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Centre extends deadline for online submission of WHO-GMP COPP applications till August 15
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Gireesh Babu, New Delhi
July 17 , 2025
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The Drugs Controller General of India (DCGI) has extended the deadline for mandating online submission of World Health Organization (WHO) Good Manufacturing Practices (GMP) Certificate of Pharmaceutical Product (CoPP) till August 15, 2025 following concerns raised by various industry associations.
The Central Drugs Standard Control Organisation (CDSCO) will be conducting multiple sessions with the stakeholders to support them to onboard the online licensing system and submit applications for smooth transition.
The central drug regulator, in a circular on June 25, mandated that all applications for WHO-GMP CoPP should be submitted only online through the Online National Drugs Licensing System (ONDLS) from July 15 onwards and no physical files will be accepted thereafter.
The move was part of the drug regulator's ongoing initiative to digitise various application and approval processes, along with other administrative procedures related to pharmaceutical regulation, in order to streamline the process and bring in ease of doing business.
However, CDSCO observed that several manufacturers are still in the process of registering and uploading documents onto the ONDLS portal.
"We have also received representations from various industry associations highlighting challenges in onboarding on ONDLS portal and they need more time to complete the process," said the drug regulator in a letter to the state drug controllers.
"In view of these concerns and to support industry interests, the deadline is hereby extended up to 15.08.2025," said Dr Rajeev Singh Raghuvanshi, DCGI in the communication.
Following this decision, the DCGI requested the State drug controllers to direct the manufacturing units in their jurisdiction to submit application for the approval of the said certificate through ONDLS portal from August 15.
"It may be noted that physical files will not be entertained for approval of grant of manufacturing license and WHO-GMP (CoPP) from 15.08.2025," said the DCGI. He added that, meanwhile, CDSCO is organising multiple knowledge sessions at Zonal/Sub-Zonal levels.
"Stakeholders may like to attend these sessions for more clarity on the online process, if required," added the regulator. It also directed the stakeholders to contact the Centre for Development of Advanced Computing (C-DAC) in certain email IDs, for any assistance regarding the ONDLS portal.
The ONDLS portal has been developed by the C-DAC in coordination with States for processing of application and online licensing of sales and manufacturing license, blood centre license, grant of manufacturing license, and large volume parenteral.
The ONDLS portal is designed as a single window platform for online processing of various applications submitted by the stakeholders for issuance of manufacturing and sales licenses including blood banks, and other certificates like CoPP, GMP, WHO-GMP, Market Standing certificate etc., and post approval changes.
It is also expected to help in establishment of uniformity with regard to the requirement of submission of documents for different type of applications as well as issuance of licenses/ permissions throughout India and support uniform administration of the provisions of the Act and Rules by utilising the latest technologies tools including e-governance through the online portal for state/UT Drug Control Authorities.
This is expected to enhance transparency, accountability, and consistency in the decision of the State and UT drug controllers, making process as well as uniformity across the country, says the Centre.
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