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In a controversial decision which has literally opened a Pandora's box, the Gujarat government has recently introduced a new differential pricing policy, which was later withdrawn, for the Drug-Eluting Stents (DES) under the Ayushman Bharat scheme. The policy, implemented through a notification on March 10, 2025, set the reimbursement price for the US FDA approved stents at Rs. 25,000, while Indian manufactured stents are priced significantly lower at Rs. 12,000. This is for the first time such a differential pricing discrimination has occurred in the state. So far, the reimbursement price was around Rs. 34,000 per stent for any stent regardless of its approval by US FDA or Indian regulator. Quite naturally, the Gujarat-based stent manufacturers were up in arms against the state government’s new differential pricing system for stents used under the Ayushman Bharat scheme. It is quite clear that the Gujarat government’s rather ill-informed decision will penalise Indian manufacturers who today hold over 73% of the domestic market and export over 5 lakh stents annually to more than 100 countries, including developed economies like Germany, the UK, Spain, Poland, Switzerland, Italy and the Netherlands. These countries do not impose such artificial price differentiation based on US FDA approval. Gujarat is today recognised as the stent manufacturing hub of the country, produces devices that are exported to approximately 100 countries and the new differential pricing system will not let them stay competitive in the state. Ultimately, due to the stiff opposition and intervention from the Association of Indian Medical Device Industry (AiMeD), the Gujarat government has now revoked the notification.
Ever since the prices of stents were capped for the first time in the country by the NPPA on February 13, 2017, a section of the stakeholders including the multinational coronary stent manufacturers and importers have been not in favour of treating all DES in one bracket and favoured a sub categorization and differential pricing for different categories in order to ensure future innovation and growth in this sector. They argued that if differential prices in DES is not adopted, they may be forced to withdraw their latest generation stents from the market and may not introduce the new generation stents. They also emphasized that some of their brands deserve to be treated differently and be given higher prices to make all the choices available for patients who should not be deprived of new generation stents if they are willing to pay for it. They also favoured a matrix of classification based on several features for a corresponding price preference. They further mentioned that proving 'superiority' of their new generation stents as per the requirements of the government is a long process where adequate clinical data is to be made available which may take years. They insisted on 'generational incremental improvements' within DES and strongly favoured differential pricing based on these incremental innovations for the sake of rewarding investment in R&D and innovation. But, the fact remains that Indian made stents are not inferior in any manner to imported stents which is evident from the fact that Indian made stents are also being exported to more than 100 countries including developed countries. Besides, the fact remains that the so-called new generation DES of MNCs do not have adequate clinical evidence to support their claim of 'superiority' and should not be given preferential price. There should be fair competition, policy transparency and protection of India's medical technology and devices industry. The government, state or centre, should think twice before introducing such ill-informed policies in future.
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