Starting today, January 1, Indian pharmaceutical companies must comply with the revised Schedule M norms under the Drugs and Cosmetics Rules, 1945, as the government enforces stricter manufacturing standards.
Overview of Revised Schedule M Norms
The revised Schedule M outlines updated Good Manufacturing Practices (GMP) for pharmaceutical products. These include:
- Manufacturing Practices: Standards for premises, plants, and equipment.
- Quality Reviews: Provisions for annual product quality reviews.
- Risk Management: Requirements for quality risk management systems.
- Pharmaceutical Quality Systems: Comprehensive systems to ensure product safety and compliance.
These changes aim to enhance product quality and ensure a prompt recall system for defective drugs.
Compliance and Challenges for MSMEs
1. Audits and Inspections:
The government now has the authority to initiate audits and risk-based inspections to ensure adherence to the updated norms.
2. Challenges for MSMEs:
- Infrastructure Upgrades: Many small and medium enterprises (MSMEs) are struggling with the high cost of infrastructure improvements and machinery procurement.
- Loan Issues: Delays in obtaining financing have further complicated compliance efforts.
3. Industry Requests for Extensions:
- MSME representatives, including the Federation of Pharma Entrepreneurs (FOPE) and Laghu Udyog Bharati (LUB), had previously appealed for an extension until December 2026 to allow sufficient time for adjustments.
- Rajesh Gupta, president of the Himachal Drug Manufacturers Association, highlighted the sector’s ongoing efforts, including awareness seminars, but stressed the need for more time to align with the new standards.
Government Stance
Despite appeals, the government declined to delay the implementation of the revised norms. A senior official emphasized that companies must comply or face action. This decision underscores the government’s commitment to strengthening drug manufacturing practices in India.
Implications for the Industry
1. Increased Oversight:
The new norms pave the way for stricter enforcement and improved accountability in the pharmaceutical sector.
2. Pressure on MSMEs:
Small and medium-sized enterprises may face operational and financial strain as they work to upgrade infrastructure and meet the new requirements.
3. Potential Benefits:
- Improved product quality could enhance the global reputation of Indian pharmaceutical companies.
- Stricter standards may lead to increased consumer confidence in locally manufactured drugs.
Conclusion: Balancing Progress and Survival
The revised Schedule M norms represent a significant step toward ensuring higher standards in the pharmaceutical industry. However, the challenges faced by MSMEs highlight the need for collaborative efforts between the government and the sector to support compliance without jeopardizing business continuity.