Mumbai : In order to streamline the process of issuance of WHO-GMP Certification Scheme for Certificate of Pharmaceutical Products (CoPP) through online mode to boost exports, the Gujarat Food and Drug Control Administration (FDCA) has introduced online facility for submission of applications for WHO-GMP CoPP with QR Code for first time in country through its DMLA software.
Since its development in 2011 jointly by Gujarat FDCA and National Informatics Centre (NIC), the DMLA online platform has been able to grant till date manufacturing and sale license online by Gujarat FDCA in the country.
“Gujarat FDCA has started issuing CoPP with QR Code online since the last one week for the first time in the country,” according to Gujarat FDCA Commissioner Dr H G Koshia while talking about the new feature in online platform and how it will be able to boost exports.
He further added, “DMLA online platform has been replicated across the country and has been an incentive for Gujarat drug manufacturers in a major way. Gujarat FDCA has also been able to dispose of applications online related to issuing licenses to wholesalers and retailers in a time bound manner since the introduction of online Extended Licensing Node (XLN) system set up in the state in 2007.
Following Gujarat online licensing model for sales licenses, 16 states replicated the model in the country. There are 40,000 plus retail and wholesale licensees in the state of Gujarat. At the time of introduction of the online system, there were 15,000 registered sale licensees in the state in 2007, which have also been digitised.
With the implementation of the online system, the process is now paperless and less time consuming. It is easier for the regulator and licensee to track the process of scrutiny through a seamless online documentation process till final issuance of license.
Gujarat government has also revised timelines for grant of manufacturing licenses and renewal of licenses to 60 days and that of grant and renewal of sale licenses to 30 days as part of Pharma Vision 2020 under the Right of Citizens to Services for speedy issuance of licenses.
With growing emphasis on boosting SMEs to help meet the regulatory requirements of not only India but also other major markets like US, Europe and Japan, there is an urgent need for the manufacturers who are revised schedule M compliant to upgrade to WHO GMP and those who are WHO GMP compliant to upgrade to US FDA or EDQM compliance.