Home / News / India /  Most small drug makers aren’t WHO-GMP certified
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Considering that only one-fifth of the small and medium manufacturers of bulk and API (active pharmaceutical ingredient) drugs have been certified under the World Health Organization’s good manufacturing practices, the Centre has launched an outreach programme to establish India as a best-in-class pharma hub, said an official in the know.

“As of now, India has around 6,790 SMEs involved in manufacturing bulk drugs and API, but only 2,006 pharma companies are WHO-GMP certified. The list is updated by Central Drugs Standard Control Organisation from time to time," the official said, seeking anonymity.

“The Centre has started an outreach programme for such SMEs operating in 10 locations for manufacturing world-class high-quality drugs so that they can become globally competitive and market leaders. Our outreach programme is completed for SMEs in Bengaluru and Ahmedabad. For the next phase, Mumbai, Andhra Pradesh and Baddi in Himachal Pradesh will be covered. The minister of state for health and family welfare Bharati Pravin Pawar is likely to participate in person," he said.

In April, WHO alleged that even Bharat Biotech was not fully compliant with the GMP norms for its Covaxin manufacturing unit in India. Concerns over the lack of a proper system to address such issues amid rising demand for supporting existing pharma clusters to improve productivity and quality, prompted the Centre to launch the strengthening of pharmaceutical industries scheme. There are over 80 pharma clusters across India catering to over 10,000 manufacturing units.

The initiatives under the scheme are aimed at further enhancing the capabilities of the Indian pharma sector through incentives, and make it much more competitive in terms of both quality and cost to help businesses get Schedule M and WHO-GMP certifications and become part of the global supply chain. As part of the scheme, small drug makers are offered credit lines and interest subsidies for upgrading technology, as well as up to 20 crore each for setting up facilities such as research centres, testing labs and effluent treatment plants across pharma clusters.

“WHO-approval opens up global opportunities for companies. It will be good for companies to participate in this initiative to upgrade quality standards for drugs and APIs," said Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance (IPA).

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