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the country’s pharmaceutical sector faces notable compliance challenges. Of the 10,500 manufacturing units present in India, only 2,000 units currently meet WHO-GMP standards. Smaller enterprises, which make up 80 percent of the industry, face significant hurdles in upgrading their facilities and processes to achieve compliance. Addressing these gaps is critical for aligning the sector with global manufacturing standards and maintaining its competitive edge.
To keep pace with the fast-changing manufacturing and quality domain, there was a necessity to revisit and revise the principles and concept of GMP mentioned in current Schedule M. This would bring our GMP recommendations at par with global standards, especially to those of World Health Organization (WHO) and ensure production of globally acceptable quality of drug.
Schedule M prescribes the Good Manufacturing Practices (GMP) for pharmaceutical products and the Revised Schedule M has been notified as rules to ensure GMP is adhered to and requirements of premises, plant, and equipment for pharmaceutical products.
Schedule M of the Drugs and Cosmetics Act, 1940, includes requirements of facilities and their maintenance, personnel, manufacture, control, safety testing, storage and transport of material, written procedures and records, and traceability for pharmaceutical products.
The Revised Schedule M is an update to Schedule M of the Drugs and Cosmetics Rules,1945. It includes upgrades to physical infrastructure, air handling systems, and machinery.
The Revised Schedule M has 13 parts which provide GMP guidelines for the specific requirements for manufacturing pharmaceutical drugs. The revised rules have five new categories of drugs including pharmaceutical products containing hazardous substances such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products and radiopharmaceuticals.
The revised rules is to be implemented on the basis of company turnovers where the medium and small manufacturers include those with an annual turnover of less than ?250 crore who will have to implement the revised rules within 12 months from its date of publication, whereas large manufacturers with an annual turnover of over ?250 crore will be given six months to do so(As per the recent notification of the Union Health Ministry Manufacturers must now comply with the improved manufacturing practices(implementation of Revised standards of Schedule M of the Drugs and Cosmetics Act) by December 31,2025.
Tackling quality issues
The Revised Schedule M can certainly help tackle quality issues in the pharmaceutical industry by improving the safety, quality and efficacy of drugs:
- Risk management: The revised Schedule M focuses on risk management, including a comprehensive risk assessment for products
- Equipment qualification and validation: The revised Schedule M requires qualification and validation of equipment
- Self-inspection: The revised Schedule M requires self-inspection
- Excipient quality: The revised Schedule M requires testing of drug components under recommended climate conditions
- Pharmaceutical Quality System (PQS): The revised Schedule M calls for stakeholders to shoulder responsibilities for ensuring quality in the final product (which is of high significance and differentiates one manufacturer from the other and that is what the Indian Pharma industry is striving to achieve)
- Documentation: The revised Schedule M can solve problems pertaining to documentation
- Failure investigation: The revised Schedule M can solve problems pertaining to failure investigation
- Technically qualified individuals: The revised Schedule M can solve problems pertaining to technically qualified individuals.
Updated guidelines
The updated guidelines call for substantial enhancements in pharmaceutical infrastructure and operational methodologies. These include the preparation and submission of detailed product development reports, rigorous validation of processes and methods, and the implementation of advanced pharmacovigilance and post-marketing studies.
GMP is mandatory standards which builds and brings quality into a product by way of control on materials, methods, machines, processes, personnel, and facility/environment, etc.
GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in the year 1988 and the last amendment was done in June, 2005.
For stakeholders in the Indian healthcare industry, the revised Schedule M represents both a challenge and an opportunity. Manufacturers, equipment suppliers, and compliance consultants have a pivotal role to play in helping the industry navigate these regulatory changes.
Adhering to the new regulation may prove necessary for domestic companies for securing and maintaining manufacturing licenses, underscoring its significance for uninterrupted operations in the pharmaceutical sector.
(The author is a consultant in the mergers and acquisitions(M&A) domain of pharma industry)
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