Opioid substitution therapy: Legal challenges

Drug dependence syndrome is a medical condition classified as a multifactorial health disorder that often follows the course of a relapsing and remitting chronic disease. Opioid substitution therapy (OST) is one of the established standard treatments for opioid dependence syndrome. OST, a process in which opioid-dependent injecting drug users, is provided with long-acting opioid agonist medications for a long period under medical supervision along with psychosocial interventions. OST service provider may have to deal with issues of license/registration/recognition/permission under various legislations such as the Drugs and Cosmetic Act, 1940; Narcotic Drugs and Psychotropic Substances Act, 1985; Rights of person with disability Act, 2016 and Mental Healthcare Act, 2017 depending on the drug prescribed, type of services provided, procuring, transportation, storage, and prescribing these narcotics and psychotropic medicines. The narcotics and psychotropic drugs are administered through various ministries and departments causing huge confusion, lack of coordination, overlapping roles and responsibilities, and various laws/rules and gives an opportunity for the abdication of the responsibilities. The “public mental health issue,” where the number of opioid users in the country is approximately two million and opioid dependence syndrome is approximately 0.5 million. The number of beds in the public governed deaddiction centers is abysmally low, number of psychiatrist, or trained medical practitioners in OST are also few in number to face this humongous challenge. Against this background, this article focuses on the legal issues surrounding the OST.