New Delhi: The drug regulator has issued detailed standard operating procedures for drugmakers to smoothen the process of testing cough syrups after the deaths of several children abroad attributed to these syrups.
Poor quality Indian-made cough syrups have been linked to the death of 84 children in Gambia and Uzbekistan since 2022.
The standard operating procedures issued by the Drugs Controller General of India (DCGI) aim to improve the process of testing cough syrups at government laboratories.
The SOPs require submission of samples directly to government-authorized testing labs, including the point persons in such labs, providing a copy of the manufacturing licence, and submitting large volumes of samples from each batch of texport consignments.
This follows a notification issued by Directorate General of Foreign Trade (DGFT), that stated that from 1 June only those cough syrups can be exported that pass quality tests at Indian Pharmacopoeia Commission (UP), Central Drug Laboratory (Kolkata), Central Drug Testing Laboratory (Maharashtra, Telangana) Regional Drugs Testing Laboratory (RDTL Chandigarh & Guwahati) and National Accreditation Board for Testing and Calibration Laboratories (NABL)-accredited state drug testing laboratories for every batch.
“In order to facilitate the process of testing of cough syrups at the said laboratories, all state licensing authorities/CDCSO zonal, sub- zonal offices and all Indian Drugs Manufacturer Association are requested to percolate the requirements to all concerned who intend to export cough syrups,” said Rajeev Raghuvanshi, DCGI.
The SOPs say the manufacturer has to submit the manufacturing licence of the product for export and the export order.
Furthermore, the top drug regulator stated that representative samples from the export consignment and thrice the quantity required for performing complete analysis of the sample along with certificate of analysis by the manufacturer of the batch and method of analysis have to be presented.
With several instances of Indian cough syrups failing quality tests in other countries due to the alleged presence of high levels of ethylene glycol and diethylene glycol, the Union government has now tightened the regulations governing export of cough syrups.
India exported cough syrups worth $17.6 billion in 2022-23 as against $17 billion in 2021-22.
The country is the largest provider of generic drugs globally, supplying over 50% of global demand for various vaccines, about 40% of generic demand in the US and about 25% of all medicine in the UK.