Centre proposes stricter microbial contamination norms under Schedule M

The Union Health Ministry has proposed tightening microbial contamination limits in Grade A clean areas to align India's pharmaceutical manufacturing standards with WHO guidelines

The government is amending India’s Drugs Rules, 1945, to revise the prescribed limits of microbial contamination in Grade A-level clean areas in accordance with the World Health Organization’s (WHO’s) standards. 

Grade A areas are critical zones in sterile pharmaceutical manufacturing where exposed products, containers, and sterilised components are handled. Maintaining stringent microbial control in these areas is essential to ensuring the quality and safety of sterile pharmaceutical products. 

According to the proposed changes, the prescribed microbial contamination in such areas has been tightened to “no growth”, as opposed to less than 1 colony-forming unit (CFU) allowed till now under the good manufacturing practices (GMP) prescribed in Schedule M. 

 

Microbial contamination is the unintentional introduction of living microorganisms such as bacteria, molds, fungi, yeasts or viruses into a controlled environment or a pharmaceutical product. 

“The updated standard treats Grade A environments as requiring complete absence of viable microbial growth in routine monitoring for active air, settle plates, contact plates, and glove prints,” an official aware of the matter said. 

Consequently, finding even 1 CFU would no longer be treated as a minor statistical average or a number below a ceiling.

The official quoted above added that the amendment would also provide for treating any microbial growth detected in Grade A areas as a trigger for investigation, in accordance with WHO guidance. 

“The proposed amendment aims to address the existing differences between the microbial contamination limits prescribed under Schedule M and the corresponding WHO requirements for Grade A areas, thereby bringing India's regulatory provisions in line with internationally recognised standards,” the Union health ministry said on Wednesday. 

Objections and suggestions have been invited from stakeholders and industry executives within 30 days of the publication of the draft notification. 

The move comes a day after the Centre proposed amendments to mandate all drug manufacturers to formally authorise a person with appropriate qualifications and experience for the batch release of drugs and maintain prescribed records for every batch manufactured. 

Similarly, the Central Drugs Standard Control Organisation has told manufacturers and suppliers of key cough syrup ingredients that no batch can leave the factory until it is registered and cleared through the government’s digital management system.