Drug Regulations and Guidelines in India

Drug Regulations and Guidelines in India

Drug is an article intended for use in the form of chemical substances which act on the living system and used in different sectors for cosmetics and diagnosis, treatment, surgeries or prevention of diseases.  The main objective behind regulating the drug sector is to prevent the sale of low graded medicines and cosmetics as it can have adverse effect on the health of the public at large. Moreover, the regulation also covers the mandatory requirement to be involved in manufacturing and sale of drugs.

What regulatory body deals with drugs in India?


This is the principal regulatory body which controls the approval, production and pricing of the products. The organisation is headed by the Drug Controller General of India and is liable to work on the following matters:

  • Conducting clinical trials for new drugs.
  • Giving approval to the drug after quality testing.
  • Acts as Central Licensing Authority responsible for import of drugs and manufacturing licence approval.
  • Give guidance on technical matters.


The authority is established under the Ministry of Chemicals and Fertilisers in India. It is responsible for controlling drug prices in India and fixing minimum price for preventing black market and easy availability of drugs in the market.

What are the laws applicable on drugs?

The Drugs and Cosmetics Act, 1940:

The Act contains provisions related to the import, manufacture and distribution of goods in India. Moreover, various committees are established for proper implementation of the above stated Act such as Drug Consultative Committee, Technical Advisory Board, and Central Drug Laboratory etc.

The Drugs (control) Act, 1950:

The Act deals with fixing the maximum prices and their maximum quantities to be sold for a fixed price of a drug and also provisions are laid down for non compliance. In case the offence is committed by the company director, manager, secretary or any other member associated with management shall be liable unless he proves that the offence is committed without his knowledge. The offence committed with relation to the above Act should be investigated by the police officer not below the rank of inspector and there will be no prosecution for offence committed under this Act except with the previous sanction of District Magistrate.

The Cosmetic Rules, 2020:

The Act defines the basic rules for sale and manufacturing of cosmetics in India. Additionally the statute contains provisions related to import mechanism, their registration and other legal formalities. The cosmetic products which are already registered for sale in India can be imported by any person by making an application in online portal of the Central Government.


It is essential to regulate drugs is India as it covers the major sector of society. To ensure good health of nation a check on pharmaceutical sector is required to reduce the adulteration of drugs and assuring the good quality of drugs to the citizen of country at reasonable price. By following proper regulatory affairs at different stages of drug development, approval and marketing helps pharmaceutical companies to certify the quality, safety, and effectiveness of the drugs.

-Kishan Garg

Associate at Aggarwals & Associates, S.A.S. Nagar, Mohali