As a step towards facilitating ease of doing business for boosting exports in the country, Union Health Ministry is mulling over to put in place a system for online disposal of export NOCs and WHO-COPP under SUGAM, which will bring transparency, predictability and reduce timelines considerably. This initiative will help in reducing the time lag in handling applications, create a hassle free environment and help industry save manpower and resources by avoiding personal follow-ups. Timelines to process Export NOCs and WHO-COPP which generally takes 15 days to 2 months can be brought down to seven to fifteen days time under SUGAM. The online system under SUGAM will help the reviewer gain access to all the documents and get real time data at both the ends for speedy disposal of certificates and permissions. SUGAM portal is equipped with a user-friendly dash board which acts as an interface between the exporter and regulatory agency. The Union health ministry had put in place SUGAM to strengthen the e-governance initiatives. In this regard, the Central Drugs Standard Control Organisation (CDSCO) had unveiled an online portal ‘Sugam’ in January 2016. Implementation of e-Governance at CDSCO through SUGAM portal has brought simplicity, transparency, reliability, accountability, timeliness and also simplified ease of business. In the first phase, digitization of applications for grant of registration certificates for import of drugs or import license of drugs in Form 10, under D&C Rules has been completed and is operational. In a communication to all the state regulatory authorities and the pharma industry associations, Drug Controller General of India (DCGI) Dr. GN Singh stated that the portal is intended for those who need to file applications for various services rendered by CDSCO. For security purposes and to avoid spams, it was decided that the applicants would need to pre-register themselves on the portal. SUGAM portal provides the single window for all its stakeholders to access the services provided by the portal by implementing role based access control and actions. It has consolidated the entire Drug Regulatory framework at centre and provides a centralized dashboard for monitoring the various regulatory clearances across the country. It also provides high level of transparency to its stakeholders as status of the submitted applications can be tracked from applicant dashboard. As well as, the portal is well integrated with the e-Nivesh that is the National portal to provide the project proponent/entrepreneur with all requisite information under one umbrella, which will reduce delays in various regulatory processes. SUGAM enables ease of business by providing the integrated workflow right from making an application for grant of permission/ license, online payment, online review process, query management and grant of permission/license online. It internally builds the database of drugs and manufacturers and their current regulatory status(approved/ banned) in India.
(Courtesy: http://www.pharmabiz.com/NewsDetails.aspx?aid=103411&sid=1