Union government sees its SUGAM National Drugs Licensing System to further strengthen the e-governance initiatives. The National Database of Manufacturers & Formulators along with the generation of unique ID for production sites will enable a smooth transition to the e-system. It will allow both operations agility and efficiency.
The data captured from the manufacturers provides a hands-on information of the pharmaceutical production and marketing activity in the country, said Shivani Nangia, project manager, e governance, Centre for Development of Advanced Computing (CDAC).
From details of user registration, manufacturing site, formulations, production and production capacity of site will now empower the government with an effective real time platform, she added.
In a presentation titled SUGAM and National Drug Licensing System, at a workshop for providing training to pharma manufacturers on drug approval under the recent amendments to the Drugs & Cosmetics Rules in Bengaluru, she said that registration on SUGAM portal for adding manufacturing unit and formulation details allows ease of application submission for licensing, tracking its status, grant of permission and related approvals. Further, it creates live statistics of the registered pharma companies, number of submitted applications, processed applications and inspections conducted.
With the Digital India, the country is on the surge of change and revolution. The drug control officials in general see the need to create simple, automated and efficient processes for the pharma industry. Moreover, the convergence of cloud computing, mobile technology, social media and big data analytics is reshaping the future of e-governance. States like Karnataka, Gujarat among others are already way ahead in these initiatives which have facilitated transparency and efficiency in operations. The e-system of licensing and drug approvals has seen to enable maximising the network-level effectiveness. The streamlined structure leads to faster turnaround and better performance. For the long run, the e-system is seen as a cost-effective approach. Its implementation helps to achieve lower operational cost, improved access, reduced processing and dispatch of applications pending for approval of drugs and issue of licenses.
Scope of work for national drug licensing system covers grant and renewal of licenses for manufacturing and sales of medicines, vaccines and blood products. Online system also issues certificates and no objection certificates (NOC). Further enforcement activities can be carried out by state drug controller officers. This is all enabled with the Management Information System(MIS) and Analytical platform.
The portal will also provide details of facility with regard to dosage, site, lab information and production capacity. There is also scope for queries to be posted on doubts about submission and cancellation of licenses.