India suspends a drugmaker’s manufacturing licence after the WHO flagged contamination in its cough syrups

The Indian government has taken action against a drug manufacturer by suspending its manufacturing license after contamination was flagged by the World Health Organization (WHO) in its cough syrups found in the Marshall Islands and Micronesia in April. The suspension of the license comes as Indian regulators are conducting inspections of drugmakers following reports of cough syrups made in India being linked to 89 child deaths in Gambia and Uzbekistan last year. These incidents have negatively impacted India’s reputation as the “pharmacy of the world,” known for providing affordable drugs globally.

The WHO identified the presence of toxic substances, diethylene glycol and ethylene glycol, in unacceptable amounts in samples from a batch of cough syrup manufactured by QP Pharmachem Ltd, a company based in the northern state of Punjab. QP Pharmachem has denied any wrongdoing and expressed its intention to appeal against the suspension.

Deputy Health Minister Bharati Pravin Pawar informed the parliament that drug samples taken from QP Pharmachem’s manufacturing premises were declared as “not of standard quality.” In addition to QP Pharmachem, the manufacturing licenses of two other companies, Maiden Pharmaceuticals and Marion Biotech Pvt. Ltd, were also suspended as their products were linked to the child deaths. These companies have also denied any wrongdoing.

Sudhir Pathak, the managing director of QP Pharmachem, stated that the company plans to appeal against the suspension order issued by the government. He mentioned that production has been halted, and he had tested the ingredients used in the cough syrup, named Guaifenesin TG, before starting production. Pathak clarified that the product was only exported to Cambodia, and he is unsure how it could have reached the Marshall Islands and Micronesia.

In response to the incidents, India has strengthened its testing of cough syrup exports, now requiring companies to obtain a certificate of analysis from a government laboratory before exporting products, a measure implemented since June. The government’s actions aim to address the issue of contaminated cough syrups and ensure the safety and quality of pharmaceutical products exported from India.