The medical devices industry needs robust regulations. This article traces the evolution of medical devices regulation in India. Medical devices whether syringes and swabs, implantable devices, or technologically advanced solutions like software-driven devices, play a key role in the monitoring, prevention, and management of various diseases. A robust and dynamic regulatory system to oversee theRead more
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This post traces the timeline of events leading to the formulation of e-pharmacy rules passed by the government of India and the current status of online sale of drugs. Introduction: E-pharmacies have played a prominent role during the Covid-19 pandemic. A FICCI white paper indicates a 2.5 times growth in the number of households usingRead more
Propelled by the Covid-19 crisis, the government recently released “telemedicine practice guidelines”. Tanya Sadana and Sreenidhi Srinivasan of Ikigai Law hosted a webinar to discuss the legal and practical challenges of telemedicine. They were joined by Dr. Guriqbal Singh Jaiya (co-author of Fundamentals of Telehealth and Telemedicine, 2019) and Dr Manuj Garg (co-founder of healthcareRead more
The Covid-19 crisis has brought up several challenges. With India under lockdown, one such challenge is ensuring people can consult doctors and access medicines with ease. This week, the Ministry of Health and Family Welfare took two steps in this direction: (1) telemedicine guidelines recognising remote consultations; and (2) a notification allowing doorstep delivery ofRead more
The simplest of wearable fitness devices consist of a tiny accelerometer embedded deep within an integrated circuit board, wrapped in lithium polymer and encased in a polycarbonate case. Accelerometers can measure small changes in acceleration force and orientation, and can sense if it is in a horizontal or vertical position, and whether it is inRead more
Healthcare in India is plagued with problems – a severe shortage of hospitals, doctors and other health service providers; a large section of the population which is poor and does not have access to health care; and inadequate governmental spending and support[1]. Despite the fact that India is behind more developed countries in the adoptionRead more
1. Central Government At the sixth session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control held in October 2014, parties were urged to consider regulating or prohibiting Electronic Nicotine Delivery System (“ENDS”) and restricting or banning advertisement and promotion of ENDS.[1] A national level Roundtable Discussion was held inRead more
Update for all players interested in the medical, pharmaceutical and/or health-tech industry. The Ministry of Health and Family Welfare has notified the New Drugs and Clinical Trial Rules, 2019 (“New Rules”). Prior to this notification clinical trials in India were governed by a scattered set of rules and guidelines mainly found under the Drugs and Cosmetic Act,Read more
The National Health Policy, 2017[1] (“Policy”) envisaged the creation of a digital health technology ecosystem, aiming to leverage the potential of digital health data. The advantages of such digitalization and the potential of technology can hardly be overlooked, yet the proposals in this policy essentially involve large-scale creation, collection and sharing of health data. AnRead more