Last Updated on May 27, 2023 by The Health Master
Additional cost allowance for QR Code
The Indian Drug Manufacturers’ Association (IDMA) has put forward a proposal to the National Pharmaceutical Pricing Authority (NPPA) requesting an additional allocation of 30 paisa per unit in the ceiling price of the top 300 scheduled formulations.
This extra allowance aims to offset the capital expenditure incurred for printing QR codes on the packaging of these drugs.
Implementation of QR Codes for Enhanced Drug Authentication:
Effective from August 1, 2023, the central government has issued a notification mandating the use of QR codes on the labels of the top 300 brands of pharmaceutical formulations.
This measure aims to combat the circulation of counterfeit and spurious drugs in the market.
Currently, 67 companies are marketing these 300 drugs, and they are actively working on establishing the necessary infrastructure to meet the implementation deadline.
IDMA’s Representation to the NPPA:
In its representation to the NPPA, the IDMA highlights the substantial initial capital expenditure associated with printing QR codes for the manufacturing sites of the top 300 drugs.
The process involves setting up infrastructure such as LAN, software, cameras, sensors, printers, and the QR code itself, resulting in considerable costs.
The IDMA further explains that the expenses for authenticating the top 300 drugs are significant, with each camera costing Rs. 4 lakh per line, thermal inkjet printers amounting to Rs. 4 lakh per line, and a minimum requirement of 3 to 4 lines for 300 brands across multiple locations.
Additionally, one-time costs for software and licenses must also be borne. Given the unprecedented increase in input costs, the IDMA requests some relief, particularly for scheduled formulations, to help offset this financial burden.
Gazette Notification and Mandatory QR Code Implementation:
On November 17, 2022, the Union Ministry of Health and Family Welfare issued Gazette Notification No. 823(E), introducing the Drugs (Eighth Amendment) Rules, 2022.
These rules introduced a new Schedule H2, which includes a list of the top 300 brands. Sub-Rule (6) and (7) were inserted after Sub-Rule (5) in Rule 96 of the Drugs and Cosmetics (D&C) Rules, 1945.
The notification makes it mandatory for pharmaceutical companies to affix QR codes on the packaging of the top 300 formulations starting from August 1, 2023.
QR Code Contents and Information:
As specified in the Gazette Notification, the QR code will contain essential details such as:
- The unique product identification code,
- Generic name of the drug,
- Brand name,
- Manufacturer’s name and address,
- Batch number,
- Date of manufacture,
- Expiry date,
- Manufacturing license number.
These comprehensive identifiers will enhance drug authentication and verification processes.
Conclusion:
The Indian Drug Manufacturers’ Association has urged the National Pharmaceutical Pricing Authority to consider an additional cost allowance for printing QR codes on the packaging of the top 300 drugs.
With the imminent implementation deadline, pharmaceutical companies are actively investing in infrastructure to comply with the government’s mandate.
The QR codes will serve as an effective tool in identifying and combating the circulation of fake and spurious drugs, ensuring consumer safety and trust within the pharmaceutical industry.
Bar code or QR code: Govt issues draft Rule to mandate on label of top 300 brands of drugs
Pharma Industry to Ministry: Launch portal for QR codes for top 300 drug brands
QR code on APIs – Active Pharmaceutical Ingredients
QR code could curb circulation of fake, spurious and substandard medicines
Mandatory QR codes on APIs: Benefit or burden,
The mandatory QR codes on APIs
Govt mandates QR code on labels of all APIs manufactured and imported
HM launches National Medical Device Policy 2023, read details
Govt plans PLI scheme for basic chemicals used in Pharma and Medical Device Industry
Medical Device alert: CDSCO issues alert on these Intra Ocular Lens
Himachal Pradesh: 11 Pharma companies told to shut operations
Difference between Validation and Calibration in the Pharma Industry
One arrested from Pharma Company for distributing counterfeit Drugs
DPCO 2013: Pharma Industry urges Govt to revisit Para 18(1) and para 13(2)
Govt amends guidelines for Promotion of Medical Device Parks Scheme
Govt to amend Cosmetics Rules 2020 to strengthen Regulation & Quality control
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
