New Delhi: Narendra Modi government appointed a fresh panel to draft new laws regarding medicines, cosmetics, and medical devices. The draft document will be submitted by November 30 by the newly formed eight-member panel, headed by India’s drug controller general, VG Somani. Among the most important regulatory bodies in India is Central Drugs Standard Control Organization (CDSCO), which supervises imports, manufactures, distributes and sells drugs and cosmetics.
It was recently amended to include medical devices. New Drugs, Cosmetics and Medical Devices Act can be framed through the formation of a committee for framing/preparation of New Drugs, Cosmetics and Medical Devices Bill, states the internal order accessed by News18.com.
The committee also comprises Rajiv Wadhawan (director, Ministry of Health and Family Welfare), Dr Eswara Reddy (joint controller), AK Pradhan (joint controller), as well as drug controllers from Haryana, Gujarat, and Maharashtra. ‘It is hereby ordered that the committee conduct pre-legislative consultations and examine the present Act, previous Drugs and Cosmetics Bills, and draft a new Drugs, Cosmetics, and Medical Devices Bill,’ stated the order dated 27 August. The order is titled ‘Constitution of Committee for Framing of the New Drugs, Cosmetics, and Medical Devices Act’.
Industry needs a new act: In 2020, the Ministry of Health and Family Welfare included medical devices within the regulatory ambit, treating them as a classification of ‘drugs’ for the purposes of regulation. Experts from the pharmaceutical industry say a new law is necessary. Since it was formed in 1940, the Act is completely out-of-date. It has been amended multiple times since 1940. An official representing a lobby group of top pharmaceutical companies said that the situation had become very confusing and unclear.
As the draft will first go to the Lok Sabha, then to the Rajya Sabha, then to the President, the law will take at least one year to be announced. According to another representative of a pharmaceutical company, ‘There are no innovations in this act. For instance: The act prohibits the sale of medicines online as it was passed prior to independence. We need the latest act as soon as possible’.
Experts have pointed out, however, that the panel should include representatives from other fields as well. ‘This is a conflict of interest to create such a committee without representation from other stakeholders such as manufacturers, doctors, academia, scientists, and consumer or patient groups,’ says Rajiv Nath, forum coordinator, Association of Indian Medical Devices Industry.