Drugs (Amendment) Rules

The Ministry of Health and Family Welfare (Govt. of India) on January 18, 2022, has issued the Drugs (Amendment) Rules, 2022 to further amend the Drugs Rules, 1945.

The amendment makes QR codes mandatory on every active pharmaceutical ingredient. The Amendment Rules will come into force from January 01, 2023.

IN RULE 96 RELATING TO THE MANNER OF LABELLING, THE FOLLOWING SUB-RULE SHALL BE INSERTED:

According to the notification, the new drug amendments rule states that every active pharmaceutical ingredient (API) imported or manufactured in India shall bear a QR (quick response) code on the label and at every packaging level. The QR code must encase essential data that can be read through computer software for efficient tracking and tracing.

THE STORED DATA MUST CONTAIN THE FOLLOWING INFORMATION

• Unique product identification code;
• Name of the API;
• Brand name (if any);
• Name and address of the manufacturer;
• Batch no.;
• Batch size;
• Date of manufacturing;
• Date of expiry or retesting;
• Serial shipping container code (SSCC);
• Manufacturing licence no. or import licence no.;
• Special storage conditions required (if any).

ARE YOU READY?

As you have seen, the amendment will come into force on the 1st of Jan 2023. You will need to implement a solution before that. OPTEL helps pharmaceutical companies achieve regulatory compliance, optimize operational efficiency and create a more intelligent supply chain.

We have products and solutions which can enable you to be compliant with Drugs (Amendment) Rules, 2022.

Our subject matter expert will gladly provide you with all the information.