India proposes stricter sterile drug manufacturing rules

The Indian Union Health Ministry has proposed stricter contamination monitoring standards for sterile medicine manufacturing facilities to align domestic regulations with World Health Organization (WHO) guidelines.

The proposed amendment targets Schedule M of the Drugs Rules, specifically focusing on Grade A cleanroom zones. These are critical areas where exposed sterile products, containers, and sterilized components are handled. Under the new rules, any microbial growth detected in these zones must trigger a formal investigation rather than being merely recorded.

The move follows regulatory actions involving Sun Pharma, which faced scrutiny after reports of contamination in its Predmet eye drops. The company reportedly withdrew the product and issued a wider recall of 11 ophthalmic products following concerns regarding Pseudomonas bacteria. Additionally, authorities recently ordered the suspension of eye-care drug production at Sun Pharma's manufacturing facility in Assam.