(MENAFN- Live Mint)

NEW DELHI: India's apex drug regulator is preparing to tighten rural drug sales by revoking the“household remedy" exemption for cough syrups in villages and remote areas, according to three government officials and a document reviewed by Mint.

This assumes significance as India confronts recurring child deaths from toxic cough syrups, highlighting weak traceability, rural drug retail and quality oversight. At least 24 children in Madhya Pradesh and Rajasthan died from use of contaminated cough syrups earlier this year.

Stripping cough syrups of“household remedy" status – this allows non-pharmacy outlets in small communities to sell certain common medicines without a formal drug licence – seeks to plug a regulatory gap that allows any retailer to sell such drugs without oversight.

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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. Of India's 6.41 lakh villages, more than half, or 3.39 lakh have people below this threshold, per the 2011 census - which will be banned if the regulatory change goes through.

A government document reviewed by Mint stated:“In view of the recent incidences due to contaminated cough syrup, it is proposed that the exemption provided for the sale of Syrups for cough may be deleted."

The removal of this provision is being discussed by a top drug panel chaired by the sector regulator Drugs Controller General of India or DCGI.

The proposal will next be presented to the Drugs Technical Advisory Board (DTAB) for further discussion, following which the relevant amendments will be made in the Drugs Rules, 1945 (Schedule K, Entry 13).

The proposal is aimed to impose strict controls on the sale of cough syrups and will force vendors in remote areas to seek a drugs sale licence, a government official said.

“When cough syrups are sold without a licence by local, unlicensed vendors, the drugs become untraceable back to the source in the event of contamination. This absence of accountability makes it nearly impossible for regulators to implement swift recalls or pinpoint the rogue manufacturers responsible," said the official requesting anonymity.

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How Schedule K works

The deaths in Madhya Pradesh and Rajasthan were linked to diethylene glycol (DEG) and ethylene glycol (EG)-industrial solvents that cause kidney failure. Without licensing requirements, regulators struggle to track supply chains or enforce recalls.

The full list of items currently permitted includes aspirin and paracetamol tablets, analgesic balms, antacids, gripe water, inhalers, lozenges, liniments, skin ointments, cotton wool, bandages, adhesive plaster, castor oil, liquid paraffin, Epsom salt, eucalyptus oil, tincture iodine, tincture benzoin co., and mercurochrome.

“Over-The-Counter (OTC) products are those that do not require a prescription but do require a sales license. However, there is a specific category of drugs permitted under a restricted license known as Form 20A. This provision is applicable to villages and remote areas where no licensed chemist shops are available," the official said.

“It allows for certain remedies or basic drugs to be sold under this specific licence. Critically, the provision stipulates that the sale of these drugs does not require the supervision of a technically competent person. Instead, the Form 20A license can be granted to an ordinary person who runs a small grocery shop to ensure the availability of basic 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 household remedies and not the 'OTC status'.

Another official further explained that deleting this exemption would force all sellers of cough syrup to obtain a drug licence, which mandates proper records, sourcing from authorised distributors, and regulatory inspections.

Queries emailed to the spokespersons of union health and family welfare ministry and DCGI on Monday remained unanswered until publishing.

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Industry reaction

The market size of the Indian pharmaceutical industry is currently valued at $55 billion, of which the India cough syrup category was valued at $262.5 million in 2024 and is projected to grow to $743 million by 2035, according to Market Research Future, a market analysis firm.

Dr Viranchi Shah, national president of the Indian Drugs Manufacturer Association (IDMA), said that while Schedule K helps expand the availability of common medicines by way of exemptions, in the wake of some recent incidences, it is appropriate to waive the exemption given to sale cough syrups.

“Many cough syrup formulas must be used only in patients above 4 years of age. The supply chain of cough syrups also needs to be strengthened. In light of these developments, it is justified to remove cough syrups from Schedule K, meaning they must be sold through retail Pharmacies / hospitals etc only," Shah said.

India's reputation as the generics drugs supplier to the world suffered after DEG-linked child deaths in Gambia and Uzbekistan in 2022. In response, the government began upgrading its Good Manufacturing Practices (GMP) for the sector.

Experts say caution is the need of the hour.

Dr Y.K. Gupta, former head of pharmacology at the All India Institute of Medical Sciences, New Delhi and president of AIIMS Kalyani, said toxic contamination risks extend to other medicines such as paracetamol syrup.

Stressing the need for tighter quality control and adherence to GMP, he said that all medicines with potential impurities must undergo rigorous testing. Public and physician awareness is equally critical, since“most winter coughs are viral in origin and typically do not require cough syrups, antibiotics or antivirals," he added.

Public health expert Dr Rajeev Jayadevan said widespread OTC access allows people to bypass clinical advice, often relying on unqualified shop staff.“Cough syrup can no longer be called a household remedy - a term that suggests it is harmless," he said, noting the history of child deaths linked to contaminated syrups.

He welcomed the DCGI proposal saying the move would curb misuse without significantly affecting access to care.

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