The 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
Late 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
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
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