Clinical Trials in India !!!!!

Clinical research is a part of the drug discovery process to ensure the safety and efï¬�cacy of any new drug. India has the second largest population in the world. Due to this large population, India clearly provides an opportunity in terms of availability of large patient populations, highly educated talent, a wide spectrum of disease, lower costs of operations. Changes have been made in the law to permit international trials. India is viewed as a favored global site for international clinical trials of drugs. Public hospitals are being promoted as clinical trial sites. 

Clinical trials in India are regulated by Schedule Y of the Drugs and Cosmetics Rules. The Rules are enforced by the office of the Drug Controller General of India (DCGI) who is also responsible for monitoring all clinical trials submitted to that office for approval. For this approval, the sponsor must submit data from pharmacokinetic and animal studies and previous phase trials; information on the regulatory status of the drug in other countries, the trial protocol, investigator’s brochures and informed consent documents. 

Trials cannot be started without clearance from the local ethics review committee (EC) at each site.

The Declaration of Helsinki is accepted as an international standard for biomedical research. Clinical study reports include a statement that the trial was conducted according to the principles of the Declaration of Helsinki, Indian Good Clinical Practice guidelines, and the Indian Council of Medical Research’s ethical guidelines for biomedical research on humans. The DCGI also stated that fingerprinting of trial participants is planned to prevent them from entering more than one trial.

Drug companies conduct clinical trials through contract research organizations (CROs), the CRO's may handle some or all aspects of a sponsor’s project including: regulatory approvals for trials, identifying recruiting sites and investigators, monitoring sites, data entry and management, submitting data for marketing approval and drafting study reports for submission to journals Some organizations focus exclusively on providing data management and statistical analysis. Site maintenance organizations (SMOs) are focused exclusively on recruiting patients and coordinating the work of investigators conducting clinical trials.

It is mandatory for clinical trials in India to conform to the Indian Council of Medical Research (ICMR’s) guidelines and to the guidelines in the Declaration of Helsinki.  The Indian Council of Medical Research’s guidelines were first published in 2000.The guidelines state that: “persons who are economically or socially disadvantaged should not be used to benefit those who are better off than them. “The 2000 guidelines state that trial subjects should be fully informed of the research before they consent.

Although it typically takes 10 to 12 years and millions of dollars to bring one new drug to market, the success rate is small. Clinical trials can provide answers regarding the use or not of a therapeutic agent that can benefit millions of patients worldwide. Being the second most populated country in the world, India can contribute significantly to global drug development programs.