DRAP cancels all registrations of high-dose tramadol for export

ISLAMABAD: In a major regulatory breakthrough, the Drug Regulatory Authority of Pakistan (DRAP) has cancelled all existing registrations of high-dose Tramadol formulations—specifically 225mg and 250mg variants—that were previously approved for export purposes.

The decision was taken during the 346th meeting of DRAP’s Registration Board as part of a broader move to align Pakistan’s pharmaceutical exports with international drug safety standards. The sweeping cancellation comes amid growing concerns over the misuse and trafficking of high-strength Tramadol, particularly in African and Middle Eastern countries, where these formulations are banned due to their high abuse potential.

The move has been widely praised by health professionals and regulatory observers as a strong signal of Pakistan’s commitment to global drug safety protocols. Under the leadership of its newly appointed CEO, Dr. Obaidullah, DRAP is being lauded for adopting the regulatory principles practiced by stringent authorities such as the U.S. FDA, UK’s MHRA, France’s ANSM, and Health Canada.

Officials in DRAP revealed that the decision to revoke registrations was influenced by discussions with Nigerian health authorities and representatives of the Global Rapid Interdiction of Dangerous Substances (GRIDS) program. These conversations identified Pakistan as a major source of high-strength Tramadol formulations—especially those exceeding 100mg—that were contributing to a public health crisis in several African nations. DRAP’s Controlled Drugs Division subsequently recommended a complete withdrawal of any Tramadol formulations not approved by international reference regulators. The board accepted the recommendations and initiated legal action under Section 42 of the Drugs Act, 1976. Show-cause notices were initially issued to 59 firms marketing 225mg and 200mg Tramadol formulations, with many of them called for personal hearings to justify why their registrations should not be cancelled. However, DRAP has now taken the bolder step of cancelling all export approvals for 225mg and 250mg formulations outright. Tramadol, a synthetic opioid used to treat moderate to severe pain, has been widely misused due to its addictive properties.