Multinational drugmakers looking to conduct the first stage of tests of a new drug on humans in India may have to wait further as the health ministry thinks the country is not ready yet for such experiments.
The first stage of trials, or phase-I, involves developing a medicine by testing newly-discovered molecules on humans after it is successfully experimented on animals.
India allows global pharmaceutical companies to conduct only phase-II and phase-III trials, after the initial safety of the drug has been confirmed in phase-I. This is primarily because the government does not want Indians to be exposed to new drug substances for the first time in the world.
Incidentally, the government allows Indian companies to conduct all stages of trials, including phase-I.
In medical research, clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. Trials of a new medicine in higher phases involves examination of minute details related to efficacy of the drug on a larger number of patients.
“Analysis of these drugs, setting up stringent monitoring systems, registering the clinical trial organisations and maintaining a database of people who volunteer for these drug trials are some of the key issues to be resolved before the phase-I trial for molecules developed outside the country could be allowed,” a health & family welfare ministry official who wished not to be named said.
The health ministry has over-ruled a decision of Drug Technical Advisory Board (DTAB) that gave the green signal to foreign drug companies for conducting phase-I trials. The ministry moved after public interest groups raised widespread concerns regarding phase-I trial by foreign companies without having adequate regulations, expertise and infrastructure.
At present, the government has no power to punish companies that violate clinical trial norms. “We are in the process of introducing such provisions in the Drugs and Cosmetics Act to penalise companies violating clinical trial norms,” the official said.