Drugmaker asked to stop production after non-standard quality samples: Govt

A Punjab-based drugmaker was asked to stop all manufacturing activities after samples collected from its premises, following an alert by the WHO, were found to be "not of standard quality", the Lok Sabha was informed on Friday.

Minister of State for Health Bharati Pravin Pawar, in a written reply in the Lower House of Parliament, said the World Health Organization (WHO) issued a medical product alert for a batch of India-made Guaifenesin syrup in the Marshall Islands and the Federated States of Micronesia.

Subsequent to the reports, the Central Drugs Standard Control Organisation (CDSCO) in coordination with State Drugs Authority, Punjab, conducted a joint investigation at M/s QP Pharmachem Ltd in Punjab.

"Drug samples drawn from the manufacturing premises under the provisions of Drugs and Cosmetics Act, 1940 for test and analysis were declared as 'not of standard quality'," the minister said.

"Further, the State Licensing Authority has directed the firm to stop all manufacturing activities with immediate effect," Pawar said.

The WHO on April 25 issued a product alert over a batch of substandard (contaminated) Guaifenesin syrup, warning that it is unsafe for use, especially in children, and may result in serious injury or death.

In response to a question on whether the Centres for Disease Control and Prevention of the United States of America has expressed concern that a drug-resistant bacteria strain allegedly linked to eye drops from India could gain a foothold in US healthcare settings, Pawar said, "No such report has been received".