The Ministry of Health proposes an amendment to Schedule M for microbiological surveillance in Grade‑A areas in accordance with WHO guidelines.

Ministry of Health and Family Welfare proposes amendment to Schedule‑M under drug regulations to strengthen microbial surveillance in Grade‑A (highest hygiene standard) areas.

The Ministry of Health and Family Welfare has presented a proposal to amend Schedule‑M under the drug regulations, aiming to reinforce microbial surveillance in Grade‑A (highest hygiene standard) areas. This move aligns with the latest guidelines issued by the World Health Organization (WHO), which call for stringent environmental controls and continuous monitoring during the sensitive stages of drug manufacturing to prevent potential microbial contamination. The proposed amendment makes regular air‑sampling, surface‑sampling, and water‑quality testing mandatory in Grade‑A areas, and also requires documentation of test results and real‑time reporting.

In recent years, several high‑level infection cases in the pharmaceutical industry have alarmed regulatory bodies, heightening concerns over patient safety and product quality. WHO's recommendations, designed to curb global antimicrobial resistance and hospital‑acquired infections, are now being implemented in India as well. The ministry says that this amendment will not only elevate hygiene standards in the production process but also ensure that export‑oriented drugs comply with international standards.

Finally, the ministry has given industry representatives the opportunity to provide detailed feedback on the proposed amendment and states that it will be published as final regulation shortly. This initiative is expected to give new direction to quality assurance and patient safety in the Indian pharmaceutical sector.