Mumbai: The drug controller general of India, or DCGI, on Monday approved clinical trials by Ahmedabad-based drug maker Cadila Healthcare Ltd, or Zydus Cadila, for what could be the first indigenously developed vaccine for the H1N1 virus that causes swine flu.
Investigators have been allowed to fast-track the trials by combining phases 1, 2 and 3 that are required for testing safety, dosage determination and efficacy, respectively.
This could allow the vaccine, which is based on an inactivated sub-unit virus strain produced in poultry eggs, to be ready for commercial release by April.
An official at Zydus said the trials will be conducted at four different centres, but declined to disclose the number of volunteers involved.
“All the procedures and the volunteer base will be in full compliance with the mandates of the World Health Organization,” the official said, asking not to be identified because she isn’t allowed to speak to the media.
The H1N1 flu pandemic has affected around 200 countries and has caused at least 12,000 deaths so far.
There have been at least 21,000 confirmed infections and 900 deaths in India since the first case was detected in May, according to data from the ministry of health and family welfare.
Three other domestic pharmaceutical and biotechnology firms—Serum Institute of India Ltd, Panacea Biotech Ltd and Bharat Biotech International Ltd—have also applied to DCGI for permission to conduct clinical trials of their versions of H1N1 vaccine.
Clinical trials of two other H1N1 vaccines, sought by multinational drug makers GlaxoSmithKline Plc (GSK) and Baxter International Inc., have also been initiated in India.