CA Rajkumar S. Adukia

Introduction :– “The Indian pharmaceutical industry is a success story providing employment for millions and ensuring that essential drugs at affordable prices are available to the vast population of this sub-continent.”

The main aim of the Pharmaceutical Industry is to develop, research and distribute drugs in order to provide health care for the people in the society. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices. Just like any other industry, they are also subject to various rules and regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs.

Since the inauguration of the Pharmaceutical Industry in the 19th century, it has covered a long way and now it has become one of the most influential and successful industry in the world with both controversy and praise on its part.

The word pharmaceutical comes from the Greek word ‘Pharmakeia‘ meaning practice and making of medication and vitamins. The modern transliteration of Pharmakeia is ‘Pharmacia‘ which means pharmacy, the making and dispensing of poisons, pharmaceuticals or medicines as well as cosmetics, lotions, perfumes etc.

1.1. Meaning of Pharmaceuticals, Pharmacy, Drugs, Medicines etc.

Pharmaceuticals means, pertaining to the knowledge or art of pharmacy; or to the art of preparing medicines according to the rules or formulas of pharmacy; as, pharmaceutical preparations.

Pharmacy means the art or practice of preparing and preserving drugs, and of compounding and dispensing medicines according to prescriptions of physicians.

Pharmaceutical Drugs are defined as chemical substances used for treating, curing and preventing different types of diseases. Commonly referred to as medicines or medication, pharmaceutical drugs are used in the medical diagnosis, treatment,

prevention or curing disease. Medicines help in fighting or preventing diseases if they are taken in the right quantity at the right time and as prescribed by the doctor.

These medicines either are prescriptive or non prescriptive.

Administration of a drug means how the drug is delivered to a patient. Pharmaceutical drugs are available in the forms of pills, tablets, capsules and syrups. They can be taken orally or intravenously (into the blood through a vein). They are administered at regular intervals or all at once depending on doctors’ advice.

1.2. Prescription and Non prescription drugs

Prescription drugs are drugs that are not locally available without a physician’s prescription. A prescription drug is a licensed medicine which is obtained only by prescription. The prescription drugs are regulated by legislation and different from over-the-counter (OTC) drugs which can be obtained without a prescription. The term “Rx” is often used as a short form for prescription drug. Any kind of prescription drug will usually have a monograph or Patient Information Leaflet (PIL) that gives detailed information about the drug.

To Read more Download Handbook on Overview of Pharmaceutical Industry with Specific Reference to Laws Of India, which contains the following topics :-


1. Introduction

1.1. Meaning of Pharmaceuticals, pharmacy, drugs, medicines etc.

1.2. Prescription and Non-prescription drugs

1.3. Meaning of Biotechnology

1.4. Relationship between pharmaceuticals and biotechnology

2. History of Pharmaceutical Industry in the world 2.1. Present scenario of Pharmaceutical Industry in the world

3. Pharmaceutical Industry in India

3.1. History of Pharmaceutical Industry

3.2. Growth scenario

4. Regulatory Framework

4.1. Overview of Drug related laws

5. Research and Development

6. Intellectual Property Rights

7. Regulatory Authorities in India

8. Regulatory Authorities around the world

9. Industry associations

  1. Important websites

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March 2021