The proposal was discussed in a recent meeting of the Drugs Technical Advisory Board (DTAB), India’s highest advisory body on drugs, which deliberated on the matter and agreed to it, said people familiar with the matter. The implementation of the proposal will, however, require an amendment to Schedule H2 of Drugs Rules, 1945, and therefore will be sent to the health ministry soon, they said.
The board was informed that criminals in collusion with hospital pharmacies were found refilling empty vials of expensive anti-cancer medicines with counterfeit drugs. These fake drugs were then mixed with genuine stocks and sold to unsuspecting cancer patients, putting their life at risk.
“These anti-cancer drugs must be issued under strict directives to implement mandatory QR codes and rigorous track and trace mechanisms on every vial and strip of medication that are marketed in India,” said the minutes of the meeting. Accordingly, it was proposed that the rules be amended.
“DTAB deliberated the matter and agreed for the proposed amendment to include all anti-cancer medicines under Schedule H2 of Drugs Rules, 1945,” according to the minutes. In a bid to weed out spurious drugs, the regulator had made it mandatory for companies to have a barcode on top 300 brands so that information such as manufacturing licence and batch number can be accessed upon scanning. The top 300 brands of drugs included widely used analgesics, pain relievers, anti-platelet, vitamin supplements, blood-sugar lowering medicines and contraceptive tablets. “The move was to ensure authenticity of drugs and enable tracing,” said one of the persons, who did not wish to be identified. The brands identified by the National Pharmaceuticals Pricing Authority included Dolo, Saridon Fabiflu, Ecosprin, Limcee, Sumo, Calpol, Corex syrup, Unwanted 72 and Thyronorm. They were shortlisted on the basis of their moving annual turnover value as per data from market research firm Pharmatrac.
The government has been trying to introduce QR codes since 2011.
