New Delhi: “We urge the pricing authority to use scientific rationale in the decision making instead of using broad-brush of drug rules on this small yet highly innovative and vital life-saving sector. A non-scientific implementation may lead to major obstacles in the natural evolution of this sector and create implementation snags leading to morbidity and mortality traps,” mentioned the Medical Technology Association of India in a statement issued on December 22, 2016.
“We have been surprised and disappointed with the decision of including the category of Drug Eluting Stents under Schedule 1 of Drug Price Control Order, 2013. The industry has been working closely with the pricing authorities to bring transparency on the pricing issue and arrive at scientific methodology to differentiate among various value-added versions of Drug Eluting Stents. The decision disregards the innovative nature of the medical technology sector which has evolved over the last 20 years globally and is still evolving,” stated the Association further.
MTaI said it is also deeply concerned with the treatment implications on patients, who may need different and innovative products for their individual and evolving medical needs. Such a decision would not only take away a clinical choice from a physician, to use different products for different patient needs but also take away patient’s right to choose for their own medical care based on quality and innovation of a product.
As per the Association, over the last 10 years, the medical technology sector in India has been struggling to get a distinct identity with clear definition in Drugs and Cosmetics Act of India. Any decisions like this without resolving the fundamental issue on medical device regulation further complicates the matter for all stakeholders, it said.
“In fact, the industry has taken a number of steps to drive access of the advanced medical technologies for a large pool of patients with its voluntarily offer to provide one type of high-quality, FDA approved stent at a CGHS approved rate of Rs 25,000 to the pricing authorities few months back. In addition, it is partnering with a number of state government reimbursement programs by providing world-class products at the lowest prices. Hence, to enable patient access without compromising patient health and quality of outcomes, we urge the pricing authority to use scientific rationale in the decision making instead of using broad-brush of drug rules on this small yet highly innovative and vital life-saving sector. A non-scientific implementation may lead to major obstacles in the natural evolution of this sector and create implementation snags leading to morbidity and mortality traps,” reasoned the Association in its reaction.
MTaI further stated that the decision will also slow down the progress of the Medical Tourism sector which is expected to grow to $ 8 billion by 2020 and dent India’s image as a healing destination for the world. By shrinking the market it will hurt the Make in India ambition, where FDI in this sector had begun to start showing a sharp growth post the current Government brought it on the automatic route.
MTaI has requested the government to have a holistic view on the decision by involving all the concerned stakeholders i.e. hospitals, physicians, companies in the discussion on price regulations to arrive at a decision which is best for patient health. Also create a vibrant environment for the medical device sector to make innovative therapies accessible to patients and uphold & strengthen the state of healthcare already achieved in the country.