The New Drugs and Clinical Trials (Draft Amendment) Rules, 2021.

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 Drugs (5th Amendment) Rules, 2021.

If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, obtain a licence in Form 29.

CDSCO issues notice regarding review of regulatory regime for drug approval.

Medical devices will, under the new Rules, be classified as per Global Harmonisation Task Force (GHTF) practice, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the Rules and are based on best international practices.