The Central Drugs Standard Control Organization (CDSCO), overseen by the Drugs Controller General of India (DCGI), will conduct inspections to assess the compliance of MSME drug manufacturers with good manufacturing practices (GMP), according to sources.
“Currently, the DCGI continues to receive applications as the deadline remains open,” stated the first official. “Post-deadline, the government will perform random inspections at these MSME drug manufacturers to determine their adherence to GMP standards. Strict measures, including notices and potential license cancellations, will be taken against any manufacturers found not in compliance.”
“This initiative is planned to take place at the end of this year, though the specifics of its execution are still being formulated,” the second official mentioned. “State governments may be involved in this process.”
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Notably, this past January, the government extended the deadline for MSME firms to enhance their facilities to December 31, 2025, extending the original deadline that ended on December 31, 2024.
The stringent measures aim to counteract criticism regarding the quality of domestically produced drugs and to eliminate non-tariff barriers to exports of Indian pharmaceuticals. Entities that do not comply will face substantial penalties, including possible factory closures.
The first official indicated that MSME drug manufacturers seeking an extension to upgrade their facilities must conduct a gap analysis in areas such as laboratory equipment, utilities, technical staff, HVAC (heating, ventilation, and air conditioning) systems. “The companies will also need to explain why they require an extension,” the official added.
Industry sources mentioned that fewer than 10 MSME drug manufacturers have submitted applications to the DCGI for an extension on the timeline for upgrading their facilities.
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Government estimates suggest that only 2,000 pharmaceutical manufacturing units in India possess GMP certification, primarily consisting of larger companies (those with revenues exceeding ₹250 crore), along with a few MSMEs.
The remaining manufacturers, totaling about 8,500 MSMEs, have not yet updated their facilities to meet WHO (World Health Organization) standards. It is important to note that MSME drug manufacturing units account for over 80% of the market share by volume in India.
Inquiries directed to the spokesperson for the union health ministry went unanswered.
Currently, MSME drug manufacturers with an annual turnover of ₹250 crore or less are under scrutiny by the government to ensure compliance with GMP regulations.
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Harish Jain, president of the Federation of Pharmaceutical Entrepreneurs (FOPE), which represents MSME drug manufacturers, stated, “At FOPE, we are encouraging our member companies to improve their facilities, viewing it as an opportunity for business enhancement. We are guiding them on the application process. Through our efforts, we secured a one-year extension, and on March 16, we held a workshop with the drug companies to encourage them to register for GMP compliance.”
What is GMP?
Good manufacturing practices, or GMP, are being enforced in the country to ensure product quality through control over materials, methods, equipment, processes, personnel, and the facility or environment. In 2023, the government issued a revised Schedule M of the Drugs and Cosmetics Rules, 1945, which outlines GMP standards for drug manufacturers.
In the initial phase, producers with an annual turnover of ₹250 crore and above were mandated to comply with GMP within six months following the notification date, while smaller companies were granted a year for compliance.
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Major drug manufacturing regions in India include Himachal Pradesh, Madhya Pradesh, Hyderabad, Maharashtra, and Gujarat, all of which are subject to oversight by the State and Central Drug Licensing Authorities.
According to the Department of Pharmaceuticals, India stands as the leading global supplier of generic medicines. The nation produces approximately 60,000 generic drugs across 60 therapeutic categories, representing 20% of the worldwide supply of generic medications.
Earlier, Mint reported that under the Department of Pharmaceuticals’ Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS), 103 applications from MSME drug manufacturers have been approved for a total financial backing amounting to ₹105 crore on a reimbursement basis.
