Indian pharma needs to embark on ‘super generic’ drug manufacture strategy to reduce cost & risk over NCE focus: Harish Jain

Indian pharma now needs to embark on a ‘super generic’ drug manufacture strategy. The huge dependence on traditional generics is driven by low cost of production. But this will result in unsustainable prospects if dependent only on traditional generics & conservative business model, said Harish K Jain, director, Embiotic Laboratories and secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA). Super generic drug development can spur improvements in terms of expanding therapeutic classes, improve bioavailability and stability, reduce side effects, decrease manufacturing costs, development of new dosage forms, new delivery mechanism and a never-attempted-before combination of known medicines, he said. For generic drug companies, introducing differentiated products via drug repurposing enables competition on the basis of product quality rather than price. Moreover for innovative drug companies, drug repurposing permits reduced development time, cost, and risk as compared to new chemical entities. Speaking on the topic ‘Innovation Space for Generic Pharmaceutical Industry and the Future Prospects’ at the Golden Global Health & Education Awards-2019 in New Delhi recently, Jain said focusing on a value-added generic or ‘super generic’ which is an improved version of an original drug that has lost its product patent protection would be a viable option to pursue from an Indian pharma standpoint. Currently, the sector is facing the challenge of price controls by governments across the world. While this is leading it to garner 20% share in volume, in terms of value it is a mere 3 percent. Hence there is a need to move up the value ladder. Stating that dependence on generics leads to a free fall from the patent cliff, Jain delved on to why reliability only on generics meant unsustainable growth. This is because fewer new chemical entities (NCEs) were filed in the last few years. When patent expiries are en-cashed, stiff competition would cause dramatic price drop to 99% of the branded product.

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