After allowing for an extended period for compliance and conducting a series of training sessions in both physical and hybrid formats, the Drugs Controller General of India (DCGI) has made it clear that there will be no further extension for the transition to online submission of World Health Organization (WHO) Good Manufacturing Practices (GMP) Certificate of Pharmaceutical Product (COPP). Through a circular issued on June 25, the central drug regulator mandated that all applications for WHO-GMP COPP must be exclusively submitted online via the Online National Drugs Licensing System (ONDLS) starting from July 15, with no acceptance of physical files thereafter. Despite the initial deadline extension to August 15, 2025, following concerns raised by industry associations, DCGI underlined that the final deadline remains fixed.
The Central Drugs Standard Control Organisation (CDSCO) organized multiple interactive sessions with stakeholders, including State Licensing Authorities (SLAs) and industry representatives, to facilitate their transition to the online licensing system and ensure a smooth application process. As the approaching deadline of August 15, 2025 nears, DCGI Dr. Rajeev Singh Raghuvanshi reiterated that no further extensions beyond this date would be entertained for physical submission of applications seeking WHO-GMP (COPP) approval. He urged SLAs to instruct manufacturing units within their jurisdiction to adhere to the online submission process via the ONDLS portal. Furthermore, he emphasized the importance of mapping relevant officials and ensuring timely approval of product lists after due verification.
In line with efforts to digitize regulatory processes, the decision to shift WHO-GMP COPP applications online is part of the broader initiative to streamline pharmaceutical regulation procedures and enhance the ease of doing business within the industry. The ONDLS portal, developed by the Centre for Development of Advanced Computing (C-DAC) in collaboration with various States, serves as a unified platform for processing applications and granting licenses related to manufacturing, sales, blood centers, and certifications such as COPP and GMP. This digital transformation aims to standardize the submission of documents and issuance of licenses across India, promoting uniform administration of regulatory provisions through modern e-governance tools.
The adoption of the ONDLS portal is expected to bring about increased transparency, accountability, and consistency in decision-making processes carried out by state and UT drug controllers, fostering uniformity in operations nationwide. By leveraging the latest technological advancements, including e-governance, the online platform aims to simplify the application process and drive efficiency in regulatory functions. Stakeholders are encouraged to utilize the portal for various regulatory activities, ensuring a more streamlined and harmonized regulatory environment in the pharmaceutical sector.
Key Takeaways:
– The deadline for online submission of WHO-GMP COPP applications will not be extended beyond August 15, 2025.
– Stakeholders are urged to transition to the online licensing system through the ONDLS portal to ensure compliance with regulatory requirements.
– The digitization of application processes aims to enhance transparency, accountability, and consistency in pharmaceutical regulation.
– The ONDLS portal serves as a centralized platform for processing various regulatory applications and approvals, promoting uniformity in drug control operations nationwide.
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