The Ministry of Health and Family Welfare on 27th October 2021 has notified the New Drugs and Clinical Trials (Draft Amendment) Rules, 2021 which shall apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee.
The Amendment has notified the term cell and stem cell derived products under rule 2(w)(v) which defined the term “new drug”
As per rule 2(w)(v) new drug” means a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, cell and stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug.
The ministry has invited Objections and suggestions from the public which shall be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in within a period of 45days.
