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Indian pharma notes revised Schedule M extension signals key step to avoid closure of units
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Nandita Vijayasimha, Bengaluru
January 07 , 2025
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Indian pharmaceutical industry is of the view that the extension of deadline for revised Schedule M compliance for the MSMEs will be a key step to avoid closure of facilities and align with global quality standards. It underscores the government's understanding of the challenges faced by MSMEs.
Kaushik Desai, a pharma consultant, pointed out, “CDSCO has taken the right step in issuing the notification on Schedule M compliance by MSMEs. The industry shall take this extension of the revised Schedule M notification in a positive spirit and make their sincere efforts to comply with the requirements specified in the given timelines. There is also a provision given of 7 days to comment on the recent extension of the revised Schedule M notification which every stakeholder including national pharma associations should have a relook at and take this opportunity of submitting their comments for kind consideration of the CDSCO.”
Now the companies who are in various stages of upgrading their systems and facility will now need to provide their gap analysis in the prescribed format and request for extension which is fixed for December 31, 2025. It would have been better from the governance point of view to ask for submission of periodic updates from the industry during the extension period, added Desai, who helps in the audits of several pharma companies in the country.
Also, the Indian pharma machinery industry is well equipped to supply machines for upgradation. The revised Schedule M has been framed on the lines of WHO GMP guidance document and will surely benefit the patients in getting the medicines of assured quality, Desai noted.
According to Harish K Jain, president, Federation of Pharmaceutical Enterprises (FOPE), which played a pivotal role in convincing the government for an extension of the revised Schedule M implementation said, “We will ensure that India will also be pharma innovation hub of the world. Therefore, we see this extension till December 31, 2025 as a welcome step as it is a positive direction and in the national interest. We are committed to upgrade our facilities and systems to global standards.”
Manoj Palrecha, president, Karnataka Drugs and Pharmaceutical Manufacturers Association and managing director, Lake Chemicals, said that the government recognized the pharmaceutical companies' lack of readiness to adhere to the revised Schedule M compliance standards. This acknowledgment led to the decision to grant an extension, which has been widely regarded as a much-needed respite for the industry. Pharma MSMEs account for around 40% of the medicines manufactured and over 50% of human resources recruitment. Revised Schedule M has two components: Documentation and infrastructure. Both need high quality trained workforce. Therefore extension came in as a breather.
Jatish Sheth, honorary secretary, Confederation of Indian Pharmaceutical Industries, the largest pharma association in the country and co-chairman, KDPMA, noted that rescheduling the revised Schedule M to the year-end was a good initiative but with a rider. A gap analysis by way of self-declaration by the company will serve two purposes. One is that the industry will now pace up to identify and address disparities between their current and desired performance. Second is that the industry will now make a commitment to upgrade by 2026.
The government will be able to assess from the self-declaration of the industries the gap required to be filled to comply with the revised Schedule M and extend support in all aspects for achieving higher growth, added Sheth.
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