The country’s medicine regulator, the office of the Drugs Controller General of India (DCGI), has temporarily stopped giving marketing approvals to new drugs in key therapeutic segments.
The approvals are to resume once DCGI streamlines a new approval system, in which the opinion of a 10-member panel of independent experts is had before the regulator decides whether to approve a drug. The committee is to get up to six weeks to provide views on each application.
New drugs are an important component in the Rs 60,000-crore-a-year domestic pharmaceutical market. India had approved 223 new drugs (including new combinations of already approved drugs) in 2010. There were 32 new drug approvals during January-March this year. Approvals during 2009 and 2008 were 215 and 270, respectively.
A 10-member New Drug Advisory Committee (NDAC) will be constituted for each therapeutic category. Panels have already been named in gastroenterology, oncology, reproductive and urology areas, antibiotics, metabolism, neurology and psychiatry, vaccines, ophthalmology, cardio vascular diseases, dermatology and allergy, analgesics and pulmonary specialities.
The NDACs are to advise DCGI on both new drug approvals and clinical trials of such categories of medicines. The members are being drawn from across the country, from public sector medical institutions such as the All India Institute of Medical Sciences, Delhi and Post Graduate Institute of Medical Education and Research, Chandigarh.
“We will be getting a fresh panel of experts every two years. It will also indirectly make the medical profession responsible for the medicines approved for production and marketing,” said an official who did not want to be named.
