It will deprive patients of latest tech advancements, say medical technology industry, associations
Government of India recently issued a notification to fix ceiling prices of coronary stents to eventually bring down the cost of coronary stents, currently hiked by about 380 per cent.
The story so far…
According to a recent data published by National Interventional Council (NIC), surgeries involving stent procedures have tripled over the last five years. In the absence of proper regulatory framework, a patient undergoing such a procedure ends up paying anywhere between 10 to 1000 per cent more than the actual cost of stent, pushing the cost of medical procedure to around Rs 200,000 – 250,000.
Nonetheless, recently the government has included all types of stents – drug-eluting stents (DES), bioresorbable vascular scaffold (BVS) and bare metal stents (BMS) in the National List of Essential Medicines (NLEM) and has fixed their ceiling prices at Rs 29,600 for DES and BVS and Rs 7,260 for BMS respectively. The cap on prices is with immediate effect. It will lead to a reduction in stent prices by 85 per cent. Reportedly, this move would directly result in the reduction of total procedure cost by around 25-30 per cent.
Ananth Kumar, Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, asserted that the step is a major decisive action on the unethical margins charged at each stage in the supply chain of coronary stents. The Ministry of Health and Family Welfare had included Coronary Stents in the National List of Essential Medicines, 2015 (NLEM, 2015) on July 19, 2016 and the Ministry of Chemicals and Fertilizers incorporated Coronary Stents in Schedule I of the Drug Prices Control Order (DPCO), 2013 on December 21, 2016.
However, the decision has not found favour with many in the stent industry. The critics believe that the move will not lead to the anticipated results, on the contrary it could have adverse effects.
A counterproductive move
Himanshu Baid, Chairman, CII Medical Technology Division, opines that the move could be detrimental to patient safety, as it will limit accessibility to cutting-edge technologies in coronary stents for Indian patients, affecting treatment quality and growth in the medical tourism sector.
Baid said that despite extensive stakeholder consultations, including eminent cardiologists and industry, on variousmethodologies to potentially control stent prices, the National Pharmaceutical Pricing Authority (NPPA) did not regard the suggestions offered in patient interest. Additionally, since this order is being enforced with immediate effect without provision of a transitory period, Indian stent industry is going to face enormous operational challenges in the coming times. He requested the NPPA to amend the order with a rational transition timeline.
Not a balanced decision
Rajiv Nath, Forum Coordinator, AiMeD also states that the government cannot vacillate from one extreme to another – once giving a free run to all kinds of malpractices and then taking such measures which are neither feasible nor sound – even in the garb of welfare populism. He said, “We have been demanding setting up of an expert body which really understands the medical device manufacturing ecosystem.”
AiMeD suggested that stent’s average price to hospitals should be the basis for arriving at a price band. It had also maintained that anything less than Rs 40,000 – 50,000 for quality stents would be dampening and unfeasible commercially.
Detrimental to domestic manufacturers?
Gurmeet Chugh, MD, Translumina Therapeutics, said, “This MRP is detrimental for the domestic stent manufacturers and may kill this upcoming industry. We are sure that the price points taken for imports and manufacturing are erroneous. There is a huge spend in R&D to keep upgrading the technologies and such knee jerk pricing regulations shall ensure the survival of only fly by night operators. Morever, the requirement of all stocks in market to be sold at revised price is impractical and unreasonable.This move may appear populist but will ultimately kill the ecosystem as Indian manufacturers will keep manufacturing, only low-end technologies.”
Need for encouraging policies
The Medical Technology Association of India (MtaI) also believes that a nascent sector like medical devices needs support with policies which would encourage technology innovation, clinical evidence and strong quality management systems to ensure best patient outcomes. Initiatives like ‘Make in India’ would lose on a major opportunity to generate highly skilled employment in absence of clear and rational policy framework. A knee-jerk policy framework without accounting for innovation will not only make India unviable to be a global destination for medical device manufacturing but will also reduce India’s competitiveness to provide world-class and highly advance medical care to patient from India and abroad.
“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,” said Rahul Khosla, President, NATHEALTH.
Need for rational price control
“Recently announced formation of a Medical Technology Assessment Board (MTAB) by the government would go a long way in standardising and regulating the stent quality in India and usher in the much needed transparency which would also enable pricing standardisation in a more rational manner,” said Anjan Bose, Secretary General, NATHEALTH.
A Bajaj Allianz General Insurance spokesperson states that to benefit from price reduction and pass it on to end consumer, the government has instructed hospitals to mandatorily charge stents and mention it separately in the billing receipt in order to bring in transparency in stent pricing. Appreciating this move, he spoke on the various initiatives taken by his organisation to interact with patients in this regard.