Govt moves pregabalin to Schedule H1 to prevent drug abuse

• The government has brought pregabalin under the stricter Schedule H1 category amid reports of its misuse and abuse.

• Pregabalina is a drug used for treating chronic pain and certain neurological conditions. 

• The Ministry of Health and Family Welfare notified the inclusion of pregabalin under Schedule H1 of the Drugs Rules, 1945, through a gazette notification on May 20.

• Schedule H currently covers drugs that are prescription-only but do not require the most stringent record-keeping, whereas Schedule H1 was introduced in 2014 as a more restrictive category for drugs with high abuse potential. 

• The decision has been taken in view of reports received from certain states regarding the misuse and abuse of pregabalin, particularly among youth.

• The drug, which is prescribed for the treatment of chronic pain, neuropathies, fibromyalgia, and certain neurological conditions, has reportedly been misused for its sedative, euphoric, and dissociative effects.

• The ministry cited seizures of illegal stocks and sales of pregabalin in parts of the country.

• The medicine was earlier regulated under Schedule H under the Drugs and Cosmetics Rules, 1945.

• Under the revised classification, the drug can now be sold only against a valid prescription issued by a registered medical practitioner (RMP).

• Retailers will now have to maintain a separate register recording details of prescriptions and sales, while manufacturers must prominently display the prescribed ‘Schedule H1 Drug Warning’ label on product packaging.

• Violations and non-compliance would attract penal action under the Drugs and Cosmetics Act, 1940, and related rules.

• The move is aimed at strengthening accountability across the supply chain, preventing unauthorised access, enhancing prescription monitoring, curbing illegal trafficking, and safeguarding public health from drug misuse and abuse.

• Import or manufacture for sale of drugs including vaccines are regulated under Drugs and Cosmetics Act, 1940 and Drugs & cosmetics Rules, 1945 and New Drugs and Clinical Trials Rules, 2019.

(The author is a trainer for Civil Services aspirants.)