Drug regulator may retain GMP relaxations in Schedule M for select products

DTAB recommends continuing GMP exemptions under revised Schedule M for disinfectants, medical gases and gelatin capsules, citing limited relevance of strict norms

India’s central drug regulatory body may retain relaxations in good manufacturing practices (GMP) for select product categories such as disinfectant fluids, medical gases and empty gelatin capsules under the revised Schedule M norms.

 

This comes after the Drugs Technical Advisory Board (DTAB), the highest statutory body on technical matters related to drugs, cosmetics and medical devices in India, recommended providing certain exemptions related to plant and equipment requirements.

 

The decision was taken at the 93rd DTAB meeting held on February 16, 2026, following requests from stakeholders to consider continuing certain exemptions provided under the previous Schedule M norms, as they are not relevant to the category.

 

Effective January 1, 2026, the revised Schedule M prescribes quality standards and GMP for drugmakers, asking them to upgrade infrastructure, improve quality control systems, and adopt stricter documentation processes.

 

The pre-revised norms, however, included certain exemptions for low-risk, non-sterile or industrial-grade disinfectants. This included less equipment and less stringent documentation compared to those required for more complex formulations.

 

Several disinfectant manufacturers had approached regulatory authorities seeking exemptions from the revised norms, arguing that some requirements are not relevant for their category and will enhance compliance costs.

 

“The Board, considering the request, opined that certain requirements of the revised standards may not be relevant to certain categories of drugs, namely medical gases, empty gelatin capsules and disinfectant fluid. Accordingly, the Board recommended continuing the exemptions provided under Schedule M prior to the amendment for these categories of drugs,” the minutes of the DTAB’s 93rd meeting stated.

 

The board had also agreed with a proposal to revise the limit for microbial contamination stipulated in the revised Schedule M to the limits advised under the World Health Organisation’s (WHO) Technical Report Series (TRS).

 

This comes after a Drug Consultative Committee (DCC) of the CDSCO was apprised of a mismatch between the recommended limit of microbial contamination stipulated in the revised Schedule M norms and the specifications in the WHO TRS 1044 Annexure II.

 

The revision would allow the maximum allowable contamination limits for air, surfaces, and personnel in high-risk zones to match global benchmarks, reducing ambiguity for manufacturers.