New Delhi: 60% compensation within a 15-day interval has to be paid by drug companies conducting clinical trials in India, in case a patient on whom the test is being conducted suffers a disability or dies. This is the new government rule under consideration.
Livemint reports that the Central Drugs Standard Control Organisation (CDSCO), the Ministry of Health and Family Welfare and the national regulatory body for Indian pharmaceuticals and medical devices are forming the new rules on clinical trials of new drugs.
“We want to dispel the impression to the companies conducting clinical trials in India that people can be used as guinea pigs here,” a health ministry official told Livemint, requesting anonymity.
The proposed ruling, aimed at regulating clinical trials in india further adds that if the investigation were to prove that the cause of death was not in any way related to the trial, the interim compensation would still not be recoverable. Some of the recommnedations that are under considerations include that the financial compensation will be over and above expenses incurred on medical management of the subject.Clinical Trial compensation to victims is given based on age and health risks involved.
- The financial compensation will be over and above expenses incurred on medical management of the subject.
- Clinical Trial compensation to victims is given based on age and health risks involved.
- If the patient during the clinical trial period comes down with any other illnesses, the sponsor shall provide medical management and ancillary care.
- If the injury is related to a clinical trial, in addition to the medical management the participant will also be provided financial compensation by the sponsor as determined by a proposed ethics committee say the new rules. The financial compensation provided will be over and above any expenses incurred in the medical management of the subject, the rules further add.
- The ethics committee to be constituted will ensure that medical experiments and research on humans are conducted in an ethical manner and will provide feedback on the ethical appropriateness of the trial.Comprising of seven members the ethics committee will have experts from medical science, non-medical stream, scientific and non-scientific members, a layman and a woman member, according to an official in CDSCO, requesting to remain anonymous.
The stakeholders are likely to discuss the proposed new rulings soon with the government.
In 2013, the judiciary was informed by the government that as many as 2,644 people had died during clinical trials of 475 new drugs between 1 January 2005 and 30 June 2012 and that only 17 of these drugs were approved for marketing in India.
Another 11,972 serious adverse events (excluding death) were reported during the same period. 506 of these cases were found to be related to clinical trials.
According to CDSCO, major pharmaceutical companies conducting medical trials in India include global giants such as Pfizer, Novartis, AstraZeneca, Merck KGaA, and Indian drug firms such as Torrent Pharmaceuticals Ltd, Biocon Ltd, and Sun Pharmaceuticals Industries Ltd.
According to senior officials, the stringent regime on clinical trials, promises greater transparency and better checks for patient safety.
“Keeping in view the need for new drugs which continues to remain unabated, we felt that there was a significant room for improvement in the rules of clinical trials. The new rules will safeguard the interest of the subjects and will bring more clarity to the approach on clinical trials,” another health ministry official cited above said.
To quicken the compensation process, the proposed rules also bind the ethics committee to complete the investigation within a period of 30 days from the date of death, a permanent disability or serious adverse event (SAE)
“For removal of doubt it is declared that the amount paid as interim compensation to the trial subject or the legal heir shall not be recoverable irrespective of the case of death,” added the second health ministry official cited above.
The draft rules also state that in case the injury is not permanent, the quantum of compensation shall be commensurate with the loss of wages of the subject. “The responsibility for medical management or compensation shall be discharged by the sponsor or the person who has obtained permission from the licensing authority,” said another official in CDSCO.
LiveMint reports that the amount of compensation paid for clinical trial-related deaths since 2013 by pharmaceutical companies till date is approximately Rs8.7 crore; while for the clinical trial-related injury other than death, a compensation to the tune of Rs47 lakh has been paid by various firms, according to the CDSCO.