Clinical Trials: A Debate On Rights Vs Research

 

Recently Union Minister of health Ghulam Nabi Azad during the inauguration of the Baxter Global Research Centre located in the Biocon’s subsidiary Syngene’s facility announced that government is seriously contemplating on relaxing norms for clinical trials. The appeasement by government is significant since it comes in just a year of introduction of tougher laws on clinical trials. Clinical trials have become matter of serious contention as they contributed to 2664 death between 2005 and 2012. Of which 89 deaths have been scientifically attributed to clinical trials and mere 45 were compensated. The NGO Swasthya Adhikar Manch has filed a PIL in Supreme Court over the deaths following which the apex court slammed the government for failing to regulate the clinical trials and reprimanded drug companies over the use of Indian subjects as guinea pigs.  Supreme Court has ordered for streamlining the clinical trials through stringent legislation following which Central Drugs Standard Control Organisation (CDSCO) and Ministry of health and family welfare has tightened the norms and approval mechanism.

Clinical trials involve the investigation of human subjects and are carried out by the pharmaceutical experts in order to verify the clinical and pharmacological effects of medicinal product or the chemical entities discovered.  This is essential to ascertain the safety and efficacy of the new products or medical procedures or surgical instruments before allowing them for popular use. These trials are governed by guidelines and directives at the International level like EU regulations and directives, ICH Good Clinical Practices (GCP), recommendations of World Medical Association Declaration of Helsinki, Guidelines for Good pharmacoepidemological practices and ICMR regulations. These are regarded as soft-law but are not legally binding. Most of the multi-national companies voluntarily comply with all these regulations. In India, Central Drug Standards control organisation (CDSCO) headed by Drug Controller General of India (DCGI) is the primary authority while Drugs and Cosmetics Act 1940 is the principal legislation for conducting drug trials. Schedule Y, Drugs and Cosmetics Rules 1945 provides the detailed compliances and conditions relating to clinical trials in India. Clinical trials not only contribute to scientific research and development but also ensure better patient care which on long run eventually helps in development of new generic drugs and medicines which will be a boon for the society. Hence India can hardly afford to ban these trials.

On January 30^th 2013 Government of India made new amendments following Supreme Court’s intervention to the Schedule Y of Drugs and Cosmetics Rules 1945. Three major amendments have been made. First, Rule 122 DAB that talks about Serious Adverse Event (SAE) Reporting and Compensation. It mandates obtaining Informed Consent Documents (ICD) from trial subjects and providing them or their legal representatives’ compensation in case of trial related death or injury. The sponsor of clinical trial has to bear ultimate and complete liability of reimbursing any cost incurred for treatment of the subjects participating in the clinical trials. If the sponsor fail to provide the medical treatment or financial compensation as per orders of the licensing authority then the authority might cancel or suspend the license of the sponsor and might even debar them from carrying out further trials in India. As per amended rules, investigators are under an obligation to report the SAE of drug within 24 hrs of occurrence and sponsor has the responsibility of sending the report to the licensing authority within 10 days of occurrence of adverse effects. These new features are not practically feasible in most of the cases as the effects are not always physical or visible and it can be reported once the investigators are convinced that the incident has been the consequence of the drug trial. The authority of determination of cause of death or injury and the quantum of the compensation lies with the licensing authority who will communicate the compensation amount within three months of receiving the report and the sponsor has to pay the amount within 30 days of receipt of order from the authority.

 Second, Rule 122 DAC deals with obtaining permission to conduct clinical trials and compliance. This underlines the need for Good Clinical Practices (GCP) even. Licensing authority reserves the right to inspect sponsors, their employees and other subsidiaries in this regard. Third, Rule 122 DD discusses about Ethics committee (EC) registration and functioning. It mandates setting up of independent ethics committee under medical institutes to monitor on going drug trials. Committees must register with DCGI prior to drug trials. In the older system drug companies were allowed to constitute their own committee with their own investigators who would even report SAE.

While the new changes were hailed by the NGO’s and human right activists’, pharmaceutical companies, sponsors of clinical trials and clinical research organisations took a critical note of the amendments. The number of clinical trials has come down drastically due to the unpredictable nature of regulatory timelines for clinical trial approval and unreasonable demands of authorities for protocol amendments and site selection etc raising the uncertainty about the timelines associated with regulatory approvals.

Drug companies rued that this framework would be too onerous for them to conduct trials for serious diseases. They fear that stringent regulations might hamper innovation, ability to develop cheaper and high quality drugs for patients around the world.  Most of the MNC’s are looking out for greener pastures like China, South Korea and Russia which provide comparatively less strict regulatory atmosphere and flexibility. India’s clinical research market currently pegged at $500 million is projected to double by 2016 due to the access to large amount of population with lower rates of compensation than in developed world. To dispel the anxieties of the pharmaceutical industry Government reiterated that while it has no intention of imposing unrealistic barrier for the drug trials, they don’t want to take the risk and compromise with the safety of the subjects of clinical trials.

Legislation is a powerful tool and it would be in the best of interest if government aims at regulating instead of restricting. Regulation is a tight rope walk as it encompasses several issues-laws, ethics, scientific development, social good and human rights. Instead of aiming for a massive revamp of the system, small changes can be incorporated in existing law.   Lacuna should be identified to ensure smooth conduct of the clinical trials. A way forward can be- more transparency in approval mechanism which is time bound. Instead of dismissing or delaying approval process, the loopholes in the regulatory mechanism has to be fixed and existing laws should be effectively implemented so that clinical trials are conducted with transparency and diligence. In India, initiating drug trials typically runs from 6 to 8 months as against 28 days in Canada and Europe. Special care should be taken while approving the clinical trials for drugs with serious side effects and the approval should sparingly extended based on the utility. Instead of having a fixed formula for compensation, each case reported to have suffered SAE during clinical trials has to be investigated individually and compensated accordingly.

The repercussions of the new amendments hence forth shouldn’t be viewed completely in black and white. Instead a proper balance has to be struck between innovation/ scientific development on one hand and the need for well chalked out regulations and rules for drug trials so that human rights are not compromised or undermined.

 

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