Repeated deadly cough syrup scandals pose hard questions for India’s drug regulators

NEW DELHI - Diethylene glycol (DEG) is an organic compound that is commonly used as an industrial solvent in antifreeze mixtures and brake fluids. But, in India, DEG is ending up with worrying frequency where it should never be – in cough syrups for children.

The repeated presence of this toxic substance in medicines has had devastating, fatal consequences in India and abroad, while also bringing the country’s lax drug regulatory set-up under intense scrutiny.

In the latest instance of such contamination, at least 22 children have been killed since September in the Indian states of Madhya Pradesh and Rajasthan

after consuming Coldrif,

a cough syrup adulterated with industrial grade DEG.

The most recent of these deaths occurred on Oct 8 when two children from Madhya Pradesh’s Chhindwara district died while undergoing treatment in Nagpur, a city in the adjacent state of Maharashtra.

Coldrif is produced by Tamil Nadu-based Sresan Pharmaceuticals, a relatively small manufacturer.

Cough syrups are made with propylene glycol (PG), a colourless and viscous liquid that is used as a solvent for syrupy medicines. It is available in two grades: pharmaceutical and commercial.

The pharmaceutical variant has a strictly controlled presence of DEG, if any, unlike the cheaper commercial kind, which has far higher levels of the compound, making it unfit for human consumption. Manufacturers, knowingly or unknowingly, use commercial-grade PG when making cough syrups to cut costs.

Even small amounts of DEG can prove fatal for children, with kidney failure a common occurrence. The syrup in question – Coldrif – contained 48.6 per cent DEG, far exceeding the maximum permissible limit of 0.1 per cent.

Over the years, DEG in Indian-made cough syrups has claimed the lives of dozens of children domestically and abroad. In 2022-23, Indian DEG-contaminated syrups were linked to the deaths of 70 children in The Gambia in West Africa and another 18 in Uzbekistan.

And between December 2019 and January 2020, at least 12 children – all under the age of five – died in India’s Jammu region, allegedly after drinking a different cough syrup similarly tainted with DEG.

India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has told the World Health Organisation (WHO) that neither Coldrif nor two other brands, Respifresh TR and ReLife – which were also flagged for DEG contamination – had been exported.

Nevertheless, the WHO issued a warning that the contaminated medicines could reach other countries through unregulated distribution channels. It also voiced its “deep concern” over gaps in India’s drug safety regulations.

Known as the “pharmacy of the world”, India accounted for 3 per cent of the world’s total pharmaceutical exports in 2023. It is particularly known for exporting affordable drugs, especially to Africa and other developing regions.

After delaying action since the first deaths in September, the authorities in India have cracked the whip. On Oct 8, G. Ranganathan, 73, the owner of Sresan Pharmaceuticals,

was arrested in Chennai

and its manufacturing unit locked up.

Inspectors from the Tamil Nadu Drugs Control Department (TNDCD) reportedly found over 360 counts of violations, including rusty equipment, unhygienic medicine storage and the failure to maintain purchase records for raw materials. The firm’s licence has also been suspended temporarily.

Several states have since banned the sales of the tainted syrups and begun recalling them from shelves.

Questions are being asked about why the authorities have repeatedly failed to prevent unsafe syrups from reaching the public, raising concerns around chronic regulatory issues, including lack of coordination between central and state actors as well as the dearth of drug inspectors and testing facilities.

“There are some hard questions that need to be asked in terms of whether inspections were regularly done at this particular manufacturer (Sresan) in recent years and if so, can there be transparent disclosure of what those inspections found,” said Mr Nakul Pasricha, the chief executive of PharmaSecure. It is a firm that helps drug manufacturers prevent counterfeiting of medicines through technology-enabled solutions such as barcoding.

Officials in the TNDCD were unavailable for comment, and the CDSCO did not respond to a query from The Straits Times.

Under India’s fragmented centre-state drug regulatory set-up, policy-setting and permissions for manufacturing and licensing are handled by the CDSCO. But implementation, including inspections to ensure quality production, is mostly handled by state agencies under CDSCO’s oversight.

The dearth of inspectors, who perform critical functions such as monitoring drug manufacturing and conducting random inspections, has especially posed a major hurdle.

According to a 2024 Comptroller and Auditor-General of India report, the TNDCD had a sanctioned strength of 488 drug inspectors but a working strength of just 344, leading to severe shortfalls in sample collection and testing operations.

Even the CDSCO suffers from a similar problem. According to latest reports, only 238 of the sanctioned 419 drug inspector posts are filled.

Ms Sumathi Chandrashekaran, an independent policy lawyer, said India faces a severe inadequate drug inspection and testing problem. “It is a compounded outcome of critical staff shortage, and technical and financial infrastructure gaps, including lab under-utilisation and low or no funding to create new ones,” she added.

Ms Chandrashekaran co-authored a 2019 study along with legal researcher Shree Agnihotri that looked into the problems that plague India’s drug regulatory set-up. One of their many troubling findings was that many states had drug testing labs largely unused, with a state like Uttarakhand using less than 10 per cent of its capacity in a given year.

In May 2023, following the scandals abroad, the CDSCO mandated a testing protocol for cough syrups in designated Indian laboratories before export.

But no such testing was mandated for the domestic market, which has many small manufacturers producing low-cost medicines. It has now asked all state governments to submit a list of cough syrup manufacturers, while initiating a joint audit of these companies.

The failure to prevent repeated cough syrup scandals has also brought up a whiff of alleged corruption. Mr Sukesh Khajuria, a public health activist who has been helping families of the 2019-20 victims in and around Jammu seek justice, alleged that the Indian government had failed to rein in corruption within the country’s drug regulatory set-up.

“Pharma companies have hidden partnerships with the party in power,” he claimed.

A 2024 report published on Scroll, an Indian online news website, said that 35 pharmaceutical companies in India had contributed nearly 10 billion rupees (S$146.4 million) to political parties. Of these, at least seven companies were being investigated for poor-quality drugs when they made their contributions.

According to Mr Dinesh Thakur, a former Indian drug executive who is now a public health activist, the problem is more fundamental. “We don’t value the lives of our children and let an incompetent, corrupt and boastful regulator run our drug supply,” he alleged.

“If we did, we would have held the regulator and the politicians who enabled or covered up the tragedy of deaths of 12 children in Jammu to account by now.”

All five accused in the case, including owners of the Himachal Pradesh-based Digital Vision Pharma, which allegedly produced the toxic syrup consumed by children in and around Jammu, remain out on bail, while the legal case against them makes excruciatingly slow progress.

The firm, meanwhile, has restarted its drug production.

The authorities also failed to act adequately on earlier alarms, belying a lack of coordination between the centre and the various state authorities. Both Digital Vision Pharma and Maiden Pharmaceuticals, the firm accused of making and exporting DEG-laced syrups to The Gambia, had been flagged on numerous occasions by several state drug control authorities for producing substandard medicines.

Even in the ongoing Coldriff case, a blame game has erupted with Madhya Pradesh and Tamil Nadu government officials accusing each other of failing to prevent the contaminated syrup from reaching the public.

Mr Pasricha, PharmaSecure’s CEO, said better coordination and enhanced action between the country’s multiple authorities, whereby a violation alert in one state is used by others to check and pre-empt potential disasters, could help alleviate problems “to some extent at least”.

“How do we bring it all under one umbrella is, of course, a larger question for regulators and the government,” he said, suggesting that India could explore the possibility of further strengthening the CDSCO’s mandate to ensure safe drugs across the country.

But even before considering complex interventions, such as tackling funding and recruitment or streamlining the regulatory architecture, policy lawyer Ms Chandrashekaran noted there are “some clear low-hanging fruits” that can be targeted to optimise existing resources.

“This would mean requiring all drug inspectors to be fully worked; ensuring testing laboratories across the country are functioning and used to the fullest; enforcing a clear reporting and accountability mechanism throughout the regulatory chain; and plugging gaps in digital infrastructure to minimise scope for regulatory discretion and ambiguity,” she added.