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Saurabh Srivastava

Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, Telangana 500037, India; Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, Telangana 500037, India. Electronic address: saurabh@niperhyd.ac.in.

2 papers in the library · 5 citations · publishing 2024-2025

Papers

Unraveling the policies, legislations, and regulations of psychedelics in Australia, Canada, Netherlands, New Zealand, and India.

Health policy (Amsterdam, Netherlands) July 8, 2025 Ramesh Joga, Sravani Yerram, Jayasri Devi Patnam et al. 5 citations

Countries vary widely in their regulation of psychedelics for medical use. Australia has legalized MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression, with a structured prescription system for authorized psychiatrists. Canada and the Netherlands support therapeutic use through regulated clinical trials and limited exemptions under strict controls. New Zealand shows exploratory interest within a controlled framework. India maintains strict prohibitions with severe penalties, despite emerging research indicating potential medical benefits. The analysis draws on government documents, regulatory databases, and peer-reviewed literature, highlighting that Australia, Canada, the Netherlands, and New Zealand have taken pioneering steps, while India's conservative stance creates barriers to exploring medical potential.

Exploring the regulatory framework of psychedelics in the US & Europe.

Asian journal of psychiatry December 1, 2024 Hitesh Kumar Behera, Ramesh Joga, Sravani Yerram et al.

Psychedelic drug therapy shows promise for treating depression, PTSD, and anxiety, differing from conventional psychiatry in mechanism, legal status, and approach. This review covers the therapeutic potential, mechanisms, and regulatory approvals of psilocybin, MDMA, mescaline, ketamine, and LSD. It outlines legal aspects and regulations in the US and Europe, noting their Schedule I classification due to misuse potential. The FDA monitors psychedelics using expedited pathways and has issued guidance for clinical investigations. The EMA focuses on atypical psychedelics, addressing safety and efficacy challenges. Marketed products like Spravato nasal spray face limited distribution. Careful regulation and legislation are needed to harness therapeutic benefits.