The Association of Indian Medical Device Industry (AIMED), an apex body of medical device manufactures in India has recommended eight key policy measures to ensure the financial viability for establishing world class medical device manufacturing parks.
The recommendations have come in the face of Andhra Pradesh, Maharashtra and Gujarat racing ahead in an attempt to establish parks of this nature.
According to ET AIMED in an attempt to make India a super international hub for medical device manufacturing has come up with recommendations including a gamut of tariff corrections and a new regulatory regime.
The apex body has asked the government to ensure the following:
(i) A separate Medical Device Regulatory Act and separate Rules with IHPRA – Indian Healthcare Products Regulatory Authority instead of the present ongoing amendment To the D & C Act with third party certification compliance audits. The AIMED has asked for a mandatory compliance and regulatory framework to be made part of the Q1 certification to ensure Patient Safety.
(ii) Formation of medical device export promotion and India’s first Import substitution council – MEDISEXPC
(iii) A Medical Devices Department; a separate Ministry for Healthcare products for facilitation, regulation and coordination of planning between Central Government and State Governments to assist existing manufacturing clusters and new medical device parks.
(iv) Continued tariff correction to capacitate business viability.
(v) MRP based tax as disincentive for high MRP, a measure to protect consumer interests.
(vi) Setting up of a voluntary ICMED 13485 certification by QCI to enable doctors and procurement agencies to place confidence in good quality medical devices.
(vii) A market access policy promoting “Buy Indian”for those manufacturers who have ICMED certification.
(viii) A preferential pricing online of 15 % for World Bank and WHO tenders to promote domestic manufacturers and counter the chinese 17% subsidy .
According to Mr Rajiv Nath, Forum Coordinator of AIMED these policy sanctions would reduce the enormous import dependency quickly, create a manufacturing eco-system of vibrancy and generate employment within the country, something which is the need of the hour.
Mr Nath added that these policies were a must to make India a super global hub for medical device manufacturing and to step up PM Modi’s ‘Make in India’ vision.
Besides fighting hard against the heavy import dependency in a sector critical for healthcare security, the country has also been facing stress on the foreign exchange front and deprivation of employment for its numbers in India. Sized at Rs. 30,000 crore, with a 70% overall import need & a 90% import reliance for high-end electronic medical devices.
The retail and institutional sale market is expected to grow to become an over Rs 2,00,000 lakh crore one by 2020. Therefore, if domestic manufacturing were not encouraged, it was bound to create multi-dimensional macro-economic and social security problems.
Medical device was also among the top five priority sectors as part of the ‘Make in India’ roll out program.
The central government has taken laudable steps to reignite domestic manufacturing, however critical policy and regulatory support is still not formulated to convert good thought into ground reality. According to AIMED, these 8-point sanctions would go a long way to fill the voids and invigorate medical device manufacturing.
AIMED has also submitted these recommendations to Shri Chandrababu Naidu, Chief Minister of Andhra Pradesh during their recent meeting with him in relation with the exclusive medical device park coming up in the state, requesting him to present them to Prime Minister Modi too.