Recently, the government of India released the Drugs and Clinical Trials Rules, 2019 to promote clinical research in the country. Analyze various challenges associated with clinical trials in India.
A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile (including pharmacodynamic and pharmacokinetic) or adverse effects of a new drug on humans.
Clinical trials in India are governed by the acts: Drugs and Cosmetics Act, 1940, Medical Council of India Act, 1956 and Central Council for Indian Medicine Act, 1970.
The Drugs and Clinical Trials Rules, 2019 aims to promote clinical research in the country. These rules will change the regulatory landscape for the approval of new drugs and conduct of clinical trials in the country. These rules will be applicable to all new drugs, ethics committee and investigational drugs applicable for human use, bioequivalence studies and clinical trial in India.
Challenges associated with clinical trials in India
- The big problem plaguing clinical research is an over-representation of low-income groups among trial subjects.
- In Many cases consent of the participants in the clinical trials is not taken.
- In most cases the ethics committee is not constituted and people on such committees are not well trained.
- There is a lack of independence for the ethics committee working.
- There is a need to register with the Clinical Trials Registry of India for all clinical trials conducted in India. But registration is mostly done for positive trial cases. So, there is a lack of transparency.
- There are no well-developed international standards dealing with clinical trials. India is a signatory of the Declaration of Helsinki but that is voluntary in nature and lack regulatory mechanisms.
- There is a chance of collusion between drug companies and doctors.
- Compensation for participating in research as well as research related injury is a major bone of contention these days.
- Moreover, regulatory failure and unethical clinical trials are also major issues.
To reap the benefits of clinical trials, our objective should be to bring about more clinical research in the country while maintaining high standards to ensure patient safety and accuracy of data.