A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Context
DOI:
https://doi.org/10.21276/61ct0k84Keywords:
Drug Classification System, Drug and Cosmetic Act India, Digitization of Prescriptions, Drug Schedules in India, Schedule H, Monitoring Drug Schedule SystemAbstract
Background: Current classification of medicines in India under Drug and Cosmetic Act into Schedule G, H, H1, X is outdated, evolved through patchwork over the years and needs to be thoroughly updated.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.
Downloads
References
Mashelkar D. A Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs. Ministry of Health & Family Welfare, Government of India; 2003.
AIOCD-AWACS, Pharma Trac. 2017.
Malik V. Law relating to Drugs and Cosmetics. 25 Edition 2016. Eastern Book Company, Lucknow.
United State Food & Drug Administration. Drug Safety and Availability. Available from: https://www.fda.gov/Drugs/DrugSafety/default.htm.[Accessed Aug 2017].
Therapeutic Goods Administration. Scheduling basics. Available from: https://www.tga.gov.au/scheduling-basics. [Accessed Aug 2017].
Medicines & Healthcare products Regulatory Agency. Medicines: reclassify your product. Available from: https://www.gov.uk/guidance/medicines-reclassify-your-product. [Accessed Aug 2017].
World Health Organization (WHO). Guidelines for Regulatory Assessment of Medicinal Products for Use in Self-Medication (Geneva 2000).
Ahmad A, Chandra S, Kanth K, Patel I, Parimalakrishnan, Mohanta GP, Balkrishnan R. Changing Pharmaceutical Regulation in India to Promote Rational Use of Antimicrobials. Asian Journal of Biomedical and Pharmaceutical Sciences 2012; 2(15): 1-5.
Suggestion from IPA on drug and cosmetic Rule 1945. The Indian Pharmaceutical Association. Available from: http://www.ipapharma.org/news/Suggestion%20from%20IPA%20on%20Drugs%20&%20Cosmetics%20Rules%201945.pdf. [Accessed Aug 2017].
Hypervitaminosis A. National Health Portal Of India. Available from: https://www.nhp.gov.in/disease/eye-ophthalmology-/hypervitaminosis-a. [Accessed Aug 2017].
Koutkia P, Chen T, Holick M. Vitamin D Intoxication Associated with an Over-the-Counter Supplement. N Engl J Med 2001; 345:66-67.
Ministry of Law and Justice. The narcotic drugs and psychotropic substances act,1985. Available from: http://lawmin.nic.in/ld/P-ACT/1985/The%20Narcotic%20Drugs%20and%20Psychotropic%20Substances%20Act,%201985.pdf. [Accessed Aug 2017].
Report of sub-committee constituted by the drugs consultative committee to examine the issue of regulating the sale of drugs over internet under the drugs and cosmetics rules, 1945; 30th September 2016. Available from: http://www.cdsco.nic.in/writereaddata/Sub-Committee%20Report%20on%20e-pharmacy.pdf . [Accessed Aug 2017].
Public consultation regarding regulation of sale of drugs in the country. Available from: http://www.cdsco.nic.in/writereaddata/public%20notice16march.pdf. [Accessed Aug 2017]
United State Food & Drug Administration. Prescription to Over-the-Counter (OTC) Switch List. Available from: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm106378.htm. [Accessed Aug 2017].
World Health Organization (2000). Guidelines for Regulatory Assessment of Medicinal Products for Use in Self-Medication; 2000. Available from: http://apps.who.int/medicinedocs/pdf/s2218e/s2218e.pdf [Accessed Aug 2017].
Downloads
Published
Issue
Section
License
Copyright (c) 2024 International Archives of BioMedical and Clinical Research
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors are required to sign and submit the completed “Copyright transfer Form” upon acceptance of publication of the paper. This is determined by a publishing agreement between the author and International Archives of Biomedical and Clinical Research. These rights might include the right to publish, communicate and distribute online. Author(s) retain the copyright of their work. International Archives of Biomedical and Clinical Research supports the need for authors to share, disseminate and maximize the impact of their research.