Asia-Pacific Roundup: India expands mandatory use of QR codes for traceability, starts phased transition
India has adopted legislation expanding the mandatory use of QR codes for tracing more drugs across the supply chain.
In 2022, the Indian government mandated that manufacturers of the top 300 pharmaceutical brands in the country should adopt QR code-based identification. That change, which came into effect in 2023, led manufacturers to print or affix bar or QR codes on the primary packaging or, if there was insufficient space, on the secondary packaging. The machine-readable codes contained information to enable authentication.
Last week, the Ministry of Health and Family Welfare published a legislative update expanding the use of QR codes to all vaccines, antimicrobials, narcotics, psychotropic substances, and anti-cancer drugs. The government called the expansion of the track-and-trace program “a major step towards strengthening the quality, safety, and integrity of India’s pharmaceutical supply chain.”
The new rules mirror the earlier requirements. Manufacturers of the four medicine classes must add a bar or QR code to the primary packaging or, if space constraints make that impossible, the secondary packaging. The code must carry nine data elements: the unique product identification code, the proper and generic names of the drug, the brand name, the name and address of the manufacturer, the batch number, the date of manufacture, the date of expiry, the manufacturing license number, and details of excipients.
Storing the information for access via software applications will facilitate authentication and verification of the product throughout the supply chain. Facilitating the authentication of medicines at various stages of the supply chain could improve tracking and verification of drug products, strengthen regulatory oversight, and support efforts to curb the distribution of spurious medicines, officials said.
Expanded use of QR codes will also support efforts to curb antimicrobial resistance (AMR) via better supply chain monitoring and the identification of counterfeit and substandard antimicrobial products.
The Ministry of Health and Family Welfare said it recognizes “the need to provide adequate time to industry and other stakeholders for implementation,” leading to a phased rollout of mandatory QR code use across product categories. Manufacturers of vaccines, narcotic and psychotropic drugs, and anti-cancer medicines must comply by 1 July 2027. The deadline for antimicrobials is 1 July 2028.
Officials are encouraging manufacturers to voluntarily adopt QR codes before the deadlines.
Press Release, Gazette Notification
India seeks feedback on changing residual shelf-life requirement for imported drugs
India is holding a consultation on planned changes to the shelf-life requirements for imported drugs.
The current version of India’s Drugs Rules, 1945, requires products to have at least 60% residual shelf life on the date of import. The licensing authority may allow imports of products with less shelf life, but only in exceptional circumstances and when reasons are recorded in writing. India’s Central Drugs Standard Control Organization (CDSCO) temporarily waived the requirement during the COVID-19 pandemic.
Last week, the Ministry of Health and Family Welfare proposed a permanent change to the import rules. Under the proposal, the licensing authority would allow the importation of drugs with at least one year of residual shelf life on the day of importation.
The proposed change does not apply to biological drugs and radiopharmaceuticals. India plans to retain the 60% requirement for those classes of pharmaceuticals, reflecting their “specialized nature and public health considerations.” Many radiopharmaceuticals decay quickly and have half-lives that are less than one year.
Dropping the 60% requirement for other drugs is intended to “facilitate greater efficiency in the pharmaceutical supply chain while maintaining the availability of quality medicines for patients,” officials said. Implementing the 12-month requirement is intended to give time for distribution and consumption before expiry, ensuring that patients continue to receive medicines with adequate usable shelf life.
Officials expect the change to “improve utilization of pharmaceutical inventories across the supply chain by reducing avoidable wastage of medicines arising from restrictive residual shelf-life requirements.” The government predicts the improvements will “optimize supply management, reduce costs, and strengthen the availability of essential medicines in the country.”
The ministry is accepting feedback on the proposals for 30 days.
Press Release, Gazette Notification
Industry concerns prompt CDSCO to clarify regulations on formulation intermediates
CDSCO has clarified India’s regulation of formulation intermediates in response to industry concerns.
The clarification applies to granules that are directly compressible, taste-masked, or modified-release, as well as to other types of formulation intermediates. Stakeholders raised concerns about the regulation of the intermediates. In November, India’s Drugs Consultative Committee noted that intermediates must be considered formulated bulk to meet applicable quality standards, such as the dissolution profile.
The committee asked CDSCO to investigate the situation, leading to further discussion this year of how to create a uniform licensing system for formulation intermediates across India. Last week’s notice reflects the outcomes of the committee’s deliberations.
New drugs with modified- or sustained-release intermediates require marketing approval from CDSCO. Building on the committee’s conclusion, CDSCO clarified that it will always categorize modified- and sustained-release products, such as gastro-resistant tablets, as new drugs. Manufacturers should submit filings for the pharmaceutical formulation and formulation intermediate for permission to sell the drugs.
Different rules apply to products made with formulation intermediates such as directly compressible granules. Manufacturers of products other than modified- or sustained-release new drugs can send data to the relevant state licensing authority requesting permission to make and sell their formulation intermediates.
CDSCO approval is needed if the formulation or formulation intermediate contains a novel excipient.
India seeks feedback on exemptions from domestic device procurement requirements
The Department of Pharmaceuticals (DoP) is holding a consultation on which medical devices to exempt from India’s domestic procurement requirements.
In February, DoP sought feedback on a list of 354 types of medical devices exempted from the requirement to seek domestic providers in some procurement processes. Based on the consultation, the DoP created lists of medical devices for addition and removal from the exemption list. DoP is seeking feedback on the lists until 15 July.
Products from Abbott, Baxter, Bayer, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, and Siemens Healthineers are among the devices that DoP is considering adding to the exemption list.
The consultation includes a justification for adding each device to the list. Many of the arguments rest on claimed advantages of the overseas companies’ products over domestic medical devices, or the claim that India lacks suitable domestic alternatives.
Other news
India’s CDSCO has started using its Sugam portal to receive applications for post-approval changes to the registration certificates and import licenses of human vaccines and anti-sera. Applicants can use the “other section checklist” module of post-approval changes. CDSCO is switching to the system to streamline the regulatory procedure and will stop accepting hard copy and emailed filings on 1 July.
The Philippine Food and Drug Administration (FDA) has discussed advancing regulatory reliance mechanisms with the Anti-Red Tape Authority and the Pharmaceutical and Healthcare Association of the Philippines.
