The Gujarat Food and Drug Control Authority (FDCA) became the first state drug regulatory body to yet again develop and successfully implement the country’s first software for issuing manufacturing license through IT application called the drug manufacturing license application for allopathic (IDMLA). At present this services is available for issuing online APIs, single ingredients and formulations product license.
The aim behind this initiative is not only to bring in good governance to ensure public safety and transparency in the system, but also simplify the process of product approval for manufacturers. To monitor and ensure proper functioning of the approval of product licenses, the Gujarat FDCA has appointed 11 senior most experts from the team, which includes five joint commissioners and six deputy commissioners for this task.
Dr Hemant G Koshia, commissioner of the Gujarat FDCA informed that currently with the help of this application his office has details and access to 2,10,000 product licenses. Which gives them on the go information on the availability of the medicines in stock along with all the details of the manufacturers. This he said comes into a major play especially during endemics and disease outbreak like that of recent swine flu incident wherein Gujarat government had played a major role in providing medical assistance.
Dr Koshia further pointed out that there are a total of 32000 manufacturers in the state including from the allopathic, ayurvedic and other sectors from which, all the 22000 allopathic manufacturers including the loan licensees are registered with them under this software. Apart from that this software ensures the online issuance of around 1500 product licenses every month to different existing manufacturers without the need for them to travel to Gujarat FDCA office.
Dr Koshia stressed, “Our office has always aimed at adopting proactive changes by continuous improvements in our work that are key for ensuring drug safety and stakeholders satisfaction. This software, which negates the use of any paper work, is highly appreciated by the stakeholders as it saves lot of their precious time and energy. But most importantly it ensure to bring in transparency and speedy delivery of services that helps in further strengthening the healthcare in the state.”
Apart from issuing fresh license, renewal of licenses and additional product permission, Gujarat FDCA's IDMLA also has approved technical person's details, company profile, and certificate issue, inspection, sampling report and fresh firm registration as well.
As recognition of their efforts, Gujarat FDCA was awarded for its IDMLA software by the US-based International Data Corporation (IDC) with the e-iconic award that was recently held in Hyderabad. Incidentally, the Gujarat’s drug regulatory agency was the only government body to compete and get recognised among the top IT czars of the country.