Pharmaceutical companies, CDSCO to discuss regulatory matters on Friday

It is expected that representatives for MSMEs pharma manufacturers may raise the issue of extension of Revised Schedule M implementation timelines

Representatives from several pharmaceutical lobby groups are set to meet officials of the Central Drugs Standard Control Organisation (CDSCO) today, and the Schedule M implementation will be on the agenda, said people privy to the development.

 

Schedule M, which sets quality standards and good manufacturing practices (GMP) for pharmaceutical companies, was notified by the health ministry in January last year and came into effect on January 1, 2025.

 

"Each industry body has been asked to send their presentations in advance. Everyone will be given five minutes to present their points," a member of an industry body said, adding that they have been always in favour of the timely implementation of Schedule M for all manufacturers.

 

According to an industry source representing a lobby group for micro, small and medium enterprises (MSMEs), discussions would include matters like the ease of doing business and regulatory guidelines and timelines.

 

After several requests by the SME pharma companies, the ministry on January 4 released a draft notification granting a one-year extension for companies with an annual turnover of less than Rs 250 crore to upgrade their facilities as per the revised Schedule M.

 

These drug units, however, have been asking for a two-year extension. “The main reasons for seeking an extension were the need to arrange finances and more time for implementing the required changes,” said an expert.

 

It is expected that representatives for MSME pharma manufacturers may raise the issue of extension of Revised Schedule M implementation timelines. Sources said that a decision on an extension is almost final.

 

India has around 10,500 pharmaceutical units, of which 8,500 belong to the MSME sector. Approximately 2,000 MSME units currently hold WHO-GMP certification.    ICMR, CDSCO release draft protocol for evaluation of HMPV test kits 

The Indian Council for Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) have jointly released the draft standard evaluation protocol for human metapneumovirus (HMPV) real-time PCR kits.

 

This move aims to establish a standardised process for evaluating the quality of in-vitro diagnostic (IVD) kits, which is crucial for licensure under the Medical Device Rules, 2017.

 

The draft focuses on the laboratory performance evaluation of HMPV real-time PCR kits, with diagnostic accuracy being checked for samples, including nasopharyngeal or oropharyngeal swabs.

 

The ICMR and CDSCO had previously issued standard evaluation protocols for 14 PCR kits, including those for chikungunya, dengue, and Zika, in December last year.

 

The draft protocol has been placed in the public domain for comments from relevant stakeholders till March 15, 2025.