Test cough syrups meant for exports on priority: DCGI
DCGI on Wednesday directed state drugs regulators and government laboratories to test cough syrup samples meant for exports “on top priority” and issue reports at the earliest.
The Drugs Controller General of India (DCGI) on Wednesday directed state drugs regulators and government laboratories to test cough syrup samples meant for exports “on top priority” and issue reports at the earliest, according to people familiar with the matter.
The move is aimed at averting unnecessary hold-ups after the Union ministry of commerce issued an order on Monday making it mandatory for cough syrup manufactures to get their stocks tested at a government laboratory before shipping for export.
“The state drugs controllers are hereby requested to give instructions to your state owned NABL 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,” read the letter sent to state drugs regulators and laboratories concerned by the Drugs Controller General of India, Rajeev Singh Raghuvanshi. HT has seen the letter.
The directive has also been issued to certified government laboratories.
The changes in the government export policy come after cases of deaths in The Gambia and Uzbekistan were linked to consumption of contaminated cough syrups manufactured in India.
The revised export policy order that was issued by directorate general of foreign trade (DGFT) under the commerce ministry will come into effect from June 1.
In December, Noida-based pharmaceutical company Marion Biotech’s cough syrup was linked to the death of 18 children in Uzbekistan.
In a briefing on October 5, WHO (World Health Organisation) issued a medical product alert over four cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — manufactured and exported by Haryana-based Maiden Pharma. The syrups likely were linked to the death of at least 66children in The Gambia.
The government laboratories that can be used for testing are Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, CDL, Kolkata, West Bengal, CDTL, Chennai, Tamil Nadu, CDTL, Mumbai, Maharashtra, CDTL, Hyderabad, Telangana, RDTL, Chandigarh, RDTL, Guwahati, Assam, and any NABL accredited State Drugs Testing Laboratory.
“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 the production of a Certificate of Analysis (CoA) issued by any of the laboratories…, with effect from June 01, 2023,” read the order issued by Santosh Kumar Sarangi, director general of foreign trade.
A day later on Tuesday Sarangi said at an event that all pharmaceutical products must meet global standards and quality requirements.
“This is a continuous effort which has been started with cough syrup. It is our endeavour that any cough syrup exported from India must meet minimum benchmark requirement of quality standards. Therefore they will be exported after being tested in specified labs,” he said.
“As per CDSCO’s (Central Drugs Standard Control Organisation) advice, whatever needs to be done for quality improvement in pharma will be done.”
With inputs from PTI
