WHO refuses vaccine approval after Indian regulator fails tests

The World Health Organization has not approved any new vaccine from India this year as the Indian regulatory system, which gives manufacturing licences for domestic vaccines, has failed to meet its quality benchmarks.

Companies like Shanta Biotech, Panacea Biotec and Serum Institute of India are among the leading vaccine makers which have not been able to file any fresh application to the WHO due to this temporary de-recognition of the country's drug regulatory system. The WHO pre-qualification is essential for companies to supply vaccines to national immunisation programmes funded by the WHO or UNICEF outside the country.

This is the first time Indian vaccine companies are being penalised for no fault of their own. There are several vaccines like Hib, rotavirus, HPV and several new combination vaccines which Indian companies are working on. None of these will be eligible for exports even if they clear the scrutiny of the drug regulator here. "We have two applications pending before the WHO for the last eight months. Getting WHO approval for global supply of a vaccine is a time-consuming process. Even after the WHO accepts an application, it takes at least two years to be approved. Even though we have world-class facilities, we cannot apply for a WHO approval until the country's drug regulatory system upgrades to the WHO's satisfaction," said Varaprasad Reddy, managing director, Shanta Biotech.

A health ministry official said the drug regulator was working overtime to see that it qualifies the WHO specifications at the earliest. "The office of the Drugs Controller General of India has even taken the assistance of the Canadian drug regulatory authority to ensure that all systems are in place. We expect the recognition to come very soon," the official said.

Echoing the official view, Rajesh Jain, joint managing director, Panacea Biotech, hoped that the changes being made at the regulator's level would allow the company to apply for export of vaccines to the WHO by the year-end.

The temporary de-recognition is part of the WHO's effort to strengthen the capacity of national regulatory systems, including regulatory authorities, national testing labs and immunisation programmes, in the developing countries.

It had in November 2007 developed a five-step process to select a drug regulator. The Indian drug regulator failed to qualify.

According to consultancy firm KPMG, vaccines dominate the Indian biopharma market and contribute about 51 per cent of its $1.4 billion revenues.