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Current Indian Science

Editor-in-Chief

ISSN (Print): 2210-299X
ISSN (Online): 2210-3007

Review Article

A Critical Appraisal on Controlled Drugs: Classification, Global Regulatory Provisions, and Distribution

Author(s): Animesh Ranjan, Gaurav, Niraj Sandeep Patil, Shivendu Shekhar Shashi and Dilpreet Singh*

Volume 1, 2023

Published on: 13 October, 2023

Article ID: e310823220567 Pages: 10

DOI: 10.2174/2210299X01666230831143846

open_access

Open Access Journals Promotions 2
Abstract

Controlled drugs, characterized by their potential for abuse and addiction, require stringent regulation to ensure their safe and appropriate use. This critical appraisal provides a scientifically sound examination of the classification of controlled drugs, global regulatory provisions governing their use, and the challenges associated with their distribution. Due to poor regulation, it is anticipated that 80% of the world’s population will have insufficient access to these painkillers. India needs a more robust enforcement mechanism, with the main goal of ensuring that medications are accessible to patients in need while preventing abuse and trafficking. As a result, studying the topic of “A Regulatory Need of Controlled Drugs” is important, serious, and indispensable. As a result, the authors of the present review discussed numerous regulatory authorities, drug enforcement agencies, and the storage and distribution of banned substances in India. In light of the findings, this review suggests future directions and recommendations. Strengthening international collaboration and information sharing can facilitate the development of more effective regulatory measures. Improved tracking and monitoring systems, incorporating technological advancements, hold promise for enhancing control over the distribution of controlled drugs.

Keywords: Controlled drugs, Regulation, Opioids, Psychoactive agents, Storage, Patients.

[1]
Roni Shye What Are Controlled Substance. Available from: https://www.goodrx.com/blog/what-are-controlled-substances (Accessed on November 1, 2022)
[2]
Prescription Opioids Drug Facts | National Institute on Drug Abuse [Internet]. National Institution Drug Abuse. 2020. Available from: https://www.drugabuse.gov/publications/drugfacts/prescription-opioids
[3]
Han, B.; Compton, W.M.; Blanco, C.; Crane, E.; Lee, J.; Jones, C.M. Prescription opioid use, misuse, and use disorders in u.s. adults: 2015 National survey on drug use and health. Ann. Intern. Med., 2017, 167(5), 293-301.
[http://dx.doi.org/10.7326/M17-0865] [PMID: 28761945]
[4]
Global Opioid Drug Market Source. Available from: research.com/market-report/global-opioids-drugs- market/23754/
[5]
Berterame, S.; Erthal, J.; Thomas, J.; Fellner, S.; Vosse, B.; Clare, P.; Hao, W.; Johnson, D.T.; Mohar, A.; Pavadia, J.; Samak, A.K.E.; Sipp, W.; Sumyai, V.; Suryawati, S.; Toufiq, J.; Yans, R.; Mattick, R.P. Use of and barriers to access to opioid analgesics: A worldwide, regional, and national study. Lancet, 2016, 387(10028), 1644-1656.
[http://dx.doi.org/10.1016/S0140-6736(16)00161-6] [PMID: 26852264]
[6]
Boiteux, L. Drugs and prisons: The repression of drugs and the increase of the Brazilian penitentiary population. Systems overload-drug laws and prisons in Latin America; Transnational Institute/Washington Office Latin America: Amsterdam, Washington, 2011.
[7]
Ribeiro, M.; Perrenoud, L.O.; Duailibi, S.; Duailibi, L.B.; Madruga, C.; Marques, A.C.P.R.; Laranjeira, R. The brazilian drug policy situation: the public health approach based on research undertaken in a developing country. Public Health Rev., 2013, 35(2), 7.
[http://dx.doi.org/10.1007/BF03391706]
[8]
Volkow, N.D.; Icaza, M.E.M.M.; Poznyak, V.; Saxena, S.; Gerra, G. Addressing the opioid crisis globally. World Psychiatry, 2019, 18(2), 231-232.
[http://dx.doi.org/10.1002/wps.20633] [PMID: 31059614]
[9]
Mahalakshmy, R. Regulation of controlled drugs in emerging countries: Unique Attention to BRICS. Asian J. Pharm., 2017, 11(03)
[10]
Peacock, A.; Bruno, R.; Gisev, N.; Degenhardt, L.; Hall, W.; Sedefov, R.; White, J.; Thomas, K.V.; Farrell, M.; Griffiths, P. New psychoactive substances: Challenges for drug surveillance, control, and public health responses. Lancet, 2019, 394(10209), 1668-1684.
[http://dx.doi.org/10.1016/S0140-6736(19)32231-7] [PMID: 31668410]
[11]
Berry, P.H.; Dahl, J.L. Advanced practice nurse-controlled substances prescriptive authority: A review of the regulations and implications for effective pain management at end-of-life. J. Hosp. Palliat. Nurs., 2007, 9(5), 238-245.
[http://dx.doi.org/10.1097/01.NJH.0000289654.14752.1c]
[12]
Dragic, L.; Lee, E.; Wertheimer, A. Classifications of controlled substances: Insights from 23 countries. Innov. Pharm., 2015, 6 (2).
[http://dx.doi.org/10.24926/iip.v6i2.383]
[13]
Nist, J.B. Liability for overprescription of controlled substances. Can it be justified in light of the current practice of undertreating pain? J. Leg. Med., 2002, 23(1), 85-113.
[http://dx.doi.org/10.1080/019476402317276687] [PMID: 11957333]
[14]
McGinty, E.E.; Choksy, S.; Wintemute, G.J. The relationship between controlled substances and violence. Epidemiol. Rev., 2016, 38(1), mxv008.
[http://dx.doi.org/10.1093/epirev/mxv008] [PMID: 26905893]
[15]
Parker, J.M. Overview of drug control: A regulatory primer on scheduling and controlled substance regulations. Clin. Res. Regul. Aff., 2006, 23(3-4), 211-225.
[http://dx.doi.org/10.1080/10601330601079851]
[16]
Heit, H.A.; Gilson, A.M. Federal regulations for prescribing scheduled controlled substances. Available from: http://www.asam.org/pain- (Accessed on November 15, 2022)
[17]
Drug law reform in latin american countries. Available from: http://druglawreform.info/en/country-information/latin-america/argentina (Accessed on November 15,2022)
[18]
Michele, L. Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act.Springfield: United States Department of Justice; Drug Enforcement Administration: Office of Diversion Control, 2010. Available from: www.gpoaccess.gov
[19]
Nakanishi, T. Pharmaceutical Regulation in Japan, Evaluation and Licensing Division Pharmaceutical Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau; Ministry of Health, Labour and Welfare, 2012.
[21]
Zheng, X. Information centre, state food and drug administration, Beijing, China. In: WHO Drug Inform; , 2005; 26, . (1) 2012 The State Council (2005). Regulation for control of narcotics and psychotropics Available from: http://www.sfda.gov.cn/WS01/CL0784/23500
[22]
Opioids Market Size. Share & Trends Analysis Report By Product (IR/ Short- acting, ER/Long-acting), By Application (Pain Relief, Anesthesia), By Region, And Segment Forecasts, 2019 – 2026, Market Research report. 2019. Available from: https://www.grandviewresearch.com/industry-analysis/opioids-
[23]
Manchikanti, L.; Singh, A. Therapeutic opioids: A ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids. Pain Physician, 2008, 2s(11), S63-S88.
[http://dx.doi.org/10.36076/ppj.2008/11/S63] [PMID: 18443641]
[24]
Sanjuda, S.K.; Nagabhushanan, T.; Sukanya, R.; Ramya, G. Regulatory requirements for controlled drugs and its impact on drug availability. World J. Pharm. Pharm. Sci., 2022, 8(4), 2105-2115.
[25]
[27]
Maximize Market Research. Available from: https://www.maximizemarketresearch.com/market-report/global-psychoactive (Accessed on November 13,2022)
[28]
EU drug markets report — a strategic analysis. Available from: www.europol.europa.eu (Accessed on November 17,2022)
[29]
International Narcotic Control Strategy Report 2013, March 5 2013. Available from: https://2009-2017.state.gov/r/pa/prs/ps/2013/03/205998.htm Accessed on November 18, 2022)
[30]
Rémuzat, C.; Toumi, M.; Falissard, B. New drug regulations in france: What are the impacts on market access? J. mark. acce. heal. pol., 2013, 1(1), 20892. Available from: http://www.jmahp.net/index.php/jmahp/article/view File/20891/29560
[31]
Rosen, L.W. International drug control policy: background and US responses. Congressional Research Service. 2015. Available from: https://scholar.google.com/scholar?um=1&ie=UTF-8&lr&cites=43788407396 (Accessed on November 18, 2022)
[33]
Indian Pharmaceutical Industry. Available from: https://www.ibef.org/industry/
[34]
Guidelines on the regulation of Therapeutic products in Newzeland, MEDSAFE, Ministry of Health, Part5, Edition1.4. 2015. Available from: http://legislation.govt.nz/act/public/1981/0118/latest/whole.html#DM53795
[35]
National policy on narcotic drugs and psychotropic substances. Available from: http://cbn.nic.in/ html/ National Policy English.pdf (Accessed on November 19, 2022)
[36]
Dr Colin, T. CONTROLLED DRUGS, Document ID 234 (v8). Available from: www.patient.co.uk/doctor/controlled-drugs (Accessed on November 19, 2022)
[37]
Available from: https://icmr.nic.in/sites/default/files/ICMR_IN.pdf ( Accessed on November 20,2022)
[38]
World Drug Report.. 2016. Available from: https://www.unodc.org/doc/ wdr2016/WORLD_DRUG_REPORT_2016_web.pdf ( Accessed on November 20,2022)
[41]
The LO. Access to opioids: A balance of harms. The Lancet. Oncol., 2017, 18(10), 1285. Available from: https://www.thelancet.com/journals/lanonc/article/PIIS1470- 2045 (17)30704-0/full . (Accessed on November 20, 2022)
[42]
The International Narcotics Control Board. Available from:https://dor.gov.in/narcoticdrugspsychotropic/manufacture- (Accessed on November 20, 2022)
[44]
Drugs Crime and Terrorism. Available from: https://www.un-ilibrary.org/drugs-crime-and-terrorism/report-of-
[45]
Narcotics Control Bureau. Available from: https://en.wikipedia.org/wiki/Narcotics_Control_Bureau
[46]
Import Export of Narcotic and Psychotropic Substances. Available from: http://www.cbn.nic.in/html/Procedure.pdf
[48]
India is vulnerable to trafficking of narcotics: Officials. Available from: https://twitter.com/moneycontrolcom
[49]
Regulatory Requirements | legal definition of Regulatory Requirements by Law Insider. 2020. Available from: https://www.lawinsider.com/dictionary/regulatory-requirements
[50]
Mikos, R.A. Preemption under the controlled substances act. J. Health Care Law Policy, 2013, 16, 5.

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