Drugs Manufacturing License Allocation (DMLA): An Effective Tool for e-Governance in fields of Drugs Manufacturing Regulation

  • Zuki Patel Visiting Professor
  • Shrikalp Deshpande
  • Hemant Koshia
  • Purva Patel

Abstract

Gujarat's Food & Drug Control Agency (FDCA) oversees the manufacturing and sales of food, drugs, and cosmetics. The FDCA is the organisation in charge of giving licences to parties involved in the production and sale of pharmaceuticals and related goods, such as drug makers, wholesalers, retailers, stockists, C&F agents, etc. The enforcement mission is to achieve the goal of making safe and effective medications available by ensuring that the menace of the production of fake/substandard drugs is eliminated. Access to information that is current and accurate, as well as the ability to speak with stakeholders clearly and promptly, are essential for enforcement actions. The enforcement task was dependent on manual methods before the initiative to incorporate software, SMS notifications, etc. The initiative “DMLA- Drugs Manufacturing License Allocation” is a web based IT solution, http://dmla.guj.nic.in/mfg/myaccount/Home.aspx, with data stored in the central server. The introduction of the new system has strengthened the enforcement function. It has helped to achieve and maintain FDCA's leadership in drug regulation in India by bringing consistency, speed, accuracy, effectiveness, accountability, and transparency to G2G, G2C, and G2B operations.

Keywords: Gujarat's Food & Drug Control Agency (FDCA), DMLA- Drugs Manufacturing License Allocation, iDMLA portal, DCGI

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References

1. India. CDSCO. Drugs and Cosmetics Act, 1940 & Rules thereunder. India: Government of India, Ministry of Health and Family Welfare; 2016 Dec 31.
2. Food & Drugs Control Administration, Gujarat; Drugs Manufacturing Licence (Allopathic) - DMLA [Internet]. Gujarat: FDA, Govt. Of Gujarat; 2023 [cited 2023 Apr 05]. Available from:
https://dmla.gujarat.gov.in/mfg/myaccount/Home_New.aspx
3. Food & Drugs Control Administration, Gujarat; Industry Portal for Drugs Manufacturing Licence (Allopathic)-IDMLA [Internet]. Gujarat: FDA, Govt. Of Gujarat; 2023 [cited 2023 Apr 05]. Available from:
https://idmla.gujarat.gov.in/mfg/myaccount/Home_New.aspx
4. Gujarat State Wide Area Network (GSWAN) [Internet]. Gujarat: Govt. Of Gujarat; 2004 Feb 28 [cited 2023 Apr 05]. Available from:
https://gswan.gujarat.gov.in/
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How to Cite
Patel, Z., S. Deshpande, H. Koshia, and P. Patel. “Drugs Manufacturing License Allocation (DMLA): An Effective Tool for E-Governance in Fields of Drugs Manufacturing Regulation”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 58-63, doi:10.22270/ijdra.v11i2.595.

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