MoHFW Extends GMP Compliance Deadline for MSME Drug Manufacturers

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Dated: 23.06.2025

MoHFW Extends GMP Compliance Deadline for MSME Drug Manufacturers

The Ministry of Health and Family Welfare, Government of India, has issued G.S.R. 10(E) dated 4th January 2025, extending the compliance timeline for Revised Schedule M (GMP Standards) for small and medium-sized drug manufacturers.

This move provides crucial relief to companies with annual turnover of ₹250 crores or less, enabling them to align with the updated Good Manufacturing Practices (GMP) under the Drugs Rules, 1945, notified earlier via G.S.R. 922(E) dated 28th December 2023.

Background

Schedule M of the Drugs Rules, 1945 lays down essential GMP norms to ensure consistent product quality, safety, and efficacy in drug manufacturing. In December 2023, the Government revised Schedule M provisions requiring all manufacturers to comply within 12 months. However, MSME manufacturers raised concerns about the short timeframe for implementation due to cost and infrastructure challenges.

Key Provisions of G.S.R. 10(E)

The new notification, published in the Gazette of India (Extraordinary), introduces the following provisions:

Extension Window: Small and medium manufacturers can now seek an extension of compliance until 31st December 2025.
Eligibility: Applicable to manufacturers with an annual turnover ≤ ₹250 crores (for FY 2023–24).
Application Procedure:
- Application must be submitted in Form A annexed with the notification.
- Submission deadline: Within three months from the date of notification (i.e., by 3rd April 2025).
- Must include a Gap Analysis and a concrete Upgradation Plan for compliance with Revised Schedule M.
Review Mechanism: Stakeholders can submit objections/suggestions within 7 days of publication of the draft notification in the Gazette. Final consideration will follow consultation with the Drugs Technical Advisory Board (DTAB).

Form A – Snapshot of Compliance Application

Manufacturers seeking an extension must fill in the following in Form A:

Name & Address
FY 2023–24 Turnover
Licence Details (number, validity)
WHO-GMP or CoPP Status
Section-wise Gap Analysis
Upgradation Strategy with Implementation Timeline
Time Extension Justification (not beyond 1 Jan 2026)
Signed Undertaking of commitment to begin upgrades within 3 months

Implications for the Pharma Industry

This extension is a strategic policy intervention aimed at:

Encouraging regulatory compliance without disrupting operations of MSME manufacturers.
Supporting Make-in-India goals and ensuring that quality standards rise uniformly across industry sizes.
Avoiding potential market disruptions due to compliance incapacity of small firms.

Final Remarks

This proactive move by the Government reflects its balanced approach to public health regulation and industry sustainability. Pharma MSMEs must act promptly to file applications within the given window and initiate their infrastructure and process upgrades as per Schedule M.

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Source: MoHFW

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