Government Reviews Import of Pre-Owned Medical Devices Amid Protests by Domestic Manufacturers

The Association of Indian Medical Device Industry (AiMeD) expressed concerns in a letter to the Union Health Minister, stating that the decision could elevate the risk of importing contaminated products and negatively impact their interests

The Modi government is re-evaluating a prior decision to permit importing specific pre-owned medical devices in India. The move is in response to solid objections from domestic manufacturers.

This development comes after the Union Ministry of Environment, Forests, and Climate Change issued an office memorandum (OM) on June 19, allowing the import of 50 high-end and high-value pre-owned medical equipment. These devices encompassed magnetic resonance imaging (MRI) and computerised tomography (CT) scan machines.

The list of pre-owned equipment approved for import, as stated in the ministry's order, includes the following:

The objective behind permitting the import of these pre-owned medical devices was to make them more affordable for smaller hospitals and healthcare establishments, particularly in Tier II and Tier III cities.

Government sources noted that this decision was made after consulting with the Union Health Ministry. However, the OM was issued by the Ministry of Environment, Forests, and Climate Change due to concerns about the potential environmental impact of importing used devices.

Recently, the Association of Indian Medical Device Industry (AiMeD) coordinator, Rajiv Nath, wrote a letter to Union Health Minister Mansukh Mandaviya expressing domestic device manufacturers' objections to this decision. They raised concerns about the increased risk of importing contaminated products, potential harm to their interests, and doubts about the long-term benefits for patients. According to Nath, 40 of the 50 used medical devices allowed for import are already manufactured in India.

AiMeD also accused the Federation of Indian Chambers of Commerce and Industry (FICCI) of influencing the government's decision and aligning with the multinational corporation (MNC) lobby. In response, FICCI defended the government's order, stating that it was based on recommendations by an inter-ministerial committee. The committee aimed to determine the list of high-end and high-value equipment that isn't manufactured domestically and could be imported under strict quality standards to improve healthcare access in Tier II and III cities.

As the matter continues to evolve, the health ministry has referred it to the director general of health services. A meeting with representatives of medical device manufacturers has also been scheduled for later this week, according to an official statement.