Mandatory Testing of Cough Syrup Exports

May 23, 2023

In a move to ensure the safety and quality of cough syrups being exported, the Indian government has made it compulsory for cough syrup makers to get their products tested in a government laboratory. This decision comes in response to recent incidents involving contaminated cough syrups that were linked to the deaths of children in Gambia and Uzbekistan. The Directorate General of Foreign Trade (DGFT) issued a notification stating that cough syrup exporters must comply with the new testing requirement starting from June 1.

Testing in Government Laboratories

According to the notification, exporters will be required to submit their cough syrup samples for testing in government-approved laboratories. The laboratories listed in the notice include the Indian Pharmacopoeia Commission in Ghaziabad, CDL Kolkata, CDTL Chennai, CDTL Mumbai, CDTL Hyderabad, RDTL Chandigarh, RDTL Guwahati, and NABL-accredited state drugs testing laboratories. The purpose of this testing is to ensure that the cough syrups meet the required safety and quality standards.

Addressing Contamination Concerns

The decision to implement mandatory testing stems from the discovery of contaminated cough syrups that led to the tragic deaths of children in Gambia and Uzbekistan. Two companies, Maiden Pharmaceuticals Ltd and Marion Biotech, were implicated in these incidents. The incidents raised concerns about the manufacturing practices and quality control of Indian pharma companies.

Additional Contamination Cases

In a more recent development, the World Health Organization (WHO) flagged contaminated cough syrups made by Punjab-based QP Pharmachem Ltd. These syrups were found in Marshall Islands and Micronesia and were marketed by Hyderabad-based Trillium Pharma. The WHO’s alert further emphasized the need for stringent testing measures to prevent the export of unsafe products.

Ensuring Safety and Quality

The new testing requirement aims to safeguard public health and restore confidence in Indian cough syrups. By subjecting the products to thorough analysis in government laboratories, the authorities can verify their safety, efficacy, and compliance with regulations. This measure is part of a broader effort to enhance the quality of pharmaceutical products manufactured in India and promote the country’s reputation as a reliable source of medicines.

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