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The Drugs Technical Advisory Board (DTAB) has decided not to pursue the proposal related to amendment of Drugs Rules, 1945 for including mandatory provision of pharmaceutical companies to spend part of their net profit for free medicines in medicine banks.
The Board took the decision after deliberating the proposal to amend Drugs Rules, 1945 for including mandatory provision of pharmaceutical companies to spend at least one percent of their net profit for providing free medicines in medicine bank to be used by the Central Government during health emergencies, disaster or any other circumstances considered necessary by the Central Government as part of Corporate Social Responsibility (CSR).
"DTAB after deliberation agreed with the proposal to defer the proposal since any amendment in the CSR framework does not fall under the ambit of Drugs and Cosmetics Act and rules made thereunder. The matter may not be pursued further," said the Board in its 93rd meeting held recently.
The Board, in a meeting in 2024, has suggested the ministry of health and family welfare (MoHFW) to write to the Ministry of Corporate Affairs to mandate the pharma companies to spend almost one per cent of their net profit for providing free medicines in medicine banks as part of the Corporate Social Responsibility (CSR).
The latest decision to not pursue the proposal, was also based on the Ministry of Corporate Affairs' reply in this matter, said the Board.
The Board, constituted by the Central government to advise the Central and state governments on technical matters during the administration of the Drugs and Cosmetics Act, had earlier considered the same proposal in its 79th meeting, held on May 16, 2018. After deliberations, it agreed on the proposal initially to be implemented on a voluntary basis.
The Board’s 90th meeting held in 2024 considered the proposal once again, as it was deliberating on certain proposals for which it had already shared recommendations to the concerned ministry for taking actions including publication of draft rules. The Ministry informed the Board that since several important notifications for amendments of rules under the Drugs and Cosmetics Act, 1940 has been issued after these recommendations, the DTAB recommendations may be critically reviewed and revised in the context of the updated rules and recent notifications.
According to the ministry of corporate affairs, the concept of CSR in India is governed by Section 135 of the Companies Act, 2013 (‘Act’), Schedule VII of the Act and Companies (CSR Policy) Rules, 2014 wherein the criteria has been provided for assessing the CSR eligibility of a company, Implementation and Reporting of their CSR Policies. India has been on its journey to set a benchmark in attaining sustainability goals and stakeholder activism in nation building.
“The CSR ambit is getting bigger and for upcoming years it would turn as a unique knowledge base for analyzing and achieving sustainability goals as among various large economies. India is a country which has assured by mandating CSR through its legislative action,” says the Ministry.
The 21st Report of the Parliamentary Standing Committee on Finance is one of the prime movers for bringing the CSR provisions within the statute. It was observed by the Standing Committee, that annual statutory disclosures on CSR required to be made by the companies under the Act would be a sufficient check on non-compliance. Section 135(4) of the Companies Act 2013 mandates every company qualifying under Section 135(1) to make a statutory disclosure of CSR in its Annual Report of the Board. Rule 8 of the Companies (Corporate Social Responsibility Policy), Rules, 2014 prescribes the format in which such disclosure to be made.
It may be noted that the major pharma companies in the country are engaged in various CSR activities, with special focus on health and wellness of the public, including initiatives to fight diseases such as malaria, tuberculosis and others, apart from funding education, research and healthcare services.
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