The Government has amended the Drugs and Cosmetics Rules, 1945 to inter alia provide as below:
“no permission for conduct of clinical trial intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form where,-
- the trial is approved by the Ethics Committee; and
- the data generated is not intended for submission to licensing authority.
The Ethics Committee shall, however, inform the licensing authority about the cases approved by it and also about cases where there could be an overlap between the clinical trial for academic and regulatory purposes and where the said authority does not convey its comments to the Ethics Committee within a period of thirty days from the date of receipt of communication from the Ethics Committee, it shall be presumed that no permission from the licensing authority is required.”
Sufficient provisions exist in the Drugs & Cosmetics Act, 1940 and the Rules, thereunder to deal with any case of misuse or non-compliance with any of the provisions of the Act and the rules. The Minister of State (Health and Family Welfare), Faggan Singh Kulaste stated this in a written reply in the Lok Sabha.