Draft Rules Set to Regulate Online Sale of Addictive Painkillers, Psychotropic Drugs: Govt
New Delhi: The Union Government has informed the Lok Sabha that draft rules have been issued to comprehensively regulate the online sale of medicines, including addictive painkillers and psychotropic drugs, with provisions for registration, inspections, and strict monitoring of e-pharmacies.
Responding to a question from Dr M K Vishnu Prasad, Minister of State for Chemicals and Fertilizers Anupriya Patel said the draft rules, published on 28 August 2018, propose amendments to the Drugs Rules, 1945 to incorporate specific provisions for sale and distribution of drugs through e-pharmacy. The notification invited comments from the public and stakeholders.
According to the draft rules, the provisions include:
Registration of e-pharmacy
Periodic inspection of e-pharmacy
Procedure for distribution or sale of drugs through e-pharmacy
Prohibition of advertisement of drugs through e-pharmacy
Complaint redressal mechanism
Monitoring of e-pharmacy operations
On whether e-pharmacies maintain end-user details for such drug sales, the Minister referred to the proposed framework, which is aimed at ensuring accountability and effective monitoring once finalised.
Patel also clarified that “sale and distribution of drugs including painkillers and psychotropic drugs are regulated by the State Licencing Authorities (SLAs) appointed by State Government under the Drugs and Cosmetics Act, 1940 and the rules made thereunder.” She added that SLAs are empowered to implement and monitor these provisions, and “in case of non-compliance, they may take action in accordance with the provisions of the said Act and rules.”
