Zydus begins H1N1 trials

Zydus Cadila has become the first Indian pharma company to begin multi-centre clinical trials of a H1N1 vaccine after it received approval from the Drug Controller General of India (DCGI).

The company believes that demand for H1N1 vaccine in India in the initial phase will be 50 to 60m doses. Zydus is now positioned to be the first Indian company to develop a H1N1 vaccine, with a predicted launch date of April 2010, giving it an opportunity to capture a slice of the market.

Pankaj Patel, chairman and managing director of Zydus, said that the company’s “researchers and vaccine experts have worked round-the-clock to strengthen our armoury in this fight against the H1N1 virus”.

This team of researchers has developed an egg-based, inactivated H1N1 vaccine which will now enter clinical trials. Zydus is hoping for a speedy completion of these trials and fast track approvals to help it reach the market by April.

The H1N1 approval is the latest step in Zydus’ efforts to strengthen its vaccine capabilities. This has seen it set up a vaccine technology centre and receive World Health Organization (WHO) prequalification for its rabies vaccine.

Probe into “false pandemic”

The Parliamentary Assembly of the Council of Europe (PACE) has passed a resolution that calls for an inquiry into the relationship between pharmaceutical companies and official agencies throughout the H1N1 outbreak.

Wolfgang Wodarg, chairman of the PACE Health Committee, claims that the WHO, in cooperation with some big pharma companies, redefined the term ‘pandemic’.

This resulted in national governments signing marketing commitments for new and additional vaccines, according to Wodarg, resulting large profits for pharmaceutical companies.

Wodarg is planning an emergency debate for this month to discuss the influence the pharma industry has over the WHO and national governments in the European Union.