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Request to reinstate compensation provision in original proposed form in Draft Rules for Clinical Trials

Dr S. Eswara Reddy
Drug Controller General of India
Central Drugs Standard Control Organization (CDSCO)
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India
FDA Bhavan, ITO, Kotla Road, New Delhi-110002

Date: 16 January 2019

Subject: Request to reinstate the compensation provision in its original proposed form in Draft Rules for Clinical Trials

Dear Dr. Eswara Reddy,

This is with reference to the article in Livemint titled, “Government to tweak solatium clause in clinical trials”, published on January 11, 2019, []. According to the news article, the Government of India (GOI) has decided to remove the provision in the Draft ‘New Drugs and Clinical Trials Rules-2018’, –,%202018.pdf with regard to the upfront payment of 60% compensation amount by the sponsors in cases of death or of permanent disability caused to clinical trial participants. The proposed clause in the Draft Rules required a review by the Ethics Committees to ascertain whether the death or permanent injury is related to the trial, before the compensation amount is paid. In the context of the rights of clinical trial participants, which the Draft Rules upheld, an amendment to remove such a clause is a significant dilution. It is imperative that such an amendment is not carried out and the original clause in the Draft Rules be retained.

The provision of the clause is premised on the basis of a “no fault compensation” where by once it is determined that a serious adverse event has occurred in a trial, compensation is paid. It sends an important message to the participants and their relatives that they are not exploited, that they are respected for taking the risks in a clinical trial. Several of us had strongly emphasized the need to retain this clause in the final Rules, given that there was an anticipated concern that pharmaceutical companies would demand removal of this clause and as it upholds clinical participants’ rights.

However, this news comes as a betrayal of the rights of clinical trial participants in India who were promised such support. Whittling down of the clause in the Draft Rules will send a message that the government is towing the line of the pharma industry who would not want a provision like this in the Rules. Providing 60% non-refundable compensation which provides due recognition to the fact that any participant/patient taking part in clinical trials and taking the risks onto herself / himself, is entitled to be awarded a fair and commensurable compensation amount in cases of death or having suffered permanent disability. Such a provision would also enrich an important aspect of retaining trust within the bio-medical research discourses; as this trust would be easily depleted if participants are made to bear the medical and financial burden of research related injuries. Further, a provision like this will also keeps a check on sponsors and others to undertake less harmful and less risky clinical trials.

As a State committed to the principle of people’s welfare, the government needs to have provisions in the law which respect the rights and dignity of participants and ensures that adequate compensation is provided to participants. Further, this compensation is justified as it would then be considered to be Distributive Justice, which comprises of the obligation to distribute benefits and burdens equally in clinical trials, and Compensatory Justice wherein there is an inherent obligation to make monetary compensations for injuries caused and that it is important to redress injury notwithstanding any fault established or blame attributable.

The often reported pressures on the Indian Government from international organizations in this regard and the comments by the Deputy Director General of World Health Organisation (WHO) as published in the media in 2018, [] , need to be centered in the public discussions on the current reported amendment in the Draft Rules. It is apparent that with the current step on compensation by the government, the rights of the participants are being compromised in order to make the regulatory environment ‘favourable’ for the multinational pharmaceutical corporations.

Removal of the provision from the draft rules is a travesty of justice and greatly undermines the dignity of clinical trial participants. The Hon’ble Supreme Court obviously did not mean to have a formal talk with the Petitioners or civil society on the rules proposed, but, did mean to consider their opinion too and incorporate changes in the Rules accordingly.

We would appreciate a continued and transparent dialogue, especially on the provisions being discussed here as well as other recommendations to the Draft Rules that were provided previously. We sincerely hope that they have been considered and accepted – a necessary iteration of the commitment of the Government of India to the rights of participants in clinical trials. We urge you to immediately revoke this decision and reinstate the compensation provision in its original proposed form in the Draft Rules to ensure your commitment to the clinical trial participants.

Sarojini Nadimpally, Veena Johari, Amar Jesani, Adsa Fatima, S Srinivasan and Yogesh Jain
Email: [email protected][email protected][email protected][email protected][email protected]; [email protected]

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