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

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dc.contributor.authorTandon, Prashanten_US
dc.contributor.authorGupta, Varunen_US
dc.contributor.authorRanjan, Ashishen_US
dc.contributor.authorGandhi, Puraven_US
dc.contributor.authorKotiyal, Ananden_US
dc.contributor.authorKapoor, Aasthaen_US
dc.date.accessioned2019-11-16T07:25:50Z
dc.date.available2019-11-16T07:25:50Z
dc.date.issued2017-07
dc.description.abstractBackground: Current classification of medicines in India under Drug and Cosmetic Act into Schedule G, H, H1, X is outdated, evolved through patchwork over the years and needs to be thoroughly updated.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.en_US
dc.identifier.affiliationsFounder 1mg Technologies Private Limited 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001en_US
dc.identifier.affiliationsVP & Head Medical Affair 1mg Technologies Private Limited, 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001en_US
dc.identifier.affiliationsManager Medical Affair 1mg Technologies Private Limited, 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001en_US
dc.identifier.affiliationsFounder, Remedy Social, C/602, Tulip Citadel, Shreyas Tekra, Ambawadi, Ahmedabad 380015, Gujaraten_US
dc.identifier.affiliationsDrug Data Analyst Medical Affair, 1mg Technologies Private Limited, 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001en_US
dc.identifier.affiliationsManager Medical Affair 1mg Technologies Private Limited, 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001en_US
dc.identifier.citationTandon Prashant, Gupta Varun, Ranjan Ashish, Gandhi Purav, Kotiyal Anand, Kapoor Aastha. A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Context. International Archives of BioMedical and Clinical Research. 2017 Jul-Sep; 3(3): I-VIIen_US
dc.identifier.issn2454-9894
dc.identifier.issn2454-9886
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/184349
dc.languageenen_US
dc.publisherIbn Sina Academy of Medieval Medicine & Sciencesen_US
dc.relation.issuenumber3en_US
dc.relation.volume3en_US
dc.source.urihttps://doi.org/10.21276/iabcr.2017.3.3.26en_US
dc.subjectDrug Classification Systemen_US
dc.subjectDrug and Cosmetic Act Indiaen_US
dc.subjectDigitization of Prescriptionsen_US
dc.subjectDrug Schedules in Indiaen_US
dc.subjectSchedule Hen_US
dc.subjectMonitoring Drug Schedule Systemen_US
dc.titleA Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Contexten_US
dc.typeJournal Articleen_US
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