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India is poised to be an emerging hub for biologics and biosimilars with an estimated CAGR of 22% in the near future. It, today, has 200 plus biosimilars in pipeline and 98 biosimilars approved in FY19 in the US and EU. It is also strongly foraying into innovator drugs and complex generics in the coming decade with enhanced focus on technology platforms like mRNA, Cell and Gene therapy, said Ravindra Pratap Singh, joint secretary, Department of Pharmaceuticals (DoP).
He was speaking on the subject of promoting pharmaceutical and medical devices sector on the sidelines of the recently concluded pre-Vibrant Gujarat Global Holistic Healthcare Summit themed “Holistic Healthcare - Good Health and Wellbeing for All” at Gandhinagar in Gujarat recently.
He further added that with the Indian pharmaceutical industry making quality bulk drugs, it presents itself as a strategic partner to de-risk supply chains. It is also currently strengthening backward integration of critical vaccine inputs. It has also streamlined the R&D pathway with New Drugs and Clinical Trial Rules 2019.
Singh further spoke about the Scheme for Strengthening the Pharmaceutical Industry to strengthen the existing infrastructure facilities in order to make India a global leader in the Pharma Sector. He said that it is an umbrella scheme having three components or sub -schemes like Assistance to Pharmaceutical Industry for Common Facilities (API-CF). Its earlier name was Cluster Development Programme for Pharma Sector (CDP-PS). The second component and scheme is Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) which aims to facilitate Micro, Small and Medium Pharma Enterprises (MSMEs) of proven track record in meeting national and international regulatory standards. PTUAS gives an Incentive of 5% per annum (maximum) for loan component (upper limit of Rs. 10 Crores) Or Credit linked Capital subsidy of 10% on loan component (upper limit of loan is Rs. 10 Crores).
The third component and sub-scheme is Pharmaceutical and Medical Devices Promotion and Development Scheme (PMPDS). It is aimed to facilitate growth and development of Pharma and Medical Devices Sectors through study/survey reports, awareness programs, creation of databases, and promotion of industry. Its beneficiaries are recognized Industry associations, organizations/firms with track record, Government/Quasi-Government agencies.
While highlighting the challenges of the Indian medical device industry, Singh said that the Indian medical devices manufacturing sector which currently stands at 11 billion USD faces lack of a level playing field vis-à-vis competing economies. The medical devices manufacturing sector suffers from a considerable cost of manufacturing, among other things, on account of lack of adequate infrastructure, domestic supply chain and logistics, high cost of finance, inadequate availability of quality power, limited design capabilities, low focus on R&D and skill development and Import dependency for high end medical devices.
“With a view to address the disability in manufacturing of medical devices in India vis-à vis other major manufacturing economies, various incentive schemes have been Introduced by the DoP like Medical Device Park scheme,” Singh concluded.
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