The Indian government has announced plans to tighten regulations on the sale of cough syrups, moving towards making prescriptions mandatory for their purchase. This initiative follows recent stringent measures concerning pharmaceuticals, including the ban on high-dose Nimesulide and previous actions regarding cough syrup after child fatalities.
Proposed Regulatory Changes
The Ministry of Health has issued a draft notification for amendments to the Drugs Rules, 1945. A key proposal involves removing the word “syrup” from Schedule-K, specifically under entry number 7 of the “Class of Drugs” column, serial number 13. This change is intended to make drug-related rules clearer and more effective, ensuring better protection of public health. The “Drugs (Amendment) Rules, 2025” are set to be implemented from their publication date in the official gazette.
The draft, released under the Drugs and Cosmetics Act, 1940, seeks public input. Individuals and stakeholders have a 30-day period to submit objections and suggestions, which the central government will review. This proposal was formulated in consultation with the Drugs Technical Advisory Board. Currently, Schedule-K lists drugs that are exempt from certain strict regulations and do not require a doctor’s prescription for purchase.
Expert Opinion on the New Rule
Dr. Santosh Kumar, a pediatric specialist and director at Sanjeevani Hospital in Darbhanga, has endorsed the government’s decision, calling it a contemporary necessity. He highlighted the prevalent misuse of liquid medications, particularly among children, often administered without correct dosages or medical advice, which can lead to adverse effects. Dr. Kumar stated that requiring a doctor’s prescription for these medicines would help reduce self-medication practices among the public.
