Drug Law: Your Rights & Protections Under the Drugs and Cosmetics Act

The Drugs and Cosmetics Act, enacted in the course of 1940, is the Indian legislation relating to the control of import, manufacture, sale, and distribution of drugs and cosmetics in India. The objective lies in the safety and effectiveness as well as the standard quality parameterisation of drugs and cosmetics put to public use.

Main Objectives:

• To prevent counterfeit, injurious drugs and cosmetics from being sold and substandard drugs from reaching the consumer.
• To regulate the licensing, manufacture, and labelling of medicines and cosmetics.
• To ensure safety, quality, and efficacy of drugs before they reach the consumer.

FAQs – Drugs and Cosmetics Act, 1940

1. What is the Drugs & Cosmetics Act of 1940?

The Act regularly deals with importing, producing, selling and distributing those drugs and cosmetics within the shores of India that concern the safety and quality of the concerned substance.

2. Why is this law important to me as a consumer?

It prevents dangerous products or substandard medicines from reaching you, ensuring that what you are using is tested and approved.

3. What does this law say about any article being called a “drug”?

Anything applied to human beings or animals for the purpose of diagnosis, treatment or prevention of disease, such as tablets, syrups, injectables, vaccines and so on.

4. What does “cosmetic” mean in this law?

Any article used for beautifying, cleansing, and grooming, such as creams, soaps, shampoos, powders, and lipsticks.

5. How are medicines brought under this Act in order to protect the consumer from counterfeit?

Manufacturers and sellers are marked with the necessity of carrying requisite licenses and observing quality control. Any selling of fake or substandard drugs is punishable by law.

6. Who tests the safety of medicines and cosmetics?

The Central Drugs Standard Control Organisation (CDSCO) and state drug authorities test and inspect what is sold.

7. Can one file a complaint about harmful or counterfeit products?

Yes. One can bring his case to the notice of the local Drug Inspector or State Drug Control Office for action to be taken against the seller or manufacturer.

8. Is every medicine cleared before being sold?

Yes. With clearance, medicines are tested and approved before being released to the public.

9. What happens to companies that violate the rules?

Companies can be fined or lose their licences, and in severe cases, directors and managers may go to jail depending on the violation.

10. Does the Act apply to Ayurvedic or herbal products?

Yes, the Act does apply to Ayurvedic, Siddha, and Unani medicines but through different regulations of the same law.

11. Can another person just open the shop to sell the drugs?

No. Medicines can only be sold by an individual or an establishment with a valid drug licence and a qualified pharmacist on its establishment.

12. Are expired medicines also included in the provision of this Act?

Yes. The sale of expired drugs is banned and is punishable under this Act.

13. Who is the authority giving permission to manufacture the medicines in India?

Central and state drug authorities give permission once they are satisfied with safety and quality standards.

14. How do I know whether the cosmetic is safe for usage?

Always check it is properly labelled, marked with an expiry date and shows the name of a manufacturer. Use only products which are trusted brands in this legal framework.

15. Where do I complain about any drug or cosmetic?

Complaints about any drug or cosmetic can be made to the local Drug Inspector and State Drug Control Office or at CDSCO (www.cdsco.gov.in).