Drug Import Procedure for Testing Gets Simplified

The Health Ministry proposed a simpler acknowledgement-based system for importing small quantities of drugs for examination, test or analysis. The step is intended to promote research, innovation and ease of doing business in the pharmaceutical sector.

The proposed amendment to the Drugs Rules, 1945 replaces a prior licensing requirement with a prior intimation and acknowledgement mechanism for many analytical and non-clinical imports. This is expected to reduce delays and lower compliance costs for laboratories, start-ups and industry players. Certain sensitive categories such as sex hormones, cytotoxic drugs, beta lactam drugs, live biologics, and narcotic or psychotropic substances will continue to require prior licensing. The reform expands a similar notification-based approach already introduced earlier for domestic test licences.