Madhya Pradesh cough syrup deaths: PIL filed in Supreme Court, seeks CBI probe
A PIL filed in the Supreme Court seeks a CBI probe into the deaths of children in Madhya Pradesh, allegedly caused after consuming contaminated cough syrup.
Madhya Pradesh cough syrup deaths: A Public Interest Litigation (PIL) was filed in the Supreme Court on Tuesday, 7 October, seeking a Central Bureau of Investigation (CBI) probe into the deaths of children in Chhindwara, Madhya Pradesh, allegedly caused by contaminated cough syrup, ANI reported. At least 14 children have died so far, while eight others remain hospitalised.
MP doctor arrest and regulatory action
The Madhya Pradesh Police arrested Dr Praveen Soni, a senior paediatrician in Chhindwara, for alleged negligence. Following the fatalities, the state government suspended three officials and transferred the state drug controller.
Several states have halted the sale and distribution of Coldrif cough syrup.
IMA condemns “intimidation” of medical professionals
The Indian Medical Association (IMA) demanded that authorities identify and take “immediate action against the actual culprits”, while also ensuring “adequate compensation for the affected families and the doctor who is a victim of defamation.”
“The onus of the death of these hapless children falls squarely on the manufacturers and the authorities. Intimidation of the medical profession is uncalled for and will be resisted,” the IMA said in a statement.
According to the association, an FIR was registered at Parasia police station on Saturday against the paediatrician posted at the Community Health Centre (CHC) and the directors of M/s Sresan Pharmaceuticals, Kanchipuram, Tamil Nadu. They have been booked under sections 105 (culpable homicide not amounting to murder) and 276 (adulteration of drugs) of the Bharatiya Nyaya Sanhita, along with section 27(A) of the Drugs and Cosmetics Act, 1940.
“The arrest of doctor in haste, just after the report of BMO, precisely shows an attempt to divert the attention of the people from the faults of regulatory bodies and the concerned pharmaceutical company,” the IMA alleged.
Toxic substances and weak regulation
The IMA said pharmaceutical-grade glycerin and propylene glycol—essential ingredients for manufacturing cough syrups—are costly. As a result, some manufacturers use cheaper, industrial-grade diethylene glycol (DEG) and ethylene glycol (EG), which are toxic yet visually indistinguishable.
“If quality control fails at the level of both the manufacturer and the regulator, cough syrups produced by a few companies may end up containing toxic substances capable of causing kidney failure and death in young children,” the statement read.
The association highlighted that similar incidents have occurred “several times in the past in multiple countries among children after apparently consuming contaminated cough syrup.”
“The prescribing doctor has no way of knowing whether a medicine is contaminated until adverse outcomes are reported among patients who have taken it,” the IMA said, urging that “regulation must therefore be made foolproof to prevent such tragedies.”
It also warned that many people in India buy cough syrups over the counter without medical advice, increasing the risk of misuse. “In most cases, coughs and colds resolve on their own without any syrup. When a doctor does prescribe one, it is based on clinical assessment of the child,” the statement added.
“Spurious drug” and regulatory lapses
Citing the 2003 Mashelkar Report, the IMA drew attention to systemic weaknesses: “The problems in the regulatory system in the country were primarily due to inadequate or weak drug control infrastructure at the State and Central level, inadequate testing facilities, shortage of drug inspectors, non-uniformity of enforcement, lack of specially trained cadres for specific regulatory areas, non-existence of data bank and non-availability of accurate information.”
“This is a clear cut case of a spurious drug as defined in section 17B of the Drugs and Cosmetic Act. Approval of the said cough syrup, monitoring of the quality and the content of the same squarely fall within the ambit of the Drugs regulatory system,” the IMA said.
The association further argued that “once the drug has been approved and made available in the market, a registered medical practitioner is the legitimate authority in prescribing any drug.”
“The drug controller issuing directions to pharmacies not to supply an approved drug falls outside their competency and authority,” the IMA said, calling such actions a “coloured exercise of power outside the boundaries of the Drugs and Cosmetics Act.”
Concluding its statement, the IMA expressed “deep concern over the alleged incompetence and inadequacy of the drug regulatory system in the country and the mishandling of this unfortunate incident.”
Meanwhile, ANI rpeorted that Madhya Pradesh Drug Regulatory Authority's reports show Refile Syrup (0.616%) and Respifresh TR Syrup (1.342%) marginally exceeded permissible limits of DEG/EG in the drug sample tests. The permissible limit is 0.1%.