Last Updated on January 14, 2024 by The Health Master
In a bid to facilitate ease of doing business, the Drugs Controller General of India (DCGI) has directed all state and union territory drug controllers to adopt the Online National Drugs Licensing System (ONDLS) portal for the issuance of sales and manufacturing licenses with immediate effect.
So far, only two Union territories—Delhi, Haryana and Jammu and Kashmir have launched the ONDLS portal.
Jammu & Kashmir: On November 30, 2021, Jammu and Kashmir launched ONDLS for all types of regulatory clearances in an endeavor to secure ease of doing business.
Delhi: On December 3, 2021, Delhi launched ONDLS for all types of regulatory clearances in an endeavor to secure ease of doing business.
Haryana: On December 19, 2021, Haryana launched ONDLS for all types of regulatory clearances in an endeavor to secure ease of doing business.
The Central Drugs Standard Control Organization (CDSCO) in collaboration with Centre for Development of Advanced Computing (CDAC) has designed and developed ONDLS for all states and UTs which shall issue all regulatory clearances related to manufacturing, blood centers, retail sale and wholesale under the provisions of Chapter IV of Drugs and Cosmetics Act, 1940.
ONDLS will help in the establishment of uniformity with regard to the requirement of submission of documents for different types of applications as well as issuance of licenses/ permissions throughout India.
On August 4, 2021, the Directorate General of Health Services dashed a letter off to all state and Union territory drug controllers asking them to complete the registration process and mapping of the officers in the ONDLS portal in coordination with CDAC.
Despite the DGHS letter, state and UT drug controllers have not taken steps to make the ONDLS operational.
As the matter is of national importance, DGCI Dr V G Somani has on December 17, 2021, written to state and UT drug regulatory authorities requesting them to make ONDLS functional immediately in their jurisdiction by making the system live in coordination with CDAC officials.
In case of any problem or any training with regard to the same, state drug regulators can advise their concerned officials who is well versed in such work to contact CDAC officials—Rahul Gautam and Anant Patel.
DCGI has further requested states and UT drug controllers to furnish the status on a weekly basis every Monday.
Dr Somani has also appealed to the director of CDAC to direct his team to coordinate with states and UTs.
The CDSCO has come up with ONDLS, following the direction from the health ministry. Several industry associations, including Laghu Udyog Bharati, called on JP Nadda, then Union minister of health and family welfare, urging him to bring uniformity in documents required for different types of applications as well as the issuance of licenses in the country.
ONDLS will help the CDSCO build a database of various drugs being manufactured in the country, including the number of their manufacturing plants and manufacturers, etc. This data is quite useful in pandemics like C-19.
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