Schedule M guideline: Revision and its nationwide implementation
Dr. M Aamir Mirza, Jamia Hamdard
The Union health ministry notified the revised schedule M (under the Drugs and Cosmetics Rules, 1945) on December 28, 2023, the draft of which was released five years ago (October 2018). The GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, in the year 1988 and the last amendment was done in June, 2005. The revised rule is to be implemented on the basis of company turnovers. The implementation by the large manufacturer may not be a challenge and most of them would be already following the international standards. The MSMEs need to be either offered stretched timelines or financial support. But overall, the industry and regulators have taken it positively.
Earning an epithet ‘the pharmacy of the world’ inherently brings a sense of accountability, and the steps in this regard have already been started. The Union health ministry of the government of India notified the revised schedule M (under the Drugs and Cosmetics Rules, 1945) on December 28, 2023, the draft of which was released five years ago (October 2018). The schedule M prescribes the Good Manufacturing Practices (GMP) which is now at par with the international quality standards, especially to those of World Health Organization (WHO). The GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, in the year 1988 and the last amendment was done in June, 2005. The term 'Good Manufacturing Practices' has now been replaced with 'Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products'. It also includes the provision of Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), annual Product Quality Review (PQR) and the qualification and validation of equipment and a computerized storage system. The implementation of the guideline includes technological and infrastructural upgradation, recruitment of the skilled personnel and a good amount of investment.
The recent blots have dented the image of Indian pharmaceutical products, like children’s deaths in Gambia and Uzbekistan, and microbial contamination into an ophthalmic product exported to the United States. So, it seems necessary to implement.
The size of the Indian pharmaceutical industry is remarkably large which can be understood by the fact that there are over 80 Pharma clusters across the country and over 10500 manufacturing facilities out of which around 8,500 fall under the MSME (Micro, Small and Medium Enterprises). There are around 2,000 units in the MSME category having WHO GMP certification. Other than size of the industry the factors which should be considered during the implementation of the revised guideline are the continuous supply of cost-effective medicines to our population and bolstering the growth of the MSME.
The revised rule is to be implemented on the basis of company turnovers, the large manufacturers (having turnover > 250 crores) were given six months and small and medium manufacturers (turnover ≤ 250 crores) have been given twelve months’ time (ended in Dec 2024) to implement the same from the date of publication of the schedule.
It should also be noted that both, large and mid/small size pharma companies, are vital parts of India’s pharma sector, one serving mainly export markets, the other serving the domestic markets with affordable quality medicines. The implementation by the large manufacturer hasn’t been a challenge and most of them are already following the international standards. The MSMEs needed either stretched timelines or financial support. Industrial organizations had written to the Prime Minister, reasoning that the revised Schedule M and price control are incompatible, as they would lead to the shortages of drugs on the National List of Essential Medicines (NLEM). The plea by the Punjab Drug manufacturers Association (PDMA) cited the concerns of being a bordering state and chances of adding to unemployment in the case of closure of MSMEs. Concerns over the poor quality of pharmacy graduates were also included. Hence in a notification issued by the central government on Jan 04, 2025 the timeline for the MSMEs below 250 crores of annual turnover has been extended for one year (i.e., December 31, 2025) with the conditions of submitting an application having the gap analysis and the detailed plans to achieve the same.
But overall, the Industry and Regulators have taken it positively. The manufacturing units in Pondicherry are already complying with most of the norms. The manufacturing units of Tamil Nadu are fully prepared now. The Central Drugs Standard Control Organisation (CDSCO) is continuously conducting several training programs and workshops in this regard. The Department of Pharmaceuticals (DoP) has merged three existing schemes APICF, PTUAS and PPDS and created a new one SPI (Strengthening of Pharmaceuticals Industry), the major objective of which is to upgrade the production facilities of Pharma units to meet up-to-date regulatory standards, by providing subsidy on reimbursement basis, which will enable them to obtain revised Schedule M and WHO GMP certifications.
The author is a New Delhi based academician and R&D consultant, having working experience of global healthcare companies. Can be reached at aamir_pharma@yahoo.com
Dr. M. Aamir Mirza is working as an Assistant Professor in the Department of Pharmaceutics, Jamia Hamdard, an NIRF Rank 1 institute and a NAAC ‘A+” grade deemed to be University. He has a multifaceted career portfolio adorned with both industry and academic accomplishments. During his industry stay he became a seasoned scientist and dealt with challenging NCE/NDA development. He is on advisory boards of some international research-based companies of India, New Zealand and Europe. Academics and Research being close to his heart, he has published more than 110 manuscripts in the journals of international repute and has been granted 02 Indian patent and filed for 04. He has contributed several chapters in books published by reputed authors like Elsevier and Bentham. He is amongst the very few scientists globally who has an expertise in Humic substances research. A well-travelled scientist; he has delivered scientific addresses in countries like USA, Austria, Japan, Netherlands, Turkey, Estonia, Spain and Russia. He has been Elite Fellow at University of Malaya (Malaysia) for the last 5 years where he takes classes on the topics related to industrial pharmacy.
