Pregabalin Included Under Schedule H1

Why in News?

The Union Ministry of Health and Family Welfare has notified the inclusion of Pregabalin under Schedule H1 of the Drugs Rules, 1945 due to increasing reports of misuse and abuse, particularly among youth.  

What is Pregabalin?

Pregabalin is a prescription medicine commonly used for chronic pain, neuropathic pain, fibromyalgia, epilepsy and certain neurological disorders. However, the drug has reportedly been misused for its sedative effects, euphoric effects, and dissociative effects. 

Authorities have also reported seizures of illegally stocked and unauthorisedly sold Pregabalin in several parts of the country. 

What is Schedule H1?

Schedule H1 is a category under the Drugs and Cosmetics Rules, 1945 that imposes stricter controls on the sale and distribution of certain medicines. It was introduced by the Government of India in 2014 to monitor indiscriminate use of medicines, prevent antimicrobial resistance and control misuse of psychotropic and habit-forming drugs.

Schedule H1 mainly includes advanced antibiotics, anti-TB drugs and certain psychotropic medicines.  With Pregabalin now classified under Schedule H1:

• The drug can only be sold on the prescription of a Registered Medical Practitioner (RMP).
• Pharmacists and retailers must maintain a separate register recording:
  • Prescription details,
  • Patient details,
  • Quantity sold.
• Manufacturers must display a prominent “Schedule H1 Drug Warning” label on packaging.
• Violations can attract penal action under the Drugs and Cosmetics Act, 1940 and related rules.

Source: PIB