CDSCO, DoP Told to Find Workable Solution on Revised Schedule M GMP Concerns

Schedule M prescribes Good Manufacturing Practices (GMP) standards that drug manufacturers must follow, including requirements such as a prompt product recall system for products known or suspected to be defective. Industry representatives have argued that the revised compliance norms are stringent and operationally challenging, especially for smaller and medium-sized manufacturers.

Officials stated that Nadda has engaged in detailed discussions with industry stakeholders, including meetings with representatives of Laghu Udyog Bharti (LUB) -an RSS affiliate representing small and micro enterprises. These discussions were held twice in the last few days, on January 10 and January 16, with senior officials from the ministry also present.

Participants at the meetings shared a pan-India survey conducted by LUB indicating that around 25% of pharmaceutical units are seeking an extension of the Schedule M compliance deadline. The survey, along with industry demands, was formally submitted to the minister during the consultations.

Sources present at the discussions stated that the industry is hopeful of a positive outcome, with an extension likely and the possibility that the ministry may announce relaxation measures or deadline adjustments this week. The Ministry is examining viable approaches that could balance regulatory quality standards with industry capacity to comply.

Schedule M is a key regulatory instrument governing GMP in India’s pharmaceutical sector, designed to ensure production of medicines under adequately controlled conditions. While the norms aim to strengthen drug safety and quality, compliance has been a point of contention for parts of the industry, particularly smaller players facing financial and technical challenges in meeting enhanced standards, reports The Economic Times.