Cough syrup deaths: IMA demands Health Minister JP Nadda's intervention, withdrawal of case against pediatrician

New Delhi: In view of pediatrician's arrest following deaths of children due to the consumption of a "contaminated" cough syrup in Madhya Pradesh, the Indian Medical Association (IMA) on Wednesday sought Union Health Minister JP Nadda's intervention into the matter and immediate withdrawal of the case against the bona fide medical practitioner.

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.

The immediate arrest of the doctor constitutes a classical example of "legal illiteracy" and sends a profoundly detrimental message to healthcare providers nationwide, the letter said.

The IMA President pointed out that the Supreme Court's laid down a proper procedure to be followed prior to arresting a doctor is lacking in this case.

A doctor prescribes a drug (even if generic) in good faith, based on its official approval by the competent regulatory bodies and its availability in the certified supply chain. They have no means or mechanism to ascertain manufacturing lapses, such as the hidden contamination of excipients with toxic substances like Diethylene Glycol (DEG) or Ethylene Glycol (EG), the letter said.

"Holding the prescribing physician culpable for an undetected defect in the drug's formulation amounts to shifting the accountability for a failure that lies entirely outside the purview of clinical practice," it said.

The letter underlined that the RMP's professional mandate is strictly limited to clinical assessment, diagnosis, and prescription of drugs approved and certified by the government's own drug control mechanisms.

The physician is not a quality control analyst responsible for testing raw materials or intermediate products for toxicity.

"By criminalizing the act of prescription in good faith, this indiscriminate action unfairly victimizes a professional acting within the bounds of law, and critically, creates widespread apprehension and fear across the entire medical fraternity. This fear may inadvertently lead to defensive medicine practices, including the reluctance to prescribe affordable generic drugs, which would ultimately affects the patients adversely," the letter stated.

The IMA also proposed five systemic reforms to ensure the quality of medicines supplied across the nation which includes strengthening regulatory manpower and Infrastructure, mandatory testing for contaminants, establishment of a robust drug recall policy, strengthening pharmacovigilance and reporting and risk-based inspections and license audits.

"We appeal to your good offices to intervene decisively, order the immediate withdrawal of the case against the bona fide medical practitioner, and focus the investigative and enforcement resources on the manufacturer and the regulatory bodies whose institutional failure led to this tragic loss of life. A strong, credible regulatory system is the bedrock of safe patient care," the letter said adding the IMA is ready to collaborate with the Ministry to implement these systemic reforms.

Five children from Madhya Pradesh are in a critical condition, while 20 have died due to the consumption of a "contaminated" cough syrup, state Madhya Pradesh Health Minister Rajendra Shukla said on Wednesday.

The children died due to suspected kidney failure, linked to the consumption of the "toxic" Coldrif cough syrup, according to officials.

Amid an investigation into the matter, the Madhya Pradesh government on Monday suspended two drug inspectors and a deputy director of the Food and Drug Administration, and also transferred the state's drug controller.

Dr Praveen Soni from Chhindwara has been arrested for "negligence".