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 The Federation Of Pharmaceutical and Allied Products Merchant Exporters (FPME) has sought regulatory clarity from the Drugs Controller General of India (DCGI) on the availability of Certificates of Analysis (CoAs) and other export documents required by merchant exporters during export clearance.
During a meeting with DCGI Dr. Rajeev Singh Raghuvanshi, the delegation highlighted difficulties in obtaining CoAs from manufacturers and official stockists despite medicines being procured through legitimate supply channels.
The discussions led to an indication that the Central Drugs Standard Control Organisation (CDSCO) would issue a Circular clarifying the requirement regarding the availability of CoAs through official stockists or authorised supply channels.
CoA issued by a quality control lab or manufacturer confirms that a specific lot of raw material, active pharmaceutical ingredient (API), or finished product meets predetermined safety, purity, and quality.
Based on the concerns highlighted, the DCGI deputed K K Haldar, additional drugs controller (ADC), CDSCO headquarters, to examine the issues in detail.
During the subsequent discussions, Haldar reviewed the practical difficulties faced by merchant exporters and examined the applicable regulatory requirements and guidelines. The availability of the CoA from manufacturers and official stockists emerged as the primary operational challenge. The delegation also discussed the verification of other export documents through the Online National Drug Licensing System (ONDLS), which is expected to become available shortly and could reduce the documentation burden on exporters.
Haldar examined the relevant documents and identified the Directorate General of Foreign Trade (DGFT) circular concerning CoAs as the principal reference, along with another relevant guideline available on the CDSCO website.
A FPME spokesperson said, “The availability of CoA from official stockists/authorised supply channels is a critical requirement for pharma merchant exporters, particularly when products have been procured through legitimate channels. The clarification proposed by CDSCO will help establish a clear and uniform process and address the practical difficulties exporters face during export clearance.”
During the interaction, Atul Balel explained the practical difficulties faced by merchant exporters when stockists do not provide CoAs for products procured through authorised channels. The DCGI advised that where a company or stockist does not provide the CoA, the exporter should first raise the matter through the company's grievance mechanism. If the issue remains unresolved, the exporter can approach the DCGI or CDSCO.
The DCGI also indicated that there is a provision under which a company cannot deny the CoA to an official stockist and stated that a CDSCO Circular would be issued to clarify and communicate the requirement. FPME said the proposed clarification could address one of the major documentation hurdles faced by merchant exporters during export clearance and bring greater consistency to the process.
The meeting also focused on reducing uncertainty in export documentation and ensuring that legitimate merchant exporters have access to documents required for regulatory and customs-related clearances. The proposed CDSCO clarification is intended to provide greater transparency on CoA availability and establish a more consistent compliance mechanism for exporters procuring medicines through authorised supply channels.
According to a FPME spokesperson, “The federation acknowledges the efforts of DCGI Dr. Rajeev Singh Raghuvanshi for addressing the concerns of pharma merchant exporters. It also acknowledges contributions of Atul Balel and Fayaz for presenting the issues before the authorities, and Dr Santosh V Indraksha, Deputy Drugs Controller (India), for facilitating the meeting with the DCGI. The federation acknowledges the focused guidance and support of K K Haldar, ADC, CDSCO headquarters for examining the regulatory requirements and participating in the detailed discussions.”
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