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gmp: ‘Most small drug companies unnerved by GMP compliance norm’


The MSME pharma companies have raised concerns over the government’s move to make good manufacturing practices (GMP) compliance mandatory for them. Several industry associations representing the MSME sector have written to the health ministry and the drug regulator saying the stipulation will wipe out competition and will have a drastic impact on the availability of medicines.

The government is all set to come out with a notification to this effect soon.

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According to an industry association, the “industry is unaware of whether their feedback is considered or not and what is the shape of final notification,” a member told ET on the condition of anonymity.

According to him, at present only about 20% of the country’s total manufacturers comply with WHO GMP requirements and most of them will face closure if revised Schedule M is implemented without adequate time and handholding.

“We had estimated in 2019 that MSME will require a minimum of ₹3-5 crore to per manufacturing unit and a minimum of three years to comply with the revised Schedule M requirements. The government should consider three years from the date of final notification as date of final compliance. These three years are required for improving infrastructure, additional manpower recruitment & training and implementation of revised SOPs,” he added. GMP standards ensure quality by way of controls on materials, methods, machines, processes, personnel as well as facilities and environment.

Union health minister Mansukh Mandaviya had announced last month that companies with a turnover of ₹250 crore and more will have to implement the revised GMP within six months. Medium and small-scale enterprises with a turnover of less than ₹250 crore will have to implement it within a year.

‘Most Small Drug Cos Unnerved by GMP Compliance Norm’.


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