Govt to tighten rules for sale of oral formulations containing alcohol

Health Ministry also mandates QR codes on vaccines and anti-cancer meds, eases sales licence norms for liquid antiseptics

In a bid to tighten regulatory control over alcohol content in cough syrups and tinctures, the Centre has released draft rules to bring certain categories of oral formulations containing alcohol under Schedule H1 of the Drugs Rules, 1945.

 

According to the proposed rule change dated October 18, all oral formulations containing more than 12 per cent ethyl alcohol, packed and sold in packs or bottles of more than 30 millilitres (ml), will come under Schedule H1.

 

Schedule H1 is a category under India’s Drugs and Cosmetics Act, which includes prescription drugs that require strict monitoring. It includes mandatory maintenance of sales records and prescription retention by pharmacies     

   

This move comes after the matter was discussed at the 66th meeting of the Drugs Consultative Committee (DCC) on June 17, chaired by the Drugs Controller General of India (DCGI).

 

“The proposed amendment is expected to enhance control over the availability and dispensation of medicinal preparations with high alcohol content. It would address potential misuse, especially in vulnerable populations,” an official in the know said.

 

In another move to curb counterfeiting of medicine, the health ministry also proposed draft rules to mandate QR codes on all vaccines, antimicrobials, anti-cancer medicines and narcotics and psychotropic drugs listed under the NDPS Act.

 

As of now, QR coding is mandatory for the top 300 best-selling brands listed in Schedule H2 of the Drugs Rules, 1945. They are required to have a QR code or barcode for tracking and authentication.

 

This comes even as the Central Drugs Standard Control Organisation (CDSCO) has been seeing increased cases of medicine batches being found as not of standard quality.

 

While the codes are used to check active substances used in the drug and track movement, the government was also exploring including details of all excipients of the medicine, according to the officials in the know.

 

An excipient is a constituent of a medicine other than the active substances, added in the formulation for a specific purpose.

 

In line with the DCC’s recommendations, the health ministry has also proposed an amendment in the Schedule K of the Drugs Rules to bring in changes to the extent and conditions for exemption of liquid antiseptics for household use from wholesale license and hospital-grade antiseptics from retail sale license. The move aims to make liquid antiseptics more accessible to consumers.

 

The health ministry has proposed to include clauses asking manufacturers of liquid antiseptics to mention on their labels whether they are "for household use" or "for hospitals or other than household use", to get the sales license exemption.