Cheap drugs, fake labels, non-functional QR codes: Karnataka FDA cancels 16 licences of retailers, wholesalers
BENGALURU: The Karnataka FDA on Sunday said it has cancelled 16 drug licences of retailers and wholesalers and suspended eight others over the alleged distribution and sale of spurious medicines.
The action followed an inspection by the Food Safety and Drug Administration's (FDA's) Drug Enforcement Wing on August 18, which busted an alleged unlicensed pharmaceutical repacking and relabelling operation at a farmhouse in Kurubarakeranahalli, Bidadi, in Bengaluru South district.
Officials said spurious drugs , machinery and printing materials worth around Rs 5.05 crore were seized during the raid, with the inventory of the seized materials estimated at Rs 4.91 crore.
A preliminary investigation found that low-cost medicines procured from neighbouring states were allegedly repacked in new vials and relabelled as expensive life-saving medicines of multinational companies, including products purportedly bearing the 'Pfizer' brand, the department said in a release.
The counterfeit labels also carried QR or scanning codes, which were found to be non-functional during verification, it said.
The department said the seized products could pose a serious threat to public health as spurious medicines may contain no active pharmaceutical ingredients, incorrect ingredients or potentially harmful substances.
A criminal case has been registered under the Drugs and Cosmetics Act, 1940.
Under Section 17B, counterfeit and fake medicines are classified as spurious drugs, while offences involving their manufacture, sale, stocking or distribution attract stringent punishment under Section 27, including rigorous imprisonment and fines, it said.
As part of the continuing investigation, action has also been initiated against retailers and wholesalers allegedly involved in distributing and selling the spurious drugs. Sixteen licences have been cancelled and eight suspended, the FDA said.
The licence of M/s Pfizer C & F Depot, Survey No. 66/3 B2, Kempalinganahalli, Nelamangala taluk, Bengaluru Rural district, has also been suspended, it said. This action is reportedly due to alleged non cooperation with the SIT probe.
The investigation team also seized 30 boxes of expired medicines, raising concerns that expired products may have been reintroduced into the supply chain.
The batch numbers and details of the seized medicines are being blocked on the Karnataka FDA portal to prevent their further sale or distribution. Samples have also been sent for laboratory analysis to ascertain their chemical composition, sterility and potency.
The seized medicines, machinery and printing materials are being documented and will be produced before the JMFC court in Bengaluru South for further proceedings.
A Special Investigation Team has expanded the probe to trace the alleged supply chain and identify other persons involved in the racket, officials said.
The department has advised consumers to purchase medicines only from licensed pharmacies against valid tax invoices and report suspicious changes in packaging or non-functional QR codes on drug labels to the Drug Enforcement authorities.
Health Minister U T Khader, speaking to reporters here, said stringent action will be taken against those involved based on the SIT report.
"The department officials have identified a big scale fake medicine network or mafia. Upon learning about the involvement of individuals from other states, we formed an SIT involving personnel from the Drug department, police and Commercial Tax department, and the investigation is ongoing. I would not like to comment further now," he said.
Further stating that some officials have also been suspended in this connection, the minister said licences of retailers and wholesalers involved in distributing and selling spurious drugs have been cancelled or suspended.
Action has also been taken against Pfizer because they did not cooperate with the SIT probe.
(With inputs from PTI)
The action followed an inspection by the Food Safety and Drug Administration's (FDA's) Drug Enforcement Wing on August 18, which busted an alleged unlicensed pharmaceutical repacking and relabelling operation at a farmhouse in Kurubarakeranahalli, Bidadi, in Bengaluru South district.
Officials said spurious drugs , machinery and printing materials worth around Rs 5.05 crore were seized during the raid, with the inventory of the seized materials estimated at Rs 4.91 crore.
A preliminary investigation found that low-cost medicines procured from neighbouring states were allegedly repacked in new vials and relabelled as expensive life-saving medicines of multinational companies, including products purportedly bearing the 'Pfizer' brand, the department said in a release.
The counterfeit labels also carried QR or scanning codes, which were found to be non-functional during verification, it said.
The department said the seized products could pose a serious threat to public health as spurious medicines may contain no active pharmaceutical ingredients, incorrect ingredients or potentially harmful substances.
A criminal case has been registered under the Drugs and Cosmetics Act, 1940.
Under Section 17B, counterfeit and fake medicines are classified as spurious drugs, while offences involving their manufacture, sale, stocking or distribution attract stringent punishment under Section 27, including rigorous imprisonment and fines, it said.
As part of the continuing investigation, action has also been initiated against retailers and wholesalers allegedly involved in distributing and selling the spurious drugs. Sixteen licences have been cancelled and eight suspended, the FDA said.
The licence of M/s Pfizer C & F Depot, Survey No. 66/3 B2, Kempalinganahalli, Nelamangala taluk, Bengaluru Rural district, has also been suspended, it said. This action is reportedly due to alleged non cooperation with the SIT probe.
The investigation team also seized 30 boxes of expired medicines, raising concerns that expired products may have been reintroduced into the supply chain.
The batch numbers and details of the seized medicines are being blocked on the Karnataka FDA portal to prevent their further sale or distribution. Samples have also been sent for laboratory analysis to ascertain their chemical composition, sterility and potency.
The seized medicines, machinery and printing materials are being documented and will be produced before the JMFC court in Bengaluru South for further proceedings.
A Special Investigation Team has expanded the probe to trace the alleged supply chain and identify other persons involved in the racket, officials said.
The department has advised consumers to purchase medicines only from licensed pharmacies against valid tax invoices and report suspicious changes in packaging or non-functional QR codes on drug labels to the Drug Enforcement authorities.
Health Minister U T Khader, speaking to reporters here, said stringent action will be taken against those involved based on the SIT report.
"The department officials have identified a big scale fake medicine network or mafia. Upon learning about the involvement of individuals from other states, we formed an SIT involving personnel from the Drug department, police and Commercial Tax department, and the investigation is ongoing. I would not like to comment further now," he said.
Further stating that some officials have also been suspended in this connection, the minister said licences of retailers and wholesalers involved in distributing and selling spurious drugs have been cancelled or suspended.
Action has also been taken against Pfizer because they did not cooperate with the SIT probe.
(With inputs from PTI)
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