• 12 Jan 2024
• Admin
• News Article

Apprehensions loom large on MSMEs to shutdown units with Revised Schedule M implementation: FOPE

The Federation of Pharmaceutical Entrepreneurs (FOPE) has noted that apprehensions loom large on MSME (micro small medium enterprises) units to shutdown following Revised Schedule M implementation mandate.

As per our estimates in 2019, implementation of Revised Schedule M will require a minimum investment of Rs. 3 crore to Rs. 5 crore and timeline of minimum three years for improving infrastructure, additional manpower recruiting & training, implementation of SOPs, Handholding by CDSCO (Central Drugs Standard Control Organisation) & state licensing authorities (SLAs), etc. As such MSMEs are already facing huge challenges threatening their survival and revised Schedule M poses additional challenge, said Harish K Jain, national president, FOPE.

Stating that in our representation we mentioned about our concerns that large number of MSME will close down resulting in shortage of medicines, Jain pointed out this will lead to India losing its competitiveness.

When the draft revised Schedule M was first published in 2018, FOPE as well as other associations had submitted detailed point wise representation to the government. However, the government has not considered any of the representations. In fact, the final notification has more new and stringent provisions than the draft, 

Schedule M was last amended in 2002 and was finally made compulsory for all in 2005. The revision was overdue considering India now is a major global pharma powerhouse.

The revised schedule M on the face of it is broadly based on WHO-GMP. However on careful analysis, it goes beyond WHO-GMP. WHO-GMP is more of a guidance and not mandatory. However Schedule M is mandatory. WHO-GMP as well as GMP mandated by other regulatory authorities are supported by guidance documents from time to time in order to remove misinterpretations or divergence in interpretations. The same is absent in Schedule M. In our representation, we mentioned about our apprehensions that large number of MSME will close down resulting in shortage of medicines. India will also lose its competitiveness. We suggested that Revised Schedule M as when it is notified should be a guidance document for first three years and then made into a law after a review, he said.

Indian pharma industry is already constrained by the stringent price regulations enforced by NPPA (National Pharmaceutical Pricing Authority) through various mechanisms. Improvements in quality do come with a price. Unfortunately NPPA does not recognize cost increase due to quality improvements by way of GMP, BA/BE Study, Pharmacopoeia Monographs, said Jain.