Representatives from major pharmaceutical lobby groups are meeting officials of the Central Drugs Standard Control Organisation (CDSCO) today to discuss regulatory matters, including the implementation of Schedule M, as reported by Business Standard.
Schedule M, which sets quality standards and good manufacturing practices (GMP) for pharmaceutical companies, was notified by the Ministry of Health in January 2024 and came into effect on January 1, 2025.
Industry sources confirmed that pharma bodies have been asked to submit presentations in advance, with five minutes allocated to each for discussion during the meeting.
Concerns from MSME Pharma Units
Micro, small, and medium enterprises (MSMEs) are expected to request an extension for compliance with Revised Schedule M guidelines. After multiple appeals, the government issued a draft notification on January 4 proposing a one-year extension for pharmaceutical companies with an annual turnover of less than ₹250 crore.
However, MSME representatives are pushing for a two-year extension, citing financial constraints and the need for more time to upgrade their facilities. India has approximately 10,500 pharmaceutical units, of which 8,500 belong to the MSME sector. Currently, around 2,000 MSME units hold WHO-GMP certification. Sources indicate that a decision on the extension is likely to be finalised soon.
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ICMR and CDSCO Release Protocol for HMPV Test Kits
The Indian Council for Medical Research (ICMR) and CDSCO have issued a draft evaluation protocol for human metapneumovirus (HMPV) real-time PCR diagnostic kits. This initiative aims to standardize the evaluation of in-vitro diagnostic (IVD) kits, as required under the Medical Device Rules, 2017.
The protocol focuses on testing nasopharyngeal and oropharyngeal swabs for diagnostic accuracy. It follows protocols for chikungunya, dengue, and Zika kits and is open for public comments until March 15, 2025.
