Govt to amend D&C Rules to specify batch number on final container

Union health ministry is planning to amend Drugs and Cosmetics (D&C) Rules to specify batch number on separate final container label of trade pack (final packed unit) for vaccines containing multi-components.

The amendment is based on the premise of Central Drugs Standard Control Organisation (CDSCO) apprising the Drugs Technical Advisory Board (DTAB) about clarification to GSK Pharmaceutical Limited that in case of multi component vaccines, the outer carton of vaccine should contain combined batch number and expiry date of component of shortest expiry date.

However, the primary label of individual components may contain their respective batch number and expiry date. Also, the firm is needed to have proper record and traceability for said combined batch number.

DTAB was apprised by CDSCO that GSK Pharmaceutical Limited, GSK House, Dr. Annie Besant Road, Worli, Mumbai vide their application number July 25, 2018 requested clarification regarding batch numbers to be declared on trade packs for vaccines containing two components in a separate final container based upon observation raised by the Central Drug Laboratory (CDL), Kasauli during the testing of Hexavalent vaccine of GSK Pharmaceutical Limited (Trade name- InfanrixHexa) (DTaP-HBV-IPV+ Hib) vaccine.

The CDL had stated that the company had not mentioned the combination batch number on the product pack even though the same was mentioned on the summary lot protocol submitted to them with samples for lot release.

InfanrixHexa comprises DTaP+HBV-IPV Pentavalent liquid suspension in Prefilled Syringe (PFS) and freeze dried Hib component in vial.

The GSK in its letter clarified following points that for packs containing two components, e.g. freeze dried vaccine in vial + diluent in PFS or freeze dried vaccine in vial+ liquid suspension of second vaccine in PFS, firm is declaring the batch number, manufacturing date and expiry date of both the component on the carton and the individual label of vial/PFS.

For such vaccines which contain two components, the firm additionally maintains a combination batch number i.e. the batch number assigned to the final packaged unit of the freeze dried vaccine+ liquid vaccine or freeze dried vaccine + diluent combo pack. This packaged lot number (combined batch number) is not declared on the label but mentioned on the company’s batch release certificate and summary lot protocol.

Global practice followed by the firm for marketing of the said product in countries like EU, Australia, Canada, etc, for the declaration of batch number is as follows – In the inner label of vial of Hib component, batch number of the Hib component is declared, in the inner label of PFS of DTaP+HBV+IPV component, batch number of the DTaP+HBV+IPV component is declared. In the outer carton, batch number of the combined DTaP+HBV_IPV/Hib vaccine is declared.

There is no specific international guideline on declaring batch number on trade packs of vaccines containing two components.

Submission was made to the DTAB that there is no specific rule in D&C Rules 1945 or guidelines for declaration of batch number on label of the trade pack (final packed unit) for vaccine containing multi-component in separate final container. DTAB after deliberation agreed to the proposal for appropriate amendment in the D&C Rules, 1945.


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