The Gujarat Food & Drugs Control Administration (FDCA) is set to expand the facility of its online application for granting product licenses, drug manufacturing license application (DMLA) for cosmetics and Ayush products as well soon. Currently, DMLA, which has enabled the regulators to deliver efficient paper less services on time, while reducing the challenges for the stakeholders is adopted only for granting product licenses for APIs, single ingredients and formulations under the allopathic segment.
 
Under this programme all the manufacturers under the allopathic segment should apply for product license in the state through online only. Apart from issuing fresh license, renewal of licenses and additional product permission, Gujarat FDCA's DMLA has approved technical person's details, company profile, and certificate issue, inspection, sampling report and fresh firm registration as well.
 
Dr Hemant G Koshia, commissioner of the Gujarat FDCA informed that on an average his office receives 1500 product license application every month. This gives them instant information on total number of product licenses granted till date giving them easy access to the availability of the medicines in stock along with all the details of the manufacturers, whenever needed.
 
He further informed that ever since the online system was launched the drug regulator has granted a total number of 70,00,000 (seventy lakh) product licenses comprising of both the APIs and formulations. While at the same time they have a data of 2,20,000 (two lakh twenty thousand) product licenses granted, which he stated includes the legacy data of 1.5 lakh product licenses granted before the launch of DMLA.
 
“We have verified, digitalized and frozen all these data into our server, which instantly helps us in retrieving any information we require on this matter. Not only has it eased our workload and raised our working standards, but also helped to bring in good governance to ensure public safety and transparency in the system, It has also simplified the process of product approval for manufacturers. Keeping all this in view we are seriously contemplating to even extend the benefits of this model to other segments like cosmetics and Ayush products. This may take some time but  we do have an excellent example to go by. For the time being it is too early  to say by when we will start, as things are still at very initial stage,” he added.
 
In another strategic development, Dr Koshia informed that after getting worldwide recognition for its XLN software, the Gujarat FDCA was recently recognised for its unique industry friendly DMLA application with Elets Knowledge Exchange 2015 award. The state drug regulator was awarded under the Government to Government (G2G) project of the year category to have used ICT tools to provide and improve internal or external government to government services, transactions and interactions.