Pregabalin and Schedule H1

About Pregabalin

• Pregabalin is a drug used for the treatment of chronic pain, neuropathies, fibromyalgia, and certain neurological conditions.
• Misuse of Pregabalin:
  • Misuse Among Youth: Reports from certain States showed misuse and abuse of Pregabalin, particularly among youth.
  • Sedative and Euphoric Effects: The drug was reportedly misused for its sedative, euphoric, and dissociative effects.
  • Illegal Stocking and Sale: Recent seizures of illegally stocked and unauthorisedly sold Pregabalin were reported from some parts of the country.

About Schedule H1 of the Drugs Rules, 1945

• Legal Provision: Schedule H1 is a part of the Drugs and Cosmetics Rules, 1945 and was introduced through Gazette notification in 2013.
• Regulated Drugs: It includes certain 3rd and 4th generation antibiotics, certain habit-forming drugs, and anti-TB drugs.
• Legal Conditions for Sale: The supply of Schedule H1 drugs must be recorded in a separate register with prescription and patient details, and records must be maintained for three years.
• Mandatory Warning Requirement: These drugs must carry the red “Rx” symbol and the prescribed Schedule H1 drug warning label on the packaging.

Inclusion of “Pregabalin” under Schedule H1

• Stricter Regulation: Pregabalin will now be regulated under stricter Schedule H1 provisions instead of Schedule H.
• Prescription Requirement: The drug can be sold only against a valid prescription issued by a Registered Medical Practitioner.
• Supply Chain Monitoring: Retailers must maintain a separate register of prescriptions and sales details.
• Public Health Protection: The measure aims to prevent unauthorized access, curb illegal trafficking, and safeguard public health from drug misuse.