MP Cough Syrup Case: Doctors' associations demand central probe, case withdrawal for arrested paediatrician

Condemning the action taken against the Registered Medical Practitioner (RMP), the IMA on Wednesday 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.

Also read- MP Cough Syrup Deaths: IMA slams Paediatrician's arrest as unfair

"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 has laid down a proper procedure to be followed before 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 include 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.

Medical Dialogues had reported that at least 11 children have died from kidney failure after consuming contaminated Coldrif cough syrup in Madhya Pradesh's Chhindwara district in the past 30 days. Following these deaths, police arrested Dr Pradeep Soni, a paediatrician posted at the Community Health Centre (CHC) in the town, who had prescribed the syrup, and registered him as an accused in the case. Apart from Dr Soni, the police have named the directors of a Tamil Nadu-based pharmaceutical company (M/s Sresan Pharmaceuticals, Kanchipuram, Tamil Nadu) as the second accused in the case.

After his arrest, the doctor confessed he had been prescribing the same cough syrup for the past 15 years to children suffering from cough and fever, completely unaware that it was contaminated. He said he could never have imagined that the syrup could be unsafe. The Coldrif cough syrup in question was manufactured by Sresun Pharmaceuticals. During a government quality check, it was found to contain Diethylene Glycol (DEG) far beyond the permissible limit, which is - 48.6%. DEG is an industrial chemical known to cause kidney failure and death.

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.

Did the paediatrician break rules in prescribing the syrup?

After Dr Soni's arrest under charges of negligence causing death, a big question has been raised whether the doctor violated medical guidelines. According to TOI sources in the Madhya Pradesh health department, Dr Soni may have breached medical protocol by writing the syrup’s brand name instead of its generic version on prescriptions. They say that this goes against the state’s long-standing rule that doctors must prescribe medicines only by their generic names, not branded ones.

The copy of the prescription assessed by TOI reportedly shows the doctor using the brand name 'Coldrif' in the prescription. As per National Medical Commission (NMC) guidelines, doctors are required to prescribe medicines strictly by their generic names, avoid endorsing branded drugs, and ensure prescriptions are written clearly and legibly. 

As per a TOI media report, the state government, back in 2012, launched its free medicine scheme and promoted the use of generic drugs through Jan Aushadhi Kendras. The health department issued a circular mandating that doctors prescribe only generic names on prescriptions. 

"The enforcement of this rule was seen as a key step toward making healthcare more affordable and transparent," said a retired health department official, seeking anonymity.

Doctors' stance on the issue

Expressing deepest condolences to the families of children who died after consuming the cough syrup, the Federation of All India Medical Association (FAIMA) urged the Ministry of Health to form a central committee to probe the cases and ensure that registered doctors are not wrongfully blamed or harassed until the investigation is completed.

In a letter addressed to the Union Health Minister, the association stated that the incident has raised serious questions about the safety, quality assurance, and monitoring mechanisms governing the manufacture and distribution of pharmaceutical products for children.

The doctors' body requested the Ministry of Health to constitute a central investigation committee under the Ministry to conduct a detailed and impartial inquiry into the incident, including all stages of manufacturing, quality testing, and distribution and ensure that the committee includes qualified medical experts, pharmacologists, and representatives from different states to maintain transparency, neutrality, and multidisciplinary oversight.

FAIMA urged the committee to conduct nationwide inspections and random testing of paediatric medicines and syrups to verify compliance with established quality standards and to submit a comprehensive report with actionable recommendations for strengthening national drug safety mechanisms and preventing recurrence of such events.

It also called for strengthening coordination between State Drug Control Authorities and the Central Drugs Standard Control Organisation (CDSCO) for uniform enforcement and surveillance, and providing medical assistance and necessary support to the affected families and ensuring that appropriate legal and administrative actions are taken as per the committee’s findings.

Further, FAIMA called for stricter enforcement and monitoring to regulate quack practices and the sale of non-OTC drugs without prescription by pharmacies. In the wake of a doctor being arrested for prescribing the faulty cough syrup, FAIMA urged the need to "ensure that registered doctors are not wrongfully blamed or harassed until the investigation is completed". FAIMA also called for "immediate release from custody" of the doctor arrested.

"The inquiry must be conducted in a manner that upholds the dignity and accountability of medical professionals while ensuring justice for the victims. Such a central, multi-state, expert-driven approach will help uphold transparency, strengthen regulatory systems, and reinforce public confidence in the national healthcare framework," the letter reads. 

Sharing the letter on 'X', FAIMA Chief Patron Dr Rohan Krishnan said in a post, "The most shameful incident happened in MP. We sympathise and provide our deepest condolences to the family of Children who died due to drinking of spurious cough syrup. FAIMA requests MoHFW to form a committee to deeply investigate the lapses. We are not going to tolerate a doc being made scapegoat of the entire issue.. Responsibility is fixed & culprit should be punished….Here weak doctors are being made scapegoat."

Similarly, the United Doctors Front (UDF) association also urged the Prime Minister’s Office to intervene and direct the Ministry of Health & Family Welfare to take immediate and coordinated action. In the letter, the association recommended the following steps: 

1. Constitute a Central Expert Committee: Form a multidisciplinary panel under the Ministry of Health comprising pharmacologists, toxicologists, pediatricians, forensic experts, and regulatory officers to conduct an impartial inquiry into all aspects — manufacturing, testing, distribution, and the supply chain of the implicated product.

2. Nationwide Quality Review: Mandate random testing of pediatric drugs and cough formulations across manufacturing units and retail outlets to ensure compliance with CDSCO-approved standards and eliminate substandard or spurious batches.

3. Accountability in Regulation: Strengthen coordination between state-level drug controllers and the Central Drugs Standard Control Organisation (CDSCO) for real-time monitoring, recall, and regulatory enforcement.

"Furthermore, we request that the committee ensure no medical professional or doctor is unjustly harassed or made a scapegoat. It should be clearly recognized that doctors rely on the regulatory and quality control systems in place and are not in a position to verify the chemical integrity of medicines themselves. Thus, any investigation should focus on the lapses of drug controllers and regulatory authorities rather than placing undue blame on individual practitioners," the letter reads. 

4. Transparent Investigation: The inquiry must be carried out transparently, with representation from recognized national medical bodies such as UDF, to maintain neutrality and scientific credibility.

5. Protection of Medical Professionals: Ensure that registered doctors are not unjustly targeted or detained before a scientific determination of the cause is established. Arrests or disciplinary actions, if warranted, should follow conclusive evidence and not precede it.

6. Public Health Support: Arrange immediate medical relief and psychosocial support for the affected families and provide compensation where applicable.

7. Preventive Measures: Strictly curb the unauthorized sale of prescription medicines and unregulated OTC cough syrups through robust enforcement at manufacturing and retail levels

8. Policy Strengthening: Encourage the committee to submit concrete, time-bound recommendations to reinforce drug safety protocols and prevent such avoidable tragedies in the future.

"The United Doctors Front stands committed to supporting the government in its efforts to protect child health and uphold the sanctity of medical ethics and patient safety. We believe that swift, evidence-based action under your leadership will not only deliver justice but also restore public faith in India's healthcare and pharmaceutical systems," the letter added.