Tag Archives: india medical devices

Stent price control: 5 reasons why ‘high-end stent’ companies might still hope

2 Feb

As the National Pharmaceutical Pricing Authority (NPPA) gets down to revisiting the prices of stents and discussing their makers’ grievances in February, here are five reasons why multinational stent companies selling relatively high-end products can still hope. Continue reading

Is self-regulation in #medtech doomed to fail?

27 Dec

The offer by needle and syringe manufacturers to voluntarily cap trade margins at 75 per cent after meeting with the National Pharmaceutical Pricing Authority apparently validates the view that without the actionable threat of price control, the healthcare sector cannot be trusted to self-regulate.

“The NPPA advised manufacturers to consider regulating price themselves; otherwise, the government would be forced to take steps as they have done to cap prices in the past for items like stents and orthopaedic implants,” reported the newspaper Mint quoting a person aware of the matter who spoke on condition of anonymity.

I asked, Rajiv Nath, President, AISNMA, the association of homegrown manufacturers that made this offer, in an e-mail : why wait for an NPPA ultimatum? If a cap was implementable, why not just go ahead and do it? I have published responses to these and other queries in their entirety in the interest of clarity. But before that, my take based on these responses and the media coverage on the issue. Continue reading

Thermometers, BP monitors and other vital stuff that India DOES NOT regulate #MedTech #safety

16 Feb

Dr Ravindra GhooiThe Indian medical devices sector has lately been in the news for the government’s decision to liberate foreign direct investment controls on it. There is also some movement on the regulatory front with a decision to set up government-recognised medical device testing laboratories in the country. Apothecurry’s guest columnist Dr Ravindra Ghooi revisits the one issue that needs immediate attention but for some reason continues unaddressed. The sector’s appallingly unregulated state. Read on.

Whether it is pacemakers, bone implants or cardiac stents, patient lives hinge on the safety and effective functioning of devices. It is assumed that like other governments, India has strict laws concerning the manufacture, quality and testing of these. It may therefore come as a shock to those unfamiliar with the Indian regulatory landscape that the government seemingly does not consider many of these devices important enough to regulate. Continue reading

#MedicalDevice pricing in India:”Don’t use a shotgun to kill an ant,”says industry veteran

4 Aug

Ajay PitreLate last month, the Maharastra Food & Drug Administration wrote to the National Pharmaceutical Pricing Authority (NPPA) to include medical devices in the Drug Prices Control Order (DPCO) which gives the NPPA its power to fix drug prices. Since the NPPA has been on overdrive, recently adding 108 drug formulations to the list of 348 already under price control, this sort of development can no longer be dismissed.

Medical devices are definitely a not-insignificant part of overall healthcare cost but should their prices be fixed by the government and should it be under the same set of rules as drugs? I spoke to Ajay Pitre to understand this issue better. Continue reading

Sushrut’s sale to Smith & Nephew : what it says, and what it doesn’t

8 May

On May 2, UK-based trauma care products company Smith & Nephew said it would acquire Pune-based Sushrut Surgicals, a homegrown closely-held maker of orthopaedic implants such as bone plates and screws used to correct fractures and deformities, for an undisclosed sum, from the Pitre family.

The move took me by surprise. After all, Ajay Pitre, MD, Sushrut was the man who, six years ago, goaded me to write about India’s homegrown medical devices sector and its potential. Continue reading

Medical technology in India: Is the worm turning?

2 Apr

Biosense's device represents rare product innovation in the Indian med tech sector
Pic sourced from http://www.biosense.in

A recent edition of TED Talks featured Myshkin Ingawale a co-founder of Mumbai-based Biosense which has invented a needle-free, handheld haemoglobin measuring device. This is big for a country where anaemia or low haemoglobin count is the leading cause of maternal mortality even though iron supplements are cheaply and plentifully available.

Many of these deaths can be averted with early diagnosis but women often lack adequate and timely access to healthcare facilities and don’t know they need iron supplements. Continue reading

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