H1N1 drug trial talks next week

Multinational drug firms Novartis, GlaxoSmithKline and Baxter are likely to initiate discussions with the Union health ministry next week on conducting clinical trials for H1N1 (swine flu) medicine.

The talks will include selection of sites, finalisation of trial modalities, price negotiation for vaccine supplies and advance placement of purchase orders.

Senior government officials say the companies are expected to agree to the ministry demand for experimental studies on 600–800 humans before applying for marketing licences. Eight centres from across the country have been shortlisted for these studies.

We are open to place advance purchase orders if they are willing to conduct clinical trials in the country; However, the prices will have to be negotiated, officials said. It is known that a single dose of H1N1 vaccine may cost between Rs 600 to Rs 800.

Earlier, addressing a press conference, health minister Ghulam Nabi Azad said the MNCs will not be given marketing permission unless studies are conducted in India. “They wanted to avoid it, as trials are going on in other countries. But we will have them conduct bridging studies here before allowing them to introduce their vaccines,” Azad said.