Hyderabad: Nineteen clinical trials have been rejected by the technical committee of New Drugs Advisory Committee as it was found that the health benefits for patients in the existing therapeutic options were not based on the medical needs of the country. Of the 47 proposals evaluated, 19 were rejected.
The rejected proposals were from companies like Novo Nordisk, Wockhardt, Novartis, Roche, Reliance Life Sciences and Cadila Pharmaceuticals.
Sources in the central Drug Control Authority said, “The proposals were rejected because they were based on trials for medicines for oncology. There is a strong move amongst scientists and pharmacologist who are demanding that new drug combinations are required for infectious diseases.”
There is a strong demand for opting for new molecules due to the developing resistance in masses towards existing antibiotics.
Dr M. Lakshmi Kantam, director of the Indian Institute of Chemical Technology, said, “It is no longer a threat but a reality. Unfortunately, there are no new drugs expected to reach the market in the near future for infectious diseases. For this reason, it becomes very important that all the energies of scientists and researchers are towards discovering new molecule combinations.”
Trials for these drugs is the need of the hour, felt members of the technical committee.
Two proposals of Cadila for pancreatic cancer vaccine were sent back for re-consideration. At the same time, application LIK066 from Novartis was also asked to be re-deliberated as the company had asked for too many expulsions in enrolling people for the trials.
