In an attempt to prevent exports of poor-quality cough syrups denting India’s reputation, the central government is planning to put a system of checks for the finished syrups at government laboratories before the final dispatch, News18.com has learnt.
The Ministry of Health and Family Welfare has been considering the proposal sent by the drug regulatory agency, Central Drugs Standard Control Organisation (CDSCO).
“The proposal is to test the finished goods at government labs before exporting,” a senior government official at the Ministry of Health and Family Welfare told News18.com. The proposal was sent to the ministry in the first week of May.
“These samples can be tested at Indian Pharmacopoeia Commission and six CDSCO network labs based in Chandigarh, Kolkata, Chennai, Hyderabad, Mumbai and Guwahati. Apart from these labs, these samples can also be tested at NABL-accredited drug testing labs of the state government, as per the proposal,” the official added.
The CDSCO laboratories include the Regional Drug Testing Laboratory (Chandigarh and Guwahati), Central Drugs Laboratory (Kolkata), and Central Drug Testing Laboratories (Chennai, Hyderabad and Mumbai).
The proposal explains that the exporter will have to produce the “Certificate of Analysis” of the batches being exported from one of the approved labs along with other documentation for release of the consignment for export.
The latest moves are driven by multiple allegations levelled by the importers of Indian medicines, including Uzbekistan, Gambia and the Marshall Islands and Micronesia, where made-in-India cough syrups were found contaminated with toxic chemicals.
“The CDSCO has requested the health ministry to take a call on their proposal. It’s true that these incidences cause embarrassment and raise doubt on otherwise excellent manufacturing capabilities,” the official quoted above said.
“We are contemplating the proposal and may make an intervention to prevent the compromised quality cough syrups from entering the global supply chain.”
What is the need of checking?
The syrup-based formulations such as cough syrups require using solvents like propylene glycol, glycerine, and sorbitol because of the insolubility of the drugs used. This is where the entire problem lies. There are adulterants commonly used with these solvents where mainly diethylene glycol (DEG) and ethylene glycol (EG) are the most common.
These adulterants are toxic to the kidney and cause death if used in high quantities. In the recent past, there have been some incidences of these adulterants being found in syrup-based formulations exported from India, including the deaths reported in Gambia, Uzbekistan and Marshall Islands and Micronesia.
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