Strict Regulations Essential in India for the Conduct of Clinical Trials

Clinical trials are significant and helpful only when carried out in an appropriate way with perfect regulation. Safety issues, ethical concerns, and other procedures should be dealt carefully when conducting these research studies. Developed nations like the US and UK have strict regulations to implement clinical trials. However, lack of vital regulation or international regulation standards is evident in India and this is reducing the significance of clinical studies in the nation.

Clinical trials in US

In the United States, clinical trials follow strict regulations. They are conducted as per the rules set by the Food and Drug Administration (FDA). Also, they have to be registered in the registry (ClinicalTrials.gov) only after confirmation of approval from appropriate national health authorities. An Institutional Review Board (IRB) ensures that a clinical trial is ethical and protects the rights of the study participants.

Clinical trials in UK

Similarly, in the UK, clinical trials, conducted according to the standards of the European Union Clinical Trials Directive, should be licensed and approved by the regulatory authority, Medicines and Healthcare products Regulatory Agency (MHRA). An independent scientific review is performed on how the trials are done, what does the trial aims at, and what treatments will be taken for comparison. Specific ethical committees are there in the nation to ensure that the trial design is sound and that the research will respect the rights, dignity, safety and well-being of the participants.

Clinical trials in India

India too has certain regulatory measures to conduct clinical trials. They are conducted as per the guidelines of the Schedule Y of the Drugs and Cosmetics Rules enforced by the office of the Drug Controller General of India (DCGI). DCGI is the regulatory body under the government of India that monitors clinical trials in the country. The process of research studies in the nation is made transparent by a mandatory registration of the trials in Clinical Trial Registry of India (CTRI). Also, each and every trial should be approved by the local Ethical Committee (EC) to ensure the safety of individuals.

Lack of proper regulation poses risk of illegal trials

However, negligence in the regulation of these research studies in India has been posing many issues today. The ECs have a great role to maintain the patient safety during trials. However, not all ECs are established as per legal provisions in the country. The ethics review has been affected because of insufficient members trained for the work and inadequate support given to them to conduct thorough reviews. An ICMR (Indian Council of Medical Research) survey found that only 40 out of 179 institutional ethical committees follow the prescribed legal provisions and function as per various ethical guidelines.

Lack of securing the informed consent is another factor promoting illegal clinical trials. An informed consent is nothing but providing information such as the purpose of clinical study, its duration, procedures, risks, and potential benefits to the participant. Upon understanding these elements, the participant is allowed to decide whether to participate in the trial or not. The trial should be conducted only upon his willingness to participate.

However, many contract research organizations (CROs) and reputed hospitals conducting clinical trials, have been taking advantage of poverty in rural areas. Economically disadvantaged people and illiterates are being recruited for the studies without proper informed consent. This has been turning the research studies illegal and unethical. Many such illegal clinical trials have come to limelight in the recent times – one such case is with regards to Hyderabad-based Axis Clinicals that is suspended by the DCGI for conducting clinical trials on anti-cancer tablet, Exemestane, on poor women without taking their informed consent.

Hence, challenges of informed consent and exposure of unethical trials because of improper regulation by ECs are some of the factors causing hurdles for conducting clinical trials in India. Because of these issues, public has a negative opinion on clinical trials, considering them as illegal and unethical. However, there is an immediate need for Indian regulatory bodies to revise or frame guidelines and regulatory approval processes on par with global standards to ensure clinical trials safe and efficient.

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