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ABSTRACT Background: Controlled drugs are pharmacological agents whose use and distribution are under strict control by the state due to their potential for abuse. In Kenya, controlled drugs are the subject of the Narcotic Drugs and Psychotropic Substances (Control) Act 1994. A substantial number of controlled drugs are essential medicines used for managing diverse conditions including pain in cancer and a variety of mental illnesses. Indeed, the WHO’s Essential Medicines List contains controlled drugs such as morphine. While governments worldwide have obligations, stemming from domestic and international laws, to prevent diversion and abuse of controlled drugs, there is need to ensure the availability of the drugs to patients as stated in the Single Convention 1961. Objectives: This study was to examine and evaluate Kenya’s attempts to balance its twin obligations of preventing diversion and abuse of controlled drugs while ensuring their access and availability to patients. In order to achieve these objectives, it focused on evaluating the existing and the evolving legal models, policies and propositions on regulation of controlled drugs in Kenya and also analyzed the measures that have been taken to regulate and control the use of controlled drugs in the country. Methodology: This research involved a systematic and contemplative analysis of Kenyan laws, regulations and policies that apply to controlled drugs. It was hence a non-empirical conceptual study where comparative analysis between the statutory systems in place in Pharmaceutical industry in Kenya and their resultant implications or impacts on the accessibility and availability of medically essential controlled drugs was done. Results: This study found that various laws and policies have so far been put in place to regulate the use of controlled drugs in Kenya. Among the findings included the fact that Kenya applies “War on drugs” policy which is based on zero tolerance approach to wipe out drug abuse and trafficking in entirety. Another model which came into limelight was the harm reduction policy which was proposed but never materialized. In this approach, needles and syringes were to be provided to the injecting drug users in order to prevent the transmission of HIV/AIDS through sharing of needles. The third policy is derived from the proposition for reclassification of certain drugs such as miraa which has recently surfaced. This is because currently miraa isn’t scheduled yet it’s known to be abused and even possesses various adverse effects. Fourthly, the policy on alternatives to incarceration in handling offenders especially addicts has also been employed. This is realized through establishment of treatment/rehabilitation facilities to provide long term solutions. Lastly, a relatively unpopular policy on decriminalization of drug users emerges as a potentially useful model in effective regulation of controlled drugs. It has been experimented with significant success in other countries. Conclusion: From the study findings, it was evident that mere establishment of laws and policy frameworks do not effectively regulate the use of controlled drugs. Punitive and overlyrestrictive laws do not necessarily prevent the abuse and misuse of controlled drugs. Instead, it impedes on the access and availability of essential controlled medicines which are indispensable in the proper and effective of patients. Recommendations: There are diverse models and approaches which can be employed appropriately and efficiently to enhance effectiveness in preventing diversion while simultaneously promoting the rational use of these drugs. It is also important to review the existing legal and policy framework so as to ensure and uphold the WHO principle of balance in the control of these drugs. The basis for the regulation of controlled drugs should be both the prevention of diversion as well as ensuring availability and accessibility for rational use.