Clinical Trials – Compensation Rule To Be Modified - ACRI India

Stringent rules are followed in every country for conducting clinical trials, with every country forming their own individual rules. While strictness is good and important, it could prove disadvantageous if extended above a certain level. This is what happened in the case of the clinical trials rules drafted by the Government of India.

In February 2018, the Union Health Ministry proposed that the companies who initiated a clinical trial in India should have to pay a compensation of 60% to a participant’s family, if he dies or suffers a permanent disability in the course of the trial. This compensation was to be mandatorily paid within 15 days, and would not be recoverable even if later investigations proved that the death or disability did not occur because of the trial.

But recently, the government has decided to modify this clause. This clause will now state that companies will not have to pay 60% compensation upfront. This has come as a relief for pharmaceutical companies. However, the clause will also state that the companies will have to pay the total amount once it is proven that the injury occurred because of the trial. While there is no time slab to be followed in this case, but this doesn’t mean that the companies can take forever to compensate. They will have to adhere to a timeline to compensate the patients.

This move has been taken after the World Health Organization (WHO) opposed the rule, considering the concerns emerging over this clause, with the Indian Council of Medical Research (ICMR) raising objections. The WHO Deputy Director General, Soumya Swaminathan, has written to the Union Health Secretary, Preeti Sudan, on 19 June 2018, “If the rules are finalized as they currently stand, sponsors capable of conducting clinical trials will go out of India. I fear that if the rules are finalized as they currently stand, there is a possibility that sponsors will not conduct clinical trials in India and go elsewhere. It will also hamper WHO’s work with India where we consider that it is a public health priority to conduct clinical trials on a particular condition in India. WHO itself may not wish to act as sponsor and other partners may be similarly discouraged.”

In this way, WHO cautioned that the clinical work in India would be hampered and that drug companies will move away if the government goes ahead with these stringent rules for compensation. If the 60% upfront compensation rule was to be approved and followed, the conduct of international and nationally-sponsored clinical trials in India would be affected, as many sponsors will consider this unacceptable.

Furthermore, the Director General at ICMR, Mr. Balram Bhargava, also wrote to the Union Health Ministry that some of the clauses in the clinical trials rules draft may be detrimental to the future of clinical trials in India.

Considering all of this, the ministry held a discussion with pharmaceutical companies and lobby groups, and came to a decision to modify the rule. Looking at this modification, it now seems that both national and international pharmaceutical companies will now have no issues in conducting clinical trials in India. This will thus bring a rise in such trials, boosting the number of trials to be conducted in the country, and thus the graph of the Indian clinical trial careers. To set up a great career in this field, you can also enroll yourself with a reputed institute like Avigna Clinical Research Institute, where you can get the best clinical research onlinetraining in Bangalore from experienced and esteemed professionals.

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