With nearly 75% of the pharma units yet to begin upgradation work for their manufacturing facilities, the government might be forced to extend the deadline to implement revised Schedule M guidelines for the small and medium-sized pharma units, sources close to the development told FE. Even the 1,700-odd units which had applied for extension with Central Drugs Standard Control Organisation (CDSCO) this year, 20-30% of the upgradation work is still pending.
“Nearly 5,000 units have not even started the upgradation work due to practical issues and lack of clarity on specific provisions under the revised rules. The extension sought by the industry might be considered given the present circumstances,” the source said.
CDSCO grants extension to pharma companies
In February, the CDSCO had granted extension to the pharma companies falling under Rs 250-crore annual turnover to comply with the revised Schedule M guidelines by December 2025. MSMEs had represented for extension of timeline to enable improvement in infrastructure, training of personnel and arranging financial resources.
“In the past one year, the situation has improved a bit but it will still take a while for a majority of MSMEs to fix issues at their end, including arranging financial resources and training of manpower,” the source said.
Pharma associates’ appeal to CDSCO
Meanwhile, pharma associations have asked CDSCO to extend the window for submission of upgradation plans by one more year (up to December 2026) so that MSMEs who did not apply earlier, particularly due to interpretative uncertainty may come forward with structured plans.
“The revised guidelines have some interpretation issues which requires clarity from the regulator. The investment to upgrade may cost between Rs 2 crore and Rs 10 crore, and there will also be recurring costs to maintain the production standards. Some more time will be needed by the industry,” said Jatish Sheth, secretary general, Confederation of Indian Pharmaceutical Industry (CIPI).
Experts said that the government’s efforts to help industry upgrade has been inadequate. In 2024, the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) was revamped to support 300 units with an outlay of Rs 300 crore for FY25 and FY26. “This scheme doesn’t even cover 10% of the affected companies,” said spokesperson of another pharma association, on condition of anonymity.
Under the rules, a major impetus is being given to improve production facilities, including enhancements for air quality, temperature control, and sanitation procedure. In addition, the guidelines emphasise on documentation and record keeping at different stages of the manufacturing process. Further, the rules specify requirements for receiving, identifying, storing, and handling of all kinds of raw materials.
Notified in December 2023, the revised Schedule M has shifted the focus from “good manufacturing practices” to “good manufacturing practices and requirements of plan and equipment for pharmaceutical products”. The rules apply to two categories of manufacturers. While the large manufacturers (turnover above Rs 250 crore) were supposed to adopt the revised rules by June 2024; MSMEs (turnover below Rs 250 crore) was given a timeline of 12 months ending December 2024.P
