Pharmaceuticals and Healthcare
key
pharmaceuticals_and_healthcare
The Medical Devices Rules - An Analysis
The healthcare industry in India has seen an impressive growth trajectory in the past few years and the Indian medical devices market has been the sunrise segment in the healthcare space. The medical devices market is currently valued at around USD 10 billion and has been growing at a compounded annual growth rate of 15%. As per market estimates, the industry is expected to reach close to USD 25 billion by 2025.
Supreme Court Strikes Down Practice Of Grant Of Reservation For In-Service Candidates In Post Graduate Medical Degree Courses
The Hon'ble Supreme Court of India (SC) has, in the case of State of Uttar Pradesh v Dr Dinesh Singh Chauhan, struck down the practice of grant of reservation for in-service candidates in post graduate medical degree courses.
Classification for Newly Notified Medical Devices
On 3 September 2020, the Central Drugs Standard Control Organization (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices released draft classifications for newly notified devices. This is a significant development.
Software as a medical device
The Government released notifications on February 11, 2020 expanding the scope of regulation pertaining to ‘medical devices’. Historically, India has not had regulations on all ‘medical devices’ – certain categories of devices were regulated under the Drugs and Cosmetics Act, 1940 like ‘drugs’.
How will the new medical-device rules impact financial investors?
On 11 February 2020, fresh notifications were released drastically expanding the scope of regulation for medical devices under Indian law. Traditionally, India has not had expansive regulation on medical devices unlike several western jurisdictions.
All medical devices notified to be regulated
About 80% to 90% of India’s requirement of medical devices is met through imports. As the present government pushes for its “make in India” agenda, the medical device industry can play a significant role. A specific law regulating all the medical devices was needed inter alia to ensure minimum standard quality of the medical devices imported, manufactured and sold in India.
Strict similarity test for pharma brands applies to nutraceuticals
In Sun Pharma Laboratories Ltd v Ajanta Pharma Ltd (CS (COMM) 622/2018 & IA 12663/2014), the Delhi High Court has held that the strict similarity test laid down for pharmaceutical brands in the Indian Supreme Court's decision in Cadila Pharmaceuticals also applies to nutraceutical brands.