DELHI: India has made it compulsory for cough syrup makers to get samples tested before exporting their products.
Starting on the first of June, the companies would have to get a certificate of analysis from the Indian government-approved laboratories.
The rule change comes after some Indian-made cough syrups were linked to deaths in Uzbekistan and Gambia. The deaths rocked the Indian pharmaceutical industry, the third largest medicine manufacturer in the world.
The announcement was made by the Indian Foreign Trade Ministry, which said in a notification that cough syrups would be permitted to be exported “subject to the testing of export samples.”
It said samples could be tested at nationwide central and state government laboratories.
Last week, Reuters reported that India was considering a policy change after domestic cough syrups were linked to child deaths abroad.
Several Indian pharma companies have come under scrutiny for the quality of their drugs, with increasing concerns over their manufacturing practices.
In March, India’s drug regulator cancelled the manufacturing license of Marion Biotech, whose cough syrups were linked to the death of 18 children in Uzbekistan.
In October last year, the World Health Organisation (WHO) also issued an alert linking four Indian-made cough syrups to the deaths of children in Gambia.
India later said the medicines complied with specifications when tested at home, but the WHO responded that it stood by its version of the statement.
