Indian drugs regulator halts production at 31 pharma firms

By Anadolu staff

ANKARA (AA) - Indian drug regulatory authorities halted production of drugs at 31 firms after a "risk-based inspection and audit of manufacturing plants," the country's health minister said on Tuesday.

A statement issued by the Ministry of Chemicals and Fertilizers said Indian Health Minister Mansukh Mandaviya, who also heads the Chemicals and Fertilizers Ministry, met representatives of pharma companies on Tuesday in the capital New Delhi.

Mandaviya told the representatives that it is important for the pharma companies to be alert to the "quality of drugs" and expeditiously move towards good manufacturing processes through "self-regulation."

He said there will be no compromise on the quality of drugs manufactured in India.

"The union minister further stated that in order to ensure the highest quality of pharma products, the regulatory authorities have started the risk-based inspection and audit of plants," the ministry said.

He said 137 firms were inspected, and action has been taken against 105 firms.

"Production has been stopped at 31 firms and cancellation and suspension of product/section licenses have been issued against 50 firms," the minister said, adding that show cause notice has been issued to 73 firms, and warning letters have been issued against 21 firms.

India recently faced a challenging situation after Indian-made cough syrups were linked to the deaths of dozens of children in foreign countries.

In April, the World Health Organization issued an alert regarding contaminated cough syrup made by an Indian company which it identified in the Marshall Islands and Micronesia.

In March, Indian health authorities canceled the license of a pharmaceutical firm located in Noida in northern Uttar Pradesh state that manufactured cough syrup linked to the deaths of at least 19 children in Uzbekistan last year.

In February, one Indian firm recalled eye drops after the US flagged 55 cases of adverse events, including one death.

The incident in Uzbekistan followed a similar case in Gambia in October last year when the WHO issued an alert for four contaminated medicines linked to acute kidney injuries and 66 child deaths. The medicines were cough and cold syrups manufactured by Maiden Pharmaceuticals Limited in India.

The Indian Health Ministry, however, informed the parliament that "control samples" of the drugs from the manufacturing unit were tested and analyzed. "As per the report of the government analyst, the samples have been declared to be of standard quality," it said.