Union health ministry may come out with a comprehensive National List of Essential Medical Devices used in the country before a selected number out of them is brought under price control, it is learnt.

Informed sources said that the essentiality of the medical devices will be determined by the Government on the basis of the critical nature of their use in the human body, its performance and regulatory approvals from international regulators.

The National Pharmaceutical Pricing Authority, meanwhile, has also collected pricing data of 14 notified medical devices and price revision in the past two years which were brought under Drugs & Cosmetics Act a few years ago.

Stents and other widely used implants will mostly likely to figure in the list of essential devices. Several hundreds of these products are currently being imported, manufactured and marketed with no regulatory control on their safety, quality and prices.

Industry sources inform that most of the companies have submitted their details in line with government's intent to bring 14 medical devices under the National List of Essential Medical Devices. This was based on the representations made through industry bodies like the Advanced Medical Technology Association (AdvaMed), Confederation of Indian Industry (CII) and the American Chamber of Commerce in India (AmCham India).

According to industry, drugs and devices are inherently different in their composition as well as the market that they cater. Identical policy measures for drugs and devices would be detrimental to the device industry.

In India, medical devices currently constitute only 6 per cent of total healthcare spending. Its ability to address the country's growing disease (particularly non-communicable disease) burden has historically been limited by the fact that medical devices are treated as drugs. Only 14 of the 14000 types of medical devices that exist are recognised in India, and even these are regulated as pharmaceuticals.
 
Asking medical device companies to submit prices at which they import and sell the devices to distributors, and also their maximum retail prices in Form V was based on the premise that patients are charged almost three to four times of the landed cost (price at which these are imported) in terms of certain devices.

Drug pricing regulator NPPA, a month ago, had directed all medical device companies including Abbott, Johnson and Johnson, Medtronic, Edward Lifesciences and Boston Scientific to submit pricing data on cardiac stents and drug eluting stents (DES) for its effective monitoring of prices. Official sources informed the government is keen to monitor prices of cardiac stents in order to prevent patients from being over-charged.

Based on the meetings with the drug regulator, manufacturers said that a uniform pricing policy on cardiac stents and DES is required for its better regulation and monitoring in the larger interest of the patients and industry.

Expressing concern over suppliers of various pharmaceutical products raising prices manifold, the drug regulator's assessment, however, also revealed that the prices multiply by four to five times by the time it reaches the patients. In the wake of the issue of overpricing of cardiac stents, the government had considered to evaluate the pricing data to define medical devices separately from drugs and regulate their prices with a different mechanism.