Over 100 MSME drug firms modernizing their pharma unit as per WHO standards | Mint

New Delhi: A total of 103 applications have been approved for Central financial assistance to MSME (micro, small and medium enterprises) drug firms wishing to upgrade to international standards, the government said, addressing an impediment to India’s pharma export ambitions.

The total financial support under the government’s revamped Pharmaceutical Technology Upgradation Assistance Scheme amounted to ₹105 crore.

According to the union health ministry, there are around 10,000 drug making firms in India that are classed as micro, small and medium enterprises (MSMEs). But only 2,000 of them have the World Health Organization’s (WHO) good manufacturing practice certificate.

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The scheme was launched last year for pharma companies to modernize their units after a string of scandals surrounding sub-standard Indian drug exports.

The government, in 2023, revised Schedule M under the Drugs and Cosmetic Act to make it mandatory for companies to follow Good Manufacturing Practices (GMP), a key step to ensuring the quality and safety of the drugs manufactured in India.

“Following amendments under Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS) in September 2024, 103 applications have been sanctioned starting from November 2024, for total financial support amounting to ₹105 crore on reimbursement basis,” said a department of pharmaceutical spokesperson.

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Two companies have so far completed the process.

In September 2024, the government enhanced the financial incentive from ₹1 crore to ₹2 crore for drug manufacturers to upgrade their facilities. Under this, pharmaceutical units with an average revenue of ₹1crore to less than ₹50 crore will get paid 20% of investments. Firms with a revenue of ₹50 crore to less than ₹250 crore are eligible to 15% of investment while those with revenue of ₹250 crore to less than ₹500 crore are eligible for 10% of investment.

The incentive is offered for expenditure incurred on items such as utilities, clean room facility, testing lab, stability chamber, effluent treatment/waste management, and production equipment.

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The spokesperson said that another 200 units have registered interest.

India drug making hubs include Himachal Pradesh, Madhya Pradesh, Hyderabad, Maharashtra and Gujarat, which fall under the regulatory radar of the State and the Central Drug Licensing Authority. 

Earlier, in January, the government gave a one-year extension to MSME drug firms to complete GMP compliance.

India is the world’s largest supplier of generic medicines. The country manufactures about 60,000 generic drugs across 60 therapeutic categories, accounting for 20% of the global supply of generic drugs, according to the pharmaceuticals department.

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