As questions continue to be raised over the policies governing clinical trials in India, new regulations and amendments to the country's pharmaceutical laws are now coming to light.
Specifically, India’s CDSCO (Central Drugs Standards Control Organization) is looking to crack down on unauthorized trials and is now calling for sponsors to reveal payments made to CROs and trial investigators.
A recent announcement by CDSCO says that “information in respect of the payments made by the sponsor to the investigator for the conduct [of the] clinical trial should be made available.”
Formal and legal agreements between sponsors, CROs (contract research organizations) and investigators should be decided prior to the start of the trial and define the relationship in terms of financial support, honorariums, fees and other payments, the order says.
Indian lawmakers also introduced a bill to replace CDSCO with a Central Drugs Authority, which would be overseen by a council of secretaries from related ministries.
Compensation Policy Changes
These latest disclosure notifications and the potential for a new drug regulator come as India will further amend the country’s Drugs and Cosmetics Act of 1940 regarding the compensation of clinical trial participants.
Originally the government had said patients in trials could be compensated if the drug did not have the “intended therapeutic benefit.”
ACRO (Association of Contract Research Organizations) and others took issue with that proposal and the government has since amended it, noting that compensation “due to failure of investigational product to provide intended therapeutic effect may be deleted as there is always a possibility that the investigational product may fail to provide intended therapeutic effect and the trial is conducted with the objective of assessing the therapeutic effect of the drug along with safety.”
Serious adverse events must now be reported to the DCGI and the ethics committee by the sponsor or his representative within 24 hours of their occurrence, according to the amendments. Both investigators and sponsors are also now required to report all serious adverse events.
In the case of a patient who dies during a trial, India’s DCGI (Drugs Controller General of India) will determine the cause of death and the amount of compensation to be paid by the sponsor or his representative within three months of receiving the adverse event report of the death.
Report on Irregularities in HPV Vaccine Trials
The announcement of the amendments comes as the Parliament of India’s Standing Committee on Health and Family Welfare issued a report condemning the way HPV vaccine clinical trials were conducted after seven girls and women died as the result of trials in 2010. The deaths, according to the report, "were summarily dismissed as unrelated to vaccinations without in-depth investigations."
The Committee’s examination, however, “has proved” that the DCGI “played a very questionable role in the entire matter. Initially, it took a call that since human subjects, as part of the studies, were receiving invasive intervention like immunization, clinical trial rules must be enforced.
“However, it remained as a silent spectator thereafter, even when its own rules and regulations were being so fragrantly violated,” the report says
One of the causes of these issues, the Committee concluded, was “that most, if not all consent forms, were carelessly filled-up and were incomplete and inaccurate. The full explanation, role, usefulness and pros and cons of vaccination had not been properly communicated to the parents/guardians. The Committee observes that there is a gross violation of the concept and legal requirement of consent which had been substantiated by the experts.”
Five Indian NGOs (non-government organizations), including Jan Swasthya Abhiyan and the All India Drug Action Network, signed a recent statement calling on the government to compensate the parents of the girls who died in the trials.
“We demand that the parents of the girls who died and the children must be compensated for the grave violations of their rights, as clearly informed consent was not taken from a large number of parents of the girls and no assent was taken from the girls who were given the HPV vaccine, and no follow up or proper management of adverse events and serious adverse events during the trial was done,” they wrote.
In an opinion piece , Dr. Amit Sengupta, a consulting obstetrician and gynecologist in Mumbai, analysed the Committee’s report and the trial industry in India in general. He took particular issue with the way CROs have run clinical trials there.
“CROs prefer non-traditional sites to conduct clinical trials because they are cheaper in countries such as India as compared to the developed world,” Dr. Sengupta wrote. “What is left unsaid is that the cost of human lives is also cheaper. Most European countries have regulations that mandate compulsory insurance for human trial subjects that includes ‘no fault liability’.”
He added: “Also left unsaid is that CROs prefer countries such as India because regulatory capacity is weak and laws and rules are yet not commensurate with requirements. There is clear evidence that trials are moving to places outside the US and Western Europe.”