CDSCO panel directs GSK to generate safety, immunogenicity data on Indian population for INFANRIX-IPV
New Delhi: Rejecting pharmaceuticals major GSK's proposal to import INFANRIX-IPV in the country without conducting a local clinical trial, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined to generate the safety and immunogenicity data on Indian population for consideration of marketing authorization.
This came after the drug maker GSK presented its proposal for grant of permission to import INFANRIX-IPV in the country without conducting local clinical trial.
INFANRIX-IPV are non-infectious substances from tetanus, diphtheria bacteria, purified proteins of pertussis bacteria, and inactivated poliovirus.
INFANRIX IPV is indicated for use in a three-dose primary schedule for immunization of infants from 6 weeks of age and over, against diphtheria, tetanus, pertussis, and poliomyelitis. INFANRIX IPV is also indicated as a single booster dose for children, up to and including 6 years of age, who have previously been immunized against DTP and polio.
INFANRIX IPV is providing immunity against diphtheria, tetanus, pertussis, and poliovirus by inducing the production of antibodies and the ability to mount an immunological memory.
The diphtheria and tetanus toxoids are obtained by formaldehyde treatment of purified Corynebacterium diphtheriae and Clostridium tetani toxins. The acellular pertussis vaccine components are obtained by extraction and purification from phase I Bordetella pertussis cultures, followed by irreversible detoxification of the pertussis toxin by glutaraldehyde and formaldehyde treatment, and formaldehyde treatment of FHA and pertactin. The three polioviruses are cultivated on a continuous VERO cell line, purified, and inactivated with formaldehyde.
Diphtheria, pertussis, tetanus, and poliomyelitis are life-threatening diseases caused by bacterial and viral infections. This vaccine acts by causing the body to produce its own protection (antibodies) against these diseases. Infanrix - IPV will be injected into the thigh muscle in children over 12 months of age, and into the upper leg muscle/thigh muscle in infants under 12 months of age. For infants and children with bleeding problems, the dose may need to be given under the skin (subcutaneously).
At the recent SEC meeting for Vaccine, the expert panel reviewed the proposal to import INFANRIX-IPV in the country without conducting a local clinical trial.
After detailed deliberation, the committee recommended to generate the safety and immunogenicity data on the Indian population for consideration of marketing authorization.
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