Amendment to Schedule-M Proposed for Microorganism Monitoring in Grade-A Areas

According to a PIB Delhi report, an important proposal to amend Schedule-M of the Drugs Rules, 1945 has been introduced by the Union Ministry of Health and Family Welfare. This proposal has been brought forth through notification number GSR 953(E) issued on 28 October, 2026. The main objective behind this amendment is to further strengthen microorganism monitoring in Grade-A areas and to align the standards of sterile drug manufacturing with the guidelines of the World Health Organization, i.e., WHO.

Through this proposed change, appropriate revisions will be made to the prescribed limits of microbial contamination in Grade-A clean areas, in accordance with WHO Technical Report Series Number 1044, Annexure-2 relating to Good Manufacturing Practices for sterile pharmaceutical products. This step will help bridge the gap between the currently enforced microbial contamination limits under Schedule-M and the relevant standards set by the WHO for Grade-A areas. As a result, India's regulatory provisions can be aligned with internationally accepted standards.

In the manufacturing process of sterile drugs, the Grade-A area plays an extremely sensitive and important role. In such areas, open pharmaceutical products, containers, and sterilized components are handled, maintained, and operated. Keeping all these factors in mind, it is imperative to maintain strict control over microorganisms in these areas, so that the quality and safety of sterile pharmaceutical products entering the market can be completely safeguarded.

With the help of this proposed amendment, the modified Schedule-M can be made fully compatible with WHO guidelines, and the regulatory framework governing the manufacture of sterile drugs across the country can be made more robust. A special provision has been made in this proposal that if any type of microbial growth is observed in Grade-A areas according to WHO standards, it will be considered a valid basis for initiating an official investigation.

This entire proposal reflects the government's commitment to further strengthening quality standards in drug manufacturing, aligning domestic regulatory requirements with global standards, and ensuring the quality of pharmaceutical products and public safety. Objections and suggestions regarding this proposed amendment have been invited from all stakeholders and the general public.

It has been stated that any objections or suggestions in this regard can be sent to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall, C Wing, First Floor, Kartavya Bhawan-1, New Delhi-110001, or submitted via the authorized e-mail address drugsdiv-mohfw[at]gov[dot]in.