The Centre had two years back issued a clear warning restricting the use of cough syrups containing Chlorpheniramine Maleate (2 mg) and Phenylephrine HCl (5 mg). The same formula was used in Coldrif, which has so far claimed the lives of 17 children in Madhya Pradesh’s Chhindwara.
On December 18, 2023, an official directive was released, stating that the aforementioned salts should not be given to children below four years. The decision was based on findings that these formulations offered minimal therapeutic benefit and posed greater health risks to young children.
The government also made it mandatory for pharmaceutical companies to include a prominent warning label on these products.
Pharma companies ignored warnings
However, despite this directive, pharmaceutical companies failed to comply. Many did not change the product labeling and state governments did not enforce the restrictions or initiate any public awareness campaigns.
Investigations revealed that the Coldrif cough syrup contained the exact banned combination of Paracetamol, Chlorpheniramine and Phenylephrine, and did not carry any warning label.
1,470 pharma companies yet to apply for WHO-GMP certification
After the Gambia tragedy, the Centre made it mandatory for every company to get WHO-GMP certification. There are a total of 5,308 MSME pharmaceutical companies in the country. Out of these, 3,838 companies have obtained certification, while 1,470 companies have not yet applied.
MP-based Shree San Pharma, which sold cough syrup, was also devoid of this certificate.
The Centre has developed the Online National Drug Licensing System (ONDLS), a single-window platform for processing license applications related to drugs, cosmetics and medical products.
However, so far, only 18 states have joined the system, while the remaining states remain inactive.
As many as 17 children have so far died due to the infamous cough syrup. Most of the deaths have occurred due to kidney failure.
Tamil Nadu’s Drug Control Department conducted an inspection at Coldrif manufacturing facility in the state. During the probe, over 350 breaches of safety and quality standards were discovered at the plant.
Shocking report reveals alarming details
A recent investigation by Tamil Nadu’s Drug Control Department has uncovered serious violations at the manufacturing facility that produced Coldrif cough syrup, which has been linked to the deaths of several children in Chhindwara, Madhya Pradesh. Authorities found the syrup was being made in filthy and unhygienic conditions. The facility lacked skilled staff, proper equipment, machinery and basic infrastructure required for safe drug production.
Test discovered harmful chemicals in syrup
Tests showed the presence of harmful chemicals—propylene glycol and diethylene glycol—in the syrup. While propylene glycol is generally safe in small amounts and is commonly used in medicines, food, and cosmetics, it can become harmful in large doses or with long-term exposure.
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