Even as all is set for Bill Gates to launch the second phase of the Children's Vaccination Programme (CVP) in Andhra Pradesh on November14, incorporating Hepatitis-B vaccine, trouble is brewing regarding procurement of this vaccine locally. The government of Andhra Pradesh has given the contract to supply 1.7 million doses of Hepatitis-B vaccine to the Hyderabad-based Shanta Biotechnics.

The Gates-funded Partnership Programme, a joint venture of AP Government and the Seattle-based Programme for Appropriate Technology in Health (PATH), is authorized to use only WHO approved vaccines for immunization. Though there are six manufacturers of Hepatitis-B vaccine in the country, only Shanta Biotechnics has obtained WHO pre-qualification. In fact, UNESCO had taken a large consignment of the vaccine from Shanta for distribution in the East European countries after the WHO clearance.

The state government's move to procure the vaccine from Shanta has been challenged by Bharat Biotech, another city-based vaccine manufacturer, in the AP High Court, seeking its intervention. The court directed the government to revoke the WHO qualification and allow Bharat Biotech also to participate in the bid. Accordingly the tenders were opened last Friday.

Interestingly, Bharat Biotech had quoted the lowest price of Rs 11.45 per dose of the vaccine as against Rs 23 quoted by Shanta. However, the government was helpless, as PATH would not agree to the waiver of the WHO regulation. The government would have to either cancel the process of procuring the vaccine locally or approach the court seeking vacation of its order allowing Bharat Biotech to participate in the bid.

According to sources, WHO stipulation is total injustice to the entire testing process that is carried out by the national scientific laboratories. Usually the vaccines and drugs manufactured by the Indian companies are tested and certified by the Central Drugs Laboratory at Kasauli in Himachal Pradesh.

However, this argument does not hold good as efforts are being made for a uniform quality standard the world over, especially in the post-WTO regime in 2005. In this case the project is being funded by an international agency like Melinda and Bill Gates Foundation. Therefore, the state government would find it difficult to cancel the contract with Shanta in favour of Bharat Biotech. The question is whether the state would have to import the vaccine in view of the controversy.