After the National Pharmaceutical Pricing Authority (NPPA) imposed price caps on coronary stents in February last year, the Prime Minister’s Office (PMO) is documented as having “indicated” to representatives of foreign medical device companies in a meeting that the Indian government has no plans to expand price controls to other devices such as knee implants. The Department of Industrial Policy and Promotion (DIPP) and the NPPA are also documented as having given similar assurances in subsequent meetings.
However, on August 16, 2017, the NPPA capped the prices of knee implants in an “immediate intervention” to “check unethical profiteering and exploitative pricing at the cost of the patients in an unregulated market”. Moreover, when asked about the assurance given to foreign medical device companies last year, the DIPP told The Indian Express that “there is no question of any assurance being given” by its “officials” and “any such statement is baseless”.
The details of the meetings were mentioned in an e-mail sent by Abby Pratt, vice-president, Global Strategy and Analysis, Advanced Medical Technology Association (AdvaMed) to the office of the United States Trade Representative (USTR) on September 8, 2017. Washington DC-based AdvaMed primarily represents US medical device, pharma* and tech majors such as Abbott, Boston Scientific Corporation, Medtronic, BD, GlaxoSmithKline, Apple and Microsoft. India’s medical device technology market is worth about $6 billion, and is expected to grow to $50 billion by 2025. India imports around 80 per cent of its medical devices, a quarter of it from companies based in the US.
In her e-mail, Pratt wrote the timeline of dialogue of foreign medical device industry with the Indian government on price controls. Pratt wrote that a group of industry officials — which she termed as “APACMed mission to India” — met Anurag Jain, Joint Secretary, PMO, “among others” on May 4 or May 5 of 2017. Pratt wrote: “During the meeting, the PMO indicated that the Indian government had no plans to expand price controls”. Many members of APACMed (Asia Pacific Medical Technology Association) are US-based companies, which are members of AdvaMed too. Jain did not respond to the queries sent by The Indian Express.
In her e-mail, Pratt then mentioned the meeting that took place on July 19, 2017, between industry representatives and the PMO and DIPP leadership. She stated: “The PMO was trying to get more information from industry and did not reveal the GoI’s (Government of India’s) plans on price controls. DIPP tried to be more reassuring that price controls would not happen.”
On August 9, 2017, representatives of foreign medical device firms met the then NPPA Chairman Bhupendra Singh. About this meeting, Pratt wrote: “Industry leaders met with the NPPA Chairman who said that there no plans to expand price controls to knee implants.” Just seven days later, on August 16, the NPPA imposed the price caps on knee implants. Singh did not responded to the queries sent by The Indian Express.
When The Indian Express asked the DIPP about why were medical device industry representatives told in July 19 meeting that the price controls would not happen, it responded: “The mandate for price control of medical devices and drugs lies with the NPPA, and thus there is no question of any assurance being given by DIPP officials in this regard. While DIPP is always willing to listen to the concerns raised by stakeholders, the same does not imply that any assurance can be given beyond its mandate. Thus, any such statement is baseless.” The DIPP further stated: “As a welfare State, India is committed to ensuring affordable healthcare to all its citizens. In the instant case, price controls were imposed on stents and knee implants, keeping in view the high cost of treatment to the patients in India.”
In response to queries from The Indian Express on the meetings, AdvaMed said: “As part of this ongoing dialogue, we have been in touch with several stakeholders and have conducted multiple conversations — each possessing its own context and background. Therefore, to pick isolated conversations without putting that in perspective, and to also understand the background may not reflect the true picture. Thereby, it will lead to misguiding the audience…”