Bengaluru: A recent govt order mandating pharmaceutical wholesalers to obtain batch-wise certificates of analysis (CoA) for every drug purchase from manufacturers drew strong objections from pharmaceutical distributors in Karnataka.A CoA is an official quality document that confirms a specific drug batch was laboratory-tested and met required safety, purity and specification standards before release or sale.In the govt order, Food Safety and Drug Administration (FDA) directed that wholesalers must obtain a CoA for every batch of medicines procured, as part of efforts to strengthen quality control and regulatory oversight in the pharmaceutical supply chain. The order said the decision was taken following maternal deaths in the state last year and the cough syrup fiasco in Madhya Pradesh.However, in a representation submitted by Karnataka Pharma Retailers & Distributors Organization (KPRDO) to the dept Saturday, pharmacists argued that the directive is impractical and could disrupt medicine supplies. They demanded withdrawal of the order.“At the outset, while procurement of CoA for all purchases may appear theoretically feasible, its practical implementation poses significant challenges. We request clarification on whether any comprehensive study or data analysis was 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,” said C Jayaram, president, KRDO.KRDO warned that implementing the requirement only here could disrupt the supply chain, stating that Karnataka manufactures only a fraction of the drugs consumed within the state, with a substantial portion sourced from other states. “If CoA is implemented only in Karnataka, how can medicines be purchased from pharmaceutical companies located in different states?” it asked.Jayaram suggested that, if implemented, such a compliance mechanism should be rolled out uniformly at the national level through a centralised digital portal where manufacturers upload batch-wise CoA details for access by wholesalers and regulators.
