CDSCO to go online for all services in next six months
The Central Drugs Standard Control Organisation (CDSCO) had declared to have its own online portal which is “Sugam” for submission of documents on 16 September 2015 and launched the portal on November 2015. Now CDSCO has set to create the full-fledged Sugam portal to help companies submit their proposal online.
Currently CDSCO has digitalized 60-70 % of its services on the portal, now agency has planned to completely digitalize the portal within next six months. Companies now can send the sample to CDSCO at Kasauli, Himachal Pradesh, India to receive certificate. Companies will receive the Certificate of analysis online itself. Within upcoming six to seven months CDSCO will not require any physical document.
Firms can apply online for license, ethics committee approval, import license of drugs in form 10, under D & C act. Firms can also apply online for license of medical devices; they also can submit approval for clinical trial.
CDSCO has recently started process for online submission for clinical trial approval for Biologicals (Vaccines) on Sugam. CDSCO will issue the certificate online after submission of required documents.
The agency is in process of starting online submission for clinical trial approval of new chemical entity. Within next three months CDSCO will be starting submission for FDC approval, grant of Certificate of Pharmaceutical Product to WHO GMP certified manufacturing units where inspections have been conducted.
CDSCO has integrated all their seven laboratories with Sugam portal and all the required data has been made in electronic state. CDSCO has developed database of drug retailers and wholesalers from ten states which includes Maharashtra, Goa, Delhi, and Gujarat which will be available on Sugam portal.
Some states have started online process for grant of drug distribution and manufacturing licences. These portals are affiliated to CDSCO which enables to get all the data generated through system. It will also provide security to all the documentation
CDSCO is also establishing a database of drug trader and manufacturer for every state which will be available to all. Recently ministry of health and family welfare will be applying new medical devices rules which will take effect from January 2018. Any agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, intending to import medical devices, will require to submit the documentation on Sugam portal.
The aim of CDSCO e-governance is to bring transparency, accountability and speed up the documentation process. It will allow making Indian pharmaceutical market a better place for foreign investment.