The Gujarat’s Drug Manufacturing licence Application (DMlA) software, an online platform for granting manufacturing licences in the State, has drawn the attention of the Central Government.
Union Health Secretary Preeti Sudan recently asked all the States to replicate the Gujarat model DMlA that enables drug regulators to deliver paperless services on time for granting product licenses to the pharma firms in the country.
The DMlA enables regulators to deliver efficient paperless services on time for granting product licenses for APIs, single ingredients and formulations under the allopathic segment.
Under the programme, all the pharma manufacturers under the allopathic segment apply for product license in the State through online only.
Implemented by the Gujarat Food and Drugs Control Administration’s (FDCA) DMlA also registers technical person’s details, company profile, certificate issue, inspection, sampling report and fresh firm registration, apart from issuing fresh license, renewal of licenses and additional product permission.
Sudan’s suggestion to States to implement the DMlA came at a meeting where many state representatives from the Food and Drug Administration (FDA) Departments expressed their difficulties to integrate with “SUGAM” portal, central government’s modules for having data of manufacturing sites and products.
Sudan said that those “States who are yet to establish the online processing and database should use the software platform used by Gujarat which has been prepared by National Informatics Centre(NIC). She mentioned that NIC shall examine the Gujarat software, which may be modified, if required for online submission and review of applications for grant of sale and manufacturing licences and comprehensive database. This software may be used PAN India, for uniform implementation, she said.
Gujarat FDCA office on an average receives 1,500 product license application every month. This generates instant information on total number of product licenses granted on real time basis thereby offering easy access to the availability of medicines in stock along with all the details of the manufacturers, said FDCA Commissioner Dr HG Koshia in his presentation shared with the state drug controllers in the presence of Sudan here recently.
The Gujarat FDCA has been able to grant a total of 2,56,750 product licenses and 450 plus manufacturing licenses through the online platform over the past seven years, said Dr Koshia.
Gujarat FDCA has also been able to dispose of applications related to issuing licenses to wholesalers and retailers online till date in a time bound manner since the introduction of online extended licensing, he added.