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Medical device makers complains against national drug regulator's price cap on knee implants

MTaI argued that knee replacement surgery is not a life-threatening procedure but an elective surgery as the patient is free to choose to go for it or go for alternate therapies.

twitter-logo Joe C Mathew   New Delhi     Last Updated: August 18, 2017  | 21:53 IST
Medical device makers complains against national drug regulator's price cap on knee implants

Medical Technology Association of India (MTaI), an association of research-based medical technology companies, has expressed concerns over the government move to cap the prices of knee implants.

The association says that while it respects the government's intention and actions for greater patient access, it is not for price control. "The Government wanted us to provide a proposal for self-regulation and we were constantly engaged with them. Post facto, we feel we could have been heard better, and we expected the regulator to have waited for our preliminary proposal that was committed in our meeting last week before this decision", MTaI stated.

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The association points out that the industry had shared with the NPPA an initial proposal to classify such products into 8-9 different categories. "We strongly feel that there was merit in looking at different categories to classify and allow free market economy principles for companies to compete", the statement said.

According to MTaI, knee replacement surgery is not a life-threatening procedure but an elective surgery as the patient is free to choose to go for it or go for alternate therapies. "A good proportion of osteoarthritis patients in India often do not opt for knee replacement due to fear of surgery. Since there is no emergency here, we are surprised by the use of Para 19 while we were engaged with the NPPA productively on some form of self-regulation", it said. Para 19 of the Order empowers the National Pharmaceutical Pricing Authority (NPPA) to fix/revise the ceiling price or retail price of any drug which it deems necessary for the interest of public in case of any extraordinary circumstances, and is to be used for essential medicines/devices.

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The association wanted such powers need to be used sparingly and only in case of extraordinary circumstances. It wanted such extraordinary circumstances to be clearly defined and governed by clearly laid-out parameters.

MTaI claims that its member companies are governed by a code of conduct and ethics, and have compliance and legal departments which keep checks and balances to ensure each company operates in accordance to the law of the land.

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