Small drug firms under watchdog's quality lens

India's standards watchdog for drug manufacturing will start random checks of small drugmakers' plants by the end of this year, according to two officials aware of the matter who spoke on the condition of anonymity.

- Priyanka Sharma

The Central Drugs Standard Control Organization (CDSCO), headed by the Drugs Controller General of India (DCGI), will do the checks to review the compliance status of MSME drug firms' good manufacturing practices (GMP), the people added.

"Right now, DCGI is still getting applications as the deadline is open," the first official said. "Only after the deadline will the government conduct random checks at these MSME drugmakers to verify whether they are meeting GMP requirements or not. Strict actions including notices and cancellation of licence will be taken against the manufacturers found non-compliant."

"This exercise would be done at the end of this year, but how this plan would be executed is yet to be designed," the second official cited above said. "State governments may be roped in." Notably, this January, the Centre extended the deadline to 31 December 2025 for micro, small and medium enterprises (MSMEs) to upgrade their facilities, with the previous deadline ending on 31 December 2024.