The Drug Regulatory Authority of Pakistan (Drap) has sealed a pharmaceutical factory in Jamshoro’s Nooriabad industrial area after discovering illegal production of high-dose tramadol tablets of 225mg despite a nationwide cancellation of registrations for these formulations due to smuggling, public health risks and misuse abroad, senior Drap officials said on Wednesday.
The action followed a surprise inspection by a federal drug inspector who visited several units in Nooriabad during a routine market survey. Officials said a factory was found actively manufacturing unregistered tramadol tablets with multiple international brand names.
Large quantities of finished packs, loose tablets, raw material, active pharmaceutical ingredients, packing materials and printed items were recovered from three different locations inside the licensed premises but outside the authorised manufacturing areas.
Senior Drap officials said the production was taking place in clear violation of the Drugs Act and outside the designated manufacturing zones despite earlier regulatory warnings. They added that the material found at the site indicated a well-established illegal operation aimed at producing banned high-strength tramadol tablets for shipment to foreign markets where these opioids are widely misused.
Officials said that various rooms used for storage of packaging material, equipment and machines inside the licensed areas were sealed on the spot. They added that the unregistered tramadol manufacturing sections were also sealed.
Samples were seized as case property, and additional samples were collected for testing under Drap procedures. Given the huge quantity of recovered material, the factory management was ordered not to dispose of anything until further instructions.
The inspectors also reported extremely poor hygienic and unsatisfactory working conditions in the licensed manufacturing areas. Officials said the factory failed basic good manufacturing practices. They said production lines were unhygienic, equipment was not compliant with quality standards and staff were found working without required controls. The firm was directed to immediately suspend all production activities across the premises, and an interim compliance report was submitted to the authority.
A detailed investigation is now under way, while a comprehensive report will be shared after the completion of the inquiry, the officials added. The raid comes months after Pakistan cancelled all registrations and export permissions for high-dose tramadol tablets of 225mg and 250mg.
The bans were imposed after international agencies and African governments warned that high-strength tramadol from Pakistan is being smuggled in massive quantities, fuelling addiction and a growing public health crisis in several countries. Earlier this year, Drap cancelled all existing registrations for these high-dose formulations after its registration board reviewed evidence showing that Pakistan had become a major source of illegally traded tramadol tablets.
Investigations had revealed that some firms were importing extraordinarily high amounts of active pharmaceutical ingredients, far beyond Pakistan’s medical needs, raising concern that the raw material was being diverted to illegal manufacturers. The regulatory board had already termed the import of hundreds of metric tons of tramadol raw material unjustified. Officials estimated that this quantity alone could produce more than billions of tablets of lower-dose strengths, far above the legitimate requirements.
Authorities feared that manufacturers were using the raw material to produce high-dose variants such as T 225, Tramaking 225 and other brands that have been banned in Pakistan but continue to surface in African countries, including Nigeria and Sierra Leone.
Senior Drap officials disclosed that previous attempts to curb illicit production had been compromised due to advance warnings reaching the illegal manufacturers in Karachi, allowing them to shut down operations before raids. They said the Nooriabad operation was kept confidential to prevent such leaks, and resulted in the successful sealing of the facility.
Officials said Drap remains committed to shutting down illegal tramadol production, and strengthening compliance with international drug safety standards. They added that further actions would follow as more evidence emerges through ongoing investigations.
