Union Health Ministry has directed all the state drugs control authorities to start utilising common software platform (statedrugs.gov.in) to process application for grant of drug manufacturing license.
The Drugs Consultative Committee (DCC) in its 56th meet recommended on the development of common software platform with support from Centre for Development of Advanced Computing (C-DAC) for online filing and processing of application for grant of drug manufacturing license.
C-DAC is an autonomous scientific society of Ministry of Electronics and Information Technology (MeitY), Government of India
It was also recommended the programme should be rolled out pan-India for which training has already been provided to 5 officials of various state drugs control departments by the C-DAC on June 10, 2019.
All state drugs control authorities should utilise common software platform (statedrugs.gov.in) by obtaining login ID and password and validating all application formats. This can be done by getting dummy application from stakeholders or if already validated should start using it in full-fledged manner.
In case of any problem, the stakeholders have been directed to mail IT helpdesk at email@example.com and can also take support from zonal or sub-zonal heads of Central Drugs Standard Control Organization (CDSCO).
The Union Health Ministry had launched SUGAM portal which enables online submission of applications requesting for permissions related to drugs, clinical trials, ethics committee, medical devices, vaccines and cosmetics. The system also builds up the database of approved drugs, manufacturers and formulations, retailers and wholesalers in India.
The project also enables complete digitization of the old CDSCO records having primarily application within the file, noting in green sheet and supporting documents.
CDSCO had also directed concerned stakeholders in the recent past to file online applications of veterinary drugs on the new SUGAM module.
The aim of the exercise is to initiate a comprehensive e-governance programme to fast track approvals and bring in transparency in the operations.
A new SUGAM module for filing online applications of veterinary drugs has been launched on the portal. All stakeholders are requested to use this facility and any suggestions to improve the services shall be addressed appropriately, the notice further stated.
Implementation of e-governance at CDSCO through SUGAM portal has brought simplicity, transparency, reliability, accountability, timeliness and also simplified ease of business.
It is a project of national importance that directly reflects the government’s Digital India initiatives and is a major influence in bringing reforms in the Indian pharma industry.