Gujarat FDCA to issue product licences, certificates online soon
Gireesh Babu, Mumbai

The Gujarat Food and Drugs Control Administration (FDCA), in collaboration with National Informatics Centre (NIC), will soon launch a software programme to issue product licences and various certificates online for the pharmaceutical companies in the state. The FDCA will also be preparing a complete database of product licenses issued by the authority till date. With this, Gujarat will be the first state in the country to introduce online product licensing services for the pharmaceutical industry.

The Gujarat division of NIC, the e-governance service-providing arm of Department of Information Technology, is preparing the software for online product licensing and certification after the successful implementation of e-governance software for issuing sales license for pharmaceutical traders in the state. The online product licensing programme is expected to be completely operational within three months, according to FDCA officials.

The FDCA is planning to compile the data of total product licenses issued in the state through a four-month campaign with the help of the industry. The authority will open a web page from May 23 and will distribute separate identity and passwords for each licensed manufacturers to enter their product details.

In the first week from May 23, the authority will ask the companies to provide primary details of the firms even as the second week will be for the companies to provide further details like the information about the technical staff and quality control team in the firm. As the third and final stage of data compiling campaign, the authority will ask the companies to provide product details within a time span of two weeks.

"Collecting the details of products from more than 3000 licensed firms in the state is a Herculean task and we wanted to complete the project as early as possible. With this campaign, we will compile the information in four weeks and will ask our district officers to crosscheck the inputs before finalisation," said a senior official from FDCA. The authority has a budgetary allocation of Rs 25 lakh for preparing the software for online product licensing.

The official added that the authority will be able to issue product licenses, Certificate of Pharmaceutical Products (COPP) and performance certificate, which does not require site inspection, through online after the launch of the new software.

"More pharmaceutical companies in the state are expanding their operations in exports and the authority has to handle a large number of applications like COPP within a short period. With the new software, we would be able to issue the certificates within 24 hours after submission of application," said the official. The FDCA has issued 750 product licenses per month up to March 2008, even as the number increased to 850 product licenses per month from the new financial year started on April 2008.

Similar to its software prepared for issuing sales licenses, the new software will also work as a centralized monitoring system, wherein the actions from the entire district licensing offices could be verified from the headquarters. Under the system, the head of the authority is able to avail details of the activities like the number of applications filed for license, total number of licenses issued, license applications on pending, reason for delay of process, duration of licensing process in each application and the number of applications rejected.

Source: www.pharmabiz.com
21st May 2008

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