New Delhi: Price regulation (MRP) of coronary stents by the National Pharmaceutical Pricing Authority (NPPA) by adding them to the National list of Essential Medicine (NLEM) 2015, will be effective within the coming three months. The government will be announcing the maximum retail prices of stents within this period. The move, though welcomed in the medical and patient fraternity, has met with strong reservations by the medical device industry.
According to the Ministry of Health and Family Welfare, the move to regulate MRPs of stents had been taken on recommendations from all quarters asking for cardiology devices, including the biodegradable ones, to be put on the list of essential medicines.
The sub committee of cardiologists, appointed under the leadership of Professor Y.K. Gupta, Head, Department of Pharmacology, (AIIMS), to assess the need for including coronary stents in the NLEM has submitted has submitted a positive report . The Government after having accepted its recommendations, has forwarded the same to the Department of Pharmaceuticals and the process of price fixation is now taking its course.
Medicines and devises that once come under the NLEM, are sold at government regulated prices, fixed by the NPPA. The others which are incorporated in the non essential list cannot go above an annual 10 % rise in price.
According to the Health Ministry’s, Joint Secretary, KL Sharma, ‘processes are already underway to ensure that a transparent and fair mechanism is adopted for price ceiling, which will benefit the poorest of the poor and make good quality stents available at the best price.’
‘Price control will ensure that base price is uniform across government, semi-private and private facilities. It will also bring in much needed transparency in the system. Drugs outside price control can be sold at prices set by the manufacturer, which is governed by profit making and market forces,’ the cardiologist added.
Ganesh Sabat, Sahajanand Medical Technologies Pvt. Ltd, which manufactures stents, lauded the decision saying that with it treatment would now be available to the middle income and the poor as well. ‘Local manufacturing means that we are offering stents at 1/5 of the cost,’ he further added.
Gurmit Singh Chugh, Managing Director, Translumina Therapeutics, DES, Manufacturer,India, appreciated the move for the transparency and accessibility it would bring about by making heart devices available to patients. However, an important point raised by him was the care the government machinery needed to take on arriving at fair MRPs .
‘Considering the fact that unlike pharmaceuticals, every Class III medical device like Drug Eluting Stents (DES) needs huge investment on R&D and clinical trials, an ad-hoc decision might be detrimental to the Industry,’ he pointed.
An apprehension expressed by the industry was the inclusion and resultant capping acting as a deterrent for manufacturers from introducing technologically advanced stents in India.
Chairman, Confederation of Indian Industry, Medical Technology Division, Himanshu Baid, felt the price control on an industry at its nascent stage did not help in creating ‘a conducive environment for FDI.’
Mr. Milan Rao, Chairman, Medical Technology Forum, Nathhealth, expressing his views said, “Medical procedures in India are among the most affordable in the world, which is a combination of cost of devices and services. Any notification should be considered only if it can bring down the overall cost of treatment for the patient, without denying them the options to avail the treatment of their choice. Additionally, such notifications significantly impact the ‘Make in India’ attractiveness of the country,”