After India decided to put in a system of checks at government laboratories before exporting cough syrups, the Drug Controller General of India (DCGI) has asked state laboratories and inspectors to test the finished products on “top priority” and issue the “test report at the earliest”.
On May 22, a notification was issued by the Ministry of Commerce and Industry, Directorate General of Foreign Trade, revising the policy where exports are allowed only after the production of a “certificate of analysis” by the exporter.
A cough syrup will only be permitted to be exported subject to the export sample being tested and the production of a Certificate of Analysis (CoA) issued by any of the selected laboratories.
The move is driven by multiple allegations levelled by importers of Indian medicines, especially cough syrups, including Uzbekistan, the Gambia, Marshall Islands, and Micronesia, where made-in-India syrups were found contaminated with toxic diethylene glycol (DEG) and ethylene glycol (EG).
In a letter dated May 24, the apex drug regulator has written to state drug controllers of Gujarat, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Jammu & Kashmir and Uttarakhand.
“The above-mentioned State Drug Controllers are hereby requested to give instructions to your State owned NABL accredited laboratories to analyse the samples received from the manufacturers of cough syrups for export purpose on top priority and issue the test report at the earliest,” the letter said.
The letter also requested all central laboratories to give top priority in analysing the sample received from the manufacturers and issue the report immediately in order to avoid delays.
The letter aims to prepare the laboratories well in advance to handle the rush before the consignments of cough syrups start coming in for testing as the changes will be effective from June 1, according to the notification.
This move could also address the concerns of manufacturers that the testing by government laboratories would be a time-consuming process and delay the shipments.
The DCGI has also requested all state licensing authorities to send the e-mail addresses of NABL-accredited laboratories based in their states to consolidate the list further.
So far, the selected laboratories are Indian Pharmacopoeia Commission in Ghaziabad, Uttar Pradesh, and CDSCO laboratories, including the Regional Drug Testing Laboratory (Chandigarh and Guwahati), Central Drugs Laboratory (Kolkata), and Central Drug Testing Laboratories (Chennai, Hyderabad and Mumbai).
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