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The Indian government has made it mandatory to put QR codes on packages of active pharmaceutical ingredients (APIs) used in medicines to curtail the menace of counterfeit and substandard drugs in the country. The new rule will become effective from January 1 next year (2023).
Having QR code on APIs will help trace pharmaceutical firms and acquire information like whether there has been any tampering with the formula, where is the origin of the raw material, and where is the product going. This will also help in distinguishing between genuine and counterfeit drugs much easier as well as ensuring fair pricing.
The data stored in the code will contain unique product identification code, name of the API, brand name, name and address of the manufacturer, date of manufacturing and expiry, etc. In addition, the QR Code scanner is linked to a software that has price data of all brands, which is controlled by The National Pharmaceutical Pricing Authority.
A notification issued by the Union Health Ministry said, "Every active pharmaceutical ingredient manufactured or imported in India shall bear a quick response code on its label at each level, packaging that store data or information readable with software application to facilitate tracking and tracing."
Active Pharmaceutical Ingredients or APIs are the main raw materials for making intermediates, tablets, capsules, and syrups. Indian companies are largely dependent on China for APIs.
The Drugs Technical Advisory Board (DTAB) had approved the proposal for mandatory QR code on the APIs in June 2019 to combat counterfeit drugs that can impose danger to people's health. Many reports have claimed that 20 per cent of the medicines made in India are fake. A government report also revealed that 3 per cent of medicines are of substandard quality. Counterfeit and low-quality drugs don't really benefit patients.
A high-level panel headed by Union health secretary was set up in July 2020 to work on a framework to implement QR code for drug packs.
Under a similar rule, India had already made it mandatory for all medicines procured under public procurement to have barcode/QR code at primary level packaging from April 1, 2020.
With inputs from agencies
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