The Department of Pharmaceuticals (DoP) plans to design future policies for the pharma sector keeping in mind the vision of becoming a member of the Pharmaceutical Inspection Cooperation Scheme (PICS). Therefore, it has urged the industry to equip and design their formulation units to meet global regulatory requirements.
On the sidelines of ‘The Future of Pharmaceutical Industry’ webinar, organised to showcase the potential of Haryana attracting the investors to the state, Navdeep Rinwa, Joint Secretary, Department of Pharmaceuticals, said that the government is working in a direction to join the PICS. And for that, both regulators as well the industry need to upgrade themselves.
He said that to get PICS membership, our regulators, both at the central as well as at the state levels, need to undergo intense training programmes and our research laboratories need to be upgraded. Similarly, at the industry level, pharma companies need to set up their facilities that comply with international regulatory requirements like the WHO GMP, US FDA etc.
Together, the vision of India becoming a member country of the PICS can be achieved which will benefit the Industry. Over 50 regulatory bodies, including the US Food and Drug Administration (US FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), are part of the PICS.
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Encouraging MSME players to be a part of this vision, he informed that considering the financial assistance that the small and medium players need from the government, it is also planning to come out with a cluster scheme. It is proposing to have 10 such clusters across the country and for each, financial assistance of Rs 20 crores and interest subvention of five per cent will be given.
He also informed that the PTUAS which is a subsidy plan on sanctioned loans of Rs two crores has been now been increased to Rs 10 crores. This will help the MSME players to adopt machinery and electronic management systems required to help a Schedule M plant attain WHO-GMP compliance which will be considered for financial assistance under the PTUS.
A PICS membership reduces duplication of inspections, facilitates the industry in export, and provides huge market access among other benefits.