India’s medical device industry is urging the government to implement several policy measures — including tariff corrections and a new regulatory regime — to ensure the financial viability of domestic device manufacturing parks in the country.
The Association of Indian Medical Device Industry is pushing for a separate Medical Device Regulatory Act and separate rules with the Indian Healthcare Products Regulatory Authority rather than proposed ongoing amendment to the Drug & Cosmetics Act with compliance audits by third party certification. The proposal calls for having a mandatory compliance and regulatory framework built on the soon-to-be launched Quality Council of India certification to ensure patient safety.
AIMED also seeks a department for medical devices — a separate ministry for healthcare products to act as a facilitator and regulator — and a coordinated plan between the central government and state governments to aid existing manufacturing clusters and new medical device parks.
In addition, the group wants continued tariff correction to enable business viability, and a maximum retail price based tax as a disincentive for high MRP to ensure consumer protection.
Other proposals call for the launch of a voluntary ICMED 13485 certification by QCI for enabling doctors and procurement agencies to have confidence in good quality medical devices, a ‘Buy Indian’ preferred market access policy for those manufacturers who have ICMED certification and a 15 percent preferential pricing online of World Bank and World Health Organization tenders to support domestic manufacturers and counter the 17 percent subsidy from China.
Rajiv Nath, forum coordinator of AIMED, presented the list to Shri Chandrababu Naidu, chief minister of Andhra Pradesh, during a recent meeting. Naidu is “gung ho” in ensuring success of this project, says Nath.
“He desired the Vizag Medical park to be among the top 3 medical device manufacturing hubs in the world instead of the top 5, as was being proposed by AIMED, and Andhra Pradesh to be the lowest cost and preferred healthcare treatment destination in the world and assured that his team and he would take steps to act on our suggestions to ensure this,” says Nath. — Jonathon Shacat