WHO gives India five more months to upgrade standard

The World Health Organization (WHO) has given five more months to the Drugs Controller General of India (DCGI) to upgrade its performance to international standards. The extension of the current deadline of October-end came after a visiting WHO team found the modernisation programmes of the Indian drug regulator on track.

The direct impact of the WHO decision will be felt on Indian vaccine makers whose new products are not considered for WHO and UNICEF supplies due to deficiencies in the operational systems of the drug regulator since January 2008. While the country’s drug regulator gives permission to sell vaccines in the domestic market, the WHO approval is necessary for all international purchases.

“The WHO has given us time till March 2009 to put all the system in place. On our part, we have informed the WHO that we are doubling our efforts and will have the entire system ready by December,” a senior health ministry official said.

“The vaccine industry will not have to wait till March. They will be able to submit fresh applications in a matter of two months.”

Due to the re-recognition of the Indian drug regulator, domestic vaccine makers like Shanta Biotech, Panacea Biotec and Serum Institute of India were not able to file any fresh application to the WHO during the year. The issue had also affected some of the foreign manufacturers as they had to postpone or cancel their plans to outsource vaccines from India for their global supplies.

Varaprasad Reddy, managing director, Shanta Biotech, said the recognition alone would not result in immediate sanction. “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,” he said

The WHO had in November 2007, developed a five-step process to qualify national drug regulators as part of ensuring quality supply of vaccines globally.

Five-step process of WHO:

Establishment of a benchmark based on the detailed description of an ideally well functioning system.

Assessment of the regulator against a published set of indicators to evaluate the level of implementation of the critical regulatory functions.

Elaboration of an institutional development plan to address the weaknesses and gaps identified.

Implementation of the plan, in part, through the Global Training Network on Vaccine Quality and other capacity strengthening efforts.

Monitoring the progress through regular follow-up assessments.