Preventing Prescription Drug Misuse: A Regulatory Perspective in the United States, Europe, and India

  • Dhruvi B Thakker Student
  • Kalpana G Patel


Prescription medicines, such as analgesics, stimulants, steroids, anti-depressants, psychotropics, and certain antibiotics are commonly mishandled in a variety of ways, including overdosing, abuse, diversion, and drug trafficking. Because of the considerable risk to public health, they are subject to strict regulatory oversight. The drugs possess abuse potential at specific dose and hence prone to abuse therefore they are categorized as Controlled substances. Therefore, they are subject to constant vigilance over the pharmaceutical supply chain. The complete clinical data as well as post marketing surveillance study of such drugs are critical to be in place as per the regulatory requirements. The countries have kept up with the times by constantly updating the system with regulatory laws and strategies to prevent cases of misuse. The current review will give a quick summary of how prescription medications and prohibited substances are regulated in the United States, Europe, and India. It will also emphasize current trends in drug usage, as well as the issues that these countries face and the preventive policies implemented to manage and prevent drug misuse. It will also make recommendations for new regulatory initiatives to address the current drug- misuse-related concerns. As a result, a review of the regulatory system in various countries will present current challenges and new lessons for countries around the globe.

Keywords: Prescription Drug, Controlled substances, Drug Misuse, Drug Overdose, Drug Abuse, Drug Diversion, Drug Trafickking


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1. U.S. National Library of Medicine. [Internet]. NLM; 2021 [cited 2021 Nov 16]. Available from:
2. Haley, Danielle F. and Saitz, Richard. The Opioid Epidemic During the COVID-19 Pandemic. JAMA; 2020.
3. Rachel V. Smith, Jennifer R. Havens, and Sharon L. Walsh. Gabapentin misuse, abuse, and diversion: A systematic review. HHS Public Access; 2016.
4. Fabrizio Schifano, Stefania Chiappini, John M. Corkery and Amira Guirguis. Abuse of Prescription Drugs in the Context of Novel Psychoactive Substances (NPS): A Systematic Review: brain sciences; 2018.
5. Molly Thomas, Celestine C Wong, Pam Anderson, Nathan Grills. Magnitude, characteristics and consequences of topical steroid misuse in rural North India: an observational study among dermatology outpatients: BMJ Open; 2020.
6. Porter G, Grills N. Medication misuse in India: a major public health issue in India. J Public Health (Oxf). 2016 Jun; 38(2):e150-7.
doi: 10.1093/pubmed/fdv072. Epub 2015 Jun 8. PMID: 26060236.
7. Chibi B, Torres NF, Sokhela ZP, Mashamba-Thompson TP. Prescription drug diversion among people living with HIV: a systematic scoping review. Public Health. 2019 Dec;177:26-43.
doi: 10.1016/j.puhe.2019.07.017. Epub 2019 Sep 5. PMID: 31494360.
8. Pushpita, Das. Drug Trafficking in India: A Case for Border Security; May; 2012.
9. United Nations Office on Drugs and [Internet]. 2021[cited 2021 Nov 15]. Available from:
10. U.S. Food & Drug Administration. [Internet]. FDA; 2020 Apr [cited 2021 Nov 18]. Available from:
11. United States Drug Enforcement Administration. [Internet]. [cited 2021 Nov 12]. Available from:
12. The European regulatory system for medicines. [Internet].EMEA; 2016 [cited 2021 Nov 11]. Available from:
13. European Monitoring Centre for Drugs and Drug Addiction. [Internet]. [cited 2021 Nov 16]. Available from:
14. Rules, The Drugs and Cosmetics Act and. [Internet]. CDSCO; 2016 Dec [cited 2021 Nov 16]. Available from:
15. THE NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES, ACT, 1985. [Internet]. [cited 2021 Nov 16]. Available from:
16. Ornell F, Moura HF, Scherer JN, Pechansky F, Kessler FHP, von Diemen L. The COVID-19 pandemic and its impact on substance use: Implications for prevention and treatment. Psychiatry Res. 2020 Jul;289:113096.
doi: 10.1016/j.psychres.2020.113096. Epub 2020 May 13. PMID: 33242814.
17. Stefania Chiappini, Amira Guirguis, John Martin Corkery & Fabrizio Schifano. et al. Misuse of prescription and over-the-counter drugs to obtain illicit highs: how pharmacists can prevent abuse. The Pharmaceutical Journal; 2020 Dec.
18. Neicun J, Steenhuizen M, van Kessel R, Yang JC, Negri A, Czabanowska K, Corazza O, Roman-Urrestarazu A. Mapping novel psychoactive substances policy in the EU: The case of Portugal, the Netherlands, Czech Republic, Poland, the United Kingdom and Sweden. PLoS One. 2019 Jun 26;14(6):e0218011.
doi: 10.1371/journal.pone.0218011. PMID: 31242225; PMCID: PMC6594604.
19. T., Casati A. Sedefov R. Pfeiffer-Gerschel. Misuse of Medicines in the European Union: A Systematic Review of the Literature. European Addiction Research; 2012.
20. Ghosh, Ajit Avasthi and Abhishek et al. Drug misuse in India: Where do we stand & where to go from here? Indian Journal of medical Research; 2019 Jun.
21. National Institute on Drug Abuse. [Internet]. [cited 2021 Nov 16]. Available from:
22. Center for Disease Control and Prevention[Internet]. 2018 Jun [cited 2021 Nov 16]. Available from:
23. Eur-Lex: Access to European Union Law. [Internet].EU; 2021 Jan 13 [cited 2021 Nov 10]. Available from:
24. European Commission Drugs policy. [Internet].EC; 2021 [cited 2021 Nov 15]. Available from: affairs/policies/internal-security/organised-crime-and-human-trafficking/drug-policy_en
25. Narcotics Control Bureau India. [Internet]. 2021 [cited 2021 Nov 16]. Available from:
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How to Cite
Dhruvi B Thakker, and K. G. Patel. “Preventing Prescription Drug Misuse: A Regulatory Perspective in the United States, Europe, and India”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 4, Dec. 2021, pp. 46-52, doi:10.22270/ijdra.v9i4.502.