The Electronic Commercialization of goods and services has been tremendous escalation over the past few decades. Enrolling themselves in the pursuit is the avant- garde species of entrants 'E-Pharmacies' whose augmentation was catalyzed by the exigency of medicines in the course of nationwide lockdown. The recent years have been a spectator of remarkable transmutation and approximately every single thing including medicines and drugs has been on one's fingertips through E- Commerce portals. However, the sphere of medical supply in its entirety in India is regulated by the drugs and cosmetics Act which was legislated way back in the 1940 and was postulated on the issues and cases precedent nearly 80 years ago. This law has not been amended sufficiently to accommodate the technological and cyber age issues confronted by the stakeholders. As rightly said "Modern Problems require modern solutions".
Committee for Framing New Drugs and Medical Devices Act
To assist the development of "de-novo" drugs, cosmetics and medical devices in the age of E- Pharmacy portals, the Ministry of Health and Family welfare passed an order on August 27, 2021 which constituted a committee of 8 members for framing New Drugs and Medical Devices Act. The committee headed by the Drug controller General of India (DCGI) VG Somani shall perform the functions of reviewing the presently existing Act of 1940, and prepare a Bill on New Drugs, Cosmetics and Medical Devices for pre-legislative consultation. The other members of the committee include Mr. Rajiv Wadhawan (Director of Union Health Ministry), Dr. S. E. Reddy (Joint Drug Controller (India)), Mr. A. K. Pradhan (Joint Drugs Controller (India)) and IAS NL Meena. The order notified that the Committee may include other members if necessary. This 8 membered panel is to present the Bill by November 30, 2021. The order states "The committee shall undertake pre-legislative consultations and examine the present Act, previously framed Drugs and Cosmetics Bills and submit a draft documents for a de-novo Drugs, Cosmetics and Medical Devices Bill by November 30, 2021."
Why a New Drugs and Cosmetics Act is required?
In the recent times, India has seen a rapid boost in the number of E-Pharmacies. According to Invest India , as recoded 2019, there are Approximate to 50 E-Pharmacies in India that have the market size (2019) of about $ 0.5B, which is approximately 2-3 per cent of the total Indian pharmacy sales. This market entrant is expected to expand at a consolidated rate of 44% to cover a market size of $ 4.5B by 2025.
Observing the trend of growth in the market, the High Court of Judicature at Madras, observed in Tamil Nadu Chemists and Druggists Association v Union Of India & Ors, "..rapid Growth of e- commerce continues to present challenges to the State and Central Government in the trade of on-line Pharmacy."
The new law is expected to address this addition in the e- market and provide a smooth road ahead. The existing law imbibed Drugs, medical devices and cosmetics in its subject matter. However, in the recent developments, the medical devices were partly separated from the family under the medical rules, 2017. Last year, a few of these devices were notified by the government were treated as drugs.
Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD) tweeted on the matter, "Medical devices have outgrown the joint family home shared to long with drugs, Separate Medical Devices Rules, 2017 was a good step to allow us to have our own home." Further he added that it was a practical step but the Central Drugs Standard Control Organization(CDSCO) won't let go.
The Committee constituted under the notification aims to provide for the upcoming challenges and the issues observed in the past few years due to the uprising of E-Pharmacies and inclusion of medical devices in the category of drugs under the Drugs and Cosmetics Act, 1940.
The constitution of the committee for Framing of New Drugs, Cosmetics and Medical Devices Act is a much needed step in the drugs and medicinal sector for uniform regulation of the brick and mortar market as well as pharmacies through E- portal. The awaited Bill is expected by November 30, 20201 with the reforms for a technological and cyber innovations.
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.