After PMO push, DoP fast tracks formulation of medical devices policy

New Delhi : The Prime Minister’s Office has been pushing the Department of Pharmaceuticals to fast track formulation of the medical devices policy that will give the sector a leg-up and attract FDI. The issue was recently discussed in detail at a meeting convened by the Prime Minister’s Office. According to sources, there is an understanding that a robust medical devices policy is required to help realise the full benefit of the relaxation of the FDI policy. FDI up to 100 per cent through the automatic route is permitted for manufacturing of medical devices in the country. According to the Department of Pharmaceuticals (DoP), the work on the policy has been expedited and it will be released soon, the sources added. The policy assumes significance given that India imports about 80 per cent of its medical device requirements.

The domestic companies that are engaged in manufacturing of medical devices include Siemens, Poly Medicure, BPL and Opto Circuits. There is a need for FDI in the sector as the domestic medical devices industry is fragmented into small and medium enterprises and primarily manufactures products such as disposables. The draft National Medical Device Policy, 2015, had proposed incentives for both new and existing medical devices firms. It had asked for interest subsidy to MSMEs, concessional power tariff, seed capital, viability gap funding, tax benefits to the sector, minimum or zero duty on raw materials and incentives for exports.

The draft policy had also suggested setting up of an autonomous body National Medical Device Authority and a single window clearance for the industry. The global market size for medical devices is about $220 billion and India has the potential to tap the opportunity. The sector in India is relatively small compared to the rest of the manufacturing industry though India is one of the top 20 markets for medical devices in the world and 4th in Asia. As per the draft, large MNCs controlling the global industry backed by multiple approvals, certification of accredited organisations and capacity to produce verified clinical trial record are able to control the major share as against the home-grown devices that lacked standardisation and certification.

A task force under the chairmanship of the DoP secretary is working on addressing issues concerning domestic production of high-end medical devices and pharma equipment manufacturing in the country. Medical devices include any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes. It also includes a device which is a reagent, calibrator, control material, kit, equipment or system whether used alone or in combination thereof intended to be used for examination and providing information for medical or diagnostic purposes.