India's pharmaceutical regulatory landscape is undergoing a major digital transformation as the Central Drugs Standard Control Organization (CDSCO) mandates exclusive online submissions for critical export certifications. The directive, issued on June 25, 2025, requires all applications for World Health Organization Good Manufacturing Practices (WHO-GMP) and Certificate of Pharmaceutical Product (COPP) to be submitted through the Online National Drugs Licensing System (ONDLS) portal beginning July 15, 2025.
Complete Phase-Out of Physical Applications
Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India, has explicitly stated that "physical files will not be entertained for approval of grant of manufacturing license and WHO-GMP (COPP) from 15.07.2025." This represents a complete departure from traditional paper-based regulatory processes that have governed India's pharmaceutical sector for decades.
All state and Union Territory drug controllers have been directed to ensure manufacturing units under their jurisdiction comply with the new digital-only submission requirements. Similarly, all zonal and sub-zonal offices of CDSCO will cease accepting hard copy applications after the specified deadline.
Strategic Digitization Initiative
The move forms part of the drug regulator's comprehensive initiative to digitize various application and approval processes, along with other administrative procedures related to pharmaceutical regulation. The primary objectives include streamlining regulatory processes and enhancing ease of doing business within India's pharmaceutical sector.
The ONDLS portal has been developed by the Centre for Development of Advanced Computing (C-DAC) in coordination with states for processing applications and online licensing across multiple categories, including sales and manufacturing licenses, blood center licenses, grant of manufacturing licenses, and large volume parenterals.
Single-Window Platform Features
The ONDLS portal functions as a single-window platform for online processing of various applications submitted by stakeholders for issuance of manufacturing and sales licenses, including blood banks, and other certificates such as COPP, GMP, WHO-GMP, and Market Standing certificates. The system also handles post-approval changes, providing comprehensive regulatory support through a unified digital interface.
Recent developments include C-DAC's creation of a dedicated online portal specifically for submission and processing of WHO-GMP (COPP) applications within the ONDLS framework. The portal offers advanced features including real-time tracking of application status, document management capabilities, and automated alerts designed to reduce processing times and improve communication between applicants and regulatory authorities.
Regulatory Uniformity and Compliance
The digital transformation is expected to establish uniformity regarding document submission requirements for different types of applications and license issuance throughout India. The system aims to support uniform administration of regulatory provisions by utilizing advanced technology tools, including e-governance capabilities through the online portal for State and Union Territory Drug Control Authorities.
According to CDSCO, this initiative will enhance transparency, accountability, and consistency in decisions made by state and UT drug controllers, creating process uniformity across the country. The COPP serves as vital documentation required for pharmaceutical product exports to multiple countries, providing evidence that products are authorized for sale in the exporting country.
Implementation Support
To ensure smooth transition, CDSCO has directed stakeholders to contact the C-DAC or ONDL support team and CDSCO for assistance regarding portal operations. The organization has urged all pharmaceutical manufacturers and related entities to familiarize themselves with the ONDLS system to ensure seamless compliance with the updated procedures.
This regulatory shift represents a significant milestone in India's pharmaceutical sector modernization, positioning the country's drug regulatory framework among the most digitally advanced globally while maintaining stringent quality and safety standards for pharmaceutical exports.
