Government and Business Case Study

Phase I Trial of Foreign Drugs – Is India Ready?

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Abstract:
In 2008, the Union Health Ministry of India had drawn a proposal to allow a Phase I trial, of drugs manufactured outside the country, on Indian volunteers. Formerly, Indian law allowed first-in-human trials of domestic manufactured drugs and Phase II and Phase III trials of foreign drugs. The government argues that its proposal will be a forerunner of India becoming a leading drug discovery and development centre. But Indian health activists worry that it will aggravate the exploitation of the country's poor without providing proper compensation. They are also concerned about insufficient infrastructure facilities, and the experience and expertise of Indian medical staff to manage the risks during such trials. On the contrary, some clinical research organisations (CROs) that undertake and supervise trials of western drugs for a fee in Indian hospitals welcomed the proposal. They claim that experiences earned by the Indian medical world in conducting Phase I trials of local drugs will help them in testing foreign manufactured drugs. At the same time, few CROs oppose the move citing that most of the Phase I trials of Indian drugs are conducted abroad due to the lack of expertise of local staff in handling adverse reactions during such trials. They also raised their concerns about the delays by the regulatory department in approving a drug trial. Furthermore, India has issues in retaining staff throughout a single drug testing process. The exit of talented staff mid-way will hinder successful completion of the project. With all these issues such as inadequate facilities, manpower and expertise, and an inefficient regulatory framework, will India be able to conduct Phase I trials successfully? Is the country equipped to undertake such drug trials?

Pedagogical Objectives:

• To biomedical research scenario in India.
• To advantages and disadvantages of undertaking Phase I trials of foreign drugs in India.
• To inadequacies in the Indian medical world to perform first-in-human trials.
• To government's efforts to make India suitable for Phase I Trials.

Keywords :  Phase 1 trial, Clinical research organisations (CROs), Pharmaceutical companies, Skilled workforce, Volunteers, Compensation, Indian Council of Medical Research (ICMR), Ethical guidelines, Informed consent, Drugs Controller General of India (DCGI), Ethics Committee, Department of biotechnology (DBT), Clinical pharmacology unit (CPU), Indian government, Health activists