Recommendations By Indian Associations On Drugs & Cosmetics (Amendment) Rules, 2022
On 18th January, 2022, the Union Health Ministry of India came out with Drugs & Cosmetics (Amendment) Rules. The final notification made it mandatory to include QR codes on every Active Pharmaceutical Ingredient (API) manufactured or imported in India. QR code should be present on each API at each level of packaging which will store data or information. The data should be readable with software applications for the mainstream purpose of tracking and tracing. The data in the QR code should include 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. The rule will come into force from the 1st January, 2023.
Sample QR Code and SSCC Code (Recommended by CDSCO):
The Union Health Ministry got a mixed response from the manufacturers and sellers of the drug industry. There are some issues that need clarifications from the Government’s side. The respective associations from India have identified some problems and have proposed recommendations for the same as follow:
| Problems | Recommendations |
|---|---|
| No clear technical guidelines for the interpretation of data and the usage of QR code is mentioned. | Requirement of harmonization of the system and a precise description of the data to be included in the QR code. |
| Application identifiers are not specified in the current QR code requirements which leads to misinterpretation of data. | Standardization would be needed to read and interpret which data in encoded where in the QR code. |
| Encoding all the data in a QR code will generate a very large QR code that will not be readable by a standard scanner. | The industry should be required to encode only Product Code, Batch & Expiry Date into the QR code and extract all other information from the Central Database, which may be hosted by the Government authorities (CDSCO/State FDAs) |
| There will be different systems of different vendors which need to be able to be read and print the QR Code. Using proprietary systems or standards developed by a particular vendor will lead to dissimilarity. | Use of international standards only so that the QR Codes can be read by anyone who complies with those standards and the available scanners/equipment in the market can be used. |
For further clarifications, some other questions were raised by the associations which are as follows:
- 1. A clarification is demanded on how to include SSCC code in the QR code while printing at packaging level as the shipping lines provide container code at the time of loading of cargo in the container at the seaport.
- 2. Track and Trace regulations mention the use of QR code. Other similar requirements for Finished Dose Pharmaceuticals in India require a 2D data matrix code. Is it the intention of the regulation to use the QR code or to remain consistent with similar Pharma regulations and use the 2D?
- 3. Will this API regulation lead to future requirements to report this data to a central government database, similar to iVEDA?
- 4. Would manufacturers have the option to use either the data matrix or the QR code? How does this apply to serialization?
- 5. Will the 11 data items listed require encoding in the barcode following a standard format where each required element is fixed in a particular sequence?
- 6. What is the guiding principle for the Unique product identification code? Which agency will provide it to the manufacturer?
- 7. How will the QR code help Track & Trace without posting the data in a central repository? What is that repository and what is the procedure to transfer/upload the data there?
Hence, the associations have requested technical guidance and the use of the best international standards to ensure ease in implementation of the requirement for QR code laid down under the subject GSR.
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