Drug shortages and rising prices are anticipated in India in the near future, as industry leaders warn that compliance with recently imposed health ministry regulations is challenging for various lobby groups and associations representing medium and small enterprises. Many of these groups have conveyed their inability to adhere to the new rules and predict the potential closure of numerous manufacturing units.
The health ministry's latest notification addresses updated Schedule M regulations pertaining to good manufacturing practices, premises, plant, and equipment requirements for pharmaceutical products. The notification includes provisions for an annual review of product quality, as well as the implementation of quality risk management as per a report by the Economic Times.
Health Minister Mansukh Mandaviya, last year proposed the phased and obligatory adoption of Schedule M for micro, small, and medium enterprises (MSMEs) within the pharmaceutical industry. The health ministry outlined that companies in the pharmaceutical sector with an annual turnover surpassing Rs 250 crore must conform to the standards within a six-month period, starting from August 1, 2023. While smaller enterprises have been allotted 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 that while they support quality improvements, the upgrade will incur additional costs.
Moreover, 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, will become economically unsustainable. This is attributed to the new regulations causing the production costs to surpass the established ceiling price.