This segment of the newsletter shares recent information related to regulatory reforms from Healthcare and Pharmaceutical sectors in India. This segment collates information on monthly basis via conducting research and appraisal of applicable statutory provisions. Below are the highlights for February 2020.

Health Care Budget allocation in Union Budget 2020-211

On February 01, 2020, the Union Minister for Finance and Corporate Affairs presented the Union Budget 2020-21 in Parliament; about Rs 69,000 crores have been allocated for Health Care, which includes Rs. 6400 crores for Prime Minister Jan Arogya Yojana (PMJAY). The Finance Minister also stated that there are more than 20,000 empaneled hospitals under PM Jan Arogya Yojana (PMJAY) and government is planning more empaneled hospitals under PMJAY in Tier-2 and Tier-3 cities for poor people. It has been proposed to set up Viability Gap funding window for setting up hospitals in the PPP mode. In the first phase, those aspirational districts will be covered where presently there are no Ayushman empanelled hospitals. This would also provide large scale employment opportunities to youth. Proceeds from taxes on medical devices would be used to support this vital health infrastructure. The Finance Minister also announced the launch of "TB Harega Desh Jeetega campaign" towards government's commitment to end tuberculosis by 2025. The Minister for Finance and Corporate Affairs also announced expansion of Jan Aushadhi Kendra Scheme to all districts offering 2000 medicines and 300 surgical by 2024.

Indian institute IVRI releases live attenuated Classical Swine Fever Vaccine (IVRI-CSF-BS) from indigenous strain of virus2

On February 03, 2020, the Indian Veterinary Research Institute (IVRI), Izatnagar under Indian Council of Agricultural Research (ICAR) has released the live attenuated Classical Swine Fever Vaccine (CSF-BS) Technology by attenuating an indigenous virulent CSF virus in cell culture. Classical Swine Fever is one of the most serious diseases in pigs causing high mortality with annual loss of approx. Rs.4.299 billion. A lapinized CSF vaccine (Weybridge strain, UK) is being used in India since 1964 for controlling the disease. The vaccine is produced by sacrificing large number of rabbits for each batch. In order to do away with sacrificing of rabbits and increase the productivity, IVRI had earlier developed a cell culture CSF vaccine by adapting the lapinized vaccine virus in cell culture. The technology has been transferred to M/s Indian Immunologicals, Hyderabad and Government of Punjab during 2016 and 2018, respectively. IVRI has further developed a new CSF Cell Culture Vaccine by attenuating an indigenous virulent CSF virus in cell culture. The vaccine virus has very high titre and lakhs of doses can be produced very easily in cell culture and country's requirement can be easily fulfilled using this new vaccine. The new vaccine will be part of the government's One Health Initiative and result in huge savings as it will nip the spread of the virus at animal stage so that it does not pass on to the human population. This new vaccine will be the most economical CSF vaccine costing around less than Rs 2/- per dose as against Rs 15-25/- of lapinized CSF vaccine and Rs.30/dose (approx) for an imported Korean vaccine being used in the country. Besides, the new vaccine gives immunity for two years as compared to 3 to 6 months protection under the vaccines currently being used. The patent application for the new vaccine, which has been developed by a team of IVRI scientists, is already submitted. The vaccine is safe, potent, does not revert to virulence and provides protective immunity from day 14 of the vaccination till 24 months studied so far. The vaccine has been tested on around 500 pigs at multiple locations.

DCGI defines all medical devices as drugs to mandate their safety and quality standard approval before drug approving authority3

The Union Health Ministry, on February 11, 2020, through a gazette notification defined all medical equipment/ devices used on humans or animals as "drugs" with effect from April 01, 2020. This notification mandates all medical devices to pass specific safety and quality standards from drug approving authority before they are introduced in the India market. At present, only 23 medical devices are regulated under the Drugs & Cosmetic Act, 1940. However, with the new announcement, all medical devices used on humans or animals have been included as "drugs" under sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act.

This includes an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including software or an accessory, intended by its manufacturer to be used especially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of: "(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception."

Further, since this notification will cover all Medical Devices, the provisions in Medical Device Rule, 2017, will be automatically applicable to them without individual or class notification which is not the proposed transition scheme by way of registration.





Originally published 28 April, 2020

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.