New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights

The enactment of the New Drugs and Clinical Trials Rules, 2019 (hereafter New Rules), on March 19 by the Ministry of Health and Family Welfare (MoHFW), Government of India (1), is the use of power delegated to the political executive by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940. Has this power been used wisely? Whose interests do these rules represent?

The crisis of ethics and integrity in Evidence Based Medicine and scientific practice

This issue of IJME carries three essays and a letter on the current crisis in Cochrane, earlier known as the Cochrane Collaboration. Cochrane expelled one of its founder members, Peter Gotzsche, on September 13, 2018, and in protest, four other Governing Board Members resigned. The essays show that what happened was not merely a clash within an organisation, but involved some basic differences on approach to Evidence Based Medicine. While these issues had been simmering for a long time, the expulsion brought them sharply into focus in the public domain

IJME Fifth National Bioethics Conference and the challenges ahead

After 22 years of the Indian Journal of Medical Ethics (IJME) and 10 years of National Bioethics Conferences (NBCs), it is time for some reflection on our achievements and the challenges ahead.

Professional codes, dual loyalties and the spotlight on corruption.

The ugly but well known and hitherto cheerfully accepted phenomenon of corruption in the health system has once again come to haunt the healthcare professions in India. It is no accident of history that the birth of The Indian Journal of Medical Ethics was intimately connected to the brazen corruption evident in the Maharashtra Medical Council (MMC) elections in 1992. But while health professionals associated with IJME understood corruption as a gross violation of ethics, mainstream doctors looked at it as a necessary evil, essential to survive in a highly competitive medical entrepreneurial environment.

New regulations on compensation for injury and death in drug trials.

In 2005, the government amended Schedule Y of the Drugs and Cosmetics Act, 1940, and Rules, 1945, to liberalise the conduct of global drug trials in India. Proponents of this policy had asserted that we needed less, and not more, regulation, in order to expand the business of drug trials. Many from the medical profession, the bioethics community and civil society groups have been critical of this policy.

Standing committee report on CDSCO: hard facts confirm an open secret.

You would think the mandate of the Central Drugs Standard Control Organisation (CDSCO) is to ensure that medicines on the Indian market are safe, effective, and necessary for public health. But the government thinks differently. According to a statement by the ministry to the Department Related Standing Committee on Health and Family Welfare, the CDSCO’s mission as stated in the committee’s report, is to “meet the aspirations…. demands and requirements of the pharmaceutical industry”. It is no wonder, then, that this industry can do just about anything it wants, at the cost of people’s health.

The legacy of scandals and non-scandals in research and its lessons for bioethics in India.

A case study entitled “Observational study of cervical cancer”, on research undertaken in a south Asian country, published in a compilation of case studies by Cash and others , is the subject of a collection of commentaries in this issue of IJME. The range of responses reflects the commentators’ individual disciplinary orientations and views on the state of medical practice in those times, and the ethical standards that applied.

IJME’s 20th year: some new directions.

With this issue of January 2012, the Indian Journal of Medical Ethics (IJME) is entering its 20th year of uninterrupted publication. In the last 19 years, the journal has never had to combine two issues, and has been published regularly in the first month of each quarter. This has been a remarkable feat for a journal on medical ethics and bioethics on a shoestring budget, with voluntary contributions of time and material resources from individuals. IJME has been able to afford some part-time staff support only for the last six years. More heartening than its survival has been the support, goodwill and enduring contribution of its readers and well wishers from India and abroad. Their number is so large that to mention every one of them is impossible. Many may not even like to be named as they have merely done what they considered right and relevant.

Can ethics committees address society’s concerns about standards in research.

Two years ago in an editorial we discussed the importance of bringing the spotlight onto the functioning of ethics committees (ECs) in India. Since the first ethical guidelines for biomedical research were formulated by the Indian Council of Medical Research (ICMR) in 1980 (and their subsequent versions in 2000 and 2006), India has officially adopted a decentralised system of ethics review and monitoring of biomedical research by institution-based ECs.

Dr Sunil Krishnalal Pandya.

On the occasion of the Third National Bioethics Conference of the Indian Journal of Medical Ethics, the editors of the journal and the coordinators and collaborators of the conference are.