Even though the Union ministry of health has taken steps to extend the deadline for implementation of the revised Schedule M manufacturing standards to one more year, many of the pharma manufacturers especially the micro small and medium enterprises (MSMEs) seek more incentives and further extension of the deadline for implementation.
The industry had repeatedly requested extension of the deadline for MSMEs, raising concerns over the future of a majority of these units which are not in a position to comply with the standards within a short timeframe. The views of some of the manufacturing associations are given below.
Need for more financial aid Responding to the draft notification issued by the union health ministry, the chairman of the Confederation of Indian Pharmaceutical Industries (CIPI), R K Jain, has commented that the MSME sector had expected a blanket extension of the revised Schedule M without any condition.
Also, all the micro, small and medium pharmaceutical enterprises expected financial aid from the government in support of the new Good Manufacturing Practices, he added.
CIPI, the alliance of pharma industries organisations representing the MSME sector in India, had earlier submitted a memorandum to the government urging for an extension of the deadline set by the ministry.
“It was a demand for an extension of the deadline as it is, not with any condition. Now they have extended it on condition that those who submit applications affirming compliance with higher standards of good manufacturing standards within a specified time not beyond December this year,” he said.
There is no choice for the MSME industries now, only to keep pace with newer quality standards being practiced the world over, Jain said by adding that the government of India has actually shown a big heart to accommodate the MSME industries. The only shortcoming the confederation finds is that the government should have avoided the requirement of submission of any application in the prescribed proforma annexed with the notification.
Jain said the step taken by the ministry conveys one fact that those industries who do not want to upgrade their facilities by investing huge amounts of money in the next one year can leave the field whenever they want as they will not get extension. But those who want to continue their operations need to comply with the higher standards through upgradation. They will have to submit the application in the next three months. Otherwise, they will invite the wrath of the regulatory authorities during this period of one year.
Need for more time 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.
HPMA demands three-year time-frame The Haryana Pharmaceutical Manufacturers Association (HPMA) has demanded to the Union health ministry to allow three years to upgrade their manufacturing plants to the standards prescribed in the revised Schedule M.
The HPMA has informed the central and state governments that they are not satisfactory with the union health ministry’s decision to provide one-year conditional extension to the pharma MSMEs having turnover of Rs. 250 crores or less, but, in place, wanted a period of three years for the full compliance of provisions of new good manufacturing standards set by the ministry.
So, the association has decided that they should not make any application in the present specified period, but will submit the applications in Form A when a second notification comes out extending the current one-year period to another two years more. Within this period totalling three years, all the small and micro units will upgrade their manufacturing plants to the standards prescribed in the revised Schedule M.
The association wanted the central ministry to take steps with the state government to stop the ongoing risk-based inspections at the manufacturing plants until they comply with the revised Schedule M norms in the next two years. “Even now the joint inspection is going on in the manufacturing units in Haryana, we want the government to stop it for now in the wake of extension of the earlier deadline”, the president of the association said.
MP DCA forms regulatory officers’ team The drug control administration under the Food and Drug Administration in Madhya Pradesh has formed one team of regulatory officers to provide support and guidance to the pharmaceutical manufacturing units in converting the manufacturing facilities to the standards prescribed under the revised Schedule M of the Drugs and Cosmetics Act.
The team will visit the companies and guide the manufacturers in the process of the upgrading work to comply with the new schedule, said Shobhit Koshta, deputy drug controller at the drug control administration.
He said all the drug manufacturing units in the state have started submitting applications for extension. As per the draft notification issued on January 4 this year by the union health ministry, the companies have to submit applications within three months seeking extension for full compliance work for the new manufacturing standards. He said the department will provide all help to the industries in the state.
Meanwhile, Dr Darshan Kataria, president of the Madhya Pradesh Small-scale Drug Manufacturers Association (MP SDMA) informed that the small and medium level pharmaceutical industries in Madhya Pradesh are busy preparing to complete the upgrading work in their manufacturing facilities and they will complete it within the stipulated period.
“The conversion and improvement work has been continuing for the last one year and it will be completed very soon. Actually, we would have completed the work within the earlier specified time, but there were some technical hurdles that slowed down the conversion process. The machine suppliers, equipment suppliers and the consultants were busy and preoccupied with a number of units in many states. They had contracts with several manufacturers belonging to various states. Since they wanted more time, we requested the government to give us a few more months to complete the work,” he said.
PDMA seeks PM’s intervention 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 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.
Telangana pharma industry seeks clarity The Telangana pharmaceutical industry has asked the Department of Pharmaceuticals (DoP) and the CDSCO to bring in more clarity in terms of provisions in the new Schedule M and in the issue of production of nutraceuticals in drug manufacturing facilities as these two aspects still remain grey areas and create confusion among the drug manufacturers.
In a seminar organised by the DoP in Hyderabad in association with PHD Chamber of Commerce and Industry, the chief speaker, the chairman of the Telangana IDMA, J Rajamouli, said the industry is concerned of the ambiguities in some provisions in the new Schedule M, which lacks clarity.
Despite repeated representations by various associations including Telangana IDMA, no response has come from the CDSCO yet. He wanted the DoP to take up the matter with the union health ministry and to the concerned authorities in order to get clarity on the matter.
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