Nasal vaccine for H1N1 selling too rapidly for FDA’s comfort

District administrations have been instructed to work with public hospitals and primary and secondary health centres in “generating awareness” about the risk of resistance. “People know about the protective benefits of the vaccine but knowledge about the risks of sporadic use is lacking,”said Uttarvar.

Experts say the user-friendly nature of the nasal vaccine may have contributed to the growing use. The injectible vaccine too is available in the market but,FDA officials said,sales of the intra-nasal one are five times those of the injectible form though it entered the Indian market a year later.

“We have acknowledged the FDA’s concern,” said Director of Health Services Dr DS Dakhure. “Currently,as per government guidelines,the sale of the nasal vaccine is allowed only under strict medical supervision.”

Dakhure conceded these rules were possibly being flouted,with over-the-counter sales responsible for the spurt in sales. Uttarvar said,“Our notice to district administrations stresses this point: H1N1 vaccines,whether injectible or oral,must be sold by chemists on valid prescriptions.”

An advisory committee of doctors had given the Centre a recommendation for an injectible alternative to Tamiflu,the standard H1N1 treatment. The committee said Tamiflu was not effective against complications,such as other viral or bacterial infections caught along with H1N1. Sources in the state DMER said the report was endorsed in Maharashtra; most of the doctors on the panel were from the state.

“Having dealt with two H1N1 waves already,this time we are being cautious. The numbers are being monitored,and all preventive measures are being taken before temperatures start dropping,” said Dr Pravin Shingare,joint director,Directorate of Medical Education and Research.