Skip to content
2000
Volume 1, Issue 1
  • ISSN: 2210-299X
  • E-ISSN: 2210-3007

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.

This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Loading

Article metrics loading...

/content/journals/cis/10.2174/2210299X01666230831143846
2023-10-13
2025-09-04
Loading full text...

Full text loading...

/deliver/fulltext/cis/1/1/CIS-1-E310823220567.html?itemId=/content/journals/cis/10.2174/2210299X01666230831143846&mimeType=html&fmt=ahah

References

  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.2020Available from: https://www.drugabuse.gov/publications/drugfacts/prescription-opioids
  3. HanB. ComptonW.M. BlancoC. CraneE. LeeJ. JonesC.M. Prescription opioid use, misuse, and use disorders in u.s. adults: 2015 National survey on drug use and health.Ann. Intern. Med.2017167529330110.7326/M17‑086528761945
    [Google Scholar]
  4. Global Opioid Drug Market Source.Available from: research.com/market-report/global-opioids-drugs- market/23754/
  5. BerterameS. ErthalJ. ThomasJ. FellnerS. VosseB. ClareP. HaoW. JohnsonD.T. MoharA. PavadiaJ. SamakA.K.E. SippW. SumyaiV. SuryawatiS. ToufiqJ. YansR. MattickR.P. Use of and barriers to access to opioid analgesics: A worldwide, regional, and national study.Lancet2016387100281644165610.1016/S0140‑6736(16)00161‑626852264
    [Google Scholar]
  6. BoiteuxL. Drugs and prisons: The repression of drugs and the increase of the Brazilian penitentiary population. Systems overload-drug laws and prisons in Latin America.Amsterdam, WashingtonTransnational Institute/Washington Office Latin America2011
    [Google Scholar]
  7. RibeiroM. PerrenoudL.O. DuailibiS. DuailibiL.B. MadrugaC. MarquesA.C.P.R. LaranjeiraR. The brazilian drug policy situation: the public health approach based on research undertaken in a developing country. Public Health Rev.2013352710.1007/BF03391706
    [Google Scholar]
  8. VolkowN.D. IcazaM.E.M.M. PoznyakV. SaxenaS. GerraG. Addressing the opioid crisis globally.World Psychiatry201918223123210.1002/wps.2063331059614
    [Google Scholar]
  9. MahalakshmyR. Regulation of controlled drugs in emerging countries: Unique Attention to BRICS.Asian J. Pharm.20171103
    [Google Scholar]
  10. PeacockA. BrunoR. GisevN. DegenhardtL. HallW. SedefovR. WhiteJ. ThomasK.V. FarrellM. GriffithsP. New psychoactive substances: Challenges for drug surveillance, control, and public health responses.Lancet2019394102091668168410.1016/S0140‑6736(19)32231‑731668410
    [Google Scholar]
  11. BerryP.H. DahlJ.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.20079523824510.1097/01.NJH.0000289654.14752.1c
    [Google Scholar]
  12. DragicL. LeeE. WertheimerA. Classifications of controlled substances: Insights from 23 countries.Innov. Pharm.20156(2). 10.24926/iip.v6i2.383
    [Google Scholar]
  13. NistJ.B. Liability for overprescription of controlled substances. Can it be justified in light of the current practice of undertreating pain?J. Leg. Med.20022318511310.1080/01947640231727668711957333
    [Google Scholar]
  14. McGintyE.E. ChoksyS. WintemuteG.J. The relationship between controlled substances and violence.Epidemiol. Rev.2016381mxv00810.1093/epirev/mxv00826905893
    [Google Scholar]
  15. ParkerJ.M. Overview of drug control: A regulatory primer on scheduling and controlled substance regulations.Clin. Res. Regul. Aff.2006233-421122510.1080/10601330601079851
    [Google Scholar]
  16. HeitH.A. GilsonA.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. MicheleL. Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act.Springfield: United States Department of JusticeDrug Enforcement AdministrationOffice of Diversion Control2010Available from: www.gpoaccess.gov
    [Google Scholar]
  19. NakanishiT. Pharmaceutical Regulation in Japan, Evaluation and Licensing Division Pharmaceutical Evaluation and Licensing Division, Pharmaceutical and Food Safety BureauMinistry of Health, Labour and Welfare2012
    [Google Scholar]
  20. Available from: http://nicfs.gov.in/wp-content/uploads/2017/01/ Narcotics-Drugs-and-Psychotrophic-Substances.pdf (Accessed on November 14,2022)
  21. ZhengX. Information centre, state food and drug administration, Beijing, China.WHO Drug Inform.20052612012 The State Council (2005). Regulation for control of narcotics and psychotropicsAvailable from: http://www.sfda.gov.cn/WS01/CL0784/23500
    [Google Scholar]
  22. Opioids Market SizeShare & 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.2019Available from: https://www.grandviewresearch.com/industry-analysis/opioids-
  23. ManchikantiL. SinghA. Therapeutic opioids: A ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids.Pain Physician20082s11S63S8810.36076/ppj.2008/11/S6318443641
    [Google Scholar]
  24. SanjudaS.K. NagabhushananT. SukanyaR. RamyaG. Regulatory requirements for controlled drugs and its impact on drug availability.World J. Pharm. Pharm. Sci.20228421052115
    [Google Scholar]
  25. Central Bureau of Narcotics.Available from: https://en.wikipedia.org/wiki/Central_Bureau_of_Narcotics#Organization
  26. List of Narcotic Drugs.Available from: https://www.therecoveryvillage.com/narcotics-addiction/narcotic-drugs/#gref
  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. RémuzatC. ToumiM. FalissardB. New drug regulations in france: What are the impacts on market access?J. mark. acce. heal. pol.20131120892Available from: http://www.jmahp.net/index.php/jmahp/article/view File/20891/29560
    [Google Scholar]
  31. RosenL.W. International drug control policy: background and US responses. Congressional Research Service.2015Available from: https://scholar.google.com/scholar?um=1&ie=UTF-8&lr&cites=43788407396 (Accessed on November 18, 2022)
  32. Available from: http://narcoticsindia.nic.in/organisation.php
  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, Edition1.4.2015Available 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 ColinT. 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.2016Available from: https://www.unodc.org/doc/ wdr2016/WORLD_DRUG_REPORT_2016_web.pdf ( Accessed on November 20,2022)
  39. World Drug Report2018Available from: https://www.unodc.org/ unodc/en/frontpage/2018/June/world-drug-report-2018-opioid-crisis-prescription-drug-abuse-expands-cocaine-and-opium-hit-record-highs.html (Accessed on November 22, 2022)
  40. Available from: http://www.emcdda.europa.eu/publications/topic-overviews/classification-of-controlled-drugs/html (Accessed on November 14,2022)
  41. The LOAccess to opioids: A balance of harms.The Lancet. Oncol.201718101285Available from: https://www.thelancet.com/journals/lanonc/article/PIIS1470- 2045 (17)30704-0/full . (Accessed on November 20, 2022)
    [Google Scholar]
  42. The International Narcotics Control Board.Available from:https://dor.gov.in/narcoticdrugspsychotropic/manufacture- (Accessed on November 20, 2022)
  43. Narcotic Drug.Available from: https://www.incb.org/incb/en/publications/annual-reports/annual- report-2018.html
  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
  47. Available from: https://www.state.gov/wp-content/uploads/2019/04/INCSR-Vol-INCSR-Vol.-I- 1.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.2020Available from: https://www.lawinsider.com/dictionary/regulatory-requirements
  50. MikosR.A. Preemption under the controlled substances act.J. Health Care Law Policy2013165
    [Google Scholar]
/content/journals/cis/10.2174/2210299X01666230831143846
Loading
/content/journals/cis/10.2174/2210299X01666230831143846
Loading

Data & Media loading...


  • Article Type:
    Review Article
Keyword(s): Controlled drugs; Opioids; Patients; Psychoactive agents; Regulation; Storage
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test