The Hindu Business Line : Biological Evans, Panacea get Govt nod for injectible polio vaccines

At present, French drug-maker Sanofi Aventis is the only company selling its injectible polio vaccine Imovax and Pentaxim in the local retail market.

P.T. Jyothi Datta

Mumbai, Aug. 25 Injectible polio vaccines may not yet be on the national immunisation programme, but local drug-makers Biological Evans (BE) and Panacea Biotec seem to have got off the blocks early, having got Government approval to market the product in the local retail market.

BE and Panacea are believed to be importing the bulk ingredient for the inactivated polio vaccine (IPV), doing only the blending, filling and final vial testing locally, an industry source familiar with the development told Business Line. The two companies are reportedly getting the bulk ingredient from Nederlands Vaccin Instituut (NVI), and in fact Panacea had announced a tie-up with NVI in 2006.

And though BE’s product is already reportedly in the market and Panacea’s is on the anvil, officials from both companies were not available for comment.

At present, French drug-maker Sanofi Aventis is the only company selling its injectible polio vaccine Imovax and Pentaxim, its pentavalent vaccine that protects against five diseases including polio, in the local retail market.

IPV has established safety and efficacy records overseas, say doctors and industry experts. The Government-run immunisation programme in India, however, is largely through oral polio drops. But there is concern over the occurrence of over 350 incidents of polio in the country this year, and the emergence of the mutated virus. Consequently, the significance of injectible polio vaccines is gaining ground.

The IPV could be phased into supplement oral drops, explains Dr Tanu Singhal, Convenor, Indian Paediatric Association’s (IPA) Committee on Immunisation. In fact, the IPA has recommended that the Centre supplements polio drops with two IPV doses separated by two months in states such as Uttar Pradesh and Bihar, she said.

Local manufacturing capacities for IPV are necessary and important to supply local demand and to keep prices economical, she added.

Price

Industry experts agree price is possibly keeping IPV from getting onto the national immunization programme. Sanofi’s IPV is about Rs 280 a dose and ideally three doses are required. The company has sold about six lakh doses in the country, an industry representative said, pointing to acceptance in the private market.

The polio drop, however, is about Rs 56 a vial, or a couple of rupees per dose, observes another industry representative. But then again, observes Dr Singhal, while IPV requires just three doses, (similar to oral polio drops that also require three doses), there are times when 15 doses are given to children to control the virus, and this pushes up costs.

IPV, though, will gain ground as India moves towards eradicating polio. Countries with little or no polio continue their immunisation programme with IPV, which is a World Health Organisation recommendation in a post-polio scenario, says Dr Singhal.

And as India gets there, it is good to have local companies supplying IPV, she observed. Specially since India requires about 25 million doses annually to cover the entire country and since the dosage is three times, the requirement to fully immunise against polio stands at 75 million, say industry experts.

The continuing battle against polio