Health Ministry To Mandate Maintaining Of Reference Sample For The Import License Holder To Tackle The Issue Of Misbranded Drugs

Union Health Ministry has proposed to amend Rule 26 of D&C Rules to make it mandatory the import license holder to maintain a reference sample. The current rule 26 of D&C Rules provides the provision for maintaining the reference sample for the manufacturing license. In order to keep the authenticity of the misbranded product the government has decided to include such provision for the import license holder also in order to maintain the authenticity of the misbranded product which are imported.

Earlier it was mandatory only for manufacturers to maintain reference samples under rule 74(l) of Drug and Cosmetic Rules, 1945. According to it7:

“The licensee 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. 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 of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.”

However, there is no such provision for the import license holder to maintain the sample. Hence, in order to prevent this discrepancy, the Health Ministry proposed to amend the Rule 26 of the Drugs and Cosmetics Rules, 1945, where the sub rule (viii) to be incorporated under Rule 26 is prescribed as below:

“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.”

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. – Mondaq

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