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Retired regulators suggest ways to tackle the menace of counterfeit drugs in the market
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Peethaambaran Kunnathoor, Chennai
March 17 , 2025
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Since the counterfeit medicine trade is becoming a complex challenge to the healthcare system and to the regulatory bodies in India, the state drug control administrations should devise special strategies including inter-state communication to tackle the rising menace, according to retired regulatory officers.
Recently, the Bengal Chemists and Druggists Association (BCDA) has informed the state government that a lion’s portion of the medicines marketed in West Bengal is counterfeit and it poses a threat to the healthcare system. The association wanted the government to investigate the source of these falsified medicines entering the state from neighbouring states. Following it, the department has started intensifying inspections, and booked some cases.
The regulators who handled the department in various states for a long time comment that strict enforcement of drug laws is the only remedy to tackle this menace. According to them, the strength of the drug control department in every state is less than sufficient, and the infrastructure facilities are poor. So, it is too difficult for every state to completely control the flow of spurious or counterfeit drugs in the market.
Mostly, the branded medicines are promoted and marketed by separate people by forming companies under wholesale licences. They mostly manufacture the product in some small companies located in various states. According to regulatory officers, the small companies are operating by and large for the marketers who even use the labels of popular companies to cheat the public.
Dr Narayan Goswami, former drug controller of Tripura is of the opinion that the marketing companies are the main culprits in the proliferation of counterfeit and falsified medicines in the market. He says that, to an extent, the counterfeit can be prevented if the address and licence number of the manufacturing companies are also printed on the label. The strips of the medications marketed by the marketing companies comprise only their addresses which are too difficult to be traced out. He said, the small companies are manufacturing products of big players for the marketing companies and the quality of such products is very low. Legal actions should be initiated against all the manufacturers and marketers for all kinds of violations.
Narendra Kumar Ahooja, Ex DC of Haryana opines that the marketing companies can be controlled by invoking Rule 84 (d) and 84 (e) which put the onus on the marketers to maintain the quality of the products they market or promote. Similarly, every drug manufacturer should be directed to inform the state licensing authorities about the whereabouts of the companies, and submit Form 51 under the drug act to describe the medicine he manufactures. Ahooja says that the investigation on counterfeit drugs should be extended up to the manufacturing level in order to find out who has manufactured it.
He says that if one drug is found to be counterfeit, the authorities should seek the help of the actual manufacturer of that drug to file a case against the counterfeiter. He said using QR code or any other protective logos will help stop forgeries. According to him, the printers who print the labels for the marketing companies should also be brought under the purview of regulation.
According to Dr. Pradeep Mattu, former drug controller of Punjab, if a well-devised track and trace system in the regulatory department is in place, it will help track the movement of drugs throughout the supply chain. It will ensure authenticity and prevent counterfeit drugs.
According to Dr. Mattu, the state regulatory bodies should be activated for interstate communication, so that the state authorities can help mutually in identifying the fake products. Similarly, the department should issue advisories to the manufacturers and to the marketers seeking information about the drugs they manufacture or market.
Dr. Subhash Mondal, retired deputy drug controller in West Bengal and secretary of the Indian Pharmaceutical Association, said strict enforcement of the drug act is the only solution to cleanse the drug market. But, about the present issue of counterfeit medicines in West Bengal, he did not comment.
Dr. Revi S Menon, retired drug controller in Kerala said bar coding on all medicine labels can be the best solution for separating the counterfeit from the original one. He said the drug regulatory department in every state needs to be strengthened for strong enforcement.
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