The Union health ministry will make it mandatory for all active pharmaceutical ingredient (API) packages to be barcoded to detect spurious drugs and monitor imported and indigenously produced raw materials used to manufacture medicines.
APIs are critical components that make drug formulations potent against disease. There are about 2,500 APIs that are used to create hundreds of thousands of drug formulations.
“Raw material is usually supplied in bulk and its authenticity affects the final product. After the barcoding rule is implemented, the misuse of names and brands and sale of counterfeit drugs should come down significantly,” said Dr S Eswara Reddy, drugs controller general of India (DCGI).
On April 2, the drug and technical advisory board (DTAB) of the government recommended that provisions be included in the Drugs and Cosmetics Rules, 1945, to make it mandatory to have QR coding on labels of APIs to trace their origin and movement from API manufacturers to drug manufacturers through a system of networking.
“The department sometimes gets complaints about false labelling, when what is mentioned on the label is not the ingredient inside the pack, or the ingredient is not from the company mentioned on the label.
“Barcoding will help determine whether the supplies are coming from the registered company, especially while dealing with companies in other countries from where raw materials are sourced,” Reddy said.
“The DTAB has already agreed to the proposal for API barcoding and recommended it to the ministry, which should soon notify it,” he added.
The health ministry had earlier unsuccessfully contemplated using barcodes on antibiotic packs to check antibiotic misuse.
Barcodes are machine-readable representations of data that’s descriptive of the material contained in a particular packaging.
Pharmacists have welcomed the API barcoding move.
“Barcoding is a better way of checking distribution of material supply. The move should work as an efficient quality-control measure,” said Sandeep Nangia, president, Retailers and Distributors Chemist Association in Delhi.
The health ministry also submitted an affidavit to the Delhi high court this week, saying that experts from DTAB and the drugs consultative committee were being consulted to make it mandatory for manufacturers to recall and destroy expired medicines and vaccines, which are sometimes repackaged and resold.