Health Ministry Bans Export of Drugs Containing Tapentadol and Carisoprodol

Health Ministry Bans Export of Drugs Containing Tapentadol and Carisoprodol

Sub: Sci

Sec: Health

Why in News

• The Ministry of Health and Family Welfare has issued a ban on the export of drugs containing Tapentadol and Carisoprodol following reports of their unapproved combinations being exported to West African countries.

Background: The Health Ministry, in collaboration with the Central Drugs Standard Control Organisation (CDSCO), identified that Aveo Pharmaceuticals was exporting unapproved drug combinations to certain countries in West Africa.

Opioids:

• Opioids are a class of natural, semi-synthetic, or synthetic chemicals that interact with opioid receptors in the brain and body to reduce the perception of pain.
• Sources:
  • Natural: Derived from the opium poppy plant (e.g., morphine, codeine).
  • Semi-synthetic: Chemically modified natural opiates (e.g., oxycodone, hydrocodone).
  • Synthetic: Fully synthesized in laboratories (e.g., fentanyl, methadone).
• Prescribed for managing moderate to severe pain, such as post-surgical pain, injury-related pain, or cancer-associated pain.
• Tapentadol: Centrally acting synthetic analgesic. Combines mu-opioid receptor agonism with norepinephrine reuptake inhibition, providing pain relief through dual pathways.
  • Classified as a Schedule II controlled substance in the United States, indicating a high potential for abuse and dependence.
• Carisoprodol: Muscle relaxant. Acts on the central nervous system to relieve muscle spasms without directly relaxing skeletal muscles.
  • Prescribed for short-term relief of acute musculoskeletal pain.
• Although both drugs are individually approved by CDSCO, their combination has not been approved in India.
• Neither Tapentadol nor Carisoprodol falls under the Narcotic Drugs and Psychotropic Substances (NDPS) list in India.

Central Drugs Standard Control Organisation (CDSCO):

• The Central Drugs Standard Control Organisation (CDSCO) – under Directorate General of Health Services, Ministry of Health & Family Welfare.
• It is the National Regulatory Authority (NRA) of India.
• CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
• It regulates the safety, efficacy and quality of notified medical devices under the provisions of Drugs and Cosmetics Act, 1940.
• Headquarters – New Delhi.