CDSCO declares sample of Bharat Biotech’s typhoid vaccine Typbar as NSQ
The Central Drugs Standard Control Organisation (CDSCO) has declared a batch of Typbar, the typhoid polysaccharide vaccine from Bharat Biotech International Ltd as not of standard quality (NSQ).
The drug regulator, in a drug alert issued, said that a batch of Typbar, manufactured by Bharat Biotech International Ltd in Genome Valley in Hyderabad, Telangana, failed the standard quality test conducted by Central Drugs Laboratory (CDL), Kasauli, Himachal Pradesh, after the sample picked up and sent by Food and Drug Administration (FDA), Goa.
CDL Kasauli is the National Control Laboratory for testing of immunobiologicals such as vaccines and antisera, meant for human use in the country. The lab has the mandate of National Regulations of Vaccines produced indigenously for domestic market, immunization programme of the Govt. of India, export and for those imported to the country.
The sample has failed since O-acetyl content is not complying with the specification, according to the test conducted by the laboratory.
Typbar is claimed as the first vaccine in India to get a World Health Organisation – Good Manufacturing Practices prequalification certificate. It is a highly purified Vicapsular polysaccharide of Salmonella typhi Ty2. Typbar would also be the world’s first vegetarian or non-bovine typhoid vaccine. Bharat Biotech is the largest primary manufacturer of typhoid vaccine in the country. The company dedicated the vaccine to Dr. John R. Robbins, the father of polysaccharide vaccines, says the company website.
Typbar should be given intramuscularly in the deltoid (upper arm) muscle in adults and in children in the vastus lateralis (anterolateral thigh) up to 12 years of age. Inject 0.5 mL intramuscularly, Primary Series (first dose): 1 dose (0.5mL) in children 2 years of age and above, and adults. Reimmunization is recommended every 2 years, with a single dose, for travelers with repeated or continued exposure to Salmonella Typhi, a bacteria which is a bacterium related to the bacteria that cause salmonella food poisoning.
The CDSCO’s alert on the vaccine comes weeks after it released the monthly drug alert based on the routine tests conducted on samples collected across the country through its offices and State drug regulators.
In the month of May, it has declared almost four per cent of the drugs, cosmetics and medical devices samples it tested in April, 2023 as NSQs. The drug regulator has tested a total of 895 drug samples during the month of April, of which 35 were declared as NSQ. This include samples labelled as manufactured by pharma majors such as Glenmark Pharmaceuticals, Alkem Health Science, and public sector undertakings Karnataka Antibiotics and Pharmaceuticals Ltd and Hindustan Antibiotics Ltd.
Sample from a batch of a combination drug tamsulosin hydrochloride and dutasteride tablets, branded as Urimax D and labelled as manufactured by Cipla Ltd in Goa facility, failed in identification and assay of tamsulosin hydrochloride and dutasteride, and the authority declared that the sample is deemed to be spurious. The sample was picked up by the Drug Control Department of Odisha and tested in the Central Drugs Laboratory, Kolkata.
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