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Drug supply to entire north east may collapse if more time is not given to comply with revised Schedule M: ASSPMA
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Peethaambaran Kunnathoor, Chennai
January 15 , 2025
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The Assam Small Scale Pharmaceutical Manufacturers Association (ASSPMA) has informed the Union health ministry that if the pharma manufacturing units in Guwahati are not provided with sufficient time and financial aid to comply with the revised Schedule M, medicine supply for the health sector in the entire north eastern part of the country will collapse.
In a letter sent to the union government, the association said that the Assam small scale pharma units are the backbone of the health sector of all the north eastern states including Assam. In that perspective, the health ministry should consider their request for a time of 24 months more to comply with the new regulations.
The association has apprised the Central government that support given to the industry is the support to the medicinal needs of the people in the north east. They urged the government that since they are the suppliers of medicines to the entire north eastern states, they should be given sufficient time to comply fully with the new good manufacturing practices (GMP).
Although there are some big players like Sun Pharma, Hetero, Natco etc in Guwahati, major part of the medicines supplied to the villages and urban areas in all the seven states and Sikkim is by the local manufacturers of Assam. Besides, they supply medicines to other parts of the country also. If they have to sustain, the government should provide all support to them, says Ranjan Kumar Deka, secretary of the ASSPMA.
“Although we are supporting the Union government’s decision in revising the Schedule M of the drugs and cosmetics act for the sake of higher quality pharmaceuticals, we are now concerned about the future of our industries as over twenty units have already closed down because of stringent regulations and lack of government support. Unlike in other states, we are facing a grave problem of skilled workers and technical persons. What we are doing now is outsourcing skilled workers from south India and also from the north, and mixing them with our local workforce. The skilled employees give training to our local people. Secondly, lack of technical persons is a serious problem for all the companies including the large players and MNCs. One of the MNCs which had a unit in Guwahati closed a few months ago due to non-availability of skilled staff. Even in such a situation, we are running our factories and manufacturing good quality medicines, the majority of which are supplied to the north eastern states. In this scenario, this 12 months’ time for the implementation of the new GMP is not sufficient for us. We need another 24 months also,” Deka told Pharmabiz over telephone from Guwahati.
Talking to Pharmabiz over telephone from Guwahati, RK Deka said if the pharma industry in Guwahati gets weakened, the whole health sector in the north east will completely shatter. He said the north eastern region is facing numerous challenges and infrastructural bottlenecks such as inadequate transport facilities, shortage of skilled manpower, unreliable power supply etc. These factors further complicate the compliance with the new regulations.
Further, the financial difficulties of the MSMEs are putting the industries into struggle in allocating required resources within the stipulated time frame. The industry needs financial loans with a 30 per cent subsidy to become fully compliant with the new schedule. ASSPMA says that only through some extended timeline, the pharma industries in Assam will grow, unless the remaining units will have to close down.
Ranjan Kumar Deka has also given a letter to the state government asking for full support to the promotion of the pharma sector in the state. While speaking to Pharmabiz, he said the state government is not that much interested in promoting the pharma industry in Assam. The small-scale players, the local manufacturers in the state, are worried about that. He is once again planning to approach the government seeking for some help.
As regards ASSPMA, the secretary said the association was formed only recently, and there are 20 members to the association. Previously, there were 35 to 40 pharma companies, out of which over 20 units downed their shutters in the last two years.
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