Counterfeit Drug Guidelines by Odisha

Unauthorized bulk transactions or the offering of heavy discounts, often leading to counterfeit or illegally diverted stock, are also strictly prohibited.

The Health Master

March 30, 2025

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Last Updated on April 2, 2025 by The Health Master

Counterfeit Drug

Bhubaneswar, Odisha: In a proactive move to safeguard public health and prevent the infiltration of spurious/counterfeit and substandard drugs, the Odisha drug control department is implementing stringent new guidelines for pharmaceutical companies, clearing and forwarding agents (CFAs), and traders operating within the state.

This important action comes, keeping in view the growing concerns about the illegal manufacturing and selling of counterfeit drugs from neighboring states into Odisha’s pharmaceutical supply chain.

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Drug Inspector Issues Stern Directives

Chandan Kumar Giri, the vigilant drug inspector at the Bhubaneswar V Range drug control office, has spearheaded this initiative by issuing a comprehensive set of guidelines aimed at regulating the manufacturing, marketing, and sales of drugs within his jurisdiction.

These guidelines, currently awaiting approval from the state drug controller, Mamina Patnaik, and after approval, they will be replicated across the state by other drug inspectors.

Zero Tolerance for Non-Compliance

The circular issued by Candan Kumar Giri leaves no room for ambiguity and for strict adherence to the newly prepared guidelines by all pharma stakeholders.

The directive explicitly warns that any lapses or violations discovered on the part of companies, firms, or individuals will be met with severe legal repercussions, including arrest and prosecution under the stringent provisions of the Drugs and Cosmetics Act, 1940, and Rules, 1945.

“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 emphatically states.

Main Guidelines:

Registration is mandatory:

All pharmaceutical companies willing to sell their drugs within the jurisdiction of Bhubaneswar V Range must register their company with the drug inspector’s office in Bhubaneswar.

This registration activity aims to create a comprehensive database of authentic companies in the market.

Accountable Distribution Network:

Pharmaceutical companies are now solely responsible for ensuring that their entire distribution network, e.g., CFAs, super stockists, stockists, wholesalers, and retailers, has valid licenses and complies with regulatory standards.

Unauthorized or independent marketing operations will face rigorous scrutiny.

Failure to disclose product and distribution network details will result in legal action.

Submission of Essential Documents:

Within one week of the circular’s issuance, all firms are required to submit their valid manufacturing licenses, drug licenses of their authorized stockists, and a comprehensive product list along with pricing details to the drug inspector.

Any new company must submit all supporting documents before starting sale activity in Odisha market

Monitoring by Trade Associations:

The drug inspector has urged chemists and druggists associations to monitor their members with respect to the strict compliance with state regulatory guidelines.

Any violations or suspicious trade activities must be quickly reported to the office of the drug inspector.

Complicity in the unauthorized drug trade will lead to legal action against both the association and the individuals involved.

New entrants seeking association membership must have their details immediately reported to the drug inspector along with supporting documentation.

Regulated Procurement and Distribution:

Pharma Traders has been instructed to procure drugs from authorized CFAs, super stockists, and stockists.

Cross-selling and unauthorized redistribution of drugs across multiple regions are strictly prohibited.

Purchasing drugs from outside Odisha is prohibited if an authorized distributor already exists within the state.

Unauthorized bulk transactions or the offering of heavy discounts, often leading to counterfeit or illegally diverted stock, are also strictly prohibited.

Responsible Practices for Retail Chemists:

Retail chemists are directed to procure drugs from authorized stockists and maintain all sale and purchase records.

Engagement in grey-market transactions or the offering of excessive discounts is strictly prohibited. Retailers are also obligated to report any abnormally high purchase orders, excessive discounts, or offers on near-expiry drugs from any trader or marketer to the drug inspector’s office.

Severe Penalties:

The drug regulator has issued a clear warning that stringent action will be taken against those who are found to be indulging in these unauthorized activities.

Any company or dealer found involved in these unauthorized activities will be liable for severe legal consequences, which may lead to the seizure of illicit drugs followed by the suspension and cancellation of drug licenses.

Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.

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