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MP SDMA demands extension of time by one year to implement Revised Schedule M in MP
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Peethaambaran Kunnathoor, Chennai
September 19 , 2024
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All the drug manufacturers in Madhya Pradesh are now engaged in the process of making changes in their manufacturing facilities to comply with the revised Schedule M of the Drugs and Cosmetics Act, but there are some disruptions in the process of conversion in the facilities that require some more time to complete the work, says Dr. Darshan Kataria, president of the Madhya Pradesh Small-scale Drug Manufacturers Association (MP SDMA).
The machine suppliers, equipment suppliers and the consultants are now busy and preoccupied with a number of units in many states. They have contracts with several manufacturers belonging to various states. So, they want more time to supply the materials and help us to operate more efficiently. Hence, we are forced to demand some more time and the deadline set by the government is too short, he said.
"We have requested for one more year to complete the revision work, and we hope that the government will allow sufficient time for us because 65 percent of our production is going for government supplies, and 25 percent for exports. The deadline set for compliance of the new GMP is expiring on December 31, but that is too short,” he told Pharmabiz over telephone.
As far as the drug manufacturers in MP are concerned, in addition to the time-constraint, there is another problem for the companies established in old industrial area where space-constraint is a hurdle for expansion work. The government is not allowing land for them and the tax rate is too high, which the small-scale operators find very difficult to meet. However, all the MSME units will survive the situation and not a single unit will close down. But several of the units from the old industrial area are now shifting to new places for expansion. Dr. Kataria said, as of now no member company of his association is planning to wind up their operations or converting their facility into marketing companies due to the revised Schedule M mandated by the Union government. Dr Kataria is a medical professional also.
He said very few manufacturers in the state are entering into the tender process with the government, however 10 to 20 per cent of the government’s total medicinal requirements are met by the local manufacturers. The companies in Madhya Pradesh are supplying to all over India including other state governments. In government purchases the government is not giving any preference for the local manufacturers, however, the industry policy of the Madhya Pradesh government is beneficial to the pharma sector in many ways.
To a query, he said there are 280 drug manufacturing companies operating in different parts of the state, out of which about 60 companies are WHO-GMP compliant. They have no problem with regard to the new schedule m, but it affects only the small-scale units. When asked what will be the reaction of the MP drug manufacturers if the government is not allowing additional time for compliance work, Dr. Kataria said there is no other option left, but the manufacturers are expecting a favourable stance from the side of the government.
Himanshu Shah, the immediate past president of the MP SDMA, said several manufacturers are ready to expand their old units provided the government allot them lands in the industrial area at reasonable rates. He said in addition to the property tax, other several forms of tax have to be paid by the company owners for acquiring land adjacent to their units, which is the major problem that puts the MSME units into quandary.
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