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HPMA demands three years’ time for full compliance with revised Schedule M
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Peethaambaran Kunnathoor, Chennai
January 14 , 2025
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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 ‘seven days period’ to file objections and suggestions to the health ministry in respect of the revised draft notification issued on January 4 this year extending the previous timeline for implementation of revised Schedule M in pharma MSMEs has ended on January 11. The ministry had given a period of seven days to the stakeholders to submit objections and suggestions to the revised draft notification issued on January 4, 2025 for the consideration of the government.
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 told Pharmabiz.
Speaking to Pharmabiz, RL Sharma, president of the HPMA said the pharmaceutical MSME sector in Haryana comprises formulation units, API industries, medical devices manufacturing companies and cosmetics manufacturing firms. All these units have their own plants and are coming under micro and small industries’ category. The number of units altogether comes around 250.
He said HPMA wanted a period of three years’ time for full compliance of the provisions, at least for the micro and small-scale units (SSIs) with less than Rs. 50 crore turnover, and some financial aid in the form of soft loans for upgradation of the facilities. A minimum of Rs. 4 crore is required for each company to upgrade the plants to the higher standards.
The association has apprised the government that they have constructed a world-class Common Facilitation Centre (CFC) at Karnal pharma park site with the help of central Ministry of MSME and state department of industries. All the laboratory tests required for a drug manufacturing company can be done there. The same should be considered for all member-units, and each unit should not be asked for separate installation of sophisticated laboratory instruments such as IR, UV, HPLC etc. Similarly, the member-units should be allowed to conduct stability studies at the CFC which was established for this purpose only.
The suggestions included one request to the government that the pharma MSMEs in Haryana should be exempted from any kind of coercive action until they complete the upgradation work. All the manufacturers started the upgrading process one year ago, but it is in the pipeline now.
Sharma said HPMA members are manufacturing medicines, medical devices and cosmetics not only for the whole of India, but for the whole world. He is planning to meet the union health minister once again to make his request to the government. In November last he led a team of industry leaders to Delhi and gave a memorandum directly to the then health minister Dr. Mansukh Mandaviya seeking extension of the deadline.
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