Cough syrup deaths: IMA slams doctor's arrest in Madhya Pradesh

New Delhi: The Indian Medical Association (IMA) has come out in defence of a doctor arrested in connection with cough syrup deaths in Madhya Pradesh, saying the approval of the syrup and monitoring its quality squarely fall within the ambit of the drugs regulatory system.

In a statement, the IMA said on Monday that in the given case, Central Drugs Standard Control Organisation (CDSCO) and MP Food and Drugs Administration failed to monitor the concentration of DEG (Diethylene Glycol) in the cough syrup.

The response of both the central and state authorities are creating problems instead of instilling confidence in the minds of the public, it said.

"Arresting a doctor who has the mandate and privilege to prescribe a drug as approved by competent authorities has sent a wrong message. Doctors across the country are apprehensive after indiscriminate action against a bonafide doctor," the statement said.

The cough syrup tragedy in Madhya Pradesh and the subsequent arrest of the doctor who prescribed the same is a classical example of legal illiteracy of the officials and the police, the IMA said.

MP Police has arrested Chhindwara-based Dr Praveen Soni, a senior paediatrician, for alleged negligence.

On Monday, several states halted the consumption and supply of Coldrif cough syrup following 14 fatalities of children linked to the medicine in Madhya Pradesh, where the government suspended three officials and transferred the drug controller.

The IMA has demanded immediate action against the actual culprits, and 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 doctors' body stated.

According to the IMA statement, the FIR was lodged at Parasia police station on Saturday on a paediatric specialist posted at the Community Health Centre (CHC) in the town, along with the directors of M/s Sresan Pharmaceuticals, Kanchipuram, Tamil Nadu.

They have been booked under BNS sections 105 (culpable homicide not amounting to murder) and 276 (adulteration of drugs), as well as 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 said in its statement.

Pharmaceutical-grade glycerin and propylene glycol required for manufacturing cough syrups are expensive, it said.

Toxic substances such as industrial-grade DEG and ethylene glycol (EG) are cheaper and 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 stated.

The doctors' body pointed out that this has happened 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.

"Regulation must therefore be made foolproof to prevent such tragedies. Many people purchase cough syrups over the counter without a doctor's recommendation, which means far more children consume them than medically necessary," it said.

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, it added.

The IMA cited Mashelkar Report of 2003 which noted, "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 the 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 body said.

Once the drug has been approved and made available in the market registered medical practitioner is the legitimate authority in prescribing any drug. Drug controller issuing directions to the pharmacies not to supply an approved drug falls outside their competency and authority.

The controller has issued such advices to the pharmacies earlier as well restricting certain drugs. This amounts to coloured exercise of power outside the boundaries of Drugs and Cosmetic Act, the statement said.

The IMA said it is concerned over the alleged incompetence and inadequacy of the drug regulatory system in the country and mishandling of this unfortunate incident.