Pharmaceutical SMEs in India Gain Time to Meet Enhanced GMP Standards Under Revised Schedule M

Posted by Written by Archana Rao Reading Time: 3 minutes

India’s Union Ministry of Health and Family Welfare (MoHFW) has issued a draft notification granting small and medium-sized pharmaceutical companies an additional year to upgrade their facilities in compliance with the revised Schedule M of the Drugs and Cosmetic Act.

The revised Schedule M establishes enhanced quality standards and Good Manufacturing Practices (GMP) for pharmaceutical manufacturers, aiming to improve overall manufacturing quality, safety, and regulatory compliance across the sector.

India’s central government announced its decision to grant small pharmaceutical companies an additional year—until December 31, 2025—to meet Good Manufacturing Practice (GMP) standards aligned with those of the World Health Organization (WHO).

As per previous notification, the regulation was set to come into force on January 1, 2025. According to news reports, various associations urged the central government to extend the timeline, allowing micro, small, and medium pharmaceutical companies more time to meet the requirements of the updated Schedule M regulations. The regulation will now come into effect from January 1, 2026. 

Extended deadline for revised Schedule M compliance

Pharmaceutical companies with annual turnovers exceeding INR 2.5 billion (US$29.14 million) were initially given six months to comply, while smaller companies had 12 months. The revised draft notification now proposes:

  1. Registration deadline: Micro, small, and medium enterprises (MSMEs) must register with the Central Drug Standards Control Organisation (CDSCO) and submit their upgrade plans within three months.
  2. Extension period: Upon registration, MSMEs will receive a 12-month extension to comply, pushing their deadline to December 31, 2025.

Failure to meet the revised standards may result in penalties, including possible factory closures. Audits will be conducted three months after registration to monitor progress, with action taken if upgrades are not implemented as committed.

Overview of revised Schedule M

The latest update to Schedule M of the Drugs and Cosmetics Rules, 1945, was notified by India’s Union Ministry of Health and Family Welfare on December 28, 2023. The revised guidelines include upgrades in physical infrastructure, air handling systems, machinery, and more.

Additionally, it introduces a comprehensive regulatory framework to align India’s pharmaceutical sector with global GMP standards. These changes focus on improving the quality, safety, and efficacy of drugs produced domestically, ensuring compliance with both national and international benchmarks.

New guidelines and requirements

The revised Schedule M is titled “Good Manufacturing Practices and Requirements of Premises, Plant, and Equipment for Pharmaceutical Products.” It encompasses critical principles such as:

  • Pharmaceutical Quality System (PQS).
  • Quality Risk Management (QRM).
  • Sanitation and hygiene.
  • Qualification and validation.
  • Complaints and adverse reactions.
  • Product recalls.
  • Change control.

The implementation timeline for the revised guidelines is phased based on the size of the pharmaceutical companies:

  1. Large manufacturers, with turnover exceeding INR 2.5 billion (US$29.14 million), are required to comply with the revised Schedule M by June 28, 2024
  2. Small and medium manufacturers, with turnover up to INR 2.5 billion (US$29.14 million) or less, are required to comply with the revised Schedule M by December 28, 2024.

Infrastructure upgrades and improved operational methodologies

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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.

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.

Addressing compliance gaps in India’s pharma sector

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Experts have made note that 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, grapple with 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.

Conclusion

The revised Schedule M marks a shift in India’s pharmaceutical regulations, reflecting the evolving landscape of global manufacturing standards. By implementing these changes, India aims to enhance its reputation as a trusted pharmaceutical exporter while ensuring the safety and efficacy of drugs for domestic and international markets.

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