With thousands of small drug manufacturers struggling to meet quality norms, the Union health and family welfare ministry is unlikely to extend the deadline for complying with the revised good manufacturing practices (GMP) under Schedule M, according to people aware of the matter.
Why is the Centre consulting states on Schedule M implementation?
“The health ministry, along with the Central Drugs Standard Control Organisation (CDSCO), is having consultation meetings with state governments and licensing authorities on a daily basis to discuss implementation of Schedule M,” sources in the ministry said.
Another official confirmed that the ministry held a consultative meeting with high drug manufacturing states on Monday. Queries mailed to the health ministry did not elicit a response till the time of going to print.
What do the revised Schedule M norms require pharma units to do?
Under the revised Schedule M norms, first notified in 2022, pharma units are required to adopt tighter quality controls, including pharmaceutical quality systems (PQS), quality risk management (QRM), product quality review (PQR), equipment validation and a robust product recall mechanism.
Will the ministry consider flexibility for small manufacturers?
“The ministry will not compromise on drug safety,” an official quoted above said, adding that while the government has hand-held those willing to upgrade facilities through waivers and incentives, many small manufacturers are adamant about not upgrading.
What happens if MSME units do not comply by the deadline?
Low compliance among an estimated 8,500 MSME pharma units could risk closures once risk-based inspections start at these units in January this year.
What is the current deadline, and what were the conditions for the earlier extension?
Initially scheduled for December 2024, micro and small pharma firms with annual turnover of Rs 250 crore or less were granted a one-year extension to comply with the revised norms until December 31, 2025.
However, this extension was conditional on conducting a gap analysis and filing an application with the drug regulator outlining a compliance strategy by May 2025.
How many MSME units have submitted upgradation plans so far?
While around 2,000 MSME units already hold WHO-GMP certification, only about 1,700, or 26 per cent of India’s estimated 6,500 MSME pharmaceutical manufacturers that were required to come up to speed with revised GMP norms have submitted upgradation plans.
Why are MSME industry bodies seeking more time?
MSME industry bodies argue that many smaller players have struggled due to capital constraints.
“All forms of upgradation require capital infusion of at least Rs 2 crore, including additional land, retrofitting facilities and staff training,” said an executive with an MSME drug manufacturing firm.
He added that many units operate from single facilities in small premises such as apartments, making it difficult for them to make the upgrades within the deadline.