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The Karnataka Pharma Retailers & Distributors Organization (KPRDO) has urged the government for pan-India implementation of procuring of Certificate of Analysis (COA) for all medicine purchases by wholesalers from pharma manufacturers.
Making a representation to the state government, C Jayaram, president and VV Kapparshettar, secretary, KPRDO said procurement of COA for all purchases may appear theoretically feasible, but its practical implementation poses significant challenges.
We request clarification on whether any comprehensive study or data analysis has been conducted to assess the magnitude of this requirement. Wholesalers handle thousands of purchase transactions involving multiple batches on a continuous basis. Collecting, verifying, and maintaining batch-wise COAs for every such transaction is an enormous operational burden, the scale of which can best be understood only by those directly engaged in wholesale trade, they added.
Further, at a time when both the Government and industry are striving toward paperless and environmentally sustainable operations, mandating the collection and storage of voluminous physical COA documents appears counterproductive. Storage of such extensive records presents logistical difficulties, especially when trade margins are already under pressure. Even if digital records are permitted, the process of systematically collecting, cataloguing, storing, and producing them upon demand would remain a highly resource-intensive and herculean task, said Jayaram and Kapparshettar.
It is also pertinent to note that Karnataka manufactures only a fraction of the total drugs required in the State. A substantial portion is procured from manufacturers in other States. In such a scenario, it would be appropriate for such a compliance mechanism to be implemented uniformly at a pan-India level through Central authorities. Post-GST, interstate trade is seamless and operates without traditional boundaries.
Additionally, interstate and online transactions, some of which function outside the conventional wholesale channel raise the question of how uniform compliance will be ensured across all trading entities. It is unfortunate that traditional brick-and-mortar wholesalers of Karnataka appear to be disproportionately impacted in matters of regulatory compliance, said Jayaram and Kapparshettar.
In this context, we humbly propose that the matter be referred to the Central Government for the creation of a centralized digital portal, similar in structure to the GST system. Under such a framework, manufacturers could upload batch-wise COA details directly onto the portal, enabling authorized access to wholesalers and regulatory authorities as required. This would ensure transparency, ease of compliance, and uniform implementation across the country, they said.
If COA is implemented only in Karnataka, KPRDO questions as to how can medicines can be purchased from pharmaceutical companies located in different states?
Now if COA is not implemented in other states, the pharmaceutical manufacturers in those states may not even be aware of such a requirement. In such a situation, wholesale drug distributors in Karnataka may not be able to procure medicines on time. This could lead to shortages of medicines and may adversely affect the public healthcare system, they said.
Therefore, only when COA is officially implemented across pan-India, will wholesale drug distributors be able to obtain batch-wise COA and purchase medicines batch-wise accordingly, said Jayaram and Kapparshettar.
Also, KPRDO indicated that recent compliance requirements are being introduced without adequate consultation with stakeholders. Traders are already managing multiple regulatory obligations from various departments, including GST, Income Tax, Labour authorities, and local bodies. The cumulative burden of these compliances take considerable time and resources, particularly for small and medium-scale wholesalers operating on minimal margins. The present requirement, if enforced in its current form, may severely disrupt their operations and viability, said Jayaram and Kapparshettar.
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