A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Context

  • Prashant Tandon Founder 1mg Technologies Private Limited 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001
  • Varun Gupta VP & Head Medical Affair 1mg Technologies Private Limited, 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001
  • Ashish Ranjan Manager Medical Affair 1mg Technologies Private Limited, 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001
  • Purav Gandhi Founder, Remedy Social, C/602, Tulip Citadel, Shreyas Tekra, Ambawadi, Ahmedabad 380015, Gujarat
  • Anand Kotiyal Drug Data Analyst Medical Affair, 1mg Technologies Private Limited, 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001
  • Aastha Kapoor Manager Medical Affair 1mg Technologies Private Limited, 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001
Keywords: Drug Classification System, Drug and Cosmetic Act India, Digitization of Prescriptions, Drug Schedules in India, Schedule H, Monitoring Drug Schedule System

Abstract

Background: Current classification of medicines in India under Drug and Cosmetic Act into Schedule G, H, H1, X is outdated, evolved through patchwork over the years and needs to be thoroughly updated. The primary aim of the scheduling system is to ensure appropriate access to medicines while balancing public health and safety. India is experiencing a rapid transition with the rising burden of chronic non-communicable diseases where regular access of affordable medicines is critical for chronic disease management to prevent complications.

Methods: We analyzed drugs commonly selling across India, through multiple information sources including 1mg drug database, PharmaTrac (AIOCD-AWACS), inventory data from distributors and retailers, performed extensive literature review and expert interviews. We studied different regulatory systems globally to understand best-practices and identify recommendations.

Results: We identified series of lacunae in current drug classification system and its implementation. Out of approximately 1,600 commonly prescribed medicines, only 656 are currently covered under the four Schedules. There are multiple overlaps in terms of drug substances covered under these schedules resulting in ambiguity. 

Conclusions: We have recommended a revised drug classification system that is more comprehensive in coverage and eliminates the overlaps between classes. Moreover, considering the implementation challenges for such a drug classification system in the diverse and fragmented ecosystem in India, we recommend a technology backed platform to help monitor the implementation.

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Published
2017-09-23
How to Cite
1.
Tandon P, Gupta V, Ranjan A, Gandhi P, Kotiyal A, Kapoor A. A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Context. IABCR [Internet]. 23Sep.2017 [cited 21Jul.2019];3(3):I-VII. Available from: https://iabcr.org/index.php/iabcr/article/view/66