India's Health Ministry Makes Prescription Mandatory for Oral Medications

The Health Ministry has issued a notice that excludes all “syrups” from over-the-counter sale of medication. The move is likely to affect a wide array of products — including cough syrups and some digestive medications. A prescription is now mandatory for purchase of all medicines consumed under this dosage format. The notification did not outline any specific formula or brands — opting instead for an umbrella change that covers nearly all oral, liquid medications. The change will not impact alternative solid formats of the same medicines. “In the Drugs Rules, 1945, in Schedule K, in the column, under the heading Class of Drugs, against serial number 13, in item number (7), the word ‘Syrups,’ shall be omitted,” read the official message from the Health Ministry. Schedule K lists categories of medicines that are exempt from certain provisions of Chapter IV of the Drugs and Cosmetics Act, 1940, subject to specified conditions. With the omission of syrups from the list, such medicines will now be subject to the applicable regulatory requirements. The amendment follows a draft notification issued at the end of December last year, inviting objections and suggestions from stakeholders and the public. The government said all comments received on the draft rules were considered before the final notification was issued. The new rules making a prescription mandatory to buy cough medicine and other syrups have already come into effect. It is not yet clear how this will be enforced by local chemists and state drug inspectors at present. Here are some of the companies and products that will be affected: It is pertinent to note that the change in rules is not the same as a ban against the product. Users will now have to secure a doctor’s prescription and show the same at the pharmacy to secure these products and other medical syrups.