Govt. decision on vaccine irks bio-tech company

By Our Staff Reporter

HYDERABAD, AUG. 18. The State Government's decision not to source the Hepatitis B vaccine from ``local companies'' under the Bill Gates-funded vaccination programme, has prompted city-based Shantha Biotechnics to question its `sincerity' in promoting biotechnology companies in the State.

Shantha Biotechnics, which makes the Shanvac B (Hepatitis B) vaccine at its Medchal unit, was one of the three companies which responded to the Government's call for tenders, the others being Bharat Biotech (Hyderabad), and Panacea Biotech of Delhi.

However, following a controversy over the production process adopted by one company, the State Government asked UNICEF to procure vaccine from multinationals, because it was not sure of the `local' quality.

Making a presentation on the company's plans and production facility at its unit in Medchal on Saturday, Mr. K.I. Varaprasad Reddy, Managing Director, Shantha Biotechnics, said the fact was that Gates Foundation approached the Andhra Pradesh Government for its maiden Hepatitis-B vaccination programme in India only because the country's first r-DNA vaccine was developed in Hyderabad by Shantha Biotechnics.

It was ironical that the State Government which claims that it supports the biotech industry was trying to patronise foreign companies for its very own requirement, he observed adding that the company would make a representation to UNICEF on the basis of the quality of their vaccine and production facility.

The Government, he said, took the decision on the pretext that Indian companies do not have WHO approvals. However he pointed out that even WHO clearly states that its approval was not necessary for ``national purchases.'' Moreover all six vaccines procured for the national immunisation programme are not WHO approved (except for one or two from the Serum Institute).

Shantha Biotechnics already has other orders from UNICEF, for 3.3 million doses in 2002 and 5 million in 2003, with a prequalification that they obtain WHO approval (international). Mr. Reddy said WHO undertook an audit in the Shantha Biotechnics unit in July for Current Good Manufacturing Practices (CGMP) certification. It made some suggestions mainly in the areas of layout (of infrastructure) and validation protocol. Another audit will be done in December, and the company expects the approval.

Mr. Reddy was also critical of the Government Biotechnology Policy. It was not enough to offer 50 acres (Biotech Park) or give sales tax deferment, he said.What was needed was to have a regulatory system to guide. There should be testing labs. The Drug Controller should be upgraded to have microbiologists and there should be incubation centres to take up training. The sector needed customs duty exemption on biotechnology equipment, which it had to import, he said.

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