Even as the controversy over inclusion of pentavalent vaccine under the national immunisation programme continues and the government is still assessing the options, the drug control authorities are preparing an advisory for the doctors in the light of the experiences of the same vaccine in the neighbouring countries.
The move is initiated as the Drugs Controller General of India (DCGI) has already given licence to some companies for selling the pentavalent vaccine in the market. The doctors are reportedly prescribing the multi-shot (the standard DPT with hepatitis-B and Hib vaccine), though the government is yet to take a decision on its inclusion in the national immunisation drive.
Sources in the health ministry said the Government of Bhutan has suspended the use of a pentavalent (DTwp_HepB-Hib) vaccine procured through UNICEF with support from Global Alliance for Vaccines and Immunization (GAVI) as a precautionary measure following reports of serious adverse events following immunization.
There were reports about the same kind of adverse reactions in Sri Lanka also. However, sources said, there was no confirmation about the withdrawal by Sri Lanka. But, the Central Drug Standard Control Organisation (CDSCO) has initiated steps to issue an advisory to doctors about the reports from neighbouring countries, sources said.
Meanwhile, the earlier reports said the government had already set up an expert committee headed by ICMR director general Dr V M Katoch to analyse all the five vaccines and the mortality rates cause by each vaccine in the country. The decision for its inclusion in the national immunisation programme will be taken on the basis of the report from this panel. Sanofi aventis, Shantha Biotech, Serum Institute of India, Bharat Biotech and Panacea Biotec are among the major companies that had introduced pentavalent vaccines in the domestic market.
In India also, the GAVI is extending financial support to the five-in-one vaccine diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and Haemophilus influenzae type b (often known as Hib) and more than 18 million children are expected to be immunised under the national drive.