Karnataka Pharma Distributors Challenge New Govt Order on Drug Quality Certificates
In Bengaluru, a recent government directive mandating pharmaceutical wholesalers to obtain batch-wise certificates of analysis (CoA) for every drug purchase from manufacturers has sparked strong objections from distributors across Karnataka. The order, issued by the Food Safety and Drug Administration (FDA), aims to enhance quality control and regulatory oversight in the pharmaceutical supply chain, following incidents such as maternal deaths in the state last year and the cough syrup controversy in Madhya Pradesh.
What is a Certificate of Analysis?
A CoA is an official quality document that confirms a specific drug batch has undergone laboratory testing and meets required safety, purity, and specification standards before release or sale. This measure is intended to ensure that only high-quality medicines reach consumers, addressing concerns over drug safety and efficacy.
Distributors Raise Practical Concerns
However, the Karnataka Pharma Retailers & Distributors Organization (KPRDO) has submitted a representation to the department, arguing that the directive is impractical and could severely disrupt medicine supplies. In the representation, C Jayaram, president of KPRDO, highlighted the operational challenges involved.
"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," Jayaram stated. He explained that wholesalers handle thousands of purchase transactions involving multiple batches continuously, making the collection, verification, and maintenance of batch-wise CoAs an enormous burden.
Supply Chain Disruption Risks
KPRDO warned that implementing this requirement only in Karnataka could disrupt the supply chain, as the state manufactures only a fraction of the drugs consumed within its borders, 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?" the organization questioned, emphasizing the need for a uniform approach to avoid logistical issues and potential shortages.
Call for National-Level Implementation
Jayaram suggested that if such a compliance mechanism is to be implemented, it should be rolled out uniformly at the national level through a centralized digital portal. This portal would allow manufacturers to upload batch-wise CoA details, accessible by wholesalers and regulators, streamlining the process and reducing operational hurdles. This proposal aims to balance quality assurance with practical feasibility, ensuring that drug safety measures do not compromise supply chain efficiency.
The ongoing debate highlights the tension between regulatory efforts to improve drug quality and the practical realities faced by pharmaceutical distributors, with stakeholders calling for a more coordinated and data-driven approach to policy implementation.
