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PDMA seeks PM’s intervention to extend time for MSMEs to comply with Revised GMP standards
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Gireesh Babu, New Delhi
December 27 , 2024
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The Punjab Drug Manufacturers Association (PDMA) has requested Prime Minister Narendra Modi to give more time to the micro and small units under Rs. 10 crore, who have not availed tax holiday benefits, for at least three years to comply with the Revised Schedule M standards.
The request comes at a time when the timeline for the companies below Rs. 250 crore turnover to comply with the revised Good Manufacturing Practice (GMP) standards is scheduled to end early 2025.
The Association, while appreciating the idea behind revising the Schedule M of the Drugs and Cosmetics Act, which is to prevent quality and safety issues with drugs manufactured in the country, and help producing drugs in better than World Health Organisation (WHO) manufacturing standards, said that several issues have to be addressed prior to implementation of these standards.
".... we request that the date of implementation of Revised Schedule M for below Rs. 10 crore turnover micro and small units who have not availed Tax holiday, may kindly be extended till the above problems are solved which could take at least 3 years," said the Association in a letter to the Prime Minister.
"The benchmark of Rs. 250 crore turnover stipulated as time frame is nowhere near the sub Rs.10 crore turnover of micro and small units in Punjab like states. Such units lack financial resources and need 3-5 years to upgrade," it added. Punjab is a sensitive border state and it cannot afford closure of units which may lead to further unemployment.
The Association reiterated that the Drugs Prices Control Order (DPCO) needs to be revised by at least 30 per cent to cover the Revised Schedule M compliance cost. This shall have a direct bearing on the consumer.
It pointed out that almost 90 per cent samples from drinking water are not potable and the high quality pills are sought to be produced using the same water and have to be taken with the same water, which is the cause of 80 per cent of the disease.
The Association also said that it has brought to the notice of the Prime Minister and other authorities that the quality of B.Pharm and school education are poor and this could affect the standards of the product.
"Before employing, Industry cannot teach B. Pharm students as to what are the fractions of a Meter, pH and Factor calculation of molecules etc. This is taught in schools. But 19 out of 20 B. Pharm pass outs have no knowledge about it," it said.
NIPER has not been pressed into service by the government to train manpower for Revised Schedule M implementation. There is also a shortage of unskilled manpower, despite high unemployment among the youth in the country. Budget for education is also very low compared to China.
Pharma units outside the tax haven region faced disadvantage for 14 years from 2003 till 2017 owing to the tax policy and paucity of funds, despite their best efforts, prevents these units from upgrading in time. The proliferation of drug industry following the tax holiday policy has created an intra-unit competition, leading a section of units to cut corners in quality, eventually resulting in issues like those faced in Gambia.
Ex-factory prices remain low and unremunerative even today because FSSAI units licensed by the Centre are producing drugs. States are averse to checking such units since they are Central Licensees. Pharma units cannot compete with them especially after upgradation, added PDMA.
"In addition near-expiry medicines pose a stiff competition. These are basically NSQ drugs which escape prosecution because the state/Central labs cannot Test the samples before their expiry," said the Association.
Industry is not responsible for any of these problems, it added. Shutting down industry is not the solution because it shall demoralize entrepreneurship. Focus on testing alone could have prevented issues related to substandard and spurious drugs, said the Association.
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