This takes on significance as India faces recurring child deaths from toxic cough syrups, highlighting poor traceability, rural drug retailing and quality oversight. At least 24 children in Madhya Pradesh and Rajasthan died earlier this year after consuming contaminated cough syrups.
Stripping cough syrups of their “home remedy” status – which allows non-pharmacy shops in small communities to sell certain common medicines without a formal drug license – seeks to close a regulatory loophole that allows any retailer to sell such drugs without supervision.
What will be affected
Such medicines and supplies, including balms, bandages, paracetamol, cough syrups, among other drugs, are currently allowed to be sold in villages with a population of less than 1,000 people. According to the 2011 census, more than half of India’s 6.41 million villages, or 3.39 million people, have people below that threshold — which will be banned if the regulatory change passes.
A government document reviewed by Mint said, “In view of recent cases caused by contaminated cough syrup, it is proposed that the exemption provided for the sale of cough syrups may be dropped.”
The removal of this provision is being discussed by the apex drug panel chaired by the sector regulator Drugs Controller General of India or DCGI.
The proposal will further be placed before the Drugs Technical Advisory Board (DTAB) for further discussion after which appropriate changes will be made in the Drugs Rules, 1945 (Schedule K, Entry 13).
The proposal aims to introduce strict controls on the sale of cough syrups and will force sellers in remote areas to seek a license to sell the drug, a government official said.
“When cough syrups are sold without a license by local, unlicensed vendors, the drugs become untraceable back to the source in the event of contamination. This lack of accountability makes it nearly impossible for regulators to institute a swift recall or identify the rogue manufacturers responsible,” said the official, who requested anonymity.
How Plan K Works
The deaths in Madhya Pradesh and Rajasthan have been linked to diethylene glycol (DEG) and ethylene glycol (EG) – industrial solvents that cause kidney failure. Without licensing requirements, regulators have difficulty tracking supply chains or enforcing recalls.
The full list of currently permitted items includes aspirin and paracetamol tablets, analgesic balms, antacids, anti-inflammatory water, inhalers, lozenges, ointments, skin ointments, cotton wool, bandages, adhesive plasters, castor oil, liquid paraffin, epsom salts, eucalyptus oil, tincture of iodine, tincture of comfrey and benzoin.
“Over-the-counter (OTC) products are those that do not require a prescription but require a sales license. However, there is a specific category of drugs allowed under a limited license known as Form 20A. This provision applies to villages and remote areas where no licensed pharmacies are available,” the official said.
“It allows certain medicinal products or essential medicines to be sold under this specific licence. Crucially, the provision states that the sale of these medicines does not require the supervision of a technically competent person. Instead, a Form 20A license can be granted to an ordinary person running a small grocery shop to ensure the availability of essential medicines in these remote areas,” the official explained.
A second official clarified that the current proposal is to remove cough syrup from the list of home remedies, not “OTC status.”
Another official further explained that removing the exemption would force all cough syrup sellers to obtain a drug license that mandates proper records, sourcing from authorized distributors and regulatory controls.
Queries emailed to spokespersons of the union ministry of health and family welfare and DCGI on Monday remained unanswered till publication.
Industry response
The market size of the Indian pharmaceutical industry is currently valued at USD 55 billion, of which the cough syrup category in India was valued at USD 262.5 million in 2024 and is expected to grow to USD 743 million by 2035, according to estimates by Market Research Future, a market analysis company.
Dr Viranchi Shah, national president of the Indian Drug Manufacturers Association (IDMA), said that while Plan K is helping to expand the availability of common medicines through exemptions, it is appropriate to waive the exemption granted to the sale of cough syrups in the wake of some recent cases.
“Many cough syrup products must only be used in patients above 4 years of age. There is also a need to strengthen the supply chain of cough syrups. In light of these developments, it is justified to remove cough syrups from Schedule K, which means they must only be sold through retail pharmacies/hospitals etc,” Shah said.
India’s reputation as a supplier of generic medicines to the world suffered following DEG-linked child deaths in Gambia and Uzbekistan in 2022. In response, the government began modernizing its Good Manufacturing Practices (GMP) for the industry.
Experts say caution is in order.
Dr YK Gupta, former head of pharmacology at the All India Institute of Medical Sciences, New Delhi and president of AIIMS Kalyani, said the risks of toxic contamination also apply to other drugs such as paracetamol syrup.
He stressed the need for stricter quality control and GMP compliance, saying all drugs with potential impurities must undergo rigorous testing. Public and medical awareness is equally important because “most winter coughs are viral in origin and usually do not require cough syrups, antibiotics or antivirals,” he added.
Public health expert Dr Rajeev Jayadevan said widespread access to over-the-counter drugs allows people to bypass clinical advice, often relying on unqualified shop staff. “Cough syrup can no longer be called a home remedy – a term that suggests it is harmless,” he said, noting the history of child deaths linked to contaminated syrups.
He welcomed the DCGI’s proposal, saying the move would curb abuse without significantly affecting access to care.
