Feb 22, 2025

In a major regulatory move, India’s Central Drug Regulator (CDSCO) have ordered the immediate withdrawal of manufacturing and export permissions for all Tapentadol-Carisoprodol combinations. This decisive action comes in response to growing concerns over their misuse and abuse potential, particularly in international markets.

Reason Behind the Ban

A recent BBC investigative report exposed the illicit export of these drug combinations from India to West African countries, where they are being abused as recreational drugs. Given the powerful effects of Tapentadol (a potent opioid) and Carisoprodol (a muscle relaxant), the combination poses serious public health risks, prompting the government to take swift regulatory action.

Regulatory Circular Issued

The government has laid out strict measures to curb the distribution of these combinations:

  • Immediate revocation of all Export NOCs and cancellation of manufacturing permissions.
  • Withdrawal of approvals: “It is also requested to withdraw all Export NOCs and manufacturing permissions issued for all combinations of Tapentadol and Carisoprodol that are not approved by the importing country.”
  • Strict compliance enforcement to prevent illicit production and distribution.

 

Impact on Manufacturers and Exporters

Pharmaceutical companies involved in the manufacturing or export of these combinations must comply immediately. Non-compliance could lead to strict penalties, license cancellations, and legal action. This move significantly impacts the pharmaceutical export industry, necessitating urgent action from stakeholders.

 

Need Regulatory Assistance?

If you’re a manufacturer or exporter affected by these new regulations, Vaayath Consulting Services can help you navigate the regulatory landscape and ensure full compliance. Reach out for expert guidance and stay ahead of evolving regulatory challenges.

 

For detailed order, Official Circular