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Drugs and Cosmetics Act – Lesson 1
The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India.
The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
This act was originally known as the Drug Act and was passed in 1940. The original act was prepared in accordance to the recommendations of the Chopra Committee formed in 1930. The related Drugs Rules was passed in 1945. Since 1940, the act has undergone several amendments and is now known as the Drugs and Cosmetics Act, 1940
Amendments in Drugs and Cosmetics Act that impact clinical research
(As amended up to 2015)
- This Act may be called the Drugs and Cosmetics (Amendment) Act, 2014
- An Act to regulate the import, manufacture, distribution and sale of drugs, Cosmetics and medical devices, to ensure their safety, efficacy, quality and conduct of clinical trials and for matters connected therewith or incidental thereto”
- Definitions such as Ayurvedic, Siddha or Unani drug, bioavailability study, bioequivalence study, Board, Central Drugs Laboratory, Central Licensing Authority, clinical trial in respective drugs, cosmetics, medical devices etc.
- No clinical trial is conducted without taking permission from Central Licensing Authority in such form and manner as may be prescribed. I. If it is approved by the Ethics Committee constituted under section 4E. II. New drug shall continue to be a new drug
- Whether the injury or death of a person in the course of a clinical trial, has been caused due to such clinical trial or not, shall be determined by such authority and in such manner as may be prescribed
- Where a participant is injured or disabled in a clinical trial, the person or body permitted under section 4A and the sponsor shall provide such medical treatment and compensation in such manner as may be prescribed
- Where death of a participant is caused due to clinical trial, the person or a body permitted under section 4A and the sponsor shall provide to his legal heir, such compensation ,in such manner as may be prescribed.
- The Drugs Control Officer or any other officer authorised by the Central Licensing Authority shall have the power to enter with or without prior notice into any premises related to clinical trial to inspect the facilities, record, data, documents, books, drugs including investigational new drugs, notified category of medical devices and cosmetics.