Cough syrup deaths: Why is India FDA protecting promoters and not common human lives?

By RN Bhaskar and Sakeena Bari Sayyed
Image sourced using Perplexity.ai

 

Had it happened in any developed country, chargesheets would have been filed against India’s drug authorities. Key inspectors would have been arrested, and the producers of contaminated pharmaceuticals would have been sentenced to prison terms for culpable murder. However, India’s policy makers love talking about a Viksit Bharat, a resplendent India but do nothing that indicates respect for life and law. The recent cough syrup episode throws a harsh spotlight on the ugly side of misgovernance, in much the same way the state of Madhya Pradesh has dealt with the Bhopal gas tragedy deaths.

Countdown to death

It all came to light in the first week of October (see timeline). In Chhindwara district of Madhya Pradesh (elected representative, BJP’s Vivek Kumar Sahu) the first news about the cough syrup deaths began doing the rounds.

Normally, the Indian FDA and the police should have seized the drug immediately, they should have blacklisted all stocks of the cough syrup. And orders should have been given to arrest the promoters of the factories which had produced these killer drugs. In Viksit Bharat none of this happened.

Finding a scapegoat

Instead, a scapegoat was found. The pediatrician who prescribed the medicine was arrested. The doctor had a valid medical practitioner license. He prescribed a drug that was legally declared to be safe and fit for use by patients. The doses prescribed were therapeutically legal. The police claimed that he was arrested because he took a 10% commission for prescribing the drug.How absurd.  Did the police not know that this is an industry practice.

It is common knowledge that many doctos across the country get incentives for most drugs prescribed. The government is already seized of this matter. So, why single out this doctor and defame him? Is it just to cover up the fault of the administration? Similarly, it is baffling that the authorities who arrested the doctor have themselves not been charge sheeted for misuse of law and miscarriage of justice.

The action against the doctor has incensed the entire medical fraternity.  The Indian Medican Association (IMA) has already held several demonstrations agains this action (https://www.thehindu.com/news/national/cough-syrup-tragedy-ima-protests-against-doctors-arrest/article70131735.ece) , and it is possible that the voices will grow shriller than they are currently.

Already, the collapse of governance in the state of Madhya Pradesh has taken another ugly turn.  The authorities have begun another investigation against a hospitalin Gwalior (https://www.indiatoday.in/india/story/madhya-pradesh-after-cough-syrup-deaths-gwalior-hospital-under-probe-over-worms-in-medicine-2803969-2025-10-16). Within days of the cough syrup deathsm a government hospital in Gwalior’s Morar town is under scrutiny after a woman complained of finding worms in a bottle of antibiotic medicine given to her child. Prima facie, all 306 bottles of the antibiotic distributed and stored at the hospital have been recalled and seized. Investigations are underway.

Killer contaminant

Gradually, media reports disclosed that the recent killer contaminant was a substance called DEG. This is an industrial chemical not fit for human consumption. It can slip into pharmaceutical use when promoters try to cut cost and buy substandard ingredients. That is why the officers of the guilty pharmaceutical company should have been arrested along with the promoters. Yet, nothing happened. Only the number of children who died because of this contaminated cough syrup kept on increasing. By 7 Oct, the toll had crossed 20. Yet, few (almost none) elected representatives tried consoling the parents or offered them compensation for the loss of their loved ones.

 

Killer Promoters – an old story

Contaminated medicines coming from India is not a new development. In 2023, substandard drugs from India caused at least 68 deaths in Uzbekistan and 70 deaths in Gambia. Uzbekistan did something which India’s authorities have been reluctant to do. Since, the promoters and producers of the substandard drugs could not be apprehended, the Uzbekistan authorities arrested the Indian managers and sentenced them to 20 years of imprisonment. Gambia raised the issue with WHO (World Health Organisations).  This time too, the WHO warns the wor,ld against three India-made cough syrupe.

The two international incidents compelled the Indian government to modify inspection rules for cough syrups. These international incidents that caused 140 deaths in Gambia, Uzbekistan and Cameroon by substandard/contaminated Indian cough syrups, the government had mandated another layer of tests and checks at government laboratories. Thus, the FDA officials were guilty of:

  1. a) Giving out manufacturing licences liberally to units that did not meet the sanitized benchmarks pharmaceutical facilities required.
  2. b) Didn’t even do a random test of the cough syrups at government laboratories. If there is anyone who needs to be charge sheeted first, it is the FDA officials and inspectors and not innocent doctors.

The substandard cough syrup offered ample evidence of this disdain for life, contempt for good manufacturing practices in pharmaceuticals, and a temptation to develop cozy relationships between wealthy pharmaceutical promoters and authorities. Indian lives are cheap. And, the sanctity of medical practitioners is just a phrase to be mouthed not practised.

US-FDA is more diligent

Look at the data that is available from local media about instances where the US authorities have discovered non observance of GMP in Indian pharma companies. US inspectors also found unhygienic conditions (rat droppings) at pharma plants and this was after India’s FDA had certified them as good places for producing exportable pharmaceutical products.

Now compare the US list with actions taken by India’s FDA. You will discover that while the US did the best they could by banning products from such substandard facilities, the Indian authorities did not do their best. Not a single pharma promoter nor a single FDA inspector was charge sheeted or arrested.

The willingness to be benign with callous promoters and inspectors stands out a sharp contrast to the arrogance and disdain with which these potentially culpable authorities treat common citizens.

Look at the chart which throws light on how Indian authorities resolve cases of substandard production facilities, contaminated pharma products and the easy grant of pharma licences to wanna be producers. The contrast is sickening if not infuriating.

Can the courts help?

In a country where the legislators are equally callous and the executive is horrifyingly compromised, can the courts step into the breach? Remember, it took several days before an elected representative could make some pronouncements against the production centres in Tamil Nadu which produced the contaminated cough syrup. Sadly, legislators and bureaucrats appear subdued when dealing with errant promoters. They are even more subdued when common people die. This is no governance.

Ideally, it is the courts that offer the only hope. It is the last bulwark that can protect the fundamental right to life of common people especially, when both the legislature and the executive have looked the other way.

India can never be a great nation unless it first learns to respect life and harshly penalize those who cause death or repudiate the ownership of property. Cough syrup deaths are pointers to all that is wrong in this country. That is why the role of the courts is crucially significant at this stage.

The cough syrup’s death could provide India an opportunity to redeem itself if the courts play the role that they are supposed to. The big question is: will they?

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