The Union health ministry has proposed and enforced key regulatory measures targeting the sale and composition of certain medicines, citing public health concerns.
The Ministry has issued a draft notification proposing amendments to the Drugs and Cosmetics Rules to tighten the over-the-counter (OTC) sale norms, particularly concerning cough syrups. The proposed changes include removing the word “syrup” from Schedule K of the Drugs Rules, 1940—an exemption list that allows certain household remedies to be sold without a formal licence in rural areas.
This change follows growing concern over the misuse and contamination of medicinal syrups. According to officials, several cough and cold formulations in liquid form have been illegally sold or misused in recent years. The proposal was endorsed by the Drugs Consultative Committee (DCC) during its November 2025 meeting, where members highlighted incidents involving contaminated cough syrups, including cases from Madhya Pradesh that led to fatalities and triggered a World Health Organization (WHO) alert over diethylene glycol contamination.
Under the new draft, while syrups will be removed from the exemption list, lozenges, pills, and tablets for cough and cold may continue to be sold OTC without a formal licence. The Ministry has invited public feedback on the proposal within 30 days, emphasizing that the amendment directly concerns public health and safety.
Industry observers noted that the move could temporarily reduce rural demand for cough syrups, as households may switch to home remedies or tablet-based alternatives due to restricted access.
Ban on nimesulide
In a parallel development, the central government has also banned the manufacture, sale, and distribution of oral formulations of nimesulide containing more than 100 mg, effective immediately.
The decision, issued under Section 26A of the Drugs and Cosmetics Act, 1940, follows recommendations from the Drugs Technical Advisory Board (DTAB) and aims to curb potential health risks associated with the pain-relieving drug.
Nimesulide, a non-steroidal anti-inflammatory drug (NSAID) used for pain, fever, and inflammation, has long been under scrutiny due to its association with liver toxicity. High-dose formulations were found to pose increased risks, prompting the government to intervene. Officials noted that safer alternatives such as paracetamol and ibuprofen are better supported by clinical evidence.
The WHO has also excluded nimesulide from its Model List of Essential Medicines, and several countries have restricted or withdrawn the drug over similar safety concerns. The nationwide prohibition on high-dose nimesulide marks a decisive step toward prioritizing patient safety and promoting the use of evidence-backed, low-risk medications.
Together, these measures underscore the government’s commitment to strengthening India’s drug regulatory system—tightening OTC sales norms, eliminating unsafe formulations, and reinforcing safeguards to protect public health.
