Earlier in October this year, a severe tragedy unfolded in Madhya Pradesh, with several infant deaths reported. Investigations revealed the cause to be a contaminated cough syrup prescribed by a medical practitioner. The event turned the spotlight on Tamil Nadu, as the brand of cough syrup that was deemed to be the root cause of the tragedy was found to have been manufactured by an establishment based at Sunguvarchathram, Kanchipuram district. It was found to contain high levels of Di-Ethylene Glycol (DEG), far more than the prescribed limits.
DEG is an industrial solvent used in brake fluids, resins, dyes, etc. and ingesting even a small dosage has severe ramifications, including death. Following the unfolding of the tragedy, the state government jumped into action and closed the company’s operations and also suspended two senior drug inspectors for their inaction. The establishment’s owner too has been arrested and further proceedings are underway.
The usage of DEG in the cough syrup as a cheaper substitute for Propylene Glycol or glycerin, used in pharma manufacturing, has led to severe causalties in the past. Over the last five decades or so, deaths linked to cough syrup contamination have been on the increase worldwide, particularly in low and middle-income countries, with events reported from places such as Bangladesh, Nigeria, Panama, Gambia, Uzbekistan, and Indonesia. In India, one of the earliest known cases of deaths linked to cough syrup contamination was reported in our city, way back in 1972, when at least 14 children died due to contaminated cough syrup made by a local manufacturer.
While the action of the state government in closing the operations and making arrests of suspects is welcome, the episode raises a few questions. Firstly, it was found that no quality checks by the state drug control administration had been carried out in the above manufacturing unit for the past two years. Inspections after the recent incident flagged over 350 violations, including 39 critical ones. One wonders if the tragedy could have been avoided had periodic quality checks been carried out as mandated and steps been initiated to address the deficiencies. The inspections at over 300 other manufacturing units in the state commissioned as a fallout from the episode cannot but bring to mind the idiom of bolting the door after the horse. The second pertains to the adequacy of the process of the inspection of drugs itself. The CAG audit report on performance of public health infrastructure and management of health services has flagged shortfalls ranging from 34 to 40 percent in the lifting and inspection of samples for the period 2016-21. The state government has been quick to blame the present opposition, which was then in power during the period under consideration, while the latter has blamed the party now in power for being negligent. It has also sought to draw attention to the inaction of the CDSO (Central Drug Safety Organisation) in carrying out checks of the manufacturing units in the state for over six years. Passing the buck and playing politics over a crucial issue involving public health does not bode well for a state which has often been seen as a hub for medical tourism. Thirdly, news reports flag a massive shortage in manpower to carry out inspection, with only 14 senior drug inspectors (the grade responsible to carry out quality checks) in the entire state which has more than 350 manufacturing units.
With an estimated Rs 12,000 to Rs 15,000 crores worth of pharmaceutical products being exported from Tamil Nadu every year to over 100 countries, the state is fast emerging as a pharma manufacturing hub and is currently placed fifth in the country (according to the Guidance TN official website). While the malaise with respect to the lack of effective controls seems to run deep at a national level, it is essential that the state takes proactive steps to set its house in order and ensure its pharma manufacturing units are fully compliant with good manufacturing practices and other legal requirements.