Jan 6, 2025

In a significant development for Micro, Small, and Medium Enterprises (MSME) in the pharmaceutical sector, the Ministry of Health and Family Welfare (MoHFW) has proposed an extension for compliance with the updated Good Manufacturing Practice (GMP) standards under the revised Schedule M of the Drugs Rules, 1945. This move aims to provide much-needed breathing room for smaller drug manufacturers to meet the new regulatory requirements without disrupting their operations.

Deadline Extension Announced

In a draft notification issued on January 4, 2025, under GSR 10(E), the MoHFW has extended the compliance deadline to December 31, 2025 for small pharmaceutical manufacturers with annual revenues of ₹250 crore or less. This new timeline offers a one-year extension from the previous deadline, which was set for December 27, 2024.

This decision is expected to benefit many MSMEs by giving them an additional 12 months to adapt to the updated GMP standards, ultimately improving product quality and ensuring alignment with international regulatory practices.

Public Consultation Period

As part of the regulatory process, the MoHFW has opened a seven-day public consultation period, allowing stakeholders, including industry representatives and the general public, to submit their feedback on the draft notification. The consultation period closes on January 11, 2025. Following the review of the public input, the final notification will be issued.

Applying for the Deadline Extension: A Step-by-Step Guide

For small manufacturers to take advantage of this extended deadline, a formal request must be submitted to the Central Licence Approving Authority. Here’s how:

  1. Form Submission: The application must be made in Form ‘A’ within three months of the publication of the final notification.
  2. Required Details:
    • Name and address of the manufacturer
    • Turnover for the period April 2023 to March 2024
    • License details
    • Approved sections of the facility
    • WHO GMP/CoPP status
    • Results of a comprehensive Gap Analysis
    • A detailed Compliance Plan/Strategy
    • Time extension requested and its justification

Vaayath Consulting Services: Your Partner in Compliance

Understanding the complexity of the new GMP standards, Vaayath Consulting Services offers expertise in helping MSME pharmaceutical manufacturers navigate this transition. They provide:

  • GAP Assessment: An in-depth analysis to pinpoint areas needing improvement to comply with the revised GMP standards.
  • Compliance Strategy Development: A tailored strategy to meet the updated regulations, ensuring a smoother transition and regulatory approval.

These services ensure that your application for the extension is robust and meets all requirements set by the Central Drugs Standard Control Organization (CDSCO).

Conclusion

This extension marks a significant step toward supporting MSME pharmaceutical manufacturers as they strive to meet the revised GMP standards. By providing an additional year, the government acknowledges the challenges faced by smaller firms and supports their efforts to enhance product quality and safety.

For more details on the draft notification and how to submit feedback, stakeholders are encouraged to visit the official notification.