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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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A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the Light of Present Day Context Section Pharmaindustry Commentary A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Context Prashant Tandon1, Varun Gupta2, Ashish Ranjan3, Purav Gandhi4, Anand Kotiyal5, 3 Aastha Kapoor 3 1Founder ;2VP & Head Medical Affair; Manager Medical Affair; 5Drug Data Analyst Medical Affair, 1mg Technologies Private Limited, 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001. 4Founder, Remedy Social, C/602, Tulip Citadel, Shreyas Tekra, Ambawadi, Ahmedabad 380015, Gujarat. ABSTRACT______________________________________________________________ Background: Current classification of medicines in Conclusions: We have recommended a revised drug India under Drug and Cosmetic Act into Schedule G, classification system that is more comprehensive in coverage and H, H1, X is outdated, evolved through patchwork over eliminates the overlaps between classes. Moreover, considering the years and needs to be thoroughly updated. The the implementation challenges for such a drug classification primary aim of the scheduling system is to ensure system in the diverse and fragmented ecosystem in India, we appropriate access to medicines while balancing recommend a technology backed platform to help monitor the public health and safety. India is experiencing a rapid implementation. transition with the rising burden of chronic non- communicable diseases where regular access of Key words: Drug Classification System, Drug and Cosmetic Act affordable medicines is critical for chronic disease India, Digitization of Prescriptions, Drug Schedules in India, management to prevent complications. Methods: We Schedule H, Monitoring Drug Schedule System analyzed drugs commonly selling across India, Received: 01.09.17 | Accepted:16.09.17 through multiple information sources including 1mg drug database, PharmaTrac (AIOCD-AWACS), Corresponding Author inventory data from distributors and retailers, Dr. Varun Gupta performed extensive literature review and expert 4th Floor, 1mg Technologies Private Limited, Motorola Building, MG interviews. We studied different regulatory systems Road, Sector 14, Gurugram, Haryana 122001 globally to understand best-practices and identify recommendations. Results: We identified series of How to cite this article: Tandon P, Gupta V, Ranjan A, Gandhi P, lacunae in current drug classification system and its Kotiyal A, Kapoor A. A Review on the Current Classification and implementation. Out of approximately 1,600 Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the commonly prescribed medicines, only 656 are light of present day context. Int Arch BioMed Clin Res. 2017;3(3):I- VII.DOI:10.21276/iabcr.2017.3.3.26 currently covered under the four Schedules. There are multiple overlaps in terms of drug substances covered Source of Support: Nil, Conflict of Interest: None under these schedules resulting in ambiguity. Copyright: © the author(s) and publisher. IABCR is an official publication of Ibn Sina Academy of Medieval Medicine & Sciences, registered in 2001 under Indian Trusts Act, 1882. This is an open access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited INTRODUCTION_____________________ Drug and Cosmetic Act has not been reviewed in a have been amended from time to time. Several efforts have comprehensive manner since its inception although the rules been made in the last 15 years, since the Mashelkar Access this article online Committee Report (2003) appeared.[1] Since then, there have Quick Response code been many proposals for reform including the Department- Website: www.iabcr.org Related Parliamentary Standing Committee on Health and Family Welfare 59th Report on the functioning of the DOI: 10.21276/iabcr.2017.3.3.26 Central Drugs Standard Control Organization (CDSCO) International Archives of BioMedical and Clinical Research | July–Sept 2017| Vol 3| Issue 3 I www.iabcr.org Tandon P, et al.: A Review on Drug & Cosmetic Act (2012) (henceforth, the 59th Parliamentary Committee followed by other classification systems, we arrived at a Report) and the Ranjit Roy Chaudhary Committee Report recommendation for a new classification system and (2013) and most recently, the Drugs and Cosmetics mapping of certain classes of drugs for the same. [1] (Amendment) Bill, 2015. However, despite these efforts large lacunae remain in terms of classification of medicines RESULTS & DISCUSSION _____________ into different schedules. The current classification of Challenges identified with current Drug Scheduling medicines in Schedule G, H, H1, X is outdated, evolved system: through patchwork over the years and needs to be thoroughly Current drug classification system primarily focuses on five updated. drug classes including Schedule G, H, H1, K, and X. A brief The primary aim of the scheduling system is to ensure overview regarding definition of these drug classes and appropriate access to medicines while balancing public related regulatory guidance is provided in the Table I. 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 Table I: An overview of current Drug Schedule classification No. of Drug Prescription critical for chronic disease management to prevent Definition [3,8] Medicines Schedule Guidance complications. A robust scheduling system framework, Covered[3] Schedule G consists for drugs implemented using some of the recent technological that can be administered only advancements can result in improvement in access of Schedule G under supervision of a 57 None medicines without compromising the public safety. Registered Medical Practitioner (RMP) In this review, we focus on highlighting the challenges Schedule H consists of drugs Medicines to confronted due to current schedule classification of which are required to be be sold only Schedule H dispensed on prescription of 537 on medicines available in Indian market and potential Registered Medical Practitioners prescription mechanisms to re-classify all the medicines for clarity and (RMP) of a RMP Medicines to better implementation. Presently, a large no of drugs are not be sold only classified under any of the schedules, leading to confusion at Schedule H1 consists of drugs on multiple points. Additionally, may drugs that have globally including antibiotics, habit prescription forming drugs and a few anti TB of a RMP; Schedule moved to OTC have not been examined in Indian context. drugs which were abused under 46 pharmacist H1 These recommendations can be considered while making Schedule H, and now have a to maintain a regulation on its sales and register/recor amendment in the Drug and Cosmetic Act and Rules. additional warning to the patient d of all medicines sold METHODS__________________________ One of the aspects of this schedule is the list of drugs that We took the following approach for this study: Not clearly Schedule K can be sold without a license, None defined We identified a complete universe of drugs commonly and doctors can directly selling across India, through multiple information sources dispense the same. Medicines to including 1mg drug database, PharmaTrac (AIOCD- be sold only on AWACS) [2], inventory data from multiple distributors and Schedule X consists of drugs prescription retailers. Once the entire list was identified, we mapped a list which are required to be of a RMP dispensed on prescription of of approximately 1,600 unique drug substances present prescription Schedule X Registered Medical Practitioners 16 copy to be across these medicines, and classified them across various (RMP) preserved for It requires special retail license disease areas. two years for selling these medicines. We conducted a systemic analysis of all the 1,600 drug and records of all substances to map them under Schedule G, H, H1, and X, medicines [3] based on the latest edition of Drug and Cosmetics Act and information available on product labels and images. Current drug scheduling system faces a challenge of being We conducted multiple interviews with expert physicians, non-comprehensive on multiple accounts including but not pharmacists, Industry experts and ex-regulators to better limited to the following: understand the gaps in current scheduling system and get recommendations on improvements. i) Out of 1,600 odd medicines commonly prescribed in We also analyzed different regulatory systems including India, only 656 are currently covered under Schedule H, United States Food and Drug Administration, Medicines and H1, G or X.[3] Because of this lacuna, many commonly Healthcare Product Regulatory Agency in UK, Therapeutic prescribed medications have no clear prescription Goods Administration scheduling system from Australia, guidance. Some of the examples are included in Table II. and the World Health Organization, to identify some of the Current lack of classification for these drugs results in a [4-7] best practices being followed by these agencies. scenario where deciding the drug classification for these Using our inputs from the above study and our medicines is open to interpretation for all stakeholders understanding regarding clinic usage and pharmacological including the Registered Medical Practitioners, class of each medicine, potential risks and best practices pharmacists,
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