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Several micro & small pharma units staring at closure as time for implementation of revised Schedule M begins
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Gireesh Babu, New Delhi
January 03 , 2025
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With the deadline for the pharma units under Rs. 250 crore turnover to comply with the revised Schedule M manufacturing standards closed by the end of December, 2024, the industry has raised concerns over the future of a majority of micro and small units which are not in a position to comply with the standards.
A section of the industry also raised hope that the government is considering their request for an extension of the deadline and there would be some positive announcements coming out in the next few days.
The revised Schedule M was notified by the Union ministry of health and family welfare in December 28, 2023, with major changes in the manufacturing standards for drugs manufactured in the country, on par with the international standards.
The Ministry has fixed a timeline of six months from the date of notification for the companies above Rs. 250 crore to comply with the revised regulations and one year for the companies below Rs. 250 crore turnover.
"States like Punjab has been facing disadvantages compared to the tax haven states till 2017, and even after that the competition has been stiff with limited room for the industry to focus on more investments," said Jagdeep Singh, president of Punjab Drug Manufacturers Association (PDMA).
He said that only about 15-20 of the total 150 units in Punjab might have upgraded to the revised manufacturing standards. If the regulation is implemented without any extension in deadline, it would wipe out a majority of the micro and small units, not only in Punjab, but across the country, he averred.
"The turnover benchmark of Rs. 250 crore stipulated for Schedule M means the existence of around 8,000 micro and small enterprises (MSEs) has been ignored," he said earlier.
The Association has also repeatedly urged the Prime Minister through letters to extend the timeline for the micro and small units to comply with the revised standards and also urged the government to look into improving other facilities including availability of potable water, qualified manpower for the industry, among others.
The government has so far not paid heed to the requests for extension of timeline.
The industry is looking up at the government for a favourable decision in the coming days regarding the issue, said another industry leader. The ministry is contemplating some solutions in connection with the revised Schedule M implementation and this could come out to help the micro and small units, said the source.
Some sources have said that the central and state drug regulators has been conducting joint inspections in various units across various geographies during the month of December, and issued stop production notices to those who are not in compliance with the previous Schedule M standards. The strict implementation of the revised norms would end up in escalation of drug prices, said an industry expert.
The revised Schedule M, for which the draft was issued in the year 2018, has major additional features compared to the previous Schedule M standards, including standards for Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), qualification and validation, establishment of system to recall the defective products, self inspection team and quality audit, supplier audit and approval, stability studies, among others.
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