Pharmaceutical companies may soon have to compulsorily print barcodes on the packages of 300 drug formulations to check the sales of spurious medicines, media reports quoting news agency PTI said.
The bar codes would enable that information such as manufacturing license and batch number can be accessed upon scanning, and help in checking the authenticity of a drug.
The amendments to Drugs and Cosmetic Rules, 1945 which, once approved, will come into force from May next year. The government is in the final stages of the process of mandating the process, the Economic Times reported.
“A sizable of the drugs mentioned in the list are mostly bought over the counter exposing people to the possibility of consuming counterfeit medicines. This amendment aims to prevent supply of fake medicines and ensure improvement in public healthcare,” an official source told PTI.
“A bar code or QR code will authenticate whether a particular drug is original or not,” the official added.
A draft gazette notification had been issued in June by the Union health ministry, which sought comments and feedback from the public. The move comes in the wake of comments and further deliberations.
It will be compulsory for the manufacturers of 300 drug formulation products as specified in the Schedule H2 of the Rule 96 of Drugs and Cosmetics Act to affix a barcode or QR code on its primary packaging or secondary package label that store data or information legible with software application to facilitate authentication, PTI said.
The data includes unique product identification code, proper and generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacturing and expiry and manufacturing license number
In the first phase, 300 drugs from top pharma brands that have a market share of 35 per will be covered. In the later stages, all drugs could be covered.
The drugs include Allegra, Amlokind, Azithral, Betadine, Calpol, Ceftum, Combiflam, Dolo, Dulcoflex, Ecosprin, Gelusil, Jalra, Lantus, Manforce, Meftal Spaz, Shelcal, Human Mixtard, Pan 40, Otrivin, Pantocid, Rantac, Stamlo, T-bact ointment and unwanted kit and Volini spray, PTI said.