Domestic MedTech industry opposes Gujarat's stent pricing favoring USFDA devices

In India's medical device industry, the Gujarat government's recent plan to impose a separate pricing system for drug-eluting stents (DES) has sparked controversy. The new regulation sets the price of stents that have been approved by the US Food and Drug Administration (USFDA) at Rs 25,000 per unit. Those approved by the Central Drugs Standard Control Organization (CDSCO) of India are, however, limited to Rs 12,000 at this time. As a clear insult to the 'Make in India' campaign and a possible danger to the survival of the local sector, this large pricing difference has sparked harsh criticism from indigenous producers.

More than 1,200 domestic producers are represented by the Association of Indian Medical Device Industry (AiMeD), which has led this conflict. The state's pricing system, according to AiMeD, is fundamentally biased, favoring multinational corporations (MNCs) while harming domestic output.

The expansion and viability of the local medical device industry could be threatened by this action, according to AiMeD Forum Coordinator Rajiv Nath, who expressed concerns that it could allow American multinational corporations to regain market dominance at the expense of Indian manufacturers.

The United States Trade Representative (USTR) has brought attention to problems with India's medical equipment price regulations, which has added another level of controversy. The price restrictions on knee implants and coronary stents in India, according to the USTR study, have not been updated for inflation and do not take production costs or technological developments into consideration. According to the paper, this deters American businesses from entering the Indian market, which could restrict Indian patients' access to cutting-edge medical technology.