PHARMACEUTICAL INDUSTRY

INTRODUCTION:

Pharmaceutical company develops, produces, and markets medicinal drugs. These

companies can deal in generic or brand medications. They are subject to a variety of laws
and regulations regarding the patenting, testing and marketing of drugs.

Generic drug (generic drugs, short: generics) is a drug which is produced and distributed
without patent protection. The generic drug may still have a patent on the formulation but
not on the active ingredient.

Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical

substances are combined to a pure drug substance to produce a final medicinal product.

PHARMACEUTICAL INDUSTRY IN INDIA:

A highly organized sector, the Indian Pharma Industry is estimated to be worth $ 5 - 10

billion, growing at about 8 to 9 percent annually. It ranks very high in the third world, in
terms of technology, quality and range of medicines manufactured. From simple
headache pills to sophisticated antibiotics and complex cardiac compounds, almost every
type of medicine is now made indigenously.

It’s playing a key role in promoting and sustaining development in the vital field of
medicines, Indian Pharma Industry boasts of quality producers and many units approved
by regulatory authorities in USA and UK.

The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registered
units. It has expanded drastically in the last two decades. The leading 250 pharmaceutical
companies control 70% of the market with market leader holding nearly 7% of the market
share. It is an extremely fragmented market with severe price competition and
government price control.

The pharmaceutical industry in India meets around 70% of the country's demand for bulk
drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules,
orals and injectibles. There are about 250 large units and about 8000 Small Scale Units,
which form the core of the pharmaceutical industry in India (including 5 Central Public
Sector Units). These units produce the complete range of pharmaceutical formulations,
i.e., medicines ready for consumption by patients and about 350 bulk drugs, i.e.,
chemicals having therapeutic value and used for production of pharmaceutical
formulations.
SIGNIFICANCE OF INDIAN PHARMA INDUSTRY

1. Competent workforce: India has a pool of personnel with high managerial and
technical competence as also skilled workforce. It has an educated work force and
English is commonly used. Professional services are easily available.

2. Cost-effective chemical synthesis: Its track record of development, particularly in the

area of improved cost-beneficial chemical synthesis for various drug molecules is
excellent. It provides a wide variety of bulk drugs and exports sophisticated bulk drugs.

3. Legal & Financial Framework: India has a 53 year old democracy and hence has a
solid legal framework and strong financial markets. There is already an established
international industry and business community.

4. Information & Technology: It has a good network of world-class educational

institutions and established strengths in Information Technology.

5. Globalization: The country is committed to a free market economy and globalization.

Above all, it has a 70 million middle class market, which is continuously growing.

6. Consolidation: For the first time in many years, the international pharmaceutical
industry is finding great opportunities in India. The process of consolidation, which has
become a generalized phenomenon in the world pharmaceutical industry, has started
taking place in India.

SOME LEADING PLAYERS IN PHARMACEUTICAL INDUSTRY

1. Ranbaxy
2. Wockhardt
3. Glaxo
4. Novartis
5. Cipla
6. Cadila Healthcare
7. Aurobindo Pharma
8. Dr Reddy’s Laboratories
9. Aventis Pharma
10. Nicholas Piramal
11. Sun Pharma
12. Glenmark Pharma
FUNCTIONS OF A PHARMACEUTICAL COMPANY:

FOUR MAJOR FUNCTIONS:

1. Research and Development

2. Regulators
3. Production
4. Quality
5. Marketing

Research and Development:

1. Drug Discovery
2. Drug Development

Drug Discovery: It is the process by which potential drugs are discovered or designed. In
the past most drugs have been discovered either by isolating the active ingredient from
traditional remedies or by serendipitous discovery. Modern biotechnology often focuses
on understanding the metabolic pathways related to a disease state or pathogen, and
manipulating these pathways using molecular biology or Biochemistry. A great deal of
early-stage drug discovery has traditionally been carried out by universities and research
institutions.

Drug development: It refers to activities undertaken after a compound is identified as a

potential drug in order to establish its suitability as a medication. Objectives of drug
development are to determine appropriate formulation as well as to establish safety.

Regulators:

This department is responsible for getting approval or license for the particular drugs
manufactured by their company. Every drug has to be approved by the central body
before it is marketed to the customers. Regulators are doing the following activities in a
pharma company

1. Keeping in touch with doctors in the government hospitals regularly

2. Introducing the newly developed drugs to the doctors, then drugs will be given to
the patients by doctors’ prescription.
3. Doctors will analyze the patients normalcy, after they have the drugs
4. As per the patients improvements, a separate report will be prepared for the drug
and will be given to the regulatory department.
5. These report will be submitted before the DCD (Drug Control Department) by
regulatory department
6. As per the doctor’s report drug will be licensed by the DCD.
About DCD: The Drugs Control Organization was functioning, as a subordinate office
under Directorate of Health Services till January 1986 and Director Health Services was
the Ex-officio Drugs Controller. Thereafter, The Drugs Control Organization became an
independent Department with Drugs Controller as Head of Department.

The Drugs Control Department of Delhi State is enforcing the provisions of following
statutes, enacted by Government of India:

1. Drugs & Cosmetics Act, 1940 and Rules made there under.
2. Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954.
3. Drugs (Prices Control) Order, 1995.

i. Inspection for grant / renewal of licences for the manufacture of allopathic drugs
including whole human blood / blood components / Blood products, surgical
dressings, diagnostic reagents/ Kits, disposable syringes/needles/perfusion sets,
repacking of drugs, homoeopathic medicines and cosmetics.

ii. Inspection for grant / renewal of licences for retail and wholesale of drugs
including homoeopathic medicines. No licence for sale of Ayurvedic /Unani /
siddha medicines and cosmetics is required.

iii. Collection of samples of drugs & cosmetics from mfg./ sale premises for test /
analysis to check their quality being manufactured and sold in Delhi.

iv. Inspections and raids with a view to detect offences under the Act specially
movement and sale of spurious drugs/ cosmetics.

v. Investigations of cases of contraventions under the Act.

vi. Inspections of the premises licensed for manufacture and sale of drugs, with a
view to ensure that conditions of the licences are complied with.

vii. Launching of prosecutions against persons / firms found contravening the

provisions of the Act.

Production:

Once the drug is approved by the DCD, Regulatory dept will give the MFR (Master
Formulation Record) to the Production Department. As per the MFR, following important
processes will be taken in a pharmaceutical company to produce tablets.

1. Dispensing Of Raw materials

2. Drying

3. Sifding
 4. Plending

5. Slugging

6. Multimill

7. Compression

8. Package

Dispensing of Raw materials: With the help of R & D, the required raw materials will be
purchased by the materials department to the purpose of production.

Drying: In which chemical component will be completed dried to remove the water
contents.

Sifdying: Small dust particles will be removed from the raw materials by these process.

Slugging: In this process, the chemical components will be made as round shaped
particles for further process.

Multimill: Here the round shaped particles will be broken and make it as powder.

Compression: These processed chemical substances will be compressed to get the desired
shape such as vowel or round. Now tablets will be ready for packaging process.

Packaging: There are two types of process

Strip Packing: Here drugs will be packed by aluminium foils

Blister Packing: Tables will be covered by PVC (Poly Vinyl Chloride) foils.

Then foils will be packed in Carton, each carton will have leaflet with adequate
information.

Quality:

Quality Assurance: This division will ensure the following things with the help of
R&D.

1. Weight,

2. Hardness

3. Thickness

4. Friability ( Tendency to loose weight)

 5. Disintegration (Dissolving power in the water; Maximum 15 minutes for all the
drugs to be dissolved in the water)

Quality Control: Three most important steps are taken in this quality control

1. Stability: It is the test to identify the expiry date for a drug and will keep the drugs
still it gets expired.

2. Analysis: HPLC (High Pressure Liquid Chromatography) it’s used to separate,

identify, and quantify drugs. HPLC utilizes a column that holds chromatographic
packing material (stationary phase), a pump that moves the mobile phase(s)
through the column, and a detector that shows the retention times of the
molecules.

3. UV Spec: Drugs will be tested by sparking the Ultra Violet rays.

Marketing Division:

Every Pharmaceutical company will have their own marketing and sales strategies to
introduce the drugs into the market. Drugs will be pushed into the market through
doctors normally. Doctors will be approached by sales professionals often. Apart from
that they will take care of retail, distributor and wholesale sales.

URL: http://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry/

http://en.wikipedia.org/wiki/Pharmaceutical_industry

http://en.wikipedia.org/wiki/HPLC