With the toxic cough syrup tragedy in Madhya Pradesh once again spotlighting drug safety lapses in India, public health experts have called for a complete overhaul of the country’s regulatory framework. They said the incident reflects deep-rooted systemic failures and urged the government to strengthen state- and national-level drug control mechanisms to prevent such tragedies in the future.
A Tragedy That Exposed Regulatory Gaps
The recent incident, in which over 20 children died in Madhya Pradesh after consuming a contaminated cough syrup manufactured locally, has triggered widespread outrage. Experts say the tragedy and the subsequent regulatory response reveal multiple layers of failure within India’s drug oversight system.
“It is definitely a failure of the regulatory authorities on many levels,” said Dr. Gopal Dabade of the Drug Action Forum – Karnataka and a member of the All India Drug Action Network (AIDAN), a coalition advocating for rational drug policy.
He noted that photographs of Sresan Pharma’s facility, now in public circulation, show “a pathetic condition” unfit for pharmaceutical production. “One really wonders whether any inspector visited the site even once in the last 14 years,” Dabade remarked.
Weak Oversight and Inadequate Infrastructure
Prof. Bejon Kumar Misra, Founder of the Patient Safety and Access Initiative of India Foundation, said the tragedy reflects a breakdown in state-level regulatory infrastructure. “It is the duty of state drug controllers not only to inspect facilities but also to take immediate corrective measures and make such actions public,” Misra said. He warned that many manufacturers continue to operate without valid licenses or fail to adhere to official formulations prescribed in the Pharmacopoeia, citing poor monitoring at the state level.
“Knee-Jerk” Responses and Double Standards
Dabade criticised what he described as reactionary measures by regulators, such as sudden advisories on the rational use of cough syrups and age restrictions for children below two years. He also questioned the government’s defensive response to the tragedy. “The first thing officials said was that the drug wasn’t exported. This suggests there are different standards for domestic and export-quality medicines—an extremely questionable stance,” he said.
Lessons Ignored: A History of Regulatory Failures
Experts pointed out that India has faced repeated drug safety crises despite having numerous expert reports recommending reforms. Dabade and Misra cited the Lentin Commission Report (1986)—which investigated the deaths of 14 patients at Mumbai’s JJ Hospital—as a key example of how findings on corruption and negligence between politicians, drug companies, and regulators have long been ignored.
Misra, who served on the Mashelkar Committee formed in the early 2000s to strengthen India’s drug regulatory system, said the committee had recommended strict penalties, including the death sentence, for those manufacturing spurious and unsafe drugs. “Unfortunately, those recommendations were diluted during implementation,” he said.
Strengthening Consumer Awareness and State Capacity
Misra stressed that consumer awareness and state-level capacity building should be top priorities. He called for five times the current manpower in drug control departments and urged fast-track prosecution for those involved in producing spurious drugs.
“There must be no less than the death penalty for manufacturers of fake drugs that endanger lives,” Misra asserted. He also urged the use of digital track-and-trace systems to monitor the entire supply chain and reassure consumers about the authenticity of medicines.
Tackling Online Sales and Pending Reforms
Both experts warned that unregulated online sale of medicines poses a major threat to public safety. “The draft regulation for online pharmacies has been pending for five years with no further action,” Misra said. He also noted that the revision of the Drugs and Cosmetics Act—needed to reflect modern developments in the sector—has been delayed for far too long.
Ensuring Accountability and Transparency
Experts emphasized the importance of enforcing Good Prescribing Practices among doctors and maintaining proper prescription records. They recommended that the government ensure free medical consultations and prescriptions through public hospitals to curb self-medication.
They also highlighted the need for a centralized national regulatory body staffed with competent domain experts to effectively oversee the sector. However, Misra said that state objections have stalled progress. “This should not be seen as a Centre-versus-State issue,” Misra said. “It’s a matter of public health and citizens’ safety.”
Call for Unbiased and Independent Oversight
As reported by pharmabiz.com, Dabade concluded that the government already possesses enough reports, data, and expert recommendations to prevent such incidents but lacks the political will to act decisively. “What we need is a regulatory authority free from bias and conflict of interest—one that prioritises public health over profit,” he said.