Outlook Explains | Govt Ends Special Exemption For Cough Syrups. What It Means

In a move aimed at tightening oversight of medicines following a series of cough syrup-related safety controversies, the Union health ministry has amended the Drugs Rules, 1945, removing a long-standing exemption that allowed syrups to be sold without the standard retail drug-licensing requirements.

The Department of Health and Family Welfare issued the notification on June 9, 2025, following a review of public feedback received on a draft proposal that had been released earlier for consultation.

The amendment, notified Monday, deletes the word "syrup" from a provision under Schedule K of the Drugs Rules. The change means cough syrups and other syrup formulations will no longer be covered by an exemption that permitted their sale in villages with populations below 1,000 through outlets that did not necessarily hold a regular pharmacy licence.

Officials say the move is intended to strengthen regulatory oversight and ensure that cough syrups are distributed only through licensed channels.

The amendment comes amid heightened scrutiny of cough syrups manufactured and sold in India after a string of international incidents exposed weaknesses in quality control and supply-chain monitoring. 

What Is Schedule K?

Schedule K of the Drugs Rules, 1945 identifies certain medicines and healthcare-related provisions that are exempt from some licensing and regulatory requirements under specific circumstances. The exemptions were introduced to improve access to essential medicines, particularly in areas where formal pharmacy infrastructure may be limited. 

One such provision allowed medicines, including syrups, to be sold in remote villages without requiring the same retail licensing framework applicable elsewhere. The rationale was to improve access to medicines in remote areas where licensed pharmacies were scarce.

With the latest amendment, cough syrups will no longer enjoy this exemption. With the removal, these products will now be subject to the standard regulatory requirements that previously did not apply under the provision. 

The government's decision follows years of concern over cough syrup safety.

Last year, India witnessed one of its most serious domestic drug-safety incidents when more than 20 children in Madhya Pradesh were reported to have died after consuming contaminated cough syrup. Investigations found that a batch of the syrup contained diethylene glycol (DEG), a toxic industrial solvent known to cause acute kidney injury and death.

The case triggered nationwide scrutiny of cough syrup manufacturing, testing and distribution practices, with authorities ordering recalls, inspections and action against manufacturers. 

The drug regulators carried out extensive audits of over 700 cough syrup manufacturers and launched a series of recalls and enforcement actions against non-compliant firms. 

India also came under international scrutiny in 2022 after Indian-made cough syrups were linked to the deaths of children in The Gambia. Similar concerns later emerged in Uzbekistan. Investigations reportedly found contamination with diethylene glycol (DEG) and ethylene glycol (EG), toxic industrial chemicals that can cause acute kidney injury and death.

In response, the government made laboratory testing mandatory for cough syrups before export in 2023 and has since intensified inspections of manufacturing facilities and quality-control processes.

Balancing Safety And Access

Public health experts say the latest amendment reflects a broader effort to improve accountability across the supply chain. 

"This regulation was necessary and welcome," said Dr Rajib Dasgupta, Professor at the Centre of Social Medicine and Community Health at Jawaharlal Nehru University (JNU). However, he stressed that regulation alone would not solve the problem.

"What needs to be emphasised is the rational use of cough syrups and the strengthening of primary-level care within public health services, both in rural areas and low-income urban communities," he said.

Dasgupta, who has also been the part of the key member of India’s National COVID-19 Task Force and serves on the National Adverse Events Following Immunization (AEFI) Committee, also pointed to concerns surrounding irrational fixed-dose combinations, formulations containing multiple active ingredients without a strong pharmacological basis, which have long been criticised by public health researchers.

The change is expected to have an impact in remote villages where medicines were often purchased directly from local sellers without prescriptions.

According to Dr Sandeep Nangiya of the Retail Distribution Chemist Alliance (RDCA), Delhi, rural consumers may face some additional inconvenience but the measure is justified from a patient-safety perspective.

"Earlier, people in villages would often buy a cough syrup directly if someone in the family had a cough or throat problem because it was easily available. There may now be some additional cost and effort involved, but considering the issues that have emerged around syrups in the last two to three years, patient safety is more important," he said.

Nangiya noted that government hospitals and public-health schemes continue to provide affordable medicines for poorer patients.

While the amendment could affect pharmacy sales, he argued that commercial considerations should not outweigh public health concerns. The change does not require pharmacies to obtain a new licence, he added, but merely alters the conditions under which syrup formulations can be sold.

"The law and licence remain the same. What has changed is the sale condition. These syrups have effectively moved from a category that could be sold more freely to one that requires greater regulatory control," he said.

The Challenge Of Self-Medication

Experts caution that stricter rules must be accompanied by stronger healthcare access.

Dasgupta warned that efforts to curb self-medication would succeed only if people had access to trusted healthcare providers. "Addressing the risk of self-medication is an urgent advocacy imperative," he said, adding that success would depend on strengthening both public and private provider networks.

He also drew a distinction between the rational prescription of cough syrups and the contamination-related tragedies that triggered recent regulatory action.

"The adverse events and deaths among children were linked to regulatory shortcomings involving contamination with diethylene glycol and ethylene glycol, which are toxic industrial solvents not intended for use in medicines," he said.

The amendment also highlights the need for broader reforms.

Nangiya argued that India's drug-regulatory framework has struggled to keep pace with changes in the pharmaceutical market.

The Drugs and Cosmetics Act currently in force traces its origins to 1940. While the law has undergone amendments over the decades, he said it does not adequately address newer challenges such as online pharmacies and app-based medicine sales.

He called for a comprehensive overhaul of the regulatory framework to improve compliance, enforcement and consumer protection.