Govt Considers Separate Category for Advanced Coronary Stents

Coronary stents were added to the National List of Essential Medicines (NLEM) in 2022, a move to make stents more affordable for patients.

The Indian government is considering establishing a separate category for advanced coronary stents with a higher price ceiling.

This move aims to attract stent manufacturers who have delayed launching their next-generation devices in India due to current price control measures.

Coronary stents were added to the National List of Essential Medicines (NLEM) in 2022, a move to make stents more affordable for patients.

This inclusion followed recommendations from an expert committee reviewing the need for these devices in the essential medicines list. With the stents now under price control, the cost of coronary procedures became more accessible.

Despite the positive impact on affordability, several stent manufacturers have expressed concerns. They have been urging the government to create a sub-category for stents with advanced features, with a higher ceiling price to reflect their superior capabilities.

Many manufacturers have yet to launch their latest stents in India due to these price constraints.

Current Concerns

The Standing National Committee on Medicines (SNCM) categorized coronary stents in the NLEM, 2022, into two main groups: bare metal stents (BMS) and drug-eluting stents (DES).

The DES category includes both metallic DES and bioresorbable vascular scaffolds (VBS), commonly referred to as biodegradable stents.

However, stent makers were dissatisfied with this classification. They approached the Ministry of Health, the Indian Council of Medical Research (ICMR), the Drug Controller General of India (DCGI), and the National Pharmaceutical Pricing Authority (NPPA) to request a revision in pricing.

The companies sought classification changes, higher ceiling prices for advanced stents, and trade margin rationalization (TMR).

Despite these appeals, the SNCM found no significant "therapeutic advantage" in the advanced stents that would justify a relaxation of price controls.

As one source explained, the manufacturers did not provide sufficient clinical evidence to prove their stents were significantly superior to the currently available DES. Consequently, the committee did not recommend differential pricing for these stents.

While no official government statement has been made, sources indicate that the authorities are considering introducing a new category for advanced coronary stents, with a higher price ceiling. This move incentivizes stent makers to introduce their high-end devices in India.

Meril Life Sciences Case Study

One of the key players affected by the current price controls is Gujarat-based Meril Life Sciences. The company developed the MeRes100, India's first locally made bioresorbable vascular scaffold, a naturally dissolving stent to clear artery blockages.

In 2020, Meril Life Sciences received a rare exemption from price caps for five years, allowing them to launch their stents at any price. This exemption was granted after Meril provided sufficient justification for the product’s higher cost.

However, following the expiry of the exemption, Meril approached the government to extend the period during which their stents would be free from price control. The request was turned down, and Meril has since held back from launching its biodegradable cardiac scaffolds in India.

Impact on Global Stent Manufacturers

Meril’s experience reflects a broader trend in the stent manufacturing industry. Many global manufacturers have withdrawn their high-end devices from the Indian market due to the stringent price caps.

These companies continue to advocate for the creation of a new category of stents with advanced features, believing that this change will allow for the introduction of more innovative and effective medical devices in India.

The government's potential move to establish a separate category could mark a turning point for the coronary stent industry, balancing affordability with the need for innovation in healthcare.