Gujarat Pioneers Online Licencing for Allopathic Medicines through FDCA-mDMLA Mobile App

The mobile app encompasses a total of 24 categories, covering key licence-related functions such as online Extended Licencing Node (XLN), drug manufacturing licence application (DMLA), iDMLA, COSMLA, AYUMLA, and CERTIFICATE.

In a move toward good governance practices, Gujarat has become the first state in India to issue online licences for allopathic medicines via the newly launched FDCA-mDMLA mobile app. The state Chief Minister, Bhupendra Patel, inaugurated the mobile application on Good Governance Day, December 25, 2023.

The FDCA-mDMLA mobile app is a significant step towards merging all online platforms into a unified system, offering faster and real-time access to the status of applications.

The mobile governance (m-governance) app is designed to facilitate the issuance of licences for allopathic medicines and assist ayurvedic medicine and cosmetic manufacturers and sellers, making it a comprehensive e-governance initiative. A senior FDA official of the Assistant Commissioner rank will oversee the m-governance system.

Dr HG Koshia, commissioner of Gujarat Food and Drug Control Administration (FDCA), highlighted the pioneering nature of the mobile app, saying, "FDCA Gujarat is the first in the country to develop a mobile app to better deliver these services to stakeholders. The direct benefit of this mobile app is that under ease of doing business (EODB), around 6,000 manufacturers and more than 52,000 drug sellers of the state will be able to access their related operations, services, and information through mobile anywhere at any time."

The mobile app encompasses a total of 24 categories, covering key licence-related functions such as online Extended Licensing Node (XLN), drug manufacturing licence application (DMLA), iDMLA, COSMLA, AYUMLA, and CERTIFICATE.

Applicants can obtain all digitally signed licences, certificates, and approvals through the mobile app, allowing them to track the status of their applications conveniently.

Dr Koshia emphasised the comprehensive nature of the mobile app, stating, "Moreover, all the services of the Right of Citizens to Public Service (RCPS) Act are also covered in the app."

The transition from e-governance to m-governance marks a significant advancement for Gujarat FDCA, bringing accountability, transparency, inclusivity, uniformity, and timeliness to all stakeholders. The shift to an m-governance model aims to centralise regulatory information, licencing rules, procedures, protocols, and processes for licensees on a single platform, enhancing accessibility.

Previously, operations were conducted offline, requiring applicants to visit the office in person for application submission, follow-ups, and licence collection.

The FDCA and the National Informatics Centre (NIC), Government of India (GoI), collaborated to create the web portal cosmla.gujarat.gov.in in 2011, streamlining the issuance of licences with transparency and rigorous regulatory oversight.

Since its development, the Gujarat FDCA's online platform and DMLA software have facilitated efficient, paperless services for granting product licences for APIs and formulations in the allopathic segment.

The state also introduced an online XLN system in 2007 to grant retail/wholesale sales licences online. Chief Minister Bhupendra Patel had previously launched the cosmetic manufacturing licence portal on December 1, 2022, as part of Gujarat's good governance initiative, aiming to enhance transparency, accountability, and efficiency in the licensing process.