Govt didn’t wait for our self regulation proposal on knee implants: MTaI

While reacting cautiously to the government's latest order that put a price cap on knee implants, the Medical Technology Association of India (MTaI) said it is surprised by the use of Para 19 while the association is still engaged with the NPPA productively on some form of self-regulation

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New Delhi: In the aftermath of a price control order by the National Pharmaceutical Pricing Authority (NPPA), the association of global medical technology companies, Medical Technology Association of India (MTaI) has stated that it is for greater patient access, and respects any decision made to that end.

MTaI, however, also clearly mentioned in its statement that it does not support the 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,” read the statement from the MTaI that was released on the evening of 18th August.

“We had, in fact, shared with the NPPA our initial proposal for classification 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,” mentioned the statement further.

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, stated MTaI.

The statement goes on to mention that the Knee replacement surgery is not a life-threatening procedure. It is, instead, 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.

MTaI expressed surprise on the hurry shown by the regulator. “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. 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. Such powers need to be used sparingly and only in case of extraordinary circumstances. Such extraordinary circumstances should be defined and governed by clearly laid-out parameters,” it said.

MTaI also reiterated that any patient access measure should be collaborative and consultative, based on mutual trust and respect, and involve all stakeholders. “This will allow us to take decisions which really ensure enduring benefits for the patient. This is something we have appealed to the authorities time and again, unfortunately in vain,” it stated in conclusion while adding 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.