The regulatory authorities are planning to amend the Rule 96 of the Drugs and Cosmetics Act for labelling of vaccines with specific reference to the origin of the vaccine, which was cited by the World Health Organisation (WHO) as a concern some time back.
WHO during the assessment at Central Drugs Standard Control Organization (CDSCO) in respect of vaccines manufactured in the country had expressed a concern that the vaccine which are manufactured by using different source of antigen have been labelled with the same manufacturing licence number without having any unique identification number which otherwise does not provide the correct information in respect of the origin of the vaccine, sources said.
“As per Rule 122 E, all vaccines are considered as new drugs and any change in the source of antigen, the new drug approval (NDA) is required to be obtained from the Licensing Authority. However, there is no specific provision under Rule 96 for labelling of the vaccine with specific reference to its origin,” sources said.
Now the CDSCO is seriously looking at the proposal to amend Rule 96 to include a specific UID number or NDA number on the label of the vaccine as granted by the Licensing Authority, it is learnt.
The Drug Consultative Committee had already discussed the matter and the proposal would be placed before the Drug Technical Advisory Board (DTAB) for approval and further action, the sources added.
The Rule 96 deals about the manner of labelling, “Subject to the other provisions of these Rules, the detailed particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed, namely: the name of the drug,” the Rule says.