The Central Drugs Standard Control Organisation (CDSCO) is embarking on a transformative journey to enhance the online application process for the World Health Organization-Good Manufacturing Practices (WHO-GMP) Certificate of Pharmaceutical Product (CoPP). In collaboration with the Centre for Development of Advanced Computing (C-DAC) and State Licensing Authorities (SLAs), CDSCO aims to optimize the Ease of Doing Business (EoDB) for the pharmaceutical sector, particularly benefiting the micro, small, and medium enterprises (MSMEs).
Addressing Industry Challenges
The pharmaceutical industry has long grappled with challenges when applying online through the ONDLS portal of CDSCO. Many companies, especially those in the MSME sector, have experienced difficulties navigating the digital landscape, leading to delays in obtaining essential WHO-GMP CoPP certificates. These delays have had a ripple effect, negatively impacting business operations and international trade.
In response to the increasing frustrations, many manufacturers have resorted to manual applications at the respective SLAs as a last resort. This workaround, while necessary, underscores the urgent need for a streamlined digital application process that can facilitate timely submissions and approvals.
A Shift to Digital Submissions
Recognizing the critical need for improvement, CDSCO has mandated that, starting August 15, 2025, all applications for the WHO-GMP CoPP must be submitted exclusively online through the ONDLS portal. This strategic shift aims to eliminate physical submissions, allowing for a more efficient and transparent approval process. The ONDLS portal will serve as a comprehensive platform for various drug licenses and certificates, effectively acting as a single-window solution.
The WHO-GMP CoPP is a vital document issued by a country’s drug regulatory authority. It certifies that a specific drug has been manufactured according to WHO GMP standards, paving the way for its registration and sale in international markets. However, delays in submissions have hampered the ability of pharmaceutical exporters to meet global demands promptly.
C-DAC’s Pioneering Role
In this endeavor, C-DAC plays a pivotal role in digitalizing the WHO-GMP CoPP application process in India. The organization has developed a robust digital system that simplifies the application submission, eliminating the need for manual and paper-based processes. This system not only streamlines the submission of applications but also provides valuable support to manufacturers and state authorities operating within the ONDLS framework.
C-DAC’s initiatives go beyond mere technological upgrades. The organization conducts training sessions and addresses queries related to the online system, ensuring that all stakeholders are well-equipped to navigate the new digital landscape. The emphasis on user education is crucial for fostering a smooth transition to the new application process.
Ensuring Compliance and Transparency
One of the key features of C-DAC’s digital system is its ability to verify crucial details electronically before processing CoPP applications. This includes validating manufacturing site registrations, technical staff information, and product data. By automating these verification processes, C-DAC aims to enhance transparency, accountability, and consistency in the issuance of WHO-GMP CoPP certificates across India’s states and union territories.
In India, obtaining a WHO-GMP CoPP involves a rigorous joint inspection process. Officials from both CDSCO and the SLA conduct these inspections to ensure compliance with GMP standards. This collaborative approach is designed to safeguard the quality of pharmaceutical products and maintain international standards for export.
The Role of Joint Inspections
For first-time applicants, the path to obtaining a CoPP begins with a thorough review of submitted documents, followed by a mandatory joint inspection. This inspection is crucial for verifying compliance with GMP guidelines and ensuring that manufacturing facilities meet the necessary criteria.
The CoPP is typically valid for three years; however, revalidation requires another joint inspection by the State FDA and CDSCO. This ongoing oversight ensures that manufacturing units maintain stringent quality controls and adhere to international standards. For ayurvedic products, the process similarly involves joint inspections by the Ministry of Ayush, CDSCO, and SLA.
Conclusion: A New Era for Pharmaceutical Manufacturing
The CDSCO’s commitment to streamlining the WHO-GMP CoPP application process marks a significant leap towards modernizing India’s pharmaceutical regulatory landscape. By embracing digital solutions, the organization seeks to alleviate long-standing challenges faced by manufacturers, particularly in the MSME sector. This initiative not only enhances operational efficiency but also strengthens India’s position in the global pharmaceutical market.
- The CDSCO is focusing on improving the online application process for WHO-GMP CoPP.
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C-DAC is instrumental in developing a digital system for streamlined submissions.
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The shift to online applications aims to eliminate delays and improve compliance.
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Joint inspections are crucial for ensuring adherence to GMP standards.
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The new system will provide ongoing support and training for users navigating the ONDLS portal.
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