Drap cancels high-dose opioid drug registration to curb smuggling

ISLAMABAD: Terming the import of 141 metric tons of Tramadol raw material as “unjustified”, the Drug Regulatory Authority of Pakistan (Drap) on Wednesday announced that it would cancel all registrations of 225mg and 250mg Tramadol tablets meant for export after the Eid-ul-Fitr.

According to the Drap, only 50mg and 100mg Tramadol are now permitted for manufacturing in Pakistan, aligning with stringent international pharmaceutical regulations. “The import of over 141,000 kilograms of the Active Pharmaceutical Ingredient (API) for Tramadol production appears unjustifiable given Pakistan’s legitimate medical needs. The Drap Registration Board has decided to cancel all registrations for 225mg and 250mg Tramadol tablets meant for export, as these high-dose formulations are widely misused and are not required in stringent pharmaceutical markets,” Drap CEO Dr. Obaidullah told The News on Wednesday.

Authorities have long suspected that a substantial portion of this imported raw material has been diverted towards illegal manufacturing of high-dose Tramadol tablets, particularly brands like T-225, Tramaking 225mg, New Royal 225mg and X-225, which have been banned in Pakistan but continue to be smuggled to African countries including Nigeria and Sierra Leone.

Investigations reveal that 141,000 kilograms of Tramadol API could produce an estimated 1.41 billion 50mg tablets or 705 million 100mg tablets, a supply far exceeding Pakistan’s medical requirements. DRAP officials argue that the excessive importation indicates a systematic effort to manufacture and smuggle illicit opioids under the guise of pharmaceutical exports.

The Drap’s newly-appointed chief disclosed that the export of Tramadol tablets had already been linked to verification of orders from importing countries. However, in response to increased regulatory scrutiny, some manufacturers appear to have turned to illegal production of high-dose Tramadol tablets.

Tramadol is a synthetic opioid analgesic, widely prescribed for moderate to severe pain management. However, its misuse has turned it into a highly sought-after recreational drug in many African nations, where it is abused for stimulant effects, endurance enhancement and euphoria. Authorities confirm that the illegal Tramadol trade has led to a growing public health crisis, with millions of people in Africa consuming the drug for non-medical purposes, often in combination with alcohol, cannabis and other substances, leading to fatal overdoses and widespread addiction.

A senior DRAP official disclosed that despite efforts to curb illicit production, enforcement actions in Karachi targeting illegal Tramadol manufacturers have been undermined by advance warnings allegedly leaked to suspects. Several attempts to raid suspected production sites failed to yield significant arrests due to such tip-offs.