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QR code on APIs to be made mandatory by Indian government from Jan. 1st, 2023 to combat counterfeit medicines

[This News is originally posted on www.zeebiz.com ]
Indian government has made it mandatory to put QR codes on Active Pharmaceutical Ingredients (APIs) used in medicines.

The government has made it mandatory to put QR codes on Active Pharmaceutical Ingredients (APIs) used in medicines. The new rule will be applicable from January 1, 2023. After that, it will be mandatory to put QR code in API. This new rule will also help in distinguishing between genuine and counterfeit drugs much easier.

This will also make it easy to trace pharmaceutical firm 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.

The stored data or information shall include the following minimum particulars, namely:—
(i) Unique product identification code,
(ii) Name of the API,
(iii) Brand name (if any),
(iv) Name and address of the manufacturer,
(v) Batch no.,
(vi) Batch size,
(vii) Date of manufacturing,
(viii) Date of expiry or retesting,
(ix) Serial shipping container code,
(x) Manufacturing licence no. or import licence no.
(xi) Special storage conditions required (if any).”.

What is API?
API stands for Active Pharmaceutical Ingredients. These are the main raw materials for making intermediates, tablets, capsules, and syrups. API plays a major role in the manufacture of any medicine and for this Indian companies are largely dependent on China.

Points to be noted:
-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.