Govt seeks quality compliance plan from MSME drugmakers

The drug quality norms are being tightened after the medicines made in India failed overseas quality tests

- Priyanka Sharma

The government plans to give micro, small and medium drugmakers three months to submit their action plans to upgrade plants and comply with the World Health Organization's good manufacturing practices (GMP) for life-saving medicines by the end of 2025, failing which they will have to shut down.

However, small drug companies said they need more time to meet the compliance requirements. The health ministry will decide on granting extensions based on the action plans submitted by MSME drugmakers, an official aware of the matter said on the condition of anonymity.

"The government has sought an upgradation action plan from the firms within three months' time," the official said, adding that companies have to file applications to the Central Licensing Authority.

The decision comes in the wake of the Centre's plan to extend the deadline for small pharmaceutical companies with revenue of ₹250 crore or less to comply with GMP by one year to 31 December 2025.