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Medical Council of India is corrupt, says health minister

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g4762 (Published 22 July 2014) Cite this as: BMJ 2014;349:g4762
  1. Priyanka Pulla
  1. 1Bangalore

India’s health minister, Harsh Vardhan, has described the Indian drug regulator, the Central Drugs Standard Control Organization (CDSCO), as a “snake pit of vested interests,” and he labelled the Medical Council of India (MCI) a corrupt organisation.

He was responding to questions from the Indian Express after The BMJ published an article by David Berger, a general medicine practitioner who had worked in northern India. In the article Berger chronicled his experiences of working in a corrupt system and said that such corruption was eroding the trust between doctors and patients.1

Berger highlighted the practice of referral payments, in which diagnostic centres pay doctors a commission for each patient referred to them. He said that this led to unnecessary, expensive, and often invasive diagnostic tests and that, although the MCI had a policy against such referral payments, the practice continued to be widespread.

Sunil Pandya, a Mumbai based neurosurgeon whose editorial in the latest issue of the Indian Journal of Medical Ethics called for an overhaul of the council, said that the council’s action on referral cuts had not been sufficient. “Bans are easy to impose,” he wrote in an email to The BMJ. “The crux is effective policing and immediate, severe deterrent punishment. Our medical councils, like most public sector agencies in our country, are woefully deficient in these.”

However, CV Bhirmanandam, a cardiologist and the vice president of the council, said that the organisation could do only so much to tackle a problem as widespread as corruption. “The MCI is there to formulate better standards to maintain medical ethics,” he said in a telephone interview. “We can’t be policing. As far as implementation goes, this requires self regulation.” He called Vardhan’s comments extremely demoralising to members of the MCI, all of whom, he said, were performing an honourable service.

Vardhan also said that corruption existed in the approval of drugs by the CDSCO and that, in the past few years, several instances of unethical practices in clinical trials had been highlighted in the media.

For example, a 2013 parliamentary standing committee report found that PATH, a non-governmental global health organisation based in Seattle, USA, had neglected to obtain informed consent from underage girls enrolled in its study of cervical cancer vaccines. Furthermore, the study had no adequate system for monitoring adverse effects from the two vaccines, Cervarix and Gardasil, manufactured by GlaxoSmithKline and Merck, respectively. The report blamed the Indian Council of Medical Research and the CDSCO, both of which it said had failed to protect the interests of the trial subjects.

As a result, rules governing clinical trials were made stricter and video recorded informed consent became mandatory. However, Arun Bhatt, president of the clinical research firm Clininvent Research, called the new regulations a knee jerk reaction to ethical breaches. Although laws governing clinical trials were introduced in 2005, “CDSCO never put a system of oversight in place,” said Bhatt, who is also an executive member at the Indian Society for Clinical Research.

He said that the CDSCO never knew whether the ethics committees at hospitals were monitoring trials adequately until media stories exposed the ethical breaches. “Every regulation in the past 2-3 years has been a reaction to [a] Supreme Court judgment,” he said. “CDSCO should have thought of all these regulations on [its] own.”

Notes

Cite this as: BMJ 2014;349:g4762

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