Madhya Pradesh Cough Syrup Deaths: PIL Filed in Supreme Court for CBI Probe

A Public Interest Litigation (PIL) has been submitted to the Supreme Court, seeking a Central Bureau of Investigation (CBI) inquiry into the deaths of children in Chhindwara, Madhya Pradesh. These fatalities are allegedly linked to tainted cough syrup, as reported by ANI. So far, 14 children have died, and eight others are still receiving medical care.

The Indian Medical Association (IMA) has criticised the treatment of medical professionals in this case. They demand that authorities take swift action against those truly responsible and provide compensation to affected families and the defamed doctor. "The onus of the death of these hapless children falls squarely on the manufacturers and the authorities," stated the IMA.

Regulatory Failures and Toxic Ingredients

The IMA has highlighted that pharmaceutical-grade glycerin and propylene glycol are essential for making cough syrups but are expensive. Consequently, some manufacturers opt for cheaper alternatives like diethylene glycol (DEG) and ethylene glycol (EG), which are toxic yet visually similar. If quality checks fail at both manufacturing and regulatory levels, these toxic substances can lead to severe health issues in children.

In response to these tragic events, Dr Praveen Soni, a senior paediatrician in Chhindwara, was arrested by Madhya Pradesh Police for alleged negligence. The state government reacted by suspending three officials and transferring the state drug controller. Additionally, several states have stopped selling Coldrif cough syrup.

Systemic Weaknesses in Drug Regulation

The IMA referred to the 2003 Mashelkar Report to highlight systemic flaws in India's drug regulation system. Issues include inadequate drug control infrastructure at both state and central levels, insufficient testing facilities, a shortage of drug inspectors, and non-uniform enforcement. The association argues that these weaknesses contribute to incidents like this one.

An FIR was filed against Dr Soni at Parasia police station on Saturday. The directors of M/s Sresan Pharmaceuticals in Kanchipuram, Tamil Nadu were also named. They face charges 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.

Concerns Over Spurious Drugs

The IMA described this situation as a clear case of a spurious drug under section 17B of the Drugs and Cosmetic Act. They emphasised that once a drug is approved for market release, it is up to registered medical practitioners to prescribe it appropriately. The association criticised actions taken by drug controllers as exceeding their authority.

Madhya Pradesh Drug Regulatory Authority's reports revealed that Refile Syrup (0.616%) and Respifresh TR Syrup (1.342%) slightly exceeded permissible DEG/EG limits during tests. The acceptable limit is set at 0.1%. This finding underscores concerns about regulatory lapses contributing to such tragedies.

The IMA expressed deep concern over what they see as incompetence within India's drug regulatory system and how this incident has been managed. They warned that many people buy cough syrups without consulting doctors, increasing misuse risks. "In most cases, coughs resolve without any syrup," they noted.