The Health and Family Welfare Ministry has proposed amendments in Drugs Rules 1945, to align microbial monitoring requirements in Grade A clean areas with World Health Organization guidelines. The proposed amendment, notified on 28th October this year seeks to harmonise country’s regulatory standards with WHO guidelines on Good Manufacturing Practices for Sterile Pharmaceutical Products. It also provides for treating any microbial growth detected in Grade A areas as a trigger for investigation.
Grade A areas are critical zones in sterile pharmaceutical manufacturing where exposed products, containers and sterilised components are handled. The revised provisions aimed to strengthen microbial control and ensure the quality and safety of sterile pharmaceutical products. The Ministry has invited objections and suggestions from stakeholders and members of the public on the proposed amendments.
