MSMEs voice concern over conditional extension of revised Schedule M without providing financial support
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Peethaambaran Kunnathoor, Chennai
January 07 , 2025
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The Bihar Pharmaceutical Manufacturers Association (BPMA) has strongly raised its voice against the decision of the Union health ministry for its conditional extension of the revised Schedule M without providing any financial support to cater to the demands of the pharma MSMEs. Responding to the draft notification issued in this regard by the ministry last Saturday, the president of the BPMA, Sanjiv Rai termed the new notification as totally an eyewash. He said the government should implement the revised Schedule M only after providing substantial financial assistance to the old companies which are facing several issues, but sustaining in the market due to quality products. Rai said the government is not aware of this factor, but alleged that there is a mafia colluding with the government wanting for the premature death of the MSMEs under the pretext of advancement. According to Rai, if the government was really inclined to the industry, it should have come out with some financial incentives to the MSME sector to encourage the pharma sector. He said the pharma MSMEs have been manufacturing quality drugs for over three decades to support the Indian healthcare system. A company with a tradition and credibility of more than 25 years or so cannot be termed as outmoded just because of the reason that it has not installed fancy machinery. It has been manufacturing quality medicines all these years, this factor has to be counted. Rai said drugs at reasonable prices are available in the nook and corner of the country today because of the MSME sector. There are drugs with sky-high prices available in the market manufactured by mafia companies, but the poor people in the country are unable to touch such medicines because of its high MRPs. President of the Kerala Pharmaceutical Manufacturers Association (KPMA), N Purushothaman Namputhiri, also commented on the same lines. He said the pharma industries in Kerala are not fully satisfied with the decision of the union health ministry because the government has not given any financial incentives to the small and medium pharma sector to upgrade their plants to be compliant with the new Schedule M. according to him, the decision of the government fails to generate confidence among the small players. When asked whether all the small and medium units are able to comply with the conditions put by the government, Namputhiri said the micro level pharma units with less than Rs. 10 crore may not be able to comply with the time frame due to technical as well as financial constraints. He also foresees that there is a possibility for the regulatory body to become more powerful over the industries in terms of requirements and international standards. He said KPMA is dejected now because of lack of government support to tide over the revised Schedule M hurdles. Meanwhile, chairman of the Telangana state branch of the Indian Drug Manufacturers Association (Ts IDMA), G Rajamouli said he felt a positive note on the part of the government in giving reasonable concessions to the industries with a turnover less than Rs. 250 crore. Mouli said, in a meeting called by the Department of Pharmaceuticals in Hyderabad sometime back, he informed the central ministry officials that personal assurances by those industries who want to continue in the field should be given to the government, and such industries should be provided with the extension, and it should be for a period of two years. Those who are not interested in upgrading their plants and do not want to continue operations in future should be asked to quit the sector on their own interest. Quality medicines are the need of the hour, for which the standards in the manufacturing facility need to be upgraded. It is the commitment of the entrepreneur to assure the quality. But, he said, the government has to become more flexible towards the industry, and said the industry in Telangana still wants clarification from the government about manufacturing food supplements in the drug production facilities. Probhas Bondhu Chakraborty, general secretary of the WB Pharmaceutical Manufacturers Association (WBPMA), has responded that the government has shown its commitment to the pharma sector by extending the deadline for upgradation to another one year. He said he is happy over the decision of the government in giving one more year to the MSME sector to comply with the revised Schedule M, but wants some financial incentives. P Ramesh Kumar, president of the Pondicherry Drug Manufacturers Association (PDMA) has said that the pharmaceutical manufacturing units in the union territory are fully complied with the revised Schedule M norms and the pharmaceutical products manufactured in the territory are at par with global standards in quality. M Varadarajan, president of the Tamil Nadu Pharma Manufacturers Association (TN PMA) said he has called for an executive committee meeting of the association to discuss the new notification and reach a conclusion. He said all the units in the state are ready to upgrade their facilities to comply with the rules. But, according to J Jayaseelan, chairman of the TN IDMA, the problem today is to think of how the Schedule M is going to be implemented, whether it is in a supportive way to the industries or in a bureaucratic manner. He said if the officials create more red-tapism, it will spoil the industry which supports the livelihood of multiple families. A balance is needed between the industry and the regulatory body, otherwise several units will have to close down, he said by adding that his units are US FDA approved ones. The chairman of the Confederation of Indian Pharmaceutical Industries (CIPI), RK Jain, has commented that the MSME sector had expected a blanket extension of the revised Schedule M without any conditions. Besides, the micro, small and medium pharmaceutical enterprises in the country were waiting for financial aid from the government in support of the new Good Manufacturing Practices.
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