**Policy Summary: Implementation of QR Codes for Medicines in India**
This policy addresses the adoption of QR codes for medicines by pharmaceutical companies in India, as mandated by amendments to the Drugs Rules, 1945, under the Drugs and Cosmetics Act, 1940. Effective August 1, 2023, manufacturers of the top 300 drug brands (as specified in Schedule H2) are required to print or affix a Bar Code or Quick Response (QR) code on their primary packaging label, or secondary packaging label where space is limited. This code must store data legible with software applications to facilitate authentication.
State Licensing Authorities (SLAs) are responsible for the effective implementation and monitoring of this rule, with the authority to take action in cases of non-compliance. SLAs have been directed to maintain vigilance regarding compliance.
The government plans to extend the mandatory QR code provision to all vaccine products and all antimicrobials, and narcotic and psychotropic substances in a phased manner, as agreed upon during the 90th Drugs Technical Advisory Board (DTAB) meeting on January 25, 2024.
The Central Drugs Standard Control Organisation (CDSCO) has published notifications regarding QR code requirements on its website (https://cdsco.gov.in/opencms/opencms/Notifications/GazetteNotifications) to inform the general public. The CDSCO has also advised industry stakeholders to conduct public awareness campaigns. Guidance for identifying and verifying spurious drugs, including the process for verifying authenticity via barcode or QR code, is available on the CDSCO website.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The primary legislation in India regulating the import, manufacture, distribution, and sale of drugs and cosmetics.
Drugs Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, providing detailed regulations for the manufacturing, sale, and distribution of drugs.
Schedule H2: A schedule within the Drugs Rules, 1945, that specifies a list of drug formulations. The manufacturers of the top 300 brands of drug formulation products, as specified in Schedule H2, shall print or affix Bar Code or Quick Response Code on its primary packaging label.
State Licencing Authorities: State-level authorities (SLAs) empowered under the Drugs Rules, 1945, to implement and monitor regulations, including QR code compliance.
Drugs Technical Advisory Board: A statutory body in India that advises the government on technical matters related to drugs and cosmetics. In this context, it deliberated on extending QR code provisions to other drug formulations.
Central Drugs Standard Control Organisation: The national regulatory body in India for pharmaceuticals and medical devices. It falls under the Ministry of Health and Family Welfare.
vaccine products: All vaccine products to which the provision of QR code is to be extended.
antimicrobials, narcotic psychotropic substances: All antimicrobials, narcotic psychotropic substances to which the provision of QR code is to be extended.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2120
TOBE ANSWERED ON01ST AUGUST,2025
ADOPTION OFQRCODES FORALLMEDICINES BYPHARMACEUTICAL
COMPANIES
2120.SMT.RACHNABANERJEE:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) the number of pharmaceutical companies that have adopted QR codes under Drugs and
Cosmetics Act, 1940 alongwith the steps taken/proposed to be taken by the Government to
ensure compliancefrom others;
(b) whether the Government plans to extend the mandatory QR code to all categories of
medicineinthe country andif so, the detailsthereof; and
(c) whether the Government is planning public awareness campaigns to educate consumers
onusing QR codestoverifymedicineauthenticity andif so, the detailsthereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a): On 17.11.2022, the Drugs Rules, 1945 were amended vide G.S.R. 823(E)
which has come into force from 1st of August, 2023 providing that the manufacturers of top
300 brands of drug formulation products, as specified inSchedule H2, shall print or affix Bar
Code or Quick Response Code on its primary packaging label or, in case of inadequate space
in primary package label, on the secondary package label that store data or information
legible with software application tofacilitateauthentication.
State Licencing Authorities (SLAs) are empowered under the said Drugs Rules for its
effective implementation and monitoring and in case of non-compliance, SLAs can take
action as per the rules. SLAs have also been requested to keep a strong vigil to check the
complianceof the said requirement.
(b): The proposal for affixing bar code or quick response code on other drug
formulation products was deliberated in the 90th Drugs Technical Advisory Board (DTAB)
meeting held on 25.01.2024. The Board has agreed to the proposal to extend the provision ofQR code toall vaccineproducts andtoall antimicrobials, narcotic & psychotropic substances
ina phase wise manner.
(c): The Central Drugs Standard Control Organisation has made the said
requirements regarding QR Codes available to the general public by publishing the
notification in this regard on its website
(https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications) and has also
advised industry stakeholdersfor public awareness campaignsinthisregard.
Further, the guidance for identification and verification of spurious drugs have also been
provided on the website of CDSCO describing the process flow for verifying the authenticity
of the drugs byreadingthe barcode or quick response code.
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