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WB pharma SSIs demand more time & financial assistance from govt to implement revised Schedule M
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Peethaambaran Kunnathoor, Chennai
January 19 , 2024
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The Government of India must come forward with some fiscal incentives to help the small and micro pharma industrial units to comply with the revised Schedule M, or else they have to fight with the corporate entities in maintaining better quality in the production of pharmaceuticals.
The support from the government will definitely help the pharma sector to stave off a possible delay in complying with the new GMP rules by the micro, small and medium industries (MSMEs), opines B K Sarkar, president of the West Bengal Small Scale Pharmaceutical Manufacturers Association (WBSSPMA).
Admitting that the new Schedule M rules are mandatory for upgrading the manufacturing facilities and it is a need of the hour when comparing the global scenario, Sarkar said the SSI pharma units in West Bengal are in a tight situation and need help either from the central government or from any funding agencies. He said it is necessary to modernize the companies and make them more scientific in all operations including documentation and validation because the pharma sector of India is growing rapidly. The SSI units are also contributing their part in the increasing growth of the pharma sector but they cannot withstand the present situation and if the crisis continues to exist they cannot implement the revised Schedule M within the limited timeframe.
“Although some financial implications come in the way, modernization must be there in the industry. Otherwise we cannot manufacture better quality products on the lines of international standards. It is necessary to modernize the system, make it more scientific and update the validation and documentation activities because the world is changing rapidly. Every year there is more than ten percent growth in the pharma sector and the exports are really jumping up. So, the new GMP is necessary for all manufacturing units, but sufficient time and incentives for upgrading facilities are necessary for all the SSI units, otherwise they cannot withstand and compete with the major players in quality aspects. In the case of pharma units in West Bengal, 80 percent of them are micro and small units who cannot afford the huge expenses. The West Bengal pharma sector is now facing a difficult situation in marketing their products and challenges are ahead. In this tight situation, without financial aid from the government it will be difficult for the industry to comply with the new rules’, Sarkar told Pharmabiz.
The industry leader replied to a question that the state government is not providing much support to the pharma sector, particularly the SSI units. As a matter of fact, they are fighting with the MNCs, he added.
When contacted, a former regulatory officer who is now the leader of the WB IPA and providing consultancy services for the pharma sector in West Bengal said in anonymity that the revised Schedule M is good for the industry to manufacture quality medicines but the norms are tougher for the SSI pharma sector. But he said this doesn’t mean that the big companies are able to manufacture better quality products and the SSI units produce lower quality medicines. The small players are also focusing on quality aspects of the production, but the huge financial implications due to the immediate modernization will become a burden for them. So, the Central government must provide some financial support to the pharma MSMEs operating across the country. He has also commented that the government of West Bengal is unfriendly with the pharma industry. He said, in previous years there were several incentive packages from the central government, but no SSI unit could utilize it because of complex procedures.
The IPA leader said the pharma industry will prosper only when the MSME sector is able to invest more, otherwise big corporates will occupy the entire sector and that is what is happening in India at present. He said the pharma sector in West Bengal requires more investment and the SSI units are not capable of investing in modernization and the only way-out is fiscal support from the central government.
BK Sarkar said his association has sent one letter to the Central government asking for extension of the deadline for compliance with the new rules and wanted some financial assistance for technological upgradation.
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