Cough syrup deaths: Sresan Pharma owner arrested, plant sealed

The owner of the Tamil Nadu-based pharmaceuticals company, Sresan Pharma, which allegedly manufactured the adulterated Coldrif cough syrup that led to the deaths of at least 23 children across Madhya Pradesh and Rajasthan, has been arrested.

The owner, identified as G Ranganathan, was reportedly taken into custody by Madhya Pradesh police in Chennai late on Wednesday (October 8) night. A reward of Rs 20,000 had reportedly been offered for his arrest.

According to news agency PTI, he was detained following a midnight operation and taken to Sunguvarchatram police station for an inquiry. After obtaining a transit permit, the Madhya Pradesh police will take him to that state for a detailed investigation.

The plant in Kancheepuram was reportedly sealed by the Tamil Nadu government as a police team from MP visited the facility as part of its probe into the fatalities — 20 children in Madhya Pradesh and three in Rajasthan.

A Special Investigation Team (SIT) of the Madhya Pradesh Police visited the company’s registered office, as well as its manufacturing unit, in Kancheepuram as part of its probe. “Yes. The factory was sealed on Tuesday evening,” a government official confirmed to news agency PTI on Wednesday.

Also read: Why cough syrup tragedy exposes India's chronic drug regulation crisis

MP minister blames Tamil Nadu

On Wednesday, Madhya Pradesh minister Narendra Shivaji Patel blamed the Tamil Nadu government for the deaths of children in his state. He said the southern state showed “grave negligence” as it was its responsibility to inspect the medicines going out of the state.

Patel also asserted that while the MP government randomly inspects medicines coming into the state, it was “by chance” that this particular stock of cough syrup remained untested.

The Tamil Nadu government has banned the sale of cough syrup Coldrif with effect from October 1 and ordered removal of stocks of the medicine from the market.

Medicine not tested in MP ‘by chance’

Talking to PTI Videos, Patel, who is Madhya Pradesh’s Minister of State for Public Health and Family Welfare, said since the medicine was manufactured in Tamil Nadu, it was the state’s responsibility to issue the licence and inspect the medicine.

“A Certificate of Analysis (COA) certificate is required to be issued for every batch of medicine produced. Where did the Tamil Nadu government go wrong? Whether a COA certificate was issued or not? Which official made the mistake is a matter of investigation. The Tamil Nadu government has shown grave negligence in how such medicines came out of their state,” he said.

“We randomly inspect medicines that come into our state. By chance, these medicines were not tested. We seriously inspect medicines manufactured here,” he said.

The Tamil Nadu government’s negligence is grave, leading to the deaths of children here, he said. “We are writing to the central government and the state (Tamil Nadu) government to take strict action against the culprits,” Patel said.

Also read: Coldrif cough syrup row: Kerala bars medicines for children without prescription

Coldrif banned

The Tamil Nadu Food Safety and Drug Administration department on October 4 declared that the samples of cough syrup collected from the manufacturing facility were “adulterated” and the company was instructed to “halt production” immediately.

The Tamil Nadu government banned the sales of cough syrup Coldrif with effect from October 1 and ordered removal of stocks of the medicine from the market. States including Kerala and Madhya Pradesh have also banned it.

Meanwhile, the seven-member SIT led by an Assistant Commissioner of Police from Madhya Pradesh formed to look into the deaths of children from allegedly consuming the cough syrup launched a probe. The SIT visited the company’s registered address in Chennai and collected relevant details as part of the inspection.

“We arrived here (Chennai) last night. We are conducting the probe. He (owner of the drug company) had left the premises three days ago. We are collecting details based on the CCTV footage (available at the registered office),” an official part of the SIT told PTI on Wednesday. The owner was later arrested.

The team was assisted by the Tamil Nadu Police locally.

Also read: Karnataka, Telangana on alert amid child deaths due to toxic cough syrup

Second notice to company

The Chennai-based pharmaceutical company had been supplying the cough syrup Coldrif to Puducherry, Madhya Pradesh, Odisha, and Rajasthan, besides some others.

The Tamil Nadu government had earlier issued its second notice against the drug manufacturer for the alleged presence of diethylene glycol in the cough syrup Coldrif, asking why criminal action should not be taken, state health and family welfare minister Ma Subramanian informed.

The company has been making the cough syrup which contained 48.6 per cent of the “poisonous substance” as per the findings of the State Drug Control department, he added.

“On October 3, the samples collected by the drug controller declared the syrups to be adulterated. We have issued stop production order to the company. We have also asked the company why it should not be shut and asked for an explanation,” he said.

The company had been manufacturing the syrup for the past 14 years since obtaining license at its facility in Sunguvarchatram in neighbouring Kancheepuram district.

It has been supplying the medicines to various states, Subramanian said, adding, the government issued an advisory to Puducherry and Odisha that the cough syrup Coldrif should not be sold in the market.

Also read: SIT to probe 14 cough syrup deaths in MP; doctors threaten stir over arrest

DCGI warning

In the wake of the deaths, the Drugs Controller General of India (DCGI) has urged all drug controllers of the states and Union Territories to ensure testing of raw materials and finished formulations of pharmaceutical products before releasing them in the market.

In Indore, production at a pharmaceutical unit was temporarily halted after more than 200 deficiencies were found against established standards.

In an advisory, the DCGI said that during recent inspections at manufacturing facilities and in the investigations of the drugs declared as “Not of Standard Quality”, it was found that several manufacturers are not testing each batch of excipients and active ingredients for compliance with prescribed standards before use.

The DCGI said that the directorate has, from time to time, emphasised the critical importance of testing of raw materials, including the excipients, before their use in the manufacturing of pharmaceutical formulations.

Also read: CDSCO to initiate serious action against Coldrif makers following 14 deaths in MP: Report

IMA writes to Nadda

In a related development, the Indian Medical Association (IMA) on Wednesday sought Union Health Minister JP Nadda’s intervention into the arrest of a paediatrician in connection with the deaths and immediate withdrawal of the case against him.

Condemning the action taken against the Registered Medical Practitioner (RMP), IMA said the root cause of this tragedy is the failure of quality control at the level of the manufacturer, and the subsequent failure of the regulatory system responsible for oversight.

“The primary legal liability and culpability for introducing an adulterated drug into the market, which violates the Drugs and Cosmetics Act, rests squarely with the manufacturer and the enforcement agencies.

“We call upon the ministry to recognize the doctor as a secondary victim of a systemic collapse and to direct the immediate closure of all legal proceedings against them, ensuring justice for their professional defamation and trauma,” Dr Dilip Bhanushali National President of IMA said in the letter to Nadda on October 8.

(With agency inputs)