The government, in a move to fast-track approvals for new drugs and promote clinical research in the country, has allowed companies waivers on conducting trials for new drugs in India in case the drug is approved and marketed in countries specified by India’s apex drug regulator — the Central Drugs Standard Control Organisation (CDSCO).
This waiver would also extend to drugs that receive these marketing approvals even while a trial is underway in India.
However, some patient activists feel such waivers would be problematic.
“The problem is that India is a country of vast ethnic diversity and most of the trials are done in the West. If a drug is discovered in a country like the US, the trials would have been done on a white population, so we need bridging trials for ethnically diverse populations to find out whether this drug would suit our population,” said S Srinivasan of patient activist group All India Drug Action Network (AIDAN).
Waivers in such cases could be “dangerous”, unless the government is careful about the situation in which it gives such exemptions, he said, adding that the waiver should be only for drugs required “urgently for national emergency, as was the case before.”
Patients who are injured during a clinical trial conducted in India will be entitled to medical management for “as long as required” in the opinion of the trial’s investigator, or until it is established that the injury is not related to the trial, show new clinical trial regulations notified by the health ministry Monday. Patients who have participated in a clinical trial for an investigational new drug may also receive access to the drug “free of cost” by the sponsor after the trial is concluded, but with certain riders, according to the new rules.
“Where any investigator of a clinical trial of investigational new drug or new drug has recommended post-trial access of the said drug after completion of clinical trial to any trial subject and the same has been approved by the Ethics Committee for clinical trial, the post-trial access shall be provided by the sponsor of such clinical trial to the trial subject free of cost,” stated the rules.
This applies to cases where the clinical trial is being conducted for an indication “for which no alternative therapy is available” and the investigational new drug has been found to be “beneficial” to the trial subject by the investigator. The trial subject or his or her legal heir has to have consented “in writing” to the use of this drug on the subject and has to declare in writing that the sponsor shall have “no liability” for this post-trial use.
“Overall, the new rules are very balanced. It will protect the rights, safety and well-being of the patients that participate in clinical trials and at the same time will enhance the conduct of ethical and quality clinical trials which will help us to develop new drugs required for our patients,” said Chirag Trivedi, president, Indian Society of Clinical Research (ISCR).
“Conditions for providing post-trial access of the drugs to the patients that require it have been defined for the first time,” he told The Indian Express.
“For global clinical trials – approval timelines are 90 working days. This will support India’s participation in global drug development since these timelines give the competitive edge to India and are in line with the ones observed in developed countries,” he added.
Some patient activists have found the “free” post-trial access to be a good move, as these drugs may often be not affordable otherwise. However, they have raised concerns with other provisions in the new regulations, including the compensation criteria and certain trial waivers.
According to Srinivasan, providing medical management until it is proven that the injury is not due to the trial is problematic.
“This can be manipulated. To prove that an injury is because of a trial or not because of it—either way, it is a slippery slope because you are studying a drug which is not well known and it is not possible to prove this,” he told The Indian Express.
“That is why we have been demanding that, irrespective of whether it is because of the trial or in-spite of the trial, there be a no-fault compensation, which is there in some countries like Australia and Taiwan,” he said.
According to a government release on the new regulations, compensations in cases of death and permanent disability, or “other” injuries to a trial participant will be decided by the Drug Controller General of India (DCGI), the head of India’s apex drug regulatory body.
However, AIDAN’s Srinivasan feels that this would put “too much pressure” on one individual. “There should be a committee to decide compensation and it should be transparent,” he said.
The previous draft of India’s clinical trial rules had mandated the sponsor to pay 60 per cent of the compensation upfront in case of death or permanent disability of the patient.
“If a patient is enrolled as a research participant, then the researcher has a duty to look after the participant. At the end of the day, it is the participant who is taking the maximum risk in a clinical trial, so they have a right to get adequate treatment, to be in good health and to get adequate compensation (in case of injuries or death),” said Veena Johari, a lawyer with Courtyard Attorneys, well-versed in India’s clinical trials regulations. “These are fundamental rights, actually,” she said.