Health ministry to amend Rule 26 of D&C Rules to mandate import license holders to maintain control samples of imported drugs
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.
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