Behind Madhya Pradesh cough syrup deaths: Bad batch, compromised system, a phone call

By then, 15 children had already died in Chhindwara.

The chargesheet filed by the Madhya Pradesh police reveals that the deaths of over 20 children were not the result of a single catastrophic error, but “the outcome of a continuous and interconnected chain of events, extending from sourcing of raw material to medical use”.

A total of 11 persons have been named as accused, and a district and sessions court has taken cognisance of the chargesheet. The case is currently being heard at the stage of arguments on charges.

At the centre of the police case is how the contaminated batch, SR-13, reached Chhindwara through a network of suppliers allegedly dealing in inferior-quality pharmaceuticals, and how monthly gifts and incentives were used to lure doctors in Chhindwara to prescribe the cough syrup.

The manufacturer

At the centre of this chain was batch SR-13 of Coldrif syrup, manufactured by Sresan Pharmaceuticals in Tamil Nadu and distributed through a network that operated almost exclusively in a single district of Madhya Pradesh.

Sresan Pharma had been in operation since 1984, giving it, as the chargesheet notes, “longstanding experience in pharmaceutical manufacturing processes”. The unit produced various liquid oral pharmaceutical formulations under the supervision of G Ranganathan, who served as both the manufacturing chemist and the proprietor.

Now the main accused in the case and currently under judicial custody, Ranganathan was previously booked on five occasions in 2019, 2020, 2022, and 2023 under various provisions of the Drugs and Cosmetics Act, investigators said. “In some of these matters, monetary penalty/fine was imposed by the court,” the chargesheet states.

During the investigation, police discovered that the firm had allegedly received propylene glycol, a key ingredient in the syrup, “without a Certificate of Analysis”. “Proper bills/invoices relating to the purchase of raw material were not found to be consistently and uniformly maintained, and in some cases, payments for raw material were arranged through third-party accounts,” it states.

“During investigation, it was found that in the manufacturing process, both industrial-grade propylene glycol as well as food-grade propylene glycol were used, whereas in pharmaceutical manufacturing, only pharmaceutical-grade propylene glycol should be used,” the chargesheet states.

When the Tamil Nadu Drug Department inspected the facility, it documented “39 critical deficiencies and 325 major deficiencies”.

Chemical analyst-cum-quality control officer K Maheshwari, who has also been arrested, was responsible for testing the cough syrup within the unit. Police alleged that the laboratory concerned did not have “the necessary instrumentation facility” to detect the contamination.

Ranganathan has denied all allegations before the district court in Parasia. His legal team submitted that he has “been made an accused by the police illegally and merely on suspicion, without any concrete or direct basis”.

Maheshwari submitted that “without properly considering the legal facts and circumstances, the prosecution has made her an accused”.

The supplier

The industrial-grade propylene glycol that entered batch SR-13 allegedly came through Shailesh Pandya, who operated Pandya Chemicals and held a valid drug department licence. This licensing meant, as the chargesheet states, that “he had technical, commercial and legal knowledge relating to raw materials used in pharmaceutical manufacturing”.

As per the chargesheet, Pandya purchased the chemical from “a firm dealing in industrial and fragrance chemicals, where industrial-grade propylene glycol is used. The accused had full knowledge of this fact.”

“Instead of receiving payment in his licensed bank account, the accused arranged for payment through the QR code of a person whose bank account was found to be located in Gujarat,” the chargesheet states.

“It is clearly established that the accused deliberately kept the financial transactions indirect, non-transparent and outside legal oversight, so as to conceal the true nature and source of the raw material,” it states.

Batch SR-13 moved from Tamil Nadu to Madhya Pradesh through what should have been a standard three-tier distribution system. According to the chargesheet, the intended chain was for Sresan Pharmaceuticals to supply the state distributor, Kataria Pharma, which would then provide the batch to the local stockist, New Apna Medical Store.

In practice, however, “this distribution channel was bypassed”, the chargesheet states.

New Apna Pharma, the stockist, “on certain occasions directly procured medicines from Sresan Pharma, without obtaining them through Kataria Pharmaceutical, Jabalpur, which is also the distributor of Sresan Pharma for the State of Madhya Pradesh”, it states.

The operation of New Apna Pharma revealed that it was “being operated by Rajesh Soni, a close family relative (nephew) of Dr Praveen Soni, and this unit was found to be operating from the house of Dr Praveen Soni in Chhindwara”, it states.

“Thus, New Apna Pharma was not operating as a commercially independent entity, but in direct family and operational proximity to Dr Praveen Soni,” it states.

Of the 330 bottles of Coldrif syrup that New Apna Pharma received from Kataria Pharmaceutical, 87 bottles went to a single location: Apna Medical Store, located adjacent to Dr Praveen Soni’s clinic and operated by his wife, Jyoti Soni.

The chargesheet notes that this “distribution pattern indicates disproportionate and targeted supply to a medical store directly linked with Dr Praveen Soni”.

Jyoti Soni has denied all allegations and told the court, “On the basis of the said test report, only the drug-manufacturing company, Sresan Pharmaceutical, is solely responsible for the production of the sub-standard cough syrup and its adulteration.”

The medical representative

Connecting the Tamil Nadu manufacturer to doctors in Chhindwara was Satish Verma, who had worked with Shresan Pharma for approximately 28 years. His role evolved over time.

“During the initial period, he formally worked as a medical representative (MR),” the chargesheet states. “In the later period, he shifted from a regular salary-based role to a commission-based work pattern.”

“Under the commission-based system, the MR receives higher financial benefits, and it was reflected that the concerned MR also earned financial benefits through commission,” it states.

Documents seized from Verma’s residence indicated how gifts and benefits were allegedly used to secure prescriptions.

“In the registers/records seized from the residence of the MR, entries were found regarding monthly gifts and financial benefits given to doctors, and it was reflected that after such benefits were given, prescriptions of the concerned medicines were written,” the chargesheet states.

“Across entire Madhya Pradesh, prescriptions of the said medicine were mainly reflected only in the Chhindwara area, and this was the same area where commission-based work for Sresan Pharma was being carried out by MR Satish Verma,” it states.

Dr Praveen Soni practised as a paediatrician in Chhindwara, treating children both as a government doctor and at his private clinic. During the period when children began falling ill, he had applied for leave from his government position, but “the application could not be sanctioned”. “Despite this, during the same period, he continued to sit at his private clinic and kept treating children,” the chargesheet states.

The chargesheet documents that he treated 17 children “related to Coldrif/related drug intake.” Fifteen of them died.

From the last week of August, children started coming to Dr Praveen Soni for treatment, and “even during this initial period, serious and abnormal kidney-related symptoms were observed in the children”.

By September 11, when the consultation with Dr Khapekar took place, the Nagpur-based doctor opined that “in view of the repeatedly occurring serious kidney-related condition in children”, the problem was being caused by some medicine.

The reference to the 1998 DEG tragedy was not casual. “The purpose of referring to the historical incident was not merely to provide information, but to issue a warning,” the chargesheet emphasises. “During the call, the reference to the 1998 DEG tragedy was a clear indication that the kidney-related conditions presently being observed were consistent with drug-induced toxicity, particularly DEG exposure,” it states.

Despite this warning from a specialist, and despite his own observations of kidney conditions developing in his young patients, Dr Soni “did not give any telephonic or written intimation, warning, or formal report to the competent authority, namely the Drug Department, in relation to any medicine,” the chargesheet states.

Dr Soni, in his defence, claimed that he had no knowledge that “the cough syrup was contaminated”.