Packages of drug ingredients to carry QR codes for tracking: Govt

The Union government has made QR (quick response) codes mandatory on packages of drug manufacturing ingredients, both domestic and imported, in a bid to crack down on fake medicines.

Earlier this week, the Union health ministry gazette notified guidelines, saying “every active pharmaceutical ingredient (API; bulk drug) 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”.

The data stored in the code is expected to have unique product ID, name of the API, brand name, name and address of the manufacturer, batch number, batch size, date of manufacturing, date of expiry or retesting, serial shipping container code, manufacturing licence or import licence number, and special storage condition required.

API is the core ingredient for manufacturing a drug. If it is fake or sub-standard, then the whole medicine quality is jeopardised. A major chunk of APIs is imported to India from China. However, the government is taking measures to ensure that India is able to manufacture most of it indigenously.

The changes in the drugs rules were made under the Drugs and Cosmetics Act, 1940, after consultation with the regulator’s subject expert panel— the drugs technical advisory board. The initiative will help easily distinguish between the real and fake drugs.

India’s drug regulatory authority is also in the process of amending the Drugs and Cosmetics (D&C) Rules, 1945.