Draft: New Clinical Trial Rules in India

India's CDSCO (Central Drugs Standard Control Organization) has released a new draft bill amending Drugs and Cosmetics Act from 1940. The document is called "Draft Drugs and Cosmetics (Amendment) Bill".

One goal is to include a rule on compensation. If a trial causes harm to a patient, the sponsor will have to pay for the patient or its family.

"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 document states in its Clinical Trials chapter.

Besides compensation for injury or death due to clinical trial, the key tasks of the chapter on Clinical Trials are:

  • No clinical trial without permission.
  • Determination regarding injury or death.
  • Deferment of clinical data requirements by the Central Licensing Authority.
  • Registration of Ethics Committee.
  • Functions and responsibilities of Ethics Committee.
  • Action against Ethics Committee.
  • Inspection by Drugs Control Officer.
  • Disclosure of name, address, etc. of persons involved in clinical trials.
  • Maintenance of record and furnishing information.
  • Various Penalties.
  • Confiscation of stock, medical device or cosmetics.
  • Cognizance of offence.
  • Power of Central Government to make rules.

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