On the clinical trial trail

11 March 2005

The union government's recent amendment to Schedule Y of the Drugs and Cosmetics Act has given a fillip to clinical trials by multinational drug companies operating in India, reports Nisha Das.

Pfizer, Eli Lilly, GlaxoSmithKline, Sanofi-Aventis and Roche are already doing it. Others are scrambling to get started. We are talking about clinical trials of new drugs. A number of the world's top pharma MNCs have already kick-started simultaneous and standalone clinical trials on various therapeutic segments in India. The reason? The union government's recent move to amend Schedule Y of the Drugs and Cosmetics Act, allowing MNCs to conduct simultaneous clinical trials, both overseas and in India. However, the government has not yet given permission for MNCs to conduct phase-I trials in India so far.

It isn't just big pharma that's looking in. Many new contract research organisations (CROs) have also outlined plans to tap India's large pool of patients suffering from cancer, diabetes and other maladies, for various drug indications.

Pharma gaint Pfizer has already picked a city in one of the north-eastern states of India to conduct clinical trials on 300 patients for a new malaria cocktail drug that combines chloroquine (to which several Indian malarial strains have developed resistance) and azithromycin, an antibiotic. Pfizer is also carrying out clinical trials for drugs to treat osteoporosis, breast cancer and schizophrenia. According to industry sources, Pfizer's cumulative investment on clinical research in India is believed to be $13 million.

Dr C N Potkar, Pfizer's director of clinical research told this reporter, "We have gradually increased our activity spectrum across a range of therapeutic areas. A group of about 40 clinical research professionals is engaged in conducting phase-II, III and IV studies. The volume of work done in India is gradually rising, but still insignificant when compared to the developed countries." At present, Pfizer is conducting around 20 clinical trials. It has independently conducted more than 40 good clinical practices (GCP) workshops and has trained more than 2,000 investigators and other professionals.

The company has also contributed to research infrastructure development at various institutes through clinical trials that have already been conducted. For instance, it has contributed dual energy X-ray absorptiometry (DeXA) machines — costing over $600,000 — to develop osteoporosis centres at leading hospitals in the country.