The Health Ministry on Saturday granted small and medium pharma companies with a turnover of less than Rs 250 crore an additional 12 months to implement the revised good manufacturing practices under Schedule M of the Drugs and Cosmetics Act.
These companies now have until December 31, 2025, to comply with the improved manufacturing practices. The extension comes following requests from manufacturing units to upgrade their facilities, the ministry said in a statement.
Good Manufacturing Practices (GMP) are being implemented in the country to improve product quality by controlling materials, methods, machines, processes, personnel, and facilities/environments, among other factors. According to the ministry, there are around 10,500 manufacturing units in the country, of which around 8,500 fall under the MSME category. India is a major exporter of medicines to low and middle-income countries (LMICs), which require WHO GMP certification. Currently, around 2,000 units in the MSME category hold WHO GMP certification.
The pharmaceutical manufacturing and quality domains have developed significantly over the last 15-20 years. "Our understanding of the domain has increased because of developments in pharmaceutical and manufacturing sciences. The linkage between manufacturing and product quality and the interdependence between the two have been established," the statement said.
To keep pace with the fast-changing pharmaceutical manufacturing and quality domain, the government revised the GMP standards in the current Schedule M of the Drugs and Cosmetics Act. "This would bring our GMP recommendations and compliance expectations in line with global standards, especially those of the WHO, ensuring the production of globally acceptable quality drugs," the statement added.
The new Schedule M was notified in December 2023. To facilitate a smooth transition from the present Schedule M to the revised one, the government provided a transition period of 6 months for large manufacturers (with a turnover of more than Rs 250 crore) and 12 months for MSMEs (with a turnover of less than Rs 250 crore). The notification was published on January 5, 2024.
In collaboration with states and UTs, the Central Drugs Standard Control Organization (CDSCO has rolled out an aggressive nationwide plan to raise awareness about the new Schedule M, its requirements, importance, technical justification, and resource availability. To date, CDSCO has completed 15 awareness sessions across different cities and manufacturing hubs, with 36,855 attendees participating in these hybrid-mode sessions. These sessions have been well-received, particularly by the MSME sector.
According to the notification, units with an annual turnover of more than Rs 250 crore were expected to comply with the revised Schedule M standards starting July 1, 2023. For units with an annual turnover of less than Rs 250 crore (MSMEs), the implementation deadline was set for January 1, 2025. Following representations from various industry associations representing the pharma MSME sector, the deadline has now been extended to December 31, 2025.
The main reasons cited for seeking the extension include arranging finances for upgradation and allowing more time for implementing the required changes. The issue of providing the extension was discussed in detail. To facilitate the upgradation of MSME facilities, the Department of Health and Family Welfare has issued a draft notification stating that these units will have three months to register with CDSCO and share their upgradation plans. A 12-month extension will be provided until December 31, 2025.
The statement also noted that after three months, an audit of these facilities will be conducted. Depending on the status of implementation, action will be taken if the upgradation plans are not being executed. To date, CDSCO has inspected over 800 manufacturing units and 252 public testing labs. The feedback from these audits indicates significant improvement in the implementation of GMP standards by MSMEs.
The statement concluded, "There is awareness and sensitization throughout the industry, and many units have already initiated the upgradation process. This is encouraging for the production of safe, efficacious, and quality pharmaceuticals and drugs in the country."
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