The Drugs & Cosmetics Act, 1940 and Rules there under have entrusted various responsibilities to Central & State regulators for regulation of Drugs & Cosmetics. It envisages uniform implementation of the provisions of the Act & Rules made there under for ensuring the safety, rights and well being of the patients by regulating the Drugs and Cosmetics. CDSCO along with State Regulatory Authorities is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
Online National Drugs licensing system (ONDLS) portal is developed by Centre for Development of Advanced Computing (CDAC) in coordination with Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India and State/UT Drugs Regulatory Authorities. ONDLS portal is a single window platform for online processing of various applications submitted by the applicants 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.
ONDLS will help in establishment of Uniformity w.r.t 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 Act and Rules by utilizing the latest technologies tools including e-governance through this online portal for State/UT Drug Control Authorities.
As there will be uniformity w.r.t 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.