Drugs and Cosmetics Acts – Lesson 1

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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.

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