The central government proposes the amendment in Drugs and Cosmetic Rule, 1945 to mandate that every Active Pharmaceutical Ingredient (API) or bulk drugs manufactured or imported in India should have Quick Response (QR) code on its label at each level packaging, to facilitate tracking and tracing. QR code stores the information in certain forms which can only be read through software application. The draft amendment also proposes that following minimum information shall be stored in the QR codes:
- Unique product identification code,
- Name of the API, y 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,
- Manufacturing license no. or import license no.
- Special storage conditions required (if any)1.
API is the crucial component of any drug formulation, therefore a safe and secure supply chain and storage condition will play important role in maintaining the quality and integrity of API or bulk drugs. The Drug Technical Advisory Board (DTAB), in its 82nd meeting, to enhance the quality supply of APIs, has recommended to include provisions under the Drugs and Cosmetics Rules, 1945 for mandatory QR coding on labels of APIs for tracing the origin and movement of APIs from manufacturers to formulators through a system of networking.
Apart from this, the Union Ministry of Commerce, through the Centre for Development of Advanced Computing (C-DAC), is planning to roll out online tracing and authentication system from April 1, 2020, for pharmaceutical export packages. The online system aims to help manufacturers and merchant traders to adopt integrated system that will enable the tracing of an exported pharmaceutical product.
The online system also has the provision to create virtual tertiary and secondary packages and generation of unique identification for manufacturers, merchant exporters, products, and packages to simplify the workflow of both manufacturers and merchant exporters.
The labelling requirement will not directly affect the quality, safety and efficacy of drug products. But it is expected to improve the quality of supply chain and facilitate the tracing and tracking of bulk drugs labeled with QR code.
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