Cough syrup tragedy: Lessons learnt!

THE Diethylene Glycol (DEG) poisoning occurred from using contaminated cough syrup has already claimed twenty-four children in several states in India.

- Dr Guru Prasad Mohanta, Abhilasha Mohanta & K. Shailaja

The blame game continues accusing from one to the other as responsible for this tragic incident It is not that the DEG poisoning occurred for the first time, the first incident occurred in America in 1937 when a company used DEG as solvent for preparing sulfanilamide elixir in an attempt to develop paediatric product as it was not soluble in water.

Unfortunately, more than one hundred children lost their lives before the product was withdrawn. This unfortunate incident led to enactment of Federal Food, Drugs and Cosmetic Act of 1938 and creation of FDA to administer and enforce the Act.

The DEG poisoning continues to be an issue in India despite several poisoning cases reported over the years and no major initiatives taken to prevent similar occurrence. Fortunately, at this time India seems to have awaken and something to be done is in everybody's mind from manufacturer to regulators. We have been always reactive rather than proactive.

Let us look into the few serious issues involved in this case. The company is given manufacturing licence by the Tamil Nadu government but the products are used in other states. The other state's concerned authority writes back to Tamil Nadu authority seeking help. That means the authorities are different when handling. Madhya Pradesh government formed special investigating team (SIT) to look into the whole issue of cough syrup related deaths. The different state governments have different capacities both in terms of adequacy number of officers and their capacity to implement the provision of the Drugs and Cosmetics Act.

Though, the regulatory mechanisms are based on the same act but implementation is different. The drug regulatory authorities failed to monitor the activities of the firm. It has been reported that the manufacturing pharma of this killer pharma was not inspected for over a decade or so. The inspection is a monitoring mechanism.