Fake drug crackdown may net chemists, wholesalers

India's apex drug regulator is working on introducing stringent rules that would hold retailers and wholesalers accountable for selling or storing spurious drugs, even with valid purchase invoices, according to two government officials aware of the matter.

- Priyanka Sharma

India's apex drug regulator is working on introducing stringent rules that would hold retailers and wholesalers accountable for selling or storing spurious drugs, even with valid purchase invoices, according to two government officials aware of the matter. Currently, under Section 19 of the Drugs and Cosmetics Act, 1940, only manufacturers are prosecuted, while traders in the supply chain remain exempt from liability.

The Central Drugs Standard Control Organization (CDSCO) has set up a committee to explore ways to tighten enforcement, aiming to plug regulatory loopholes that allow counterfeit medicines to enter the market unchecked. The move comes at a time when India's reputation as the "pharmacy of the world" has suffered following reports linking India-made cough syrups to the deaths of children overseas.

The proposed rules would likely remove legal exemptions that currently shield retailers and wholesalers from prosecution if they can produce valid purchase invoices. "A committee has been formed and will shortly submit their report. The committee has sought suggestions from the State Licensing Authorities (SLAs), till what extent punishment can be extended. Right now, there are certain exemptions in the Drugs and Cosmetic Act, 1940. So, the plan is to narrow down these exemptions," an official familiar with the discussions explained, requesting anonymity.

The issue was deliberated in a December Drugs Consultative Committee (DCC) meeting chaired by Drugs Controller General of India (DCGI) Rajeev Raghuvanshi. Mint has seen a copy of the minutes of the meeting.