Drap orders recall of nine ‘poisonous’ syrups
ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) has directed pharmaceutical companies to recall nine contaminated syrups, the authority’s CEO told Dawn.
In the past two months, the regulator has found at least seven pharmaceutical companies involved in producing syrups with high proportions of Propylene Glycol (PG), a prohibited substance.
Drap CEO Dr Asim Rauf said nine more syrups, manufactured by five pharma companies, were found contaminated, taking the number of companies involved in producing contaminated syrups to seven.
According to a document issued by Drap, syrups manufactured by the companies PDH Pharmaceuticals, Raazee Therapeutics, Siza International, and others have been found to be contaminated.
The syrups include Allerphene, Zevirol, Texcol DM, Texcol EX, Virol, Torax DM, Bronyl and Speczine.
Earlier this month, the regulator seized a batch of PG imported from a Thailand-based company after detecting impurities.
The acceptable level of impurities in PG excipient — used in cough syrups — is 1.1 per cent, and any contamination above that level can lead to multiple organ failure. The batch, imported from Thailand’s Dow Chemical, had an impurity level of 25pc.
According to a document issued by Drap, upon ingestion, PG impurities, also called ethylene glycol (EG), metabolise into toxins that affect the central nervous system and heart and can cause kidney damage, which can be fatal.
The issue of poisonous syrups caused global embarrassment for Pakistan in December 2023 when the Maldives informed about contamination in medicines imported from Pakistan.
The South Asian state claimed that substances found in the syrups were used in hydraulic brake fluids, stamp pad inks, paints, plastics and cosmetics.
The World Health Organisation also issued an alert regarding the products of a Lahore-based pharmaceutical company, Pharmix Laboratories (Pvt) Ltd.
Published in Dawn, January 31st, 2024