The Government of India has reiterated that the sale and distribution of painkillers and psychotropic drugs are regulated by State Licensing Authorities (SLAs) under the Drugs and Cosmetics Act, 1940. To ensure stricter oversight, the Centre has also published draft rules aimed at comprehensively regulating the online sale of medicines, including addictive and controlled drugs.

Key highlights

Regulation under existing law

• SLAs, appointed by state governments, monitor and enforce provisions of the Drugs and Cosmetics Act, 1940.

• In cases of non-compliance, SLAs are empowered to take action as per the law.

Draft rules for e-pharmacy regulation

• Published via notification dated 28 August 2018, inviting public and stakeholder comments.

• Provisions include:

  • Mandatory registration of e-pharmacies.

  • Periodic inspection of e-pharmacy operations.

  • Defined procedures for sale and distribution of drugs online.

  • Ban on advertisement of drugs through e-pharmacy platforms.

  • Complaint redressal and monitoring mechanisms.

Focus on addictive medicines

• Draft rules target painkillers and psychotropic substances that carry potential for misuse.

• Aims to ensure responsible distribution while safeguarding public health.

  
  

The move underscores the government’s focus on closing regulatory gaps in online medicine sales, particularly for high-risk and addictive drugs. If implemented effectively, these rules could strengthen accountability, reduce misuse, and protect patient safety.