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Posted 21 June 2022 | By Nick Paul Taylor 

Asia-Pacific Roundup: India proposes QR codes on key medicines within the year

2784 India’s Ministry of Health has revived a proposal to add bar codes or quick response (QR) codes to the packaging of 300 top medicines to facilitate product authentication. The requirement is set to come into force at the start of May 2023.
 
Proposals to include a barcode on drug packaging date back to 2015 when the Indian government released a draft proposal for consultation. The proposal was never finalized because many “pharmaceutical companies showed their inability to introduce this sophisticated technology in their manufacturing processes,” according to India’s Drugs Technical Advisory Board (DTAB).
 
The latest proposal calls for a barcode or QR code to carry eight pieces of information: a unique product identification code, generic name, brand name, manufacture date, batch number, expiration date and the manufacturing license number.
 
The proposal calls for the code to be added to the primary packaging label; however, the secondary label can be used if space is insufficient on the primary label Wherever the code is placed, it should “store data or information legible with software application to facilitate authentication,” according to the proposal.
 
While the proposal gives manufacturers less than a year to implement the requirements, the industry was warned of India’s intent to resurrect the plan. DTAB agreed to the voluntary introduction of track-and-trace requirements for 300 pharmaceutical brands in 2018. The government set up an inter-departmental committee focused on the topic in 2020, and DTAB recommended the introduction of coding requirements for the top 300 brands last year.
 
The proposal is part of India’s long history of trying to mandate the use of bar and QR codes. Officials proposed requiring exports to carry the information in 2011. That export-focused requirement was delayed indefinitely in 2014, only for India’s Directorate General of Foreign Trade to resurrect it in recent years. The export system now is advancing in parallel to a push to require active pharmaceutical ingredient packages to carry QR codes.
 
The consultation is open until 13 July. Comments can be emailed to drugsdiv-mohfw@gov.in.
 
Draft Proposal
 
TGA seeks feedback on adopting EMA registry study, cancer trial guidelines
 
 
Australia’s Therapeutic Goods Administration (TGA) is holding a consultation on the planned adoption of European Medicines Agency (EMA) guidances on registry-based studies and the use of patient-reported outcomes (PROs) in oncology clinical trials.
 
TGA seeks to adopt both EMA documents in their entirety, with an annotation to registry-based studies guideline advising sponsors to refer to TGA recommendations and requirements regarding the pharmacovigilance responsibilities 
 
EMA adopted its final guideline on registry-based studies last year. The document features advice about key methodological aspects that are specific to the use of patient registries by marketing authorization applicants and holders. EMA also used the document to provide considerations and aspects of registries that it views as “important as good regulatory practice” in the studies.
 
The appendix on PROs is older, having come into effect in 2016. EMA added the appendix to its guideline on the evaluation of anticancer medicinal products in man to set out its views on the regulatory value of data generated from PROs in oncology clinical trials.
 
Feedback on TGA’s plan will be accepted until 29 July. The agency is asking affected stakeholders to say whether they support or oppose the adoption of each document and share any additional information that they think is relevant.
 
TGA Consultation
 
Philippine FDA posts implementing guidelines two types of new drug reviews
 
The Philippine Food and Drug Administration (FDA) has published implementing guidelines that describe its abridged and verification review process for new drugs. FDA created the document as part of its push to make more use of assessments completed by other regulatory agencies.
 
In abridged reviews, FDA performs a limited independent assessment of specific parts of the dossier but otherwise relies on the prior decision of a reference drug regulatory agency. Verification reviews apply if a submission has been approved by at least two reference agencies. FDA only validates the submission and ensures the product conforms to the requirements approved by the other agencies.
 
The Philippine government published an administrative order covering the creation of three facilitated registration and evaluation pathways, including abridged and verification, in 2020. The draft guidelines aim to support the implementation of the administrative order.
 
In the document, FDA sets out the eligibility criteria, documentary requirements, review and evaluation process and timelines for the two review pathways. FDA is aiming to perform abridged reviews in 45 working days, at most, and verification reviews within 30 working days. The circular is set to take effect 15 calendar days after its publication in a newspaper of general circulation.
 
  
 
Draft Guidelines
 
Pakistan’s DRAP moves to align drug rules with PIC/S manufacturing guidelines
 
The Drug Regulatory Authority of Pakistan (DRAP) is seeking feedback on plans to align legislation with the Pharmaceutical Inspection Co-operation Scheme’s (PIC/S) guide to good manufacturing practices (GMPs).
 
In the proposal, DRAP sets out potential revisions to the Drugs (Licensing, Registering and Advertising) Rules, 1976. The authority is planning to update its conditions for the grant or renewal of a license to manufacture drugs to make the PIC/S guide the key reference text, rather than its own schedule that sets out requirements for manufacturing facilities.
 
Currently, the rules feature statements such as “the factory premises shall comply with the conditions specified in Schedule B.” If the changes are finalized, that line will become “the factory premises shall comply with the conditions specified in Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP guidelines, as updated from time to time.” DRAP proposed similar changes for other statements.
 
DRAP is accepting feedback on the planned changes for 14 days.
 
DRAP Notice
 
TGA authorizes overseas-registered contrast diagnostic agents to ease shortage
 
TGA has authorized the supply of overseas-registered iodinated contrast media diagnostic agents to ease the shortage created by the COVID-19 lockdown in Shanghai.
 
The lockdown stopped production at a GE Healthcare facility in the city. GE has since returned the facility to 100% production capacity but the impact of the disruption to the supply of the dye used to visualize blood flow and monitor tumors is still being felt. GE, the largest player in the Australian market, expects to resume normal supply in the country in mid-July.
 
To ease the shortage in the meantime, TGA is allowing the Australian wings of Guerbet, Bayer and GE to supply multiple overseas-registered products. The section 19A approvals cover a range of volumes of GE’s Omnipaque, Guerbet’s Xenetix and Optiray and Bayer’s Ultravist. TGA has approved the supply of the overseas products until 28 February.
 
The agency continues to recommend the “urgent conservation of stock until the shortage is resolved as current supply is very limited.”
 
TGA Notice

 

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