BANGALORE — After a series of revelations last month about instances of unethical clinical trial practices in India, the country's lawmakers are pledging to enact stringent laws to punish violators. “I am pushing very hard to make existing guidelines into a stringent law this year,” Vishwa Mohan Katoch, secretary to the Indian Department of Health Research, which is responsible for overseeing clinical trials, told Nature Medicine.
The push for harsher penalties is the second major legal development in recent months to improve the integrity of trials. The first came on 18 November when the Drug Controller General of India (DCGI), the country's main medical regulator, announced new rules regarding compensation for trial victims. Under the new legal rule, expected to go into force in the coming months, failure to pay compensation in the event of an adverse effect or death will result in the companies being barred from conducting any further clinical trial in India. “Only when these two laws are enacted will the menace of illegal trials stop,” says Prathap Tharyan, a psychiatrist and medical ethicist at the Christian Medical College in Vellore, India.
The moves follow the outcry over the 2 January decision by the government of Madhya Pradesh, a state in central India, to fine a dozen doctors allegedly involved in controversial drug trials just 5,000 rupees ($100) each. Information obtained in June 2011 under India's Right to Information Act by Anand Rai—a former resident doctor at the government-run MY Hospital in Indore— indicated that at least eighty-one patients, including 18 children, suffered serious adverse effects in the trials. The sponsors were several Indian firms and Indian subsidiaries of companies including Merck, Pfizer, and others, according to documents obtained by Rai. He contends that his whistleblowing activity cost him his job, a claim the hospital has denied.
The drug companies touched by the scandal deny any wrongdoing. A Pfizer spokesperson told Nature Medicine that its study site at the city of Indore in Madhya Pradesh “did not recruit any study-defined patients, hence, no patient received a Pfizer investigational drug or Pfizer medication. The site was closed.” Meanwhile, Merck spokesperson Ian McConnell explains that its subsidiary MSD did provide DCGI details regarding its clinical studies “and was not found liable for any compensation.” Panacea Biotec, the heavyweight vaccine manufacturing company headquartered in New Delhi, says it had pediatric clinical trials done in Indore “to evaluate the efficacy of certain vaccines” but denies the trials were unethical because they were conducted “under the approval of the DCGI and the ethics committees.”
Industry experts take a cautious view of the wider explosion of clinical research in India. “Only 50% of illegal trials ever get exposed,” says Kanikaram Satyanarayana, deputy chief of the Indian Council of Medical Research (ICMR), based in New Delhi. “More worrisome is the fact that global pharmas—to avoid media glare and adverse publicity—are moving their trial sites from metro cities to smaller towns,” he says.
While blaming the institutional ethical committees for the present problems, Katoch says the situation is improving especially after DCGI made it mandatory for all sponsors to register the trials with the ICMR's Clinical Trials Registry of India (CTRI) to make them more transparent. “In just four years, the number of registered trials jumped from 11 at the end of 2007 to over 2,380 by the end 2011,” Abha Agarwal, who is in charge of CTRI, told Nature Medicine.
But, unfortunately, the number of deaths of trial subjects has risen, too. Health Minister Ghulam Nabi Azad told the Indian Parliament last year that there were 668 trials-related deaths during 2010, up from 137 in 2007. “These figures are understated because many deaths are not reported to the DCGI,” says Chandra Gulhati, editor of the Monthly Index of Medical Specialities journal in New Delhi. However, the families of only 22 of those 668 were compensated by around ten foreign drug companies, which together paid 5 million rupees, with most families receiving on the average a paltry 200,000 rupees each.
Drug companies emphasize that patients in their trials were sick to begin with, being treated for very advanced stages of cancer, for example, and so “one cannot be absolutely certain of the exact cause of death,” Aparna Thomas of Sanofi told Nature Medicine. “Our Indian affiliate follows the DCGI guidelines, and the compensation amounts were determined by the respective Ethics Committees.”
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Jayaraman, K. India mulling stricter laws to curb unethical trials. Nat Med 18, 182 (2012). https://doi.org/10.1038/nm0212-182