Last Updated on July 23, 2025 by The Health Master
WHO-GMP
The Central Drugs Standard Control Organization (CDSCO) has announced a special and important move towards digitalization, making it mandatory for all manufacturing units to submit applications for WHO-GMP and COPP (Certificate of Pharmaceutical Product) approvals exclusively through the ONDLS portal starting July 15, 2025.
This initiative will streamline the application process and eliminate physical file submissions.
The ONDLS portal has already been in use for various online licensing processes, including:
- Sale licenses,
- Manufacturing licenses,
- Blood center licenses, and
- Manufacturing licenses for large-volume parenterals.
CDAC recently developed the dedicated online module for WHO-GMP and COPP applications on the ONDLS portal.
Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General (India), has issued a letter to all State and Union Territory Drugs Controllers to ensure compliance within their jurisdictions.
Zonal and Sub-Zonal offices have also been instructed not to accept hard copies of WHO-GMP and COPP applications after the July 15th deadline.
To apply for a WHO-GMP certificate and/or COPP certificate through the ONDLS portal, manufacturing units must first ensure their license and product details are approved on the portal.
The step-by-step procedure is as follows:
- • Registering the manufacturing site.
- • Registering details of the current technical staff.
- • Adding all licensed products and basic license data via the old license management system.
- • Submitting the license data to the relevant state drug regulatory authority for approval.
- • Once the state drug regulatory approves the data, a new license number will be generated against the old one.
- • Only after data approval can the COPP application be filed.
For any assistance regarding the ONDLS portal, users can contact CDAC at:
- uttamkumar@cdac.in
- ondlssupport-noida@cdac.in
and CDSCO at:
- it-cell@cdsco.nic.in
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Standardizing Approval Formats: CoPP and WHO GMP certificates
Brazilian Regulators successfully completes GMP Audit of Alembic Pharma
Indian Pharma Industry to face New GMP Regulations Compliance
USFDA approval granted for Prucalopride Tablets
USFDA inspection: At Unichem with 3 observations: Roha
USFDA inspection: At Natco Pharma with 7 observations: Hyderabad
FSSAI: Food Labelling and Display – Chapter-19
Role of pharmacist in Healthcare system
Counterfeit Cholesterol Drugs Seized in Hyderabad: DCA Telangana
Drug alert: 186 drug samples declared as NSQ in May 2025
Key Notes on Revised Schedule M: API Part-6
