AiMeD demands separate law for regulation of medical device industry, writes to Mandaviya opposing new regulatory Bill

The bill if/when passed will be replacing the existing 80-year-old Drugs and Cosmetic Act of 1940. The Union Health Ministry had sought comments from stakeholders and the public on the proposed draft bill last year.

However, Rajiv Nath, Forum Coordinator, AiMED, in his recent letter to Mandaviya conveyed the industry's utter shock on seeing the bill being listed to be presented in the parliament for passage without enough discussions or deliberations on the final draft which the industry claims it did not receive from the Ministry after it took suggestions from the industry.

As per a government document, “The bill seeks to regulate the import, manufacture, distribution and sale of drugs, medical devices and cosmetics; and ensure their quality, safety, efficacy, performance and clinical trial of new drugs and clinical investigation of investigational medical devices and clinical performance evaluation of new in vitro diagnostic medical device including AUSSH drugs, medical devices and cosmetics with the objective of highest possible regulatory standards and a transparent regulatory regime and to repeal the Drugs and Cosmetics Act, 1940."

The bill proposes new definitions for clinical trials, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability study, investigational new drug and imported spurious drugs, medical device and aims to regulate online pharmacy stores.

To regulate e-pharmacy, the draft bill says, “No person shall himself or by any other person on his behalf sell, or stock or exhibit or offer for sale, or distribute, any drug by online mode (e-pharmacy) except under and in accordance with a license or permission issued in such manner as may be prescribed."

The Centre has also proposed a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB).

The bill also proposes regulation of traditional medicine such as Ayurveda, Siddha, Sowa-Rigpa, Unani and Homeopathy, with the constitution of respective Drug Technical Advisory Board.

Also Read: Medical Devices Of All Four Categories Will Be Brought Under Regulation By October 1: DCGI

However, the Association expressed its dismay over the Centre’s plan to bring the New Drugs, Medical Devices and Cosmetics Bill, 2023 to Parliament in the monsoon session without holding even a single meeting with major stakeholders.

“This move has been made in a strange manner by a Committee formed by regulators from Central Drugs Standard Control Organisation (CDSCO) with even the chairman not being from Directorate General of Health Services (DGHS) etc as is usually the practice,” the Association’s letter said.

“This process was highly flawed with conflict of interest to empower regulators by a Bill drafted by regulators without even seeking inputs from MDTAG (Medical Device Technical Advisory Group) and discussion with stakeholders despite being directed to do so,’’ it added.

Further elaborating on the need for a separate chapter on medical devices under the law, AiMeD stated that it was strange that the Parliamentary Committee’s 138th report, released on September 12, 2022, which recommends a separate law for medical devices as was being regularly sought by Indian manufacturers, had not been taken into consideration. It added that, since 1982, the Central Government has been attempting incorrectly to regulate medical devices as drugs, reports The Hindu.

“These two are entirely different medical products. Most progressive countries have brought in reforms and have separate laws for Medical Devices. Countries including Canada, Japan, Brazil have introduced the change. Earlier even NIT Aayog had drafted a separate bill for medical devices - ‘The Medical Device (Safety, Effectiveness and Innovation) Bill 2019’ with the intention to have a Separate Law and Separate Regulatory,’’ the Association said.

The industry body subsequently wrote to Mandaviya demanding that the Bill be returned to the Health Ministry, with an advisory to resubmit separate laws to regulate drugs and medical devices after the due consultative, democratic and pre-legislative process.

Lately, in response to the letter, the Union Health Minister communicated with the Industry body and assured them of enough discussions on the bill. Confirming the development, Nath told that the Health Minister assured him that regulations are not being put up to derail the Make in India efforts of AiMeDs members and once the industry body studies the final draft they should be able to share their concerns with the Health Ministry.

Thanking the Minister, Nath in his statement was quoted by Business World as saying, "We are thankful to the Honourable Health Minister for meeting us and for his assurances to have the MoH&FW & CDSCO team look into our concerns as he was surprised that the Bill had not been discussed adequately with us."

"Our biggest concerns were the need to have a separate law and not a separate Chapter under the Drugs law as that was what was assured earlier to us in 2016 by the MoH&FW team present then and this was in line with Parliament Committee recommendations considering the huge potential of the industry and separate laws by other progressive nations - EU , Canada, Japan , Brazil & even Saudi Arabia," it added.

AiMeD now awaits suspension of the Bill in Parliament and initiation of public discussions on the Bill and on their concerns.