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 license or import license number, and special storage condition required.
API is the core ingredient for manufacturing a drug. If it is fake or sub-standard, its quality is jeopardized. A significant chunk of APIs is imported to India from China.
Tthe Government is taking measures to ensure that India can manufacture most of it indigenously.
The changes in the rules of the drug 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 real and fake drugs.
India’s drug regulatory authority is also amending the Drugs and Cosmetics (D&C) Rules, 1945.