The World Health Organization (WHO) has issued an alert on 7 August 2023 regarding another Indian-made cough syrup. This time an objection has been lodged regarding Indian syrup from Iraq.
It is noteworthy in this context that this is the fifth time in the last 10 months when Indian medicines can be banned.
According to WHO, this medicine is manufactured by Fourrts (India) Laboratories Pvt Ltd under the name Cold Out Cough Syrup.
The manufacturer of this syrup is Forts India Laboratories Private Limited of Tamil Nadu. Its production unit is located in Maharashtra under the name Dabilife Pharma Private Limited.
After laboratory analysis of Cold Out Syrup, its samples were found to have unacceptable amounts of Diethylene Glycol (0.25%) and Ethylene Glycol (2.1%) as contaminants. Whereas for both ethylene glycol and diethylene glycol the allowable safety limit should not exceed 0.10%.
This Cold Out Syrup (Paracetamol & Chlorpheniramine Maleate) is of poor quality and dangerous to health.
Paracetamol and chlorpheniramine combination syrup is used for the treatment and relief of cold and allergies.
According to the UN agency, both the manufacturer and marketer Dabilife Pharma Pvt Ltd, India, have failed to give guarantees on the safety and quality of the product to the WHO.
Consumption of diethylene glycol and ethylene glycol can prove fatal to humans. Its use, especially in children, can result in serious illness or death. Toxic effects may include abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental status, and death, including acute kidney disease.
Recently WHO instructed all health care professionals to promptly report any suspected or confirmed cases of adverse events associated with the use of a contaminated drug product to national regulatory authorities and the National Pharmaco-vigilance Centre.
Cough syrup made in India has been linked to the deaths of dozens of children in Uzbekistan, the Gambia and Indonesia. Thereby prompting the government to tighten the export policy for cough syrups. Now it is mandatory to test before exporting to other countries.
In this context, in May 2023, the Government of India had issued an order that cough medicine to be exported would have to take a certificate. Which will be issued after very stringent tests and this test will be done in a government laboratory.
The Ministry of Trade had issued this directive in May, which has been implemented from June 1, 2023.
The $41 billion pharmaceutical industry in India is one of the largest drug manufacturers in the world. But for the past few months, India's pharmaceutical industry has been embroiled in international controversies as people have died due to drugs made in India in Gambia, Uzbekistan and the US.