The Union health ministry will soon amend Rule 26 of D&C Rules to mandate import license holders to maintain control samples of imported drugs so that circulation of spurious drugs can be verified and tracked effectively.
It is learnt that there is no such provision or condition available in the import license under the Drugs and Cosmetics (D&C) Rules, 1945. It becomes very difficult to verify the authenticity of spurious, misbranded or sub standard drugs found in the market as the control samples of these imported drugs are not available with the import license holder.
Keeping patient safety into consideration, the Drugs Technical Advisory Board (DTAB) in its recent meet approved to include a provision in D&C Rules, 1945 for requirement of keeping the control samples of the drugs imported by the import license holder against the import license issued by Central Drugs Standard Control Organisation (CDSCO).
Therefore, in order to remove this discrepancy, it was proposed to amend the Rule 26 of the D&C Rules, 1945 i.e., ‘Conditions of import license’ for incorporating the following condition – 26(VIII)- the licensee shall maintain reference samples from each batch of the drugs imported by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch.
In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry or potency. In case of drugs where no date of expiry or potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.
As per Rule 74(l) of the D&C Rules, 1945, indigenous manufacturers shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch.
Reference: The Pharmabiz