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Report Highlights Concerns Over Potential Drug Shortages and Price Surges in India Due to Health Regulations
- By Newsdesk
- New Delhi
- Jan 12, 2024
Drug shortages and increased prices are expected to emerge in India in the near future, as industry leaders caution that compliance with recently imposed health ministry regulations poses a challenge for various lobby groups and associations representing medium and small enterprises. Many of these groups have communicated their inability to adhere to the new rules and foresee the potential closure of numerous manufacturing units.
The most recent notification from the health ministry addresses the updated Schedule M regulations related to good manufacturing practices, premises, plant, and equipment requirements for pharmaceutical products. The notification incorporates provisions for an annual review of product quality, along with the implementation of quality risk management, as reported by the Economic Times.
Last year, Health Minister Mansukh Mandaviya proposed the phased and mandatory adoption of Schedule M for micro, small, and medium enterprises (MSMEs) within the pharmaceutical industry. The health ministry specified that pharmaceutical companies with an annual turnover exceeding Rs 250 crore must comply with the standards within a six-month period, starting from August 1, 2023. Smaller enterprises have been granted a one-year duration to meet the specified requirements.
Sanjay Singla, a representative of Laghu Udyog Bharti (LUB), an affiliate of the Rashtriya Swayamsevak Sangh (RSS), expressed concerns about the challenging implementation of the revised Schedule M for small and medium sectors. He emphasized their support for quality improvements but highlighted that the upgrade would result in additional costs.
Furthermore, the Punjab Drug Manufacturers' Association (PDMA) asserted that the production of drugs listed in the National List of Essential Medicines (NLEM), subject to price control, would become economically unsustainable. This is attributed to the new regulations causing production costs to exceed the established ceiling price.