The Central Drug Standard Control Organisation (CDSCO) is planning to launch an online portal for licensing the import of medical device from March, under SUGAM, an online solution for submission, application and grant of permission for the import of drugs, in compliance with Union health ministry's initiative of e-governance. The online issue of licences for new drugs is also under consideration of CDSCO.

At present the portal only provides benefit for the grant of registration certificates for import of drugs or import license of drugs. Soon the medical device industry can also avail the benefit of online grant of registration certificate and renewal of licence for the import of medical devices.

Dr G N Singh, Drug Controller General India (DCGI) says, “We will be launching the portal soon and this initiative will put the e-governance in place. So that the stakeholders get the licence in time and benefit of the devices are given to the patients on time. We want to reduce the regulatory requirement to the minimum. There should not be any regulatory hindrance for the industry which is doing so well. So we felt the need of launching the online portal for the medical device sector.”

Online licensing system provides an opportunity for user to apply for licenses through online licensing system. It also provides an option to track the status of application online through an application reference number provided by the system during the submission of application.

User can register themselves online for the user name and password and can access the portal by logging through valid login credentials to apply for licenses. An online interface for user to submit fresh applications, upload supporting documents, respond to queries from CDSCO officials. The user account lists out all the licenses held by it through the country, licenses issued, suspended and cancelled, details of the facilities for manufacturing at each location, import licenses details, details of the technical staff working at each facility etc.

The applicants who can apply for the licence includes importer, Indian agent, corporate, foreign enterprise holding Indian subsidiary and manufacturing unit.