CDSCO commences daily updation of cough syrup samples submitted in labs to enable time bound testing

The Central Drugs Standard Control Organisation (CDSCO) has started carrying daily updates of the number of batches of cough syrup samples submitted with each of the laboratories prior to exports in its website, in order to enable time bound testing and release of reports.

The drug regulator in May has directed specific state laboratories to examine the cough syrup samples with priority after the Directorate General of Foreign Trade (DGFT) notified that from June 1, only cough syrups that pass quality tests from designated laboratories will be allowed for exports.

Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India) (DCGI), has informed all drug manufacturers’ associations and exporters that it has decided to publish the number of batches of cough syrup samples received at each of the central and state drug testing laboratories on a daily basis on the CDSCO website.

“This is to enable work distribution amongst the lab and for release of test reports in a time bound manner by these laboratories,” said Raghuvanshi. Accordingly, the drug manufacturers and exporters may refer to the daily list and submit the sample to the laboratory having fewer samples as compared to other lab, he added in a circular.

According to reports, the DCGI has also issued standard operating procedures in May, to streamline the processes of testing in the laboratories and ensure the standard quality across the laboratories.

On May 22, the DGFT has issued a notification amending the export policy of cough syrup from free exports to the mandate that the cough syrup shall be permitted to be exported subject to the export sample being tested and the Certificate of Analysis (CoA) issued by certain laboratories to be submitted.

It also enlisted the laboratories, including the Indian Pharmacopoeia Commission, Ghaziabad, Central Drugs Laboratory, Kolkata, Central Drugs Testing Laboratories (CDTLs) in Chennai, Mumbai and Hyderabad, Regional Drugs Testing Laboratories (RDTLs) in Chandigarh and Guwahati and any NABL accredited State Drugs Testing Laboratory to conduct tests and issue the CoAs.

“The export of ‘Cough Syrup’ under ITC (HS) Codes falling under the Heading 3004 shall be permitted subject to the export sample being tested and production of Certificate of Analysis (CoA) issued by any of the laboratories as mentioned in Para-1 above, with effect from June 1, 2023,” said the DGFT’s notification.

According to reports, the DCGI’s standard operating procedure for testing of cough syrups advises the manufacturer to submit their license of the product for export and the export order, among others as part of the testing.

The measure comes after the reports and medical alerts from the World Health Organisation (WHO) and others that the cough syrups exported from the country has resulted in adverse events and death of several children in some of the countries.

WHO has earlier alleged that the cough syrup exported from India has resulted in death of children in Gambia and Uzbekistan and the Indian drug regulator conducted tests on the samples from the companies which were allegedly involved in the export of these cough syrups. This, along with reports of an adverse event from the United States against an ophthalmic product manufactured in India, has raised concerns over the quality of drugs exported from the country and the Government of India started various actions to ensure quality of medicines. The DGFT’s order comes as part of this effort.

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