New Delhi: A lobby of foreign medical device makers has taken up India’s recent decision to further reduce the price of coronary stents with Indian ambassador to the US, Navtej Sarna.

On 12 February, India’s drug pricing regulator cut the price of drug-eluting and biodegradable stents to Rs27,890 from Rs29,600, and marginally raised the price of bare metal stents from Rs7,260 to Rs7,660. The step came a year after the National Pharmaceuticals Pricing Authority (NPPA) slashed stent prices by as much as 85%.

In a letter to Sarna dated 20 February, Scott Whitaker, president and CEO of AdvaMed, an association of global medical device manufacturers, expressed “disappointment" over the decision. AdvaMed’s members include stent makers such as Abbott Healthcare Pvt. Ltd, India Medtronic Pvt. Ltd.

In his letter, Whitaker said price control measures have sent “shock waves" through the life sciences industry. He also said the government at the “senior most levels" acknowledged that the goal of the 2017 price control order to significantly reduce patients’ costs has not been met.

The decision, according to Whitaker, was taken without any “regard to patient needs and the likely impact on medical technology innovation in India". “This move was particularly surprising in the light of our industry’s productive conversations with the nodal agencies involved in this decision and reassurances from the highest level of the government that this issue would be resolved". With companies applying to withdraw their economically unviable products and announcing that they would not launch new technologies into India, he said it is sending “deeply disheartening" message to the industry that “India has closed its door to the medical technology industry and that patients’ interest are not at the centre of policy making". Mint has reviewed a copy of the letter.

Earlier on 12 February, Whitaker had also written to Prime Minister Narendra Modi suggesting the government adopt trade margin rationalization instead of price control to address the issue of excessive mark-ups in medical devices.

“We sincerely hope that you will consider this alternative system, which has recently gained broad stakeholder support due to the dual effect of benefitting patients while preserving the environment for innovation and investment in India," the letter said.

Multinational companies and the senior US trade representatives had been pressing India not to extend price caps, allowing higher pricing for technologically advanced devices. Pitching the case of US medical device companies, earlier in September the US trade representative (USTR) Robert E. Lighthizer had written to the commerce and industry minister Suresh Prabhu and principal secretary to the Prime Minister Nripendra Misra saying “price control policy" had “troubled" them. Fearing that price controls may be expanded to additional medical devices, it said that US producers are forced to “rethink about their presence in the Indian market".

Additionally, it urged the government to not extend price caps to other devices until a policy is formulated that not only addresses government’s priorities related to patients’ costs but will also promote trade, innovation and access.

“Until such a policy is developed, I urge you to not expand price controls to additional medical devices. I propose that our teams renew their engagement on this important bilateral trade issue with the objective of reaching a mutually beneficial outcome as soon as possible," read the letter by Lighthizer. The matter was earlier discussed during Modi’s visit to Washington DC in June.

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