The national drug regulator is putting the finishing touches to the New Drugs and Clinical Trials Rules 2018 and will hold a meeting with various stakeholders next week to receive their suggestions and comments. The Central Drugs Standard Control Organisation (CDSCO) is learnt to be conducting the hearing on November 22 following an order issued by the Supreme Court on a writ petition filed by Swasthya Adhikar Manch (SAM), an Indore-based non-profit group.
At the hearing on the SAM’s petition, the government counsel told the top court that many objections and suggestions had already been received. However, the apex court directed the government to give a personal hearing to those who made suggestions on the clinical trial rules.
The draft clinical trial (CT) rules, published by the health ministry in February, are expected to promote biomedical research in the country by proposing to reduce approval time for applications to between 30 and 60 days. The regulations lay out the requirements for carrying out biomedical research involving human participants, their biological material and data.
Clinical trials are a relatively new research segment in India and the country’s contribution to the field remains low. Only 1.4 per cent of the world’s clinical trials take place in India, despite the country’s disease burden of 20 per cent, and regulations in this field are in its nascent stage. A 2014 research paper, based on records collected from 50 human volunteers (HVs) participating in a BA/BE study by a Hyderabad-based contract research organisation, throws light on the role of middlemen and the remuneration negotiation process.
“The profile of the HVs showed that all 50 participants belonged to the low income group. All of them took part owing to insufficient income,” Shilpa Krishna, a research scholar at the University of Hyderabad and a co-author of the report, told Pharmabiz in a telephone interview. None of the HVs, some of them were graduates, knew anything about the trial in which they were participating, she added.
According to experts, the proposed rules would help change this situation for the better as there are several clauses to protect the interest of CT subjects. Regulations for compensation are made more rigorous and the ethics committees that monitor trials are allowed to decide on the compensation for patients if they suffer any adverse events.
At present, a CT subject who suffers a serious adverse event (SAE) gets free medical management as long as required or until it is established that the injury is not related to the CT. If the injury is found to be related to the CT, the subject is entitled to financial compensation. But no damages will be paid for injury or death of a volunteer if it is proven to be unrelated to the trial.
However, as per the new rules, in cases of SAEs that result in death or disability as a result of a CT or bioavailability and bioequivalence (BA/BE) study, the sponsor should have to pay an interim compensation of 60 per cent of the total amount within 15 days of receipt of the EC opinion. The remaining amount must be paid within 30 days of receipt of a letter from the CDSCO, if it is confirmed the SAE is related to the study.