jena in a written reply in the Lok Sabha on 10/03/13.
New Delhi, 5 March, 2013(PIB): he Ministry of Health & Family Welfare has envisaged bringing in a clear provision in the law with its objective of promoting generic drugs. It has published a draft notification GSR 748(E) dated 5.10.2012 for inviting comments of stakeholders on amending the rules pertaining to the conditions for the grant or renewal of licences, for manufacture of drugs under the Drugs and cosmetics rules, 1945 to facilitate approval of drug formulations containing single active ingredient by the State Licensing Authorities in their proper/generic name only. It has also taken up the matter with the State/UT Governments requesting
Bill on Mandatory Usage of Generic Names of Medicines

them to formulate a time bound action plan for promotion of generic drugs. For promoting prescription of generic
administered by the CGHS Division of this Ministry. At the hospitals level also, circulars by Medical Superintendants of hospitals in Delhi have been issued from time to time encouraging/motivating doctors to prescribe generic drugs. All the Sate/UT Governments have also been requested to take similar steps in their Hospitals/Health Institutions. This information was given by Minister for Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Rajya Sabha on 10/03/13 April 2013
drugs by the medical practitioners, this Ministry has from time-to-time issued circulars to the Directors/Medical Superintendants/ Chief Medical Officers/In-Charges of all the central Government hospitals/dispensaries/ wellness centres situated in Delhi and in other parts of the country
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April 2013
Pharma Life
Kallam Anji Reddy, pioneer of Indian pharma industry, passes away
Hyderabad, 16 March, 2013: allam Anji Reddy, a doyen of Indian pharma industry and founder of Dr Reddys Laboratories (DRL), passed away in Hyderabad on 15/03/13 Friday afternoon. He was 73. Reddy, who is survived by his wife Swarajyam, son Satish Reddy and daughter Anuradha, was undergoing treatment for lung-related ailment for sometime now. A researcher and one of the pioneers of the local generic drug industry, Dr Reddy was honoured with the Padma Bhushan award in 2011 for his contribution to the pharma sector. Born in a turmeric farmers family in Tadepalli of Guntur district in Andhra Pradesh, Reddy graduated from Bombay University in BSc (Tech) with specialisation in pharmaceutical science and fine chemicals and obtained his PhD in chemical engineering from National Chemical Laboratory, Pune. He started his career with the then public sector drugs major Indian Drugs and Pharmaceuticals Ltd (IDPL). After working with IDPL till 1975, April 2013
Reddy founded Uniloids focusing on research and then Standard Organics Ltd, another pharma firm. In 1984, he
out-licensing the discoveries to global majors for co-development. Reddy also set up Institute of Life Sciences in Hyderabad, a public-private partnership with the Andhra Pradesh government for carrying out cutting- edge research in life sciences. For sometime now, Reddy was keeping off the day-to-day activities of the company though he remained the chairman. The company is being managed by Satish Reddy, who is MD and COO and son-in-law G V Prasad the vice-chairman and CEO of Dr Reddys Labs. Apart from his business contribution, Reddy was also a philanthropist who institutionalised several corporate social responsibility initiatives. Naandi Foundation, a public charitable trust which he set up in 1998, is one of the largest safe drinking water providers. It also provides mid-day meals to 1.3 million government school children and farmers. Reddy had also taken up the cause of safe motherhood and new born care. He founded the Neonatal Intensive Care and Emergencies, or NICE Foundation, which does a largescale community outreach programme. GLOBAL PHARMA
founded Dr Reddys Labs with a focus on exports market. Though being a copy-cat exporter in the initial days, DRL stepped up focus on research and development by taking up drug discovery initiative in 1993. He led the company to a global scale by securing several patents worldwide and
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Pharma Life
Planning Commission for empowering Health Ministry to strengthen drug regulatory system
New Delhi, 11 March, 2013: ven as the debate is going on whether the drug regulatory system should be transferred to the Department of Pharmaceuticals (DoP), the Planning Commission has recommended empowering of the Ministry of Health and Family Welfare to strengthen the drug regulatory system. The Planning Commission in its final document for the current Five Year Plan, however, does not refer to the division of powers or changing the existing mechanism over the drug regulatory system in the country. Price controls and price regulation, especially on essential drugs, should be enforced. The Essential Drugs List should be revised and expanded, and rational use of drugs ensured. Public sector should be strengthened to
protect the capacity of domestic drug and vaccines industry to meet national needs. Safeguards provided by Indian patents law and the TRIPS Agreement against the countrys ability to produce
entitlement of every citizen, essential health services at different levels of the healthcare delivery system. Government should increase public expenditure on health from the current level of 1.2 per cent of GDP to at least 2.5 per cent by the end of the Twelfth Plan, and to at least three per cent of GDP by 2022. General taxation should be used as the principal source of healthcare financing, not levying sector specific taxes. Specific purpose transfers should be introduced to equalise the levels of per capita public spending on health across different states. Expenditures on primary healthcare should account for at least 70 per cent of all healthcare expenditure. The technical and other capacities developed by the Ministry of Labour for the RSBY should be leveraged as the core of UHC operations - and transferred to the Ministry of Health and Family Welfare, it said.
essential drugs should be protected. MoHFW should be empowered to strengthen the drug regulatory system, the document said. The panel also suggested a National Health Package to offer, as part of the
Govt paves way for elected MCI body
NEW DELHI, 10 MARCH, 2013: ith the Union Cabinet clearing the Indian Medical Council (Amendment) Bill, 2013, the way has been paved for an elected apex medical regulator. The Medical Council of India (MCI) is currently being run by a sevenmember Board of Governors headed by its chairman and nominated by the government. Its term expires on May 13 this year, before which it has to have an elected body. The elected MCI body was disbanded by the government and a Board of Governors was installed to run the apex body that controls medical colleges in the country after its then Chairman Ketan Desai was arrested by the CBI over charges of corruption. The Indian Medical Council (Amendment) Bill, 2013, which will be tabled in Parliament during Budget session, seeks to give government powers to remove the President or other office-bearers of MCI if found indulging in corrupt practices or serious offences of moral turpitude.
Once passed, the Indian Medical Council (Amendment) Bill, 2013, seeks to bring about such necessary changes requiring the government to act in case of serious charges against MCI officebearers.
the total number of terms. The changes have been necessitated as the government had no control over the elected body under the present law governing it. The new Bill also makes mandatory renewal of enrolment of doctors every 10 years in the registers maintained by the body or state councils. The proposed Bill, which was passed by the Cabinet on Thursday, is likely to be introduced in the budget session of Parliament, paving the way for reconstitution of the medical regulators board of governors.
The changes in the new law governing the apex medical regulator, proposed by the Ministry of Health and Family Welfare, include fixing tenure of the President of the elected-body of MCI to a maximum period of four years for two continuous terms. Earlier, the President could have a fiveyear tenure and there was no limit on
The National Commission for Human Resources for Health (NCHRH) Bill, which proposed to set up the NCHRH as an over- arching body to subsume the MCI, Nursing Council and Dental Council, was rejected by the Parliamentary Standing Committee after it was introduced in Rajya Sabha. The Committee has asked the Health Ministry to come up with a new Bill instead. April 2013
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RNI No. APENG/2012/40690
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April 2013

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Pages 40

VOL. 2 | NO. 2 | APRIL 2013

SCHOTT KAISHA inaugurates pharma packaging plant in Jambusar

* Responsible for selection of news under the PRB Act

Research & Development

Herbal medicines causing kidney failure, bladder cancer in India

Research & Development

Adverse drug reaction cases going unnoticed in state ?

US FDA reviews pancreas risks from new diabetes drugs

Research & Development

Research & Development

Research & Development

State AGs Pressure FDA for Abuse-Resistant Generic Pain Drugs

New Delhi, 12 March, 2013 (PIB):

Curbing of Sub-Standard Drugs

Drug Controller General of India to inspect bulk drug plants exporting to EU

BSF seizes Phensedyl

Ghanian firms marketing fake drugs from India?

SCHOTT KAISHA inaugurates pharma packaging plant in Jambusar

Managing Director, SCHOTT KAISHA

Schott Kaisha to invest Rs 100 cr more for expansion in Gujarat

About SCHOTT KAISHA

SCHOTT Forms Pharmaceutical Packaging Joint Venture in India - 01Dec-2008

Delivering total customization

Robotic batch sorting April 2013

High quality ceramic printing for a lasting impression

Range of ampoules from 1 ml to 25 ml

Electronically controlled after-forming-line

From plain necks to screw necks to lyophilized to siliconised vials

Camera inspection for vials

Broad range of vials from plain neck to screw neck

Glass Prefillable Syringes

Syringes are available in sterile and non-sterile form

Safepac sterile syringe systems

About SCHOTT India

SCHOTT has been a strong supporter to Indias rapidly growing pharmaceutical

SCHOTTs Assurance of Reliability and Quality

European Union bans cosmetics with animal-tested ingredients

No need for non-veg, veg labels on drugs and cosmetics: SC

Poor growth of anti-infective segment remains a concern for pharmaceutical sector

revenues. The slowdown in this segment has impacted the growth

Who Should Attend

For more info contact,

The Pharmaceutical Education and Research Institute

Number of free drugs set to increase

Costly life saving drugs, urokinase injections and surfactant for

Price of Cancer Drugs

Bill on Mandatory Usage of Generic Names of Medicines

Govt paves way for elected MCI body

RNI No. APENG/2012/40690

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