The news: On October 10, 2025, the bench of CJI BR Gavai and Justice K Vinod Chandran dismissed the PIL filed by Advocate Vishal Tiwari seeking CBI enquiry into the deaths of children due to cough syrups in Madhya Pradesh and Rajasthan.
Source: Media
Analysis
Events so far
The deaths of children reported from Madhya Pradesh and Rajasthan states over the last two weeks, have been linked to three contaminated cough syrups:
- Coldrif by Sresan Pharmaceuticals
- Respifresh by Rednex Pharmaceuticals
- ReLife by Shape Pharmaceuticals
These contaminated cough syrup samples were found to contain diethylene glycol (DEG) – a toxic substance found in industrial solvents.
G Ranganathan, the owner of Sresan Pharmaceuticals, has been arrested.
Inspection of the Sresan Pharmaceuticals found violations of 364 manufacturing rules – 39 “very serious” and 325 “major.”
Two senior drug inspectors in Tamil Nadu have been suspended.
Dr. Praveen Soni, one of the doctors who prescribed the syrup, has been arrested for negligence.
What may have led to these deaths?
- Contamination in only a few batches of samples and not all.
- Poor knowledge and training of the staff of the pharmaceutical company.
- Poor inspection by the Drug Control department.
- Poor guidelines and procedures for testing and approval of medicines. (The World Health Organization has highlighted gaps in India’s drug safety regulations)
- Poor guidelines and procedures for inspection and approval of pharmaceutical companies.
- Bribery during licencing of pharmaceutical companies and approval of drugs.
Who should be held responsible?
- The Food & Drug Administration departments of respective states.
- The Drug inspectors who inspected the company Sresan pharmaceuticals.
- The pharmaceutical company owners and managers for overlooking safety and other aspects of drug production.
Are the doctors or the hospitals responsible?
Doctors are not responsible for this because the medicine prescribed by them were not supposed to be contaminated with the toxic substances. They prescribed the composition for treatment of the disease and contamination of the product consumed is not there responsibility.
If the cough syrups were procured by the hospitals, they should do an internal audit of the procedures they follow in procurement. Many government hospitals follow the policy of buying the drugs from dealers with lowest price quotes, completely overlooking the quality of the drug being purchased.
Critical questions
- Will these deaths lead to a change in the procedures and guidelines of drug control departments of various states?
- Will the drug control department provide compensation to the families of children who died due to the contaminated syrups?
- Will other pharmaceutical companies learn from this and improve their safety checks and procedures to prevent drug contamination?
Is CBI enquiry required?
An enquiry is definitely required in the pharmaceutical companies and procedures followed for licensing and approval by the food and drug administration in states. But the States are competent to investigate the matter. Though CBI has the power and authority, it does not have the expertise to investigate the lapses in the pharmaceutical company and during the inspection of the company. Therefore, CBI enquiry is not required.
Similar events in past
In 2023, Indian cough syrups contaminated with diethylene glycol were linked to the deaths of 70 children in The Gambia and 18 children in Uzbekistan.
In December 2019 and January 2020, at least 12 children under five died in Jammu allegedly due to cough syrup.
Significance
We now have an opportunity to improve our licensing procedures and improve the drug manufacturing facilities in our pharmaceutical companies.
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