The central government is likely to remove the clause, which has been mentioned in the draft version of clinical trial rules, mandating the sponsor to pay 60 per cent of the compensation upfront in case of death or permanent disability of the patient.
“There is a serious opposition to this provision of clinical trial rules by industry and even the WHO (World Health Organisation). In the final version, we may remove this clause as it can prove to be too onerous for companies and sponsor organisations that run various clinical trials in India,” said a senior government official on the condition of anonymity.
The draft version of New Drugs and Clinical trials Rules, 2018 – which was issued in February this year – stated that if a “trial subject” suffered from permanent disability or died during a “clinical trial or bioavailability study or bioequivalence study”, the sponsor would have to pay 60 per cent of the compensation within 15 days of the opinion of “Ethics Committee”.
According to draft rules, any institution or organisation that intends to conduct clinical trial or bioavailability study or bioequivalence study shall be required to have an “Ethics Committee”. The central licensing authority will consider the matter once Ethics Committee issues its opinion. The draft rules state that remaining 40 per cent of the compensation has to be paid to the patient within 30 days of order passed by the central licensing authority.
On June 19, WHO deputy director general Soumya Swaminathan wrote a letter to Union health secretary Preeti Sudan stating that “if the rules are finalized as they currently stand”, sponsors that are capable of conducting clinical trials out of India, will go out of India. Swaminathan stated that WHO’s major concern is the reaction sponsors are likely to have to the scenario whereby the ethics committee determines a death or permanent disability is related to the “product (drug)”, but the sponsor disagrees. “In this case, 60 per cent of the fee has to be paid upfront before the central licensing authority goes through its expert review process to adjudicate and this is not reimbursable regardless of the decision of the further steps of the process,” she added. Swaminathan added that if these rules are finalized as they currently stand, “it will also hamper WHO’s work with India where we consider that it is a public health priority to conduct trails on a particular condition in India, WHO ourselves may not wish to act as a sponsor, and other partners may be similarly discouraged”. According to draft clinical trial rules, the compensation – which will be given to the kin of the patient in case of death or to the patient herself in case of permanent disability or injury – has to be calculated through a complex formula mentioned in the seventh schedule of the rules.
Veena Johari, an advocate well versed with the clinical trial regulations of India, told The Indian Express: “Participants should be given compensation, including no fault compensation, once an Ethics Committee determines there has been a trial-related injury or death. Whittling down of this section would send a message that the government is towing the line of industry who would not want a provision like this in the Rules.
The retention of this rule will ensure that participants in clinical trials are not being exploited, or used and forgotten, but that if an injury or death occurs, they are provided some immediate amount for the risk undertaken by them.” On September 12, Supreme Court was hearing a writ petition of Swasthya Adhikar Manch on reforming regulations related to clinical trials in India. During the hearing, the central government’s counsel assured the court “that a personal meeting will be held with those who make objections and give suggestions (on draft clinical trial rules)and a date and time will be fixed for this purpose”.
On September 17, the Central Drugs Standard Control Organisation (CDSCO) held an interactive session on clinical trials in New Delhi. Major pharmaceutical industry organisations, WHO as well as United States Food and Drug Administration (USFDA) were present at this session. Swasthya Adhikar Manch and other civil society organisations were not called at this session.