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The Ministry of Health and Family Welfare has announced a proposed amendment to the Drugs Rule, 1945, extending the compliance timeline for small and medium pharmaceutical manufacturers in India. This decision follows multiple representations from industry stakeholders requesting additional time to implement the provisions of revised Schedule M under the Drugs and Cosmetics Act, 1940.
The Government of India had earlier notified the revised Scheduled M through G.S.R. 922(E) dated 28 December 2023, which was published in the Gazette of India on 5 January 2024. As per the original notification, manufacturers with a turnover of ₹250 crores or less were provided a 12-month timeline to implement the revised provisions. However, with this deadline approaching, industry bodies have urged the government to extend the implementation period to allow for smoother compliance.
Purpose of the Extension
The extension aims to provide small and medium pharmaceutical manufacturers with additional time and resources to effectively implement the revised Schedule M regulations. Manu manufacturers have faced financial and operational challenges in upgrading their facilities to meet the new compliance standards. By extending the deadline, the government seeks to ensure a smoother transition, maintain the quality of pharmaceutical products, and support the sustainability of businesses in the sector without causing disruptions in drug supply chains.
Proposed Amendment and Extension Details
In response, the Central Government has issued a draft notification intending to amend G.S.R 922(E). Key highlights include:
Extension of compliance timeline: Small and medium manufacturers (turnover less than ₹250 crores) can seek an extension until 31 December 2025
Application requirement: Eligible manufacturers must submit Form A to the Central License Approving Authority within three months from the date of publication of this notification
Submission of an upgradation plan: The application must include a plan of upgradation detailing the necessary steps towards compliance
Implications for the Pharmaceutical Industry
This extension provides much needed relief for small and medium pharmaceutical manufacturers, allowing them additional time to upgrade their facilities and comply with the new regulatory framework. The move also ensures a balanced transition, enabling manufacturers to align with global quality standards while maintaining business continuity.
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