In a very important development pertaining to the pharmaceutical industry, the government has made it mandatory to put QR codes on Active Pharmaceutical Ingredients (APIs) used in medicines and the new rule will be applicable from January 1, 2023.
This would allow helping in distinguishing between genuine and counterfeit drugs and it would be easy for government agencies to trace pharmaceutical firms and acquire information like if the formula has tampered and where is the origin of the raw material and where is the product going.
These are the guidelines: -It will be mandatory to put QR code on the API.
-The new rule will be applicable from January 1, 2023.
-Health Ministry issued notification.
-Now it will be easy to identify genuine and counterfeit medicines.
-The QR code will contain the manufacturer and batch number information.
-Expiry and importer information will also be available.
Medicines produced with counterfeit and low-quality APIs can be harmful to benefit patients that is why the DTAB i.e. Drugs Technical Advisory Board had approved this proposal in June 2019 and according to a government report, 20 per cent of the medicines made in India are fake and 3 per cent of medicines are of substandard quality.
The idea was proposed in 2011, however, due to the repeated refusal of pharma companies, a decision could not be reached as pharma companies were more concerned about the fact that different government departments would issue different guidelines.
However, in the face of the Covid pandemic and the need for transparency the demand from the companies that a uniform QR code should be implemented across the country, after which in the year 2019, the Central Drugs Standard Control Organization prepared this draft and it clealry suggested to make QR code mandatory for APIs.
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