Gujarat FDCA Rolls Out Online Pharma Certificates to Streamline Process

This digital approach is part of the Gujarat FDCA's commitment to leveraging technology for governance, evident in the launch of the FDCA-mDMLA mobile app.

The Gujarat Food and Drugs Control Administration (FDCA) is set to streamline the procurement process for medicines by introducing online availability of Non-Conviction Certificates (NCC) and Performance Certificates (PC) for pharmaceutical companies.

The move towards online issuance of certificates is a strategic step to enhance the drug regulatory system in Gujarat, making it more efficient and time-saving. This initiative aligns with the preparations for the upcoming 10th Vibrant Gujarat Global Investor Summit (VGGS)-2024.

Dr H G Koshia, commissioner, Gujarat FDCA & Pharma Guardian Officer, Gujarat, said, "Making NCC and PC for pharma companies available online will make the procurement process of medicines, which is generally implemented through Government tenders, seamless and less time-consuming."

He highlighted that the online availability of NCC and PC for pharmaceutical companies aims to facilitate the Ease of Doing Business (EoDB).

This digital approach is part of the Gujarat FDCA's commitment to leveraging technology for governance, which is evident in the launch of the FDCA-mDMLA mobile app on Good Governance Day, December 25, 2023. Gujarat has become the first state in India to issue online licences for allopathic medicines through this mobile app.

The m-governance app consolidates various online platforms into a unified interface, offering stakeholders seamless real-time access to the status of their applications.

Further, Dr Koshia emphasised that the app caters to 24 categories, covering key licence-related functions such as online Extended Licensing Node (XLN), drug manufacturing licence application (DMLA), iDMLA, COSMLA, AYUMLA, and CERTIFICATE.

The primary beneficiaries of this mobile app include around 6,000 manufacturers and over 52,000 drug sellers in the state, fostering ease of doing business and providing access to relevant operations, services, and information anytime, anywhere.

The mobile application aligns with principles of accountability, transparency, inclusivity, uniformity, and timeliness, enhancing the overall regulatory framework without disrupting existing systems and protocols.

The issuance of NCC is crucial for pharmaceutical manufacturers participating in government tenders, as it declares that the licensee has not been convicted of violations related to the Drugs and Cosmetics (D&C) Act, 1940, and Rules 1945 for sales units.

By introducing online certificates, Gujarat FDCA aims to expedite the procurement process, mainly through government tenders, contributing to a more efficient and streamlined pharmaceutical supply chain in the state.

This initiative reinforces Gujarat's commitment to embracing digital solutions in governance and sets a precedent for other states in India to enhance their drug regulatory systems through technology-driven approaches.

The digital transition is expected to significantly benefit pharmaceutical stakeholders, particularly MSMEs, by reducing administrative hassles and ensuring a smoother regulatory experience.