Centre asks small drugmakers to submit plans to meet quality norms in 3 months

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.

“The government has sought an upgradation action plan from the companies 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.

India is tightening drug quality norms after domestically manufactured medicines failed quality tests overseas due to alleged contamination. Of India’s 10,000 MSME drug companies, only 2,000 are WHO GMP-certified.

GMP norms are being implemented in India to ensure quality drugs by way of control on materials, methods, machines, processes, personnel and facility or environment. According to WHO, GMP refers to the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.

Revised norms

In 2023, the government revised Schedule M of the Drugs and Cosmetics Rules, 1945, which prescribes GMP standards for drug companies. In the first phase, drugmakers with an annual turnover of ₹250 crore and above were to compulsorily follow GMP within six months, while smaller companies were given one year.

Now, the small drugmakers must submit an undertaking to the government stating that they have analysed the shortcomings at their plants and propose to start upgrading them within three months of filing their plans. The companies have to provide a range of details such as FY24 turnover, the gap analysis of their plants, equipment, labs, utilities, technical staff, HVAC (heating, ventilation and air-conditioning) systems, and documents. Besides, they must justify the time needed for compliance.

“This exercise will also let us know how many verified drug makers  are there in the country. The government is very serious about the quality and safety of the medicines manufactured in India and hence, all the companies have to follow the WHO-GMP standards. Those who fail to submit the application may have to close their operations as none of the firms can work without compliance,” said the official.

Mint reported on 5 January that the government had extended GMP compliance for MSME drugmakers by one year and asked for comments from stakeholders within seven days to amend the previous notification dated December 2023.

Queries sent to the Union health ministry spokesperson remained unanswered.

“We are working very strongly on GMP compliance and have submitted our comments to the government on 11 January, seeking two years extension in the time period as upgradation of the plants requires huge finance, manpower, collateral security, training and implementation,” said Harish Jain Manawat, president of the Federation of Pharmaceutical Entrepreneurs (FOPE).

Manawat said FOPE welcomed the one-year extension, but for smaller companies, the time period is inadequate.

“However, we have urged our member companies to start working on a war footing mode, whether we get more time or not, and those who fail to do so have to bear the repercussions,” he said.

About 50% of the FOPE’s member companies are yet to upgrade their plants as per the revised Schedule M standards, Manawat said.

Last year, the government started the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme to provide financial aid to drugmakers to upgrade their plants to global standards.