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Concerned over the possibility for infiltration of illegally manufactured, substandard and counterfeit medicines from neighbouring states to Odisha’s pharmaceutical supply chain, a drug inspector of the Odisha drug control department has issued guidelines for pharma companies, CFAs and traders for manufacturing, marketing and sales of drugs in his jurisdiction.
The guidelines, issued by Chandan Kumar Giri, drug inspector at the drug control office of the Bhubaneswar V Range, have been forwarded to the state drug controller Mamina Patnaik for approval, and for subsequent replication by other drug inspectors in the state.
The circular to all pharmaceutical stakeholders by CK Giri mandates strict compliance with the guidelines. It warns that if any lapse is found on any company’s or firms or individual’s side, strict legal action, including arrest and prosecution under the Drugs and Cosmetics Act, 1940 & Rules 1945 will be initiated.
“This directive serves as both a warning and a mandatory regulatory instruction for all stakeholders engaged in the pharmaceutical trade under the Bhubaneswar V Range. Strict adherence to procurement, distribution, and regulatory compliance is compulsory, and any violation will result in severe legal consequences,” the circular to the stakeholders warns.
As per the guidelines, all the pharmaceutical companies operating in the jurisdiction of Bhubaneswar V Range of the DCA must register their market entry to the drug inspector’s office in Bhubaneswar before initiating sales or distribution. It is the responsibility of the companies to ensure that their entire distribution network (C&F, super stockists, stockists, wholesalers, and retailers) is compliant with leakproof and operating only through licensed dealers. Unauthorized or independent marketing operations will be strictly scrutinised, and if any company fails to inform the office about their products and distribution network, it will have to face legal action. All firms must submit their valid manufacturing licenses, drug licenses of their authorized stockists, and a complete product list with pricing details to the drug inspector within one week of the circular date. Similarly, if any new company enters the Odisha market, its details must be intimated to the office along with all supporting documents before commencing operations.
The drug inspector wants the chemists and druggists association and other trade bodies to actively monitor their members and ensure strict compliance with state regulatory guidelines. No trade association should allow their members to procure, distribute, or stock medicines from unauthorized sources. Association must report any violation or suspicious trade practice to the office without delay. If an association is found complicit in unauthorized drug trade or allowing a member for such illegal business within its jurisdiction, it will be held accountable, and legal action will be initiated against such association and individuals. Any new entrant approaching them for marketing, the details of such individuals must be brought to the drug inspector’s notice immediately along with all the documentary supports.
As regards procurement and distribution, the drug inspector’s office has informed the traders that medicines must be procured exclusively from authorized CFAs, super stockists, and stockists. Cross-selling and unauthorized re-distribution of medicines across multiple territories should be strictly avoided. Firms must not procure medicines from outside of Odisha if an authorized distributor is already operating within the state. No entity should engage in unauthorized bulk transactions or large discounts beyond permissible limits because such activities often indicate counterfeit or illegally diverted stock.
The retail chemists are advised that they must source medicines strictly from authorized stockists and maintain proper purchase documentation. They should not engage in grey-market transactions, or offer excessive discounts. Likewise, they must inform the office about any abnormally high purchase orders, excessive discounts, or offers on near-expiry drugs by any trader or marketer or any individual.
By giving strict warnings to the manufacturers and traders, the drug regulator informs them that his office will take direct action against any individual or entity that jeopardizes public health by engaging in unauthorized drug trade. Any company or dealer or association is found violating the directives, they will be liable for legal consequences with seizure followed by immediate suspension and cancellation of drug licenses under the Drugs and Cosmetics Act, 1940 & Rules, 1945, says the circular.
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