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Allowing separate timelines for large units and MSMES may create two categories of manufacturing facilities: Experts
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Gireesh Babu, New Delhi
January 13 , 2025
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Allowing separate timelines for the large scale manufacturers and micro, small and medium enterprises (MSMEs) who have turnover of less than Rs. 250 crore in pharma sector to comply with the manufacturing standards under the revised Schedule M may create a situation where drugs are manufactured in the country in two categories of manufacturing facilities ---one compliant with the revised standards and another non compliant with the same standards, according to a regulatory expert.
The Central government, which notified the implementation of the revised Schedule M standards, on par with the World Health Organisation's (WHO) Good Manufacturing Practices (GMP) and other international standards, in December, 2023, had provided six months for the pharma units above Rs. 250 crore turnover and one year from the notification for the units below Rs. 250 crore turnover to comply with the standards.
Following several representations from the industry, earlier this month, the Centre has extended the timeline for the MSMEs below Rs. 250 crore turnover to one more year till the end of December, 2025 to comply with the manufacturing standards, with a condition that the units should submit applications with gap analysis and plan to achieve the standards within the time limit.
"This will create double standards in the industry," said Ravi Udaya Bhaskar, former director general, Pharmexcil and honorary director general, All India Drugs Control Officers' Confederation (AIDCOC), the apex body of drug control officers in the country.
"Anyone who understands the objective of Schedule M will not create two categories of industry (large scale and MSME) for the operation of the Schedule M.As far as I know, nowhere in the world two different periods are announced for the operation of legislation," he added. This will create availability of drugs manufactured in two types of manufacturing facilities and this would be against the public interest.
Another drug regulatory expert asked why should the government allow some of the manufacturers to continue making drugs at non compliant facilities, if the revised provisions do result in making higher quality products.
The revised Schedule M, labelled as 'Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products' 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.
They also point out that the final notification itself was delayed by large, since the draft notification for revised Schedule M was issued in the year 2018 and it took almost five years for the government to finalise it in December, 2023. If the MSMEs are not able to upgrade their manufacturing standards, the government needs to handhold them and bring them to the mandatory regulatory standards, instead of creating multiple standards for the drugs manufactured in the country.
Even the large companies with more than Rs. 250 crore turnover, manufacture many of the drugs on contract basis in smaller units. Besides, the MSME manufactures several life saving drugs including cardiovascular and cancer drugs, say experts.
The revised Schedule M says that the manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the licence and do not place patients at risk due to inadequate safety, quality or efficacy. To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented pharmaceutical quality system incorporating Good Manufacturing Practices (GMP) and Quality Risk Management (QRM).
The MSME industry has been demanding the government to provide more time for them to comply with the regulatory standards, considering various challenges they face including financial issues in upgrading the standards, availability of adequate quality manpower to conduct the operations including the extensive documentation requirements as per the revised Schedule M standards.
The industry associations have said that they are submitting their suggestions and objections, including request for more time for the micro and small units to comply with the standards, in response to the draft notification issued earlier this month to extend the deadline to end of December, 2025.
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