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Printers of packing materials should also be held responsible for counterfeits: Dr NK Ahooja

Peethaambaran Kunnathoor, Chennai
Wednesday, April 3, 2024, 08:00 Hrs  [IST]

Concerned over the recent myriad raids and seizures of spurious and counterfeit drugs carried out by the drug regulatory officers in various parts of the country, former drug controller of Haryana, Dr. Narendra Kumar Ahooja has commented that the regulators should book the printers of packing materials as culprits along with the counterfeiters invoking Section 120 B of the D&C Act.
Since the definition of the word ‘manufacture’ in Section 3 (f) of the drug act includes ‘packing’, the printers who are supplying the printed packing materials are equally responsible along with the manufacturers of counterfeit and spurious drugs as the printers are supplying the printed materials. It is their duty to ascertain and confirm whether they are supplying the materials to genuine manufacturers or to fraudsters. 
“So, it can be taken that the printers who print packing materials for counterfeiters are actually the culprits and the main accused. Section 120 B should be invoked against such printers,” said Dr. Ahooja who was responding to questions from Pharmabiz.
According to him, the major threat now faced by the Indian pharmaceutical industry is the fraudulent activities of the counterfeiters who manufacture drugs in the name and style of other companies. Alarmingly, these drugs do not contain any active pharmaceutical ingredients, hence they cause health hazards. These drugs do not make any pharmacological action in the body of a patient. Counterfeiters supply these drugs to the retailers without any invoices and without issuing any bill. Therefore, even when these products are seized from the market, it becomes very tough for the drug inspectors to reach out to the actual manufacturer. Without establishing the supply chain of these drugs, investigation cannot reach upto the counterfeiters, says the former DC.
Another serious problem arising out of this is that the drug inspectors issue notices to the manufacturers whose names are printed on the labels, but the actual manufacturer of the counterfeit may be different. The name of the manufacturing unit on the label becomes the victim of the fraudulent activity committed by the counterfeiters. Dr. Ahooja feels that this fraud happens because of some lacuna in the drug act and the casual approach of investigators.
Talking about the recent incidents of spurious and counterfeit drug seizures, he said the FDA officials in Chattisgarh have recently raided and took hold of swapping labels used by distributors and secondary packaging of eye drops by removing the labels. The distributors were removing the labels of one company and pasting labels of another company because of price differences.
Another example he quoted was the raids conducted by the DCA officials in Telangana. Some fraudsters in Himachal Pradesh were committing frauds with similar unscrupulous persons in Ghaziabad in UP. The Telangana DCA along with crime branch police busted several manufacturing units of spurious drugs in Hyderabad and also in other states.
Dr Ahooja said the Section 3 (b) (iii) part of the definition of the drug says that all substances intended for use as components of a drug are also coming under the term ‘drug’. Besides, all the excipients and additives including empty gelatin capsules are included as drugs by virtue of this definition. However, this does not include the printed and packing materials which are integral part of the drug safety. So, these printed and packing materials need to be brought under the purview of regulation.


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