The recent have left Indians shaken and angry, as the country that sees itself as a pharma powerhouse faces painful issues regarding its drug safety protocols.
All of the victims were aged under five. Most of them died over the past month after they were prescribed contaminated cough syrup, containing fatal levels of diethylene glycol (DEG) — an .
It was the same deadly compound linked to past tragedies connected to Indian-made cough syrup, including , as well as , and well 12 in Jammu in 2019 and 2020.
Owner of ‘Sresan Pharmaceuticals’ arrested
‘s Central Drugs Standard Control Organization (CDSCO), state officials and other regulatory bodies responded to the latest tragedy by , issuing pediatric cough syrup advisories, and launching an investigation into the manufacturing process.
“We have initiated risk-based inspections at 19 drug manufacturing units across six states to identify quality lapses,” CDSCO official D R Gahane said in a statement.
The owner of Sresan Pharmaceuticals, the Indian company behind the tainted cough syrup in Madhya Pradesh, has since been arrested, and his company shut down.
However, experts warn India’s pharmaceutical industry continues to operate under a patchwork of uneven state regulation, corruption-riddled testing, and poor inter-state coordination.
Standards differ from state to state
India is the world’s largest vaccine supplier, producing well over half of global demand. It is also , supplying at least 20% of the market, though some estimates put it as high as 40%. At the same time, however, each Indian state oversees its own pharma manufacturing, allowing
Soumya Swaminathan, a former chief scientist at the World Health Organization (WHO), warned that India’s drug regulatory framework urgently needs comprehensive reform.
“The quality of oversight varies significantly from state to state, and corruption remains a serious concern,” she told DW.
“Moreover, weak coordination among state regulators continues to undermine effective nationwide safety enforcement,” the scientist added.
Swaminathan described the Madhya Pradesh poisonings as a “devastating tragedy.”
Medicine procurement ‘basically a patronage scheme’
Dinesh Thakur, a prominent whistleblower who exposed widespread fraud at Ranbaxy, one of India’s largest pharmaceutical companies, shares similar concerns.
“Yes, there is more than adequate evidence that public procurement at the state level is littered with corruption. How else can one explain why Madhya Pradesh purchased drugs from companies blacklisted by the government?” Thakur told DW.
The public health activist points to a recent report by India’s Comptroller and Auditor General, which showed that the Madhya Pradesh Public Health Services Corporation Limited continued to purchase and distribute medicines banned for human use by the government, endangering public health.
“State level public procurement is basically a patronage scheme for manufacturers who fund political campaigns,” added Thakur.
Many drugs below official standards
Medical journals and studies estimate that between 20% and 25% of the medicines available in the market are below the required standards. Additionally, counterfeit drugs have spawned a sprawling shadow industry in India, posing acute risks to public health and destabilizing the country’s fast-growing pharma sector.
Nakul Pasricha, managing director and CEO of PharmaSecure, said the country needs regular and sustained testing and inspections, and stricter action against violators.
“Are the current penalties a sufficient deterrent? That should be examined. We need to create more awareness among patients and consumers to be wary. I believe we need to leverage technology and solutions to have better traceability and information dissemination,” Pasricha told DW.
“Manufacturers are now being asked to incorporate and disclose excipient information on drug labels. Why can’t we have complete visibility available by leveraging QR codes already being applied to labels?” said Pasricha, who works with pharmaceutical makers to track and verify their supply chains and ensure the authenticity of their drugs.
Pasricha says his company applies unique codes on medicine packages that consumers can check using their phones to confirm the drug is authentic.
Has ‘pharmacy of the world’ outgrown its regulators?
India’s pharmaceutical market is worth around $50 billion (€43 billion), according to various industry and government estimates, and the world’s most populous country is among the top three largest producers of pharmaceuticals by volume.
“India has the expertise to produce world-class medicines, but the scale of the industry may have outgrown its quality controls. Without consistent, independent testing, the system relies on trust rather than verification which helps explain the recent cough syrup-linked deaths,” Rajeev Jayadevan, medical professional and health communicator, told DW.
Jayadevan said that India is often referred to as the “pharmacy of the world,” because of its vast generic drug industry that supplies affordable medicines to many countries. This position, however, also brings immense responsibility, he added.
“While many Indian pharmaceutical companies adhere to good manufacturing practices and export to the most tightly regulated markets, several smaller firms might be operating with uneven regulatory oversight,” he added.
Edited by: Darko Janjevic
The post India’s cough syrup tragedy shows huge drug safety gaps appeared first on Deutsche Welle.
