More than 100 plants in the capital, Islamabad, and in Lahore and Multan in the Punjab province are downing tools in response to amendments by the regional government to the Drug Regulatory Authority of Pakistan Act (DRAP), 2012 and the 1976 Drug Act.
“The provincial government cannot change federal regulations,” Kaiser Waheed, Chairman of the southern division of the Pakistan Pharmaceutical Manufacturers’ Association (PPMA), told in-Pharmatechnologist.com.
‘Out of Specification’
He said the proposed changes would do away with the Out of Specification (OOS) production category, which is used by international regulators for batches that do not meet pharmacopeial specifications.
Instead, he said, the new rules would mark all failed products with the stronger term “Spurious”, a classification that also encompasses unregistered and counterfeit medicines, and products containing no API (active pharmaceutical ingredient).
OOS classification is given when lab test results do not comply with acceptance criteria in drug applications, drug master files (DMFs), official compendia, approved marketing submissions, or the manufacturer’s own specifications.
It can affect finished drug products, excipients, water quality, validation, stability, and other components. OOS prompts investigation of GMP practices and recalls of affected batches, but not the penalties of “spurious” manufacture.
Negotiations
As well as the PPMA, the Pakistan Chemists’ and Druggists’ Association, the Pakistan Pharmacist Association, and the Pakistan Pharmaceutical Distributors’ Association are participating in protests.
The PPMA’s Kaiser Waheed told us pharmaceutical manufacturers feel the new regulations turn local regulatory officers into “judge, jury, and executioner” whose on-the-spot powers are too strong.
He said the Pakistan Pharmaceutical Manufacturers’ Association is negotiating with the government, and has filed an application with the courts to block the amendments. “We feel sanity will prevail,” so facilities can return to making medicines, he said.
The protests were originally scheduled for Monday this week but were postponed because of the murder of Punjab’s home minister, Shuja Khanzada, in a suicide bombing on Sunday, August 16.