The government has decided to remove a clause in the draft clinical trials rules that mandate the sponsor (the entity initiating the trial) to pay 60% of compensation upfront in case of death or permanent disability of the patient, in a major relief for pharmaceutical companies. An amendment in the draft rules will state that companies would pay the total amount once it is proven that the injury occurred because of the trial.

“The government has decided to do away with the advance payment of 60%, which was earlier part of the draft rules. Instead, it has been decided that the sponsor may pay the full amount only after it is proven that the trial resulted in the injury or death," said a person aware of matter.

However, companies will have to adhere to a timeline to compensate patients and cannot take forever, said another person privy to the discussions.

The earlier proposal said the interim compensation will not be recoverable even if investigations prove that the death or disability did not occur because of the trial.

The Union health ministry’s proposal made in February last year included a mandate for the company to pay, within 15 days, 60% of the compensation if a person dies or suffers a permanent disability in the course of a trial.

“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% of the compensation within 15 days of the opinion of ethics committee," the draft rules had stated.

The move to do away with 60% compensation upfront has been made in the wake of opposition from the international health agency World Health Organization (WHO) and concerns emerging in the government over this clause, with the Indian Council of Medical Research (ICMR) raising objections.

WHO deputy director general Soumya Swaminathan had on 19 June written to Union health secretary Preeti Sudan stating that “if the rules are finalised as they currently stand", sponsors capable of conducting clinical trials will go out of India. The WHO had told the Centre that its work with India would be “hampered" and drug companies would go away if the government goes ahead with stringent draft rules for compensation in case of death or injury from clinical trials.

India should reconsider the compensation clause because approving the rules in the current form would affect the conduct of international and nationally-sponsored clinical trials in India, Swaminathan said. Many sponsors are likely to consider this “unacceptable", she said. It is not the usual practice internationally for ethics committees to make such decisions and it would place an unfair burden on them, given their lack of expertise, she said.

“I fear that if the rules are finalised as they currently stand, there is a possibility that sponsors will not conduct clinical trials in India and go elsewhere," she said. “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," she said. Mint has reviewed a copy of the letter.

ICMR director general Balram Bhargava had also written to the Union heath ministry that some of the clauses may be detrimental to the future of clinical trials in India.

Following these suggestions, the ministry held discussions with pharma companies and pharma lobby groups and have decided to modify the rules.

The All India Drugs Action Network (AIDAN), a non-government organisation that was the part of the consultative process, said they were against any dilution of the rule. “We had also asked for the data on the compensation paid since the formula came into effect, which was not available," said Malini Aisola, co-convenor, AIDAN.

According to India’s drugs regulatory authority Central Drugs Standard Control Organisation (CDSCO), major pharmaceutical companies conducting medical trials in India include global giants such as Novartis, Pfizer, Merck KGaA, and AstraZeneca, as well as Indian drug firms such as Torrent Pharmaceuticals Ltd, Sun Pharmaceuticals Industries Ltd, and Biocon Ltd.

Close