New Delhi: Criticized for drafting what the industry thought were untenable norms for clinical trials, India’s health ministry has blinked and amended guidelines for compensation of participants in trials that go wrong.
In their earlier version, the norms under the Drugs and Cosmetics Act made it mandatory for companies to compensate trial subjects who suffered injury or death even if these had not been caused by the drugs being tested. The new norms specify that the compensation need be given only if there’s proof that the death or injury was caused by the trial.
The Drug Technical Advisory Board (DTAB), which advises the health ministry on scientific matters, suggested these amendments and the ministry accepted them and changed the norms.
The previous law stated that “in the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required”.
In a meeting on 16 May, DTAB recommended that “medical management should be provided in case the injury is due to clinical trial related activities only, as the free medical management may create undue influence for patient to enrol in a clinical trial”.
Currently, only physical injuries are compensated in the few cases where a direct connection between the injury or death and the trial is established.
The minutes of the meeting viewed by Mint further state that “DTAB therefore recommended that the clause may be amended to read as: in the case of clinical trial related injury to a subject occurring during the clinical trial, he or she shall be given free medical management as long as required”.
The other significant amendment concerns the “intended therapeutic effect” of the product under trial. The section, which said the drugs being tested could only have the intended or desired effects and not any other effect, has been deleted as DTAB noted “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”.
The new norms come at a time when clinical research activity in India has come to a standstill due to the lack of a proper regulatory regime.
“We have taken several measures to reform the sector,” said G.N. Singh, the drugs controller general of India (DCGI). “The industry has to be patient as we put systems in place. We are simplifying the processes for all stakeholders involved.”
Industry experts estimate a loss of $150-200 million (Rs.900-1,200 crore today) in the past six months on account of regulatory changes.
“There is no doubt that research has been impacted by some of the irrational rules in the recent compensation guidelines, as well as the slowdown in the approval process for clinical studies,” said Anil Raghavan, managing director of Quintiles India, a leading contract research organization. “Given the prevailing lack of clarity and uncertainty, industry and institutional sponsors have adopted a wait-and-watch position and the next three-four months will be crucial for the future of medical research in the country.”
The clinical trials business in India is estimated to be worth around $500 million, according to research firm Frost and Sullivan, which projects that it will grow to $1 billion by 2016.
DTAB has also relaxed timelines to be followed by the ethics committees. Serious adverse events can now be reported and the quantum of compensation decided within 30 days and not 21. The timelines for the independent expert committee to establish cause of death during a trial has been increased to 60 days from 30. The “licensing authority” or DCGI gets another two months after getting the expert committee’s report to take a final call on the compensation amount and the cause of death in the latest version of the rules.
In a 3 January ruling, the Supreme Court revoked the powers of the Indian drug regulator to approve trials for new chemical entities, placing the responsibility on the Union health secretary, who was asked to personally vet all approvals.
Since then, only six trials had been approved until last week, when an apex committee cleared 50 trials at one go. A new chemical entity is essentially a new molecule that is still in the early stage of the drug discovery process. The January Supreme Court directive was in response to a public interest litigation filed by activist group Swasthya Adhikar Manch in February 2012.