By IANS,
New Delhi : The government has given the go-ahead to carry out clinical trials for evaluating the safety and efficacy of the measles inhalable vaccine, the Lok Sabha was informed Friday.
In a written reply, Minister of State for Health and Family Welfare Dinesh Trivedi said that clinical trials of the vaccine are being conducted in the country.
He said the Central Drugs Standard Control Organisation has granted permission to Serum Institute of India Ltd in Pune to conduct the phase 1, 2 and 3 clinical trials to “evaluate the safety and efficacy of the measles inhalable vaccine”.
It is a dry powder that can be inhaled directly into the lungs.
He said permission to conduct phase 2 and 3 clinical trials was granted after satisfactory evaluation of data generated from the phase 1 trial.
Trivedi said the trials are co-sponsored by the World Health Organisation (WHO). Serum Institute is also working on preparing a swine flu vaccine.
Nearly 200,000 children die of measles and related complications in India every year.
It is considered that the new vaccine may reduce the risk of infection from unsterilised needles and may also prove more effective against the disease.
Trivedi said permission to market the new vaccine is only granted after submission and satisfactory evaluation of phase 2 and 3 clinal trial data along with other required documents as per requirements of the Drugs and Cosmetics Act and Rules.
“The marketing approval, therefore, will depend on when the company will complete the clinical trial as per approved protocol and submit the study report along with application for new drug permission,” he added.