The Andhra Pradesh High Court has ruled as illegal the tender condition stipulated by the Government of Andhra Pradesh for the supply of hepatitis B vaccine. Justice J Chalameswar partly allowed a writ petition filed by Bharat Biotech challenging the tender condition which required the domestic manufacturers of the vaccine to have approval certificate from WHO.

The petitioner contended that the condition was to eliminate all the domestic manufacturers of hepatitis B and help Shanta Biotechnics, which alone had the WHO certification. The judge, in his order, pointed out that there was no reason for specific international certification when national authorities under the relevant statute supervise the efficacy of the project. He also pointed out that the price factor was given a go by in this case.

It may be recalled that the government of Andhra Pradesh had given the contract to supply hepatitis B vaccine to Shanta Biotechnics for its Children's Vaccination Programme in association with the Seattle-based PATH ( Programme for Appropriate Technology in Health). Shanta got the WHO approval this year and the government chose Shanta as no other company had the WHO pre-qualification. Bharat Biotech, which also manufactures hepatitis B vaccine, challenged the condition of WHO pre-qualification in the High Court, seeking its intervention against the "arbitrary and whimsical" decision of the state government in the vaccine procurement process. In its bid, Bharat Biotech had quoted the lowest price of Rs 11.25 per dose of the vaccine as against Rs 23 per dose quoted by Shanta Biotech.

Steering clear of the controversy, PATH had stated that it was the responsibility of the state government to procure vaccine for CVP and it was the government, which had asked for WHO pre-qualification. Till now the vaccine had been imported.