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Delhi DC deptimplements online national drugs licensing system
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Laxmi Yadav, Mumbai
December 24 , 2021
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The Delhi drugs control (DC) department has implemented the online national drugs licensing system (ONDLS) for online processing of various licenses issued by the department including manufacturing and sales licenses, good manufacturing practice (GMP) certificates, etc.
According to a circular issued by AK Nasa, head, office of controlling and licensing authority, Delhi on December 15, 2021, drugs control department, Delhi has adopted the ONDLS and the same is now live with effect from December 3, 2021.
All the stakeholders including drug manufacturers, cosmetics manufacturers, blood centres, testing laboratories, chemists are directed to use the portal for all the services provided by the department, stated the circular.
The Central Drugs Standard Control Organization (CDSCO) in coordination with Centre for Development of Advanced Computing (CDAC) have developed ONDLS for online processing of various applications submitted by the applicants for issuance of manufacturing and sales licenses including blood centres and other certificates like certificate of pharmaceutical product (CoPP), GMP, WHO-GMP, market standing etc. and post approval changes.
ONDLS will 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. ONDLS will also help in uniform administration of the provisions of the Drugs and Cosmetics Act and Rules thereunder by utilizing the latest technologies tools including e-governance through this online portal for state/Union territory drug control authorities.
The CDSCO has come out with ONDLS following the direction from 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 type of applications as well as issuance of licenses in the country.
Amit Chawla, vice president of Indore unit of Laghu Udyog Bharati was part of the delegation called on the health minister three years back appealing to him to introduce a uniform drug licensing system across the country and increase the validity of WHO-GMP certificate from two years to three years.
Nadda assured the representatives of industry associations of taking steps in the direction of a single window platform for issuance of various licenses required by drugmakers in the country as well as enhancing the validity ofWHO-GMP certificate.Accordingly, the validity of WHO-GMP certificate was increased to three years by CDSCO in 2018 and online national drugs licensing system came into force from April 15, 2021. Delhi drugs control department adopted it early this month followed by Jammu Kashmir.
Hailing the implementation of online national drugs licensing system, Chawla said "With this, there will be uniformity with regard to all the activities carried out by state/UT drug control authorities, it will ensure transparency, accountability and consistency in their decision-making process as well as uniformity across the country.It will facilitate ease of doing business.Its implementation helps to achieve lower operational cost, improved access, reduced processing and dispatch of applications pending for approval of drugs and issue of licenses, said Chawla.
This will help the CDSCO build a database of various drugs being manufactured in the country, number of their manufacturing plants and manufacturers etc. These data are quite useful in pandemics like Covid-19, he added.
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