Arunima Rajan – ETHealthworld.com – October 15, 2015 – Can National Medical Device Policy turn the tug-of-war between government and entrepreneurs in to a win-win solution? Arunima Rajan finds out.
— A flurry of commitments is being made by the government this year to strengthen the Make-in-India campaign including the National Medical Device Policy. But can a policy help to deliver healthcare goals? —
What is the major deterrent for innovating in India? "ECOSYSTEMS!" says Zoya Brar, founder and managing director of Core diagnostics. "What makes Silicon Valley so different?" asks Brar. "There are three top-notch universities - Stanford, UCSF, and UC Berkeley. There is access to venture capital. And there are several anchor corporations in many domains - Genentech in pharmaceuticals, Kaiser Permanente in Healthcare, Cisco in telecommunications, Intel in computer chips, Apple in consumer devices... the list goes on. This creates the perfect amalgamation engine for innovation. There is not a single such complete ecosystem in India - not even in Bangalore or Hyderabad. Creating ecosystems is a two or three- decade journey, after we get serious about it. And we are not yet serious about it," explains Brar.
Brar's comments shocks no one in the healthcare sector. Most entrepreneurs often struggle to enter India's public healthcare system. And their tone is matter- of- fact while discussing the challenges of the system. "Department of Biotechnology and Biotechnology Industry Research Assistance Council has unveiled several grants for innovators. However, to enter the public health system is very difficult. Researchers spend months on clinical trials and approvals for their products," says Ayesha Chaudhary, a healthcare entrepreneur. A flurry of commitments is being made by the government this year to strengthen the Make-in-India campaign including the National Medical Device Policy. But can a policy help to deliver healthcare goals?
In fact, in one way or other most entrepreneurs blame lack of clear regulations for the current state of the medical device sector. Vibhav Joshi, co-founder, Sattva MedTech, an award winning medical devices start-up, underscores the need for regulations for a robust start-up ecosystem. "The policy draft looks at regulating clinical trials, strengthening ethics committees and introducing pricing control for essential diagnostics and equipment. These shall be critical to how the indigenous medical device industry develops. We'll have to wait for more details to see whether they prove a boon or a curse," says Joshi.
Currently, medical devices come under Drug and Cosmetics Act, which creates lot of hurdles for entrepreneurs. "It is a cause of concern for everyone in the healthcare industry, including the health ministry. Currently, the revised Drug and Cosmetics Act is pending for approval. The aim of draft National Medical Device Policy is to promote indigenous medical devices industry, provide for suitable ecosystem to promote innovations and to safeguard medical devices industry against tariff and non-tariff trade barriers. Medical device sector has been perceived as five sunrise sectors of India. The focus areas of the proposed policy are promotion, skill development, trade facilitation, boosting innovation and enterprise development," says Dr. Jitendar Sharma, Head- Healthcare Technology, NHSRC and Director WHO Collaborating Centre for Priority Medical Devices & Health Technology Policy.
Jitendar Sharma emphasises that currently, Drugs and Cosmetics Act obligates Central Drugs Standard Control Organization (CDSCO), for regulating all medical products in India. Even the National Medical Device policy talks of a single nodal co-ordination body to facilitate co-ordination between various departments and ministry and taking industry trade promotion initiatives. It also provides a platform for co-ordination between industry and government, on issues and concerns. Further, it also wants to bring out corrective measures to encourage trade and production. CDSCO is responsible for regulatory issues such as licensing, registration for labelling of medical approvals and monitor safety. "The difference between both bodies is similar to what is in between a court and social NGO. A court is authority to legally solve the problem. A social NGO only facilitates discussion to prevent problems," says Sharma. “A drug inspector usually inspects a medical device factory for inspection. A drug inspector is usually a pharmacist. He is not an engineer. The entire system is going to change soon. The regulatory body which is CDSCO has started to build teams of clinical engineers for this complex work. Plus, there will be personnel performing regulatory activities of the government," says Sharma.
It is also clear that draft National Medical Device Policy will have an impact on the pricing of medical devices. "It doesn't want to control the industry by controlling the prices of all devices. But it certainly aims to safeguard the interests of patients by improving cost effectiveness and access to life saving technologies," says Sharma.
Significantly, serving the diagnostics needs of Indian patients is not rate limited by capital or technology say senior healthcare executives. "It is rate limited by skill and is specifically true for In Vitro Diagnostics. In the case of In Vivo Diagnostics, however, the situation is quite different. Machines like MRI, PET, CT, etc. are mostly imported, and are highly capital intensive, and expensive. Here, Make-in-India makes perfect sense. India has had several decades of experience in developing and manufacturing X-Ray, Ultrasound, and even CT machines at a fraction of the cost of the imports. However, the same is not true for some of the more technologically complex imaging modalities such as MR, PET-CT, Angiography, etc.," says Zoya Brar.
However, there are different viewpoints too. "Heightened physician awareness to better clinical outcomes and increasing patient requirement to avail of high quality care, have made it imperative for providers to deliver targeted therapy. This has been made possible by the availability of sensitive and specific diagnostic tests, along with technologically advanced medical devices and equipments. Government has introduced new policies which are in sync with medical equipment industry. India is beginning to look forward to being recognized as a manufacturing destination for sophisticated medical technology. International companies are also setting up their manufacturing units in India or are acquiring domestic players. These developments are a new ray of hope for local medical equipment production which will fulfil the healthcare needs locally and globally," concludes Dr. Sushil Shah, Chairman, Metropolis Healthcare Ltd.
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