Drugmakers face bans for fake claims as govt set to tweak rules

India plans to enforce strict action against applicants who submit fake or misleading documents to obtain drug licences—a move that could reshape compliance norms in the country’s $50 billion pharmaceutical industry.

- Priyanka Sharma

According to a senior official and draft rules reviewed by Mint, the health ministry has proposed amendments to the Drugs Rules, 1945 to empower licensing authorities to ban any entity found guilty of submitting falsified or fabricated documents "for such period as deemed fit”.

The changes, based on recommendations of the Drugs Technical Advisory Board (DTAB), will give the Central Drugs Standard Control Organization (CDSCO) and state regulators explicit powers to debar offenders—a gap that until now was handled only through administrative action.