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This new rule will help distinguish between genuine and fake medicines, here’s how

As per a new rule, the government has mandated pharma companies to put QR code on APIs from next year. Read on to find out what it means.

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The Indian government has now made it mandatory for drug manufacturers to put QR codes on Active Pharmaceutical Ingredients (APIs) being used in their medicines. Scheduled to be applicable from January 1, 2023, the new rule will make it much easier to distinguish between genuine and counterfeit medicines.

Furthermore, the QR codes will help tracing information about the product and manufacturing company like batch information, raw material origin, formula tampering and product destination. The proposal was approved by the Drugs Technical Advisory Board (DTAB) back in June 2019 as drugs made with APIs that are low cost or counterfeit do not benefit patients.  

Up to 20% of medicines made in India are reportedly counterfeit. As per a government report, 3% drugs were found to have substandard quality.

An effort to put up a system in place has been underway since 2011. However, consensus with pharma companies took time, being wary of having to overcome different guidelines from different departments.

The industry had sought to get a uniform QR code implemented across the country. A draft was prepared by Central Drugs Standard Control Organization (CDSCO) in 2019 following the demand.

APIs or Active Pharmaceutical Ingredients are the main raw materials used in manufacturing tablets, capsules, syrups and intermediates. APIs are to the pharmaceutical industry what processor chips are to the mobile phone industry. It should be noted that Indian firms heavily depend on China for pharma APIs.

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