India Pharma Outlook Team | Thursday, 15 May 2025
The Laghu Udyog Bharati which supports small-scale industries, have requested the government to lift the requirement that the cough syrups be analyzed at government-approved laboratories prior to export. The policy was launched in May 2023 as a reaction to international concern following suspicion of contamination of Indian-made syrups, which resulted in child fatalities in Gambia due to suspected contamination with diethylene glycol and ethylene glycol.
On a May 10 letter to Union Health Minister JP Nadda, LUB general secretary Om Prakash Gupta said “For the manufacturers and exporters, these are areas of concern as it results in potential delays”. As per LUB testing usually takes 45 days and costs ?25,000 per batch, which is a heavy financial burden on small manufacturers.
LUB has asked that the government to find some viable solution and requested an exception not only for cough syrups but even for other medicines being exported like suspensions, dry syrups, tablets, injections, and infusions. They also claimed that in the past two years there haven't been major complaints about such products and logically questioned whether it is absolutely essential to have obligatory testing.
The testing requirements necessitate that exporters procure a certificate of analysis from a government-authorised laboratory in an effort to re-establish confidence in Indian pharma exports. But the LUB asserts that the increased cost and time impact the competitiveness of Indian MSME pharma.