Medical equipment makers have complained against the recent decisions of the Central Government Health Scheme (CGHS) and Employees’ State Insurance Corporation (ESIC) to notify three different price points for procurement of devices.
What has irked the industry, especially domestic manufacturers, is the fact that devices with just one approval from the drugs controller general of India, has been given the lowest procurement price, compared to the ones with approvals from the US (food and drug administration) and European (CE) regulators.
While domestic players find this an indirect way of suggesting that Indian products are less superior (in quality) than others, several foreign medical device makers ask why their products should be awarded a lower price, compared to US-approved products.
In a letter to ESIC, Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry, questioned the higher price allowed in ESIC tenders for supply of devices such as electrosurgical generators and diathermy that had the USFDA approval. Neither products with Indian registration or any other European registration have been given the same price.
Another example highlighted by medical device makers was that of CGHS, where it prescribed three different ceiling prices for drugs eluting coronary stents on the basis of the country of registration. While a drug eluting stent with the US approval has a ceiling price of Rs 65,000 a piece, the limit for Europe-approved stent is Rs 50,000 and Indian one is Rs 40,000.
“How can you say a product with an European certification does not merit the same value a US-certified product enjoys?” a senior executive of a multinational medical device company asked. Speaking on the sidelines of a Ficci event on medical electronics, the executive said aggrieved companies were approaching the public sector procurement agencies and the health ministry with their complaints.
According to Nath, the government should desist from making any discriminatory clause that undermines the efficiency and capability of Indian medical device regulatory system. “Is this the way the government intends to promote the domestic medical devices sector?” Nath asks.