The Union Health Ministry has notified amendments to the Drugs Rules, 1945, to expand the ambit of Schedule H2 and bring additional categories of drugs under the QR code-based track-and-trace framework.
Under the amended provisions, all vaccines, antimicrobials, narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, and all anti-cancer drugs have been included under Schedule H2 of the Drugs Rules, 1945.
With this amendment, manufacturers of these drug formulations will be required to print or affix a bar code or Quick Response (QR) code on the primary packaging label of the product or, where there is inadequate space, on the secondary packaging label. The QR code shall store information that can be accessed through software applications to facilitate authentication and verification of the product throughout the supply chain.
The QR code will contain key product information, including the unique product identification code, generic and brand names, name and address of the manufacturer, batch number, manufacturing and expiry dates, manufacturing licence number, and details of excipients, wherever applicable.
The requirement for QR code-based identification was earlier applicable to the top 300 pharmaceutical brands in the country. The present amendment significantly expands its coverage to include all vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs, thereby broadening the scope of traceability and strengthening safeguards against the circulation of counterfeit and substandard medicines.
According to a release issued by the Ministry, the enhanced traceability mechanism will facilitate authentication of medicines at various stages of the supply chain and enable improved tracking and verification of drug products.
The measure is expected to strengthen regulatory oversight and support efforts to curb the distribution of spurious medicines in the market. It will also contribute to the national fight against antimicrobial resistance (AMR) by enabling better identification and monitoring of counterfeit and substandard antimicrobial products.
Recognising the need to provide adequate time to industry and other stakeholders for implementation, the Ministry has prescribed phased timelines for compliance. The provisions relating to vaccines, narcotic and psychotropic drugs, and anti-cancer medicines shall come into force from July 1, 2027, while the provisions relating to antimicrobials shall become effective from July 1, 2028.
Meanwhile, the Ministry has also notified amendments to the Clinical Establishments (Registration and Regulation) Act, 2010, on June 22, 2026, pursuant to the Jan Vishwas (Amendment of Provisions) Act, 2026, which was published in the Official Gazette on April 8, 2026.
The reforms are aimed at promoting trust-based governance, reducing the compliance burden, improving ease of doing business, and ensuring proportionate regulatory enforcement, while continuing to safeguard patient safety and the quality of healthcare services across the country.
The amendments also provide for a structured adjudication process, including an opportunity for hearing before the imposition of penalties, mechanisms for recovery of penalties, and an appeal framework for aggrieved parties.
“These measures are expected to encourage voluntary compliance, reduce unnecessary litigation, and ensure proportionate action in cases of minor procedural non-compliances, while maintaining regulatory oversight over clinical establishments,” said the release.
“By replacing criminal penalties for procedural lapses with a fair and balanced administrative mechanism, the reforms seek to improve the ease of doing business in the healthcare sector while preserving the highest standards of patient care, safety and accountability,” it added.
Published – June 25, 2026 06:47 pm IST
