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India Extends Deadline for Pharma SMEs to Comply with Revised Schedule M GMP Standards

8 hours ago
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  • The Indian government has granted a one-year extension for pharmaceutical SMEs with an annual turnover under INR 2.5 billion (US$28.77 million) to comply with revised Schedule M standards.
  • The revised Schedule M outlines Good Manufacturing Practices (GMP) and quality benchmarks for the pharmaceutical sector.
  • The extension follows requests from small and medium manufacturers needing more time to upgrade infrastructure, train personnel, and secure funding.
  • The Union Health Ministry announced the new deadline in response to industry concerns.
  • Affected manufacturers must submit an upgrade plan via Form A to the Central License Approving Authority (CLAA).
  • The original deadline to submit Form A was March 31, 2025; it has now been extended to May 11, 2025.
  • Form A serves as a declaration of intent, detailing how manufacturers will meet the updated GMP and equipment standards within the extended timeframe.

  • Initial Deadline & Classification:

    • In January 2025, the government set December 31, 2025 as the deadline for ~8,500 MSME pharma units to comply with revised Schedule M standards.

    • Large manufacturers (turnover > INR 2.5 billion / US$28.77M): Given 6 months to comply (deadline: June 28, 2024).

    • Small and medium manufacturers (turnover ≤ INR 2.5 billion): Granted 12 months to comply (initial deadline: December 28, 2024).

  • Extended Timeline for SMEs:

    • Compliance deadline for SMEs extended by 1 year; now effective until December 31, 2025.

    • To qualify, SMEs must submit an upgrade plan (Form A) to the Central License Approving Authority (CLAA) by May 11, 2025.

  • Enforcement and Penalties:

      • Audits to begin 3 months after Form A submission to assess compliance progress.

      • Non-compliance may result in penalties, including potential factory closures.

  • Strategic Objective:

      • The revision aligns Indian pharma regulations with global GMP standards, improving drug quality, safety, and efficacy.

      • Aims to enhance India’s global reputation as a reliable pharmaceutical exporter.

References

  1. Koul, S. (2025, February 25) Over 8.5K MSME pharma units get 1-yr breather to adopt Schedule M standards, Business Standard, website

  2. Conditional extension of timeline to small and medium pharmaceutical manufacturers for compliance with revised Schedule ‘M’ notification, (2025, February 12); Press Information Bureau, website

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