Govt tweaks policy to prevent export of spurious cough syrup

The Centre after internal deliberations has amended the export policy for cough syrups.

The government has amended the export policy to prevent shipping of adulterated and substandard cough syrups.

From June 1, pharma companies will be allowed to export cough syrups only after producing the certificate of analysis (CoA) from any of the six central and regional drug testing laboratories or any NABL-accredited laboratory across the country.

“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 1 June 2023,” said a notification from the Ministry of Commerce and Industry.

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The pharma companies will have to take the CoA from any of the central drug testing laboratory (CDTL) at Kolkata, Chennai, Mumbai, Hyderabad, Chandigarh and Guwahati.

The notification seen by Moneycontrol said that the pharma companies will also be allowed to export the cough syrup after production of Certificate of Analysis (CoA) issued by Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh.

The central government has amended the Chapter 30 of the schedule 2 of the ITC (HS) export policy related to export of cough syrups.

Also read: Uttar Pradesh Drugs regulator cancels Marion Biotech's manufacturing licence

The health ministry, along with the department of pharmaceutical and directorate general of foreign trade (DGFT), were in discussion for testing the cough syrups for possible contaminations.

The adulteration in the cough syrups exported by domestic Indian pharma companies have been a cause for concern for the government in the last few months.

In the last six months, the World Health Organisation (WHO) has issued two ‘Medical Product Alert’ for substandard cough syrups, identified in The Gambia and Uzbekistan, containing unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

Dr Viranchi Shah, National President of the Indian Drug Manufacturers Association (IDMA) stressed on developing a quality management system as provisions for analysing and testing every batch before export was already there.

Also read: Uzbekistan claims cough syrup made in Noida responsible for death of 18 kids

“In the modern world, over-reliance on testing should not be our goal, the goal should be building a quality management system. As an industry, we are also internally interacting on how we work with the government to strengthen the quality management system,” he said.

Even if it’s done (testing before export), as an association, we don’t have any problems, we have always been encouraging our members to adopt the best quality standards, he added.

Also read: Pharmexcil suspends membership of Marion Biotech over Cough Syrup Deaths

Uday Bhaskar, Director General, Pharmexcil, said the government should work for implementation of the Schedule M of the Drugs and Cosmetics Act, 1940 in the country.

“Every manufacturer has different products and combinations for export. How is it possible to check lakhs of samples before they are exported?” Bhaskar asked.

In December 2022, Uzbekistan claimed that at least 18 children in the country had died after allegedly taking an India-manufactured cough syrup. According to Uzbekistan's health ministry, laboratory tests of a batch of syrups found "the presence of ethylene glycol", a toxic substance.

In March, a joint probe was conducted by the Centers for Disease Control and Prevention (CDC) of the US and the Gambian health authorities on the made-in-India cough syrups on the link to the death of 66 Gambian children.