New Delhi: Pre-market human trials of swine
flu vaccine to check its efficacy on Indians may start in the
next fortnight as the Indian Council of Medical research is in
final stages of "positive" negotiations with an international
pharmaceutical company in this regard.
"We will finalise the deal with the international vaccine
manufacturing company by December 15 with which we will place
the order. So far, negotiations have been positive," a Health
Ministry official said.
"Government is negotiating with three international
vaccine manufacturers. By next fortnight, the phase IV trials
are expected to begin. This will be done to check the safety
and the immunogenicity of the foreign-made vaccine on Indian
population," Dr V M Katoch, DG, ICMR said.
Sources in the Health Ministry also said international
vaccine manufacturer Glaxo Smith Kline has quoted the lowest
price and is under consideration.
More than 21,000 people have been affected by swine flu
virus in India. Nearly 700 deaths have been reported from
different cities here.
Dr Katoch said, "Since no Indian company is ready yet for
the phase IV trial, we are considering the foreign brands as
they are already tried, tested and in use in other countries.
"Zydus Cadila of Ahmedabad, the Indian swine flu vaccine
manufacturing company, has recently got a nod from the Drug
Controller General of India to carry out human studies of its
vaccine. They can carry it out any time in December."
PTI
