Amendment: Rule 96 of D&C Rules for labeling vaccines with specific reference to origin of vaccine

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The Union health ministry will soon amend Rule 96 of Drugs and Cosmetics (D&C) Rules for labeling of vaccines with specific reference to the origin of the vaccine.

The ministry’s decision in this regard comes after the World Health Organization (WHO) expressed its concern that the vaccines which are manufactured by using different source of antigen have been labeled with the same manufacturing license number without having any unique identification number which otherwise does not provide the correct information in respect of the origin of the vaccine.

The WHO expressed its concern on the issue during the National Regulatory Authority assessment conducted some time back at Central Drugs Standard Control Organization (CDSCO) in respect of vaccines manufactured in the country.

As per Rule 122 E, all vaccines are considered as new drugs and any change in the source of antigen, the new drug approval is required to be obtained from the Licensing Authority. However, there is no specific provision under Rule 96 for labeling of the vaccine with specific reference to its origin.

The ministry, therefore, proposed that Rule 96 should be amended to include new drug approval number on the label of the vaccine granted by the Licensing Authority as defined under Rule 21(b) of the D&C Rules.

The matter was first considered in the 44th meeting of the Drugs Consultative Committee (DCC) held on July 20, 2012 and the committee agreed to the proposed amendment of the ministry.

The matter also came up for discussion during the Drugs Technical Advisory Board (DTAB)’s meeting held on November 25 last year. The DTAB after deliberations agreed to the proposed amendment.

Source: Pharmabiz


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