Will the coronary stent take the place of the condom in the list of essential medicines?

The answer lies in an upcoming report that will recommend what all should go into the national list of essential medicines (NLEM), a list from which the Delhi high court struck out condoms last year.

While manufacturers hope that stents will be kept out of the list, patients will have to pay more for these tiny expandable tubes that open up narrowed or weakened arteries to prevent chest pains and reduce chances of a cardiac arrest.

The background goes like this: In two orders issued in 2013 and ’14, the National Pharmaceutical Pricing Authority (NPPA) capped the price of condoms, which were then included in the NLEM. Manufacturers challenged the case in the Delhi high court, which in July 2015, moved condoms to the list of non-scheduled formulations.

Medicines and devices listed in the NLEM must be sold at the price fixed by NPPA, while those in the non-scheduled list are allowed a maximum annual price hike of 10%. Drugs outside price control can be sold at the prices set by the manufacturer.

In a similar verdict in October 2015, the Madras high court in a separate case kept condoms out of the medicine category and rejected price caps on them.

Now, a core committee on essential medicines, headed by V.M. Katoch, is ready with its recommendations for what should go into the NLEM and what should not.

According to the Cardiological Society of India, about 3 lakh stents are used annually. If stents make the cut, they would be the third medical device to enter the essential medicines list after birth-control measures like condoms (since removed) and intrauterine devices. An intrauterine device is a small contraceptive device, often ‘T’-shaped, which is inserted into the uterus.

Price caps are not to the liking of any industry, though.

Stent-makers say the inclusion in the NLEM and the consequent price cap could stop the introduction of technologically advanced stents in India.

According to Abby Pratt, vice-president (global strategy & analysis) at Advanced Medical Technology Association (AdvaMed), a platform for foreign medical device-makers, “First and foremost, stents do not meet the basic criteria established by the core committee for essentiality. In addition, as we have seen in the extensive work by the World Health Organization, there needs to be unique approach specific to medical devices and one cannot replicate the methodology used for medicines with medical devices."

Pavan Choudhary, co-chairman of the medical technology division of the Confederation of Indian Industry, added: “Bringing stents to essential medicines list may disincentivize companies and they may stop investing in the product, denying advan-ced technologies for patients. As a result of that, it might lead to a situation where outbound medical tourism will increase."

Some critics say a medicine should be added to the NLEM only if it is a national emergency and that medical devices anyway cannot be called medicines.

While bare-metal stents come for 10,000-20,000, those that slowly release drugs cost 23,000- 1 lakh. Bio-absorbable stents cost 1.5 lakh- 2 lakh.

Amulya Nidhi, co-convener of the Swasthya Adhikar Manch, an NGO working in medical sector, said, “The cost of medical equipments in the country is higher. Considering the increasing cost of treatment for heart diseases in private sector, this is a welcome move to include it in the list of essential medicines. The prices of stents are exorbitant, ranging even to the range of 2 lakh. However, the government should also consider the cost of treatment also. Even if the equipment prices are capped, if treatment prices increase, it would affect the poor patients."

Major stent-makers include Abbott Laboratories, Medtronic Plc., Boston Scientific Corp., Terumo Corp., Sahajanand Medical Technologies Pvt. Ltd and Meril Life Sciences Pvt. Ltd.

“About 35-40% of the population suffers from heart diseases. So, the question is about the availability of better treatment, not low-cost treatments. In India, even the USFDA-approved stents are available at a range of 25,000," said an executive at a stent-maker who did not want to be identified.

USFDA is short for the US Food and Drugs Administration.

The proposal to cap prices of stents was on hold for long as there was pressure to create a separate law for medical devices. Moreover, the department of pharmaceuticals plans to come up with a National List of Essential Medical Devices.

Anil Dhall, director of cardiology at the Delhi Heart and Lung Institute, said, “Rather than a price cap, there should be a dyn-amic regulatory process. There are various generations of stent. A cap would affect the availability of quality stents in India."

Compared to medicines, reduced prices for medical devices do not necessarily translate to greater access, Pratt said. She said the medical technology sector is fully committed to working alongside the government to facilitate access to healthcare.

“In order to promote access of medical devices to Indian patients, government should look at essentiality of procedure as a whole and not focus on a single component as patients are billed for whole procedure and not just the device," she said.

She said that recent research shows that medical device costs have declined by more than 6% (year to year) over the past four years, whereas drug and procedure prices have increased by 4-8% over the same period.