Abstract

REGULATORY REQUIREMENTS FOR CONTROLLED DRUGS AND ITS IMPACT ON DRUG AVAILABILITY

S.K. Sanjuda*, M. V. Nagabhushanam, T. Sukanya, R. Gnana Ramya, Brahmaiah Bonthagarala, G. Ramakrishna and Y. Ratna Sindhu

ABSTRACT

Controlled Drugs are prescription drugs which include both “Narcotic Drugs and Psychotropic Substances”. Opioid analgesics are the major drugs which are being used for the treatment of severe pain associated with cancer and other diseases. Abuse of these substances has been rising at an alarming rate; hence it has been declared a “public health emergency” globally. From historic times these drugs were used frivolously which may further lead to restricted access worldwide. 80% of the world's population is expected to have inadequate access to these medications for pain relief due to improper regulation. India needs a stronger enforcement system with the primary responsibility of ensuring the availability of drugs to the needy patient while curtailing mishandling and trafficking. Hence „Regulatory requirements of Controlled Drugs‟ is an imperative, stern as well as indispensable theme to study.

Keywords: Controlled Substances, Regulatory Authority, Offenses and Penalties, Drug Abuse, BRICS, SAARC, US, JAPAN, EU.