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Genuine Drug Manufacturer Can Protect Himself From Fake Manufacturers

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 “To make more profit some stockists/ retailers sell sub-standard drugs produced by some fake manufacturer, with same packaging and batch no. as on genuine drugs manufactured by an identified manufacturer.

If such sub-standard drug is lifted by the drug inspector, the retailer/ stockist produces the bill given by the identified manufacturer. How can the identified manufacturer prove himself as genuine.”

As per Rule-65, record of the purchase of drug intended for sale or sold by retail shall be maintained by licensee and such record shall show the entries in a register i.e. date of purchase, name & address of the person from whom purchased and the number of the relevant license held by him, the name of the drug, quantity, batch number & the name of the manufacturer of the drug.

Purchase bill including cash or credit memos shall be serially numbered by the licensee and maintained by him in a chronological order. Supply of a drug by wholesale shall be made against the cash or credit memo bearing the name and address of the licensee and also indicate the date of sale, name & address of the licensee to whom sold & his sale license number. The wholesaler have to maintain the record of purchase of the drug intended for sale as wholesale showing the date of purchase, name, address of the person from whom he has purchased the drug, name of the drug, quantity and batch number and name of the manufacturer of the drug for inspection by a Drug Inspector. It is not possible that the fake stockist or seller maintains the above mentioned particulars regarding the fake drug.

If some stockist or retailer sells substandard drugs manufactured by fake manufacturer resembling the same packaging, batch no., name of manufacturer of a genuine drug manufacturer for more profit, it is a crime and the drug is spurious. If any sample of such drug is lifted by the drug inspector and on analysis is found to be Not of Standard Quality and the prosecution instituted against the Genuine Manufacturer. In this situation the genuine manufacturer has right to satisfy the court that the subject drug is not manufactured by him by comparing, packing material & method, printing, color, design, size of label, thickness of P.V.C. used in blister packing, size and manner of printing of label etc. Because it is not possible that the manner of packing will completely match the fake packing method. In his defense, the manufacturer has to investigate the matter by purchasing the fake drug himself or by any number of persons from whom the fake drugs is being sold and collect the evidence that the person selling the drug in a bulk quantity has only a bill for lesser quantity from the genuine manufacturer. The manufacturer has also a remedy to lodge an FIR with the police for proper investigation in the matter.

The manufacturer has to use the unique code along with a bar code on the label of his product for protection.

Nationally acclaimed  expert on Drugs
and Cosmetics Act (1940)

GLS Pharma


Cubit Pharma

Medical Devices ASEAN 2018