The Programme for Appropriate Technology in Health (PATH), part of the Bill & Melinda Gates Foundation that is funding the Children's Vaccination Programme (CVP) in Andhra Pradesh, stated that it had no role in procuring the Hepatitis-B vaccine from Shanta Biotechnics. Seeking to steer clear of the controversy surrounding the contract given to the Hyderabad-based biotech firm Shanta Biotechnics, James Cheyne, Associate Director of PATH, said the state government had taken the responsibility of procuring the vaccine and his organization had the responsibility of implementing the programme. "We offer only technical and financial assistance to the project. The vaccine procurement is being done by the state government," Cheyne said.

He said last year the vaccine had to be imported through UNICEF as no Indian company had WHO approval. This year Shanta Biotech got the WHO pre-qualification and that might be the reason how it got the contract. It was the state government, which asked for WHO pre-qualification even during the procurement process in the first phase, he said.

As far as the Foundation was concerned, it was guided by the principle of relying on local producers instead of importing it. The same was the case with the manpower requirement. All those who were involved in the CVP were Indians.

Dr Raj Kumar, Project Manager of PATH India, said notwithstanding the controversy, there was sufficient stock of the vaccine till the issue was sorted out.

It may be recalled that Bharat Biotech International Ltd (BBIL) had challenged the condition of WHO pre-qualification in the AP High Court seeking its intervention against the 'arbitrary and whimsical' decision of the state government in the vaccine procurement process. The court had directed the state government not to insist on the WHO pre-qualification for processing the two bids received in the tender process, one from BBIL and the other from Shanta. In the bids Bharat Biotech had quoted the lowest price of Rs 11.75 per dose of the vaccine whereas Shanta had quoted Rs 23 per dose.

The case took an interesting turn with Shanta entering the legal battle impleading itself by filing a petition in the High Court.

Top producers doubt if state would buy vaccines. Representatives of four vaccine producing pharmaceutical companies in the country expressed apprehensions over the marketing of Hepatitis-B vaccine and asked for firm orders from the state government for their products. The representatives of the four companies, who were in the city for a Round Table with Bill Gates, included Dr Krishna Ella of Bharat Biotech, Khalil Ahmed of Shanta Biotech, Rajesh Jain of Pace Biotech and Cyrus Poonawala of the Pune-based Serum Institute. They are reported to have told Bill Gates that they were ready to manufacture the required quantity of the vaccine provided the state government procured the supplies from them. They said till now there was no proper assessment of the requirements in the state and, therefore, there was uncertainty over the marketing of their products.

One of the participants told Bill Gates that though it had been established that certain communicable diseases were transmitted by cattle and pigs, there was no way the diseased animals could be eliminated because of stringent laws in the country.