New Delhi: Cough syrups will no longer be sold without a prescription in India. The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, issuing a notification on 9 June that removes ‘syrups for cough’ from Schedule K—the list of medicines that can be sold without a prescription from a registered medical practitioner.
The amendment comes after considering public suggestions and objections on a draft proposal issued on 29 December last year. The proposal itself had come after several children died in Madhya Pradesh late last year after consuming contaminated cough syrups. The episode, which pointed to failures in raw material sourcing and quality control, prompted the country’s apex drug regulatory body to act.
The amendment removes the word ‘syrups’ from a category of medicines listed under Schedule K, effectively ending their over-the-counter (OTC) availability. Commonly sold cough syrups such as Benadryl, Glycodin, Zedex, Tusq DX, Grilinctus, Cofsils, Himalaya Koflet, and Dabur Honitus will now require a valid prescription to be purchased at retail pharmacies. Lozenges, typically used to soothe sore throats and suppress coughs, will, however, continue on the OTC list.
Schedule K had granted exemptions from retail drug licensing provisions for specific drug categories in areas with limited pharmacy access. According to the notification, the Central Government exercised powers under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, to make the change.
The notification states that these rules may be called the Drugs (Fifth Amendment) Rules, 2026 and adds that they “shall come into force on the date of their publication in the Official Gazette”.
The exemption was originally designed to ensure medicines reached people in areas where licensed pharmacies were scarce. Over time, it became a gap in the regulatory framework.
Doctors say that the gap had consequences. Cough syrups containing codeine sulphate and dextromethorphan have been used recreationally by teenagers and young adults. Codeine, an opioid, produces effects similar to morphine at higher doses. Some formulations contain ingredients with hallucinogenic properties. Physicians have also flagged instances of parents administering antihistamine-based cough syrups to young children as a sedative, a practice that went unchecked partly because these products were available without supervision.
Cough, as Dr Kuldeep Kumar Grover, Associate Director of Pulmonology and Critical Care at CK Birla Hospital, Gurugram, points out, is frequently a symptom of conditions such as infections, asthma, and allergies that require evaluation, not self-medication. “Prescription-based access encourages proper evaluation, accurate treatment, and safer medication use,” he said.
Responding to the amendment, All India Organisation of Chemists and Druggists (AIOCD) general secretary Rajiv Singhal said the move was a “positive and significant step” that would help ensure medicines are distributed more responsibly and prevent misuse of regulatory exemptions.
However, AIOCD said that the Health Ministry should consult all stakeholders and re-examine exemptions that allow certain medicines to be stocked and dispensed outside licensed pharmacies. According to the organisation, such a review is needed to prevent misuse of the rules and ensure medicines are supplied through proper channels.
Schedule K of the Drugs Rules, 1945, exempts certain categories of medicines from specific provisions of the Drugs and Cosmetics Act and related rules. Earlier, one of these exemptions allowed cough syrups to be sold in villages with fewer than 1,000 residents without meeting some retail pharmacy licensing requirements. As per the latest amended rules, cough syrups have been removed from this exemption list, meaning they can now be sold only through licensed pharmacies, including in small villages.
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A history of misuse
The Madhya Pradesh deaths were not the first time that Indian-manufactured cough syrups killed children. The first recorded Diethylene glycol (DEG) poisoning in India was in Chennai in 1972, when 15 children died from contaminated medicine. It was followed by at least 14 deaths in Mumbai in 1986, 11 in Bihar in 1988, 33 in Gurgaon in 1998, and 12 in Jammu and Kashmir in 2020.
Diethylene glycol (DEG) is a toxic industrial chemical commonly used in products such as anti-freeze. When it contaminates medicines and is consumed, it can severely damage the kidneys, liver and nervous system, and can be fatal, especially in children.
In Gambia in 2022, the World Health Organization (WHO) linked dozens of children’s deaths to four syrups made by Haryana-based Maiden Pharmaceuticals, finding unacceptable amounts of diethylene glycol and ethylene glycol in it. Months later, 18 children in Uzbekistan died after consuming Dok-1 Max, produced by Marion Biotech of Noida, which was found to contain ethylene glycol—a poisonous chemical used in industrial anti-freeze.
These tragedies claimed over 150 children’s lives. Investigations by the Drug Controller General of India found that industrial-grade solvents—diethylene glycol and ethylene glycol—had contaminated the formulations, causing kidney failure. The incidents led to product bans and put India’s pharmaceutical manufacturing under scrutiny internationally.
Alongside contamination, there is the issue of misuse. Dr Mohsin Wali, Senior Consultant at Pacific One Health, a multi-specialty hospital in Delhi, and former physician to the President of India, said the use of codeine-containing syrups for non-medical purposes had been building into a public health problem for years. The gazette notification, Dr Wali said, was “necessary to save lives and prevent abuse”.
The gaps that remain
The amendment governs how cough syrups are sold. It does not, however, regulate how they are manufactured.
Chetali Rao, a Senior Scientific & Legal Researcher with Third World Network, a non-profit organisation, said both the Madhya Pradesh episode and the earlier deaths in Gambia and Uzbekistan resulted from contamination in raw materials, not distribution failures. “The government must complement this regulatory reclassification with enforceable quality standards across the manufacturing process,” she said.
K.M. Gopakumar, who works on medicine access issues and is Senior Researcher and Legal Advisor at Third World Network, called the move a step in the right direction on abuse prevention but said it left the deeper problem unaddressed. “The government also needs to issue detailed guidelines for the prescription of cough syrups and manufacturing processes, including the quality of starting materials,” he said.
This is an updated version of the report
(Edited by Nardeep Singh Dahiya)