India Pharma Outlook Team | Tuesday, 23 September 2025
The first comprehensive worldwide framework created to guarantee access to controlled drugs for medical and scientific uses while reducing the risks to public health that may arise from misuse and diversion was released by the World Health Organization (WHO) with the full edition of its guideline on balanced national controlled medicines policies.
This publishing came after a brief statement outlining the new guideline was issued during the Seventy-eighth World Health Assembly. Millions of patients around the world still lack access to many controlled medications, which are necessary for treating pain, performing surgeries, treating seizures, assisting with palliative care, and managing mental health and substance use disorders. These medications include opioids, benzodiazepines, barbiturates, and amphetamines.
As stated by WHO, up to 98% of patients in low-income countries are without adequate pain relief, while elsewhere weak safeguards have contributed to opioid-related epidemics. Across the globe, adults and children living with advanced cancer or HIV/AIDS remain in pain without access to morphine. In many countries, patients with epilepsy remain untreated because the critical anti-seizure medicines are subject to excessive regulations and lack of education and understanding of their use in the clinical settings.
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In contrast, excessive regulation for controlled medicines in many countries has resulted in over-prescribing and created a demand for strong opioids, which has resulted in a significant increase in associated health harms, including substance use and use disorders, dependence and overdose.
The newly issued guideline by WHO recommends the adoption of balanced national policies that both secure continuous, affordable access, and limit the risks of harmful non-medical use of controlled medicines.