Pfizer Ltd will be shortly filing an application for permission for conducting clinical trials of a new combination drug for malaria. The combination is that of azithromycin with chloroquine. "We are planning to submit a clinical trial application by April end. We plan to start the trial somewhere in August," said Chandrasekhar N. Potkar, director, Clinical Study Management and Monitoring, Pfizer India. The company is expecting the permission from the Drug Controller General of India by July end.
The clinical trials will be carried out at four to six sites in India, on 300 patients, mainly in the north-eastern states. If permission is received, the project will take off in June this year.
The positive results from the clinical trials will lead to an alternative treatment for malaria, a disease widely prevalent in India. Pfizer is likely to extend the study to Indonesia and Kenya.
Pfizer has spent around $ 12.5 million over the last seven years on clinical trials in India, with $ 3 million being spent in 2002.
Currently clinical trials are being conducted in India for drugs for the treatment of menopause, breast cancer, and schizophrenia.
Pfizer officials say that there is scope for improving the regulatory process in the country. For instance, under the Drugs and Cosmetics Act, a company cannot do Phase 1 clinical trials in India unless the drug has been discovered in the country. Also, clinical trials can only be done in India provided it is one stage earlier than the rest of the world, which makes it difficult to do cutting-edge trials in this country. For Phase 2 and Phase 3 trials, regulatory approval takes twelve weeks, compared to thirty days in the United States. There are also issues relating to the non-availability of data protection also.