Online application for granting product licenses i.e. Drug Manufacturing License Application (DMLA) created by the Gujarat Food & Drugs Control Administration (FDCA) will become role model for National Level implementation. This indication was given by Dr S Eswara Reddy, Drugs Controller General of India (DCGI) in a meeting of Drug Consultative Committee held on 9th April to deliberate on aspects related to use of information technology which can be aligned with the drug regulations. This will also become a part of Digital India vision of Prime Minister Shri Narenda Modi.
The Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the entire gamut of Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). Ms. Preeti Sudan, Secretary, Health and Family Welfare, Government of India guided the senior officials in the meeting about recent developments in the field. There was discussion about challenges and problems and how to improve Digitalization in the system.
Ever since the online system was launched the drug regulator FDCA, Gujarat is granting a total 2000 product licenses every month. Since the year 2011, total of 2,56,750 product licenses and 450 plus manufacturing licenses have been granted by FDCA. This unique industry-friendly DMLA application is going on national platform under the guidance of Dr Hemant G Koshia, commissioner of the Gujarat FDCA. 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 has a database of 3,56,000 products based in Gujarat.
For implementation at national level, Gujarat FDCA officials will work in association with National Informatics Centre (NIC). The app will be useful for Bulk products, Formulations, Drug Licensing, Fee payment and Digital Signature etc. The app will be helpful 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. It is an ICT tool to provide and improve internal or external government to government services, transactions and interactions.