Prior to the amendment of the rules, there was a provision allowing cough syrups to be sold in villages with a population of less than 1,000 without adhering to certain retail licensing regulations. However, under the new system, this exemption will no longer apply to cough syrups.
अब बिना डॉक्टर की पर्ची के नहीं मिलेगा कफ सिरप, केंद्र सरकार ने कड़े किए नियम
On Tuesday, the Central Government amended the Drugs Rules, 1945, banning the over-the-counter (OTC) sale of syrup-based medicines—including cough syrups—without a doctor’s prescription. Consequently, cough syrups will now be sold exclusively through licensed pharmacies. Through this amendment, the government has revoked the exemption that previously allowed certain retail shops in small villages to sell cough syrups without adhering to standard licensing regulations. This decision follows the removal of the word “syrup” from the category of medicines exempted under Schedule K, thereby tightening regulatory oversight on such products.
This change has been notified under the Drugs (Fifth Amendment) Rules, 2026, with the aim of ensuring better control over the manufacture, sale, and distribution of syrup-based medicines. ‘Schedule K’ of the Drugs Rules, 1945, lists categories of medicines exempted from certain legal provisions regarding their manufacture, sale, and distribution, subject to specific conditions. These exemptions were originally granted to facilitate easy access to medicines for the public in specific circumstances.
Prior to the amendment, regulations permitted the sale of cough syrups in villages with a population of less than 1,000 without complying with certain retail licensing norms. However, this exemption no longer applies to cough syrups. Now, the sale and distribution of cough syrups in such villages can only be conducted through duly licensed pharmacies, in mandatory compliance with the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Additionally, the Ministry of Health and Family Welfare stated that this amendment was introduced to strengthen regulatory oversight of syrup-based medicines and to align the rules with current public health and safety requirements. According to the Ministry, this move will promote the responsible distribution and sale of cough syrups and ensure better adherence to regulatory standards across the country.
The Ministry has also advised cough syrup manufacturers, distributors, and sellers to strictly comply with all licensing and regulatory requirements under the Drugs and Cosmetics Act and the Drugs Rules. Following this change, consumers will now be required to present a valid prescription issued by a registered medical practitioner to purchase such medicines; in other words, a doctor’s prescription will now be mandatory for buying cough syrup.
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