DCGI Streamlines Cough Syrup Testing

New Delhi : To ensure timely testing of cough syrups at the government authorized laboratories, the Drug Controller General of India (DCGI) Rajeev Raghuvanshi has written to all drug manufacturers and exporters to submit cough syrups samples to the laboratory having lower workload and to ensure that no single laboratory gets overburdened.

Also, to facilitate this, DCGI plans to publish the record of samples being tested in each lab for the manufacturers to plan their testing schedules. This is being done to avoid any delays in testing of cough syrups to prevent export delays.

In view of cough syrups failing quality testing in other countries being linked to death of children in Uzbekistan and Gambia, the Union government recently changed the exports policy for cough syrups making prior testing mandatory before supplying to other countries.

“It has been decided to publish on daily basis on CDCSO website w.r.t. the number of batches of cough syrups samples received at each of the Central/State Drug Testing Laboratories. This is to enable work distribution amongst the labs and for release of test reports in a time bound manner by these laboratories,” said the DCGI in a letter to all drug manufactures and exporters seen by Mint.

Accordingly, drug manufacturers and exporters may peruse the same and submit samples to the labs having fewer samples as compared to the other labs, he said.

Queries sent to the health ministry did not respond till press time.

In a notification issued on 1 June, Directorate General of Foreign Trade (DGFT) stated that 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.

As per the official data, 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.

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