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Track and trace law expected to cover 80% of global drug supply by 2020

Our Bureau, Mumbai
Wednesday, October 11, 2017, 08:00 Hrs  [IST]

By 2020, track and trace regulation is expected to cover 80% of the global drug supply. More and more countries are introducing laws that will have an impact on companies producing, distributing, or dispensing pharmaceuticals across the globe.

The US FDA has already started first phase of Drug Supply Chain Security Act (DSCSA). European Union sets February 2019 for serialized authentication of pharma products. Emerging markets like Australia, Egypt, Russia, Saudi Arabia and Taiwan have also initiated steps to implement track and trace regulation.

In Australia a new regulation for bar code identification for all pharma products was passed last year. The country has barcoding and serialization law for blood components and fresh blood products. In September 2016, new regulations were published, requiring enhanced labeling (but not serialization) for all medicines for the Australian market. The law will be enforced by September 2020.

In Egypt the serialization and track and trace reporting requirement includes barcoding, serialization, and government reporting of information on all pharmaceutical products and transactions to a central repository. The country has evinced an interest to follow Turkey’s model for a traceability and compliance reporting system. The implementation of track and trace law in Egypt spans over 10 months starting from September 1, 2017 to June 1, 2018.

In Russia pharma serialization and tracing pilot guidelines approved by Minister of Health in March 2017 is a step towards pharmaceutical serialization initiative which is likely to become mandatory by the end of 2018. The system involves putting unique serialized identification codes on drug products, and capturing and reporting to a central repository key events associated with the those products as they move through the supply chain. It is expected to be conducted from February 1 to December 31 this year, with a final report expected by February 1, 2018.

In Saudi Arabia regulators have completed phase 1 which requires barcoding on products. Enhanced serialization has been implemented in the second phase beginning March 2017. The requirements are following GS1 standards for both the barcode and data. Product scope for the regulations includes all pharmaceutical products, including human and veterinary. The original law has always stated that there will be forthcoming requirements for reporting information about the products to central repository.

Pharmaceutical companies need to replace linear barcodes with GS1 DataMatrix barcodes comprising of a unique product identifier, batch number, expiry date and serial number.

As the Pharmaceutical Affairs Act, Taiwan Food and Drug Administration (TFDA) has implemented track and trace system for three priority categories -- Plasma-derived medicinal products, Vaccine and Botulinum toxin from July 1st, 2017. The product license holders, wholesalers and retailers are required to submit the tracking and tracing information electronically before 10th of every month.

Serialization of pharmaceutical products and reporting to a national, centralized hub will be compulsory in Brazil as per law 13.410. On December 28, 2016 the Brazilian President signed the law 13.410, thus amending the ones dating back to 2009 and 2013.

In Brazil it is mandatory to serialize both the unit and case (transport packing container) of all pharmaceutical products. Cases will have to include information about units they contain. Tracking will be required at each level of the supply chain, including manufacturer/importer, wholesaler, distributor, and pharmacy levels. Pharmaceutical products manufactured outside of Brazil may be serialized upon entering the Brazilian market.

The 2D barcode or Datamatrix is required to be encoded with ANVISA registration number, Serial number, Lot number and Expiry date. Brazilian coding standards are similar to GS1 standards. Batch number and a GTIN follows the same format required by GS1. However, there are differences regarding the (numerical) serial number (13, not 20 digits), the production and expiration date (MM/AAAA format). The numerical ANVISA registration number contains 13 digits.

Each player within the drug supply chain will have to report when a product passes through their facility. Pharmacies, distributors and other trading partners need to report supply chain information back to centralized reporting authority established by ANVISA rather than Marketing authorization Holder (MAH) which is in practice currently. This centralized system will store and analyze all information related to pharmaceutical products covered by the new law.

Once the pilot project is completed, pharmaceutical industry will have three years to fully implement serialization which will result in a December 2021 deadline. By 2022, all pharmaceutical products will have to be serialized and traced throughout the supply chain.

In India exported pharmaceutical products are required to have 1D or 2D barcode on the secondary level and 1D at the tertiary level packaging encoding the GTIN code, batch number, expiration date and serial number of respective packaging. As of now 2D barcode at the primary level is not mandatory.

Governments of countries worldwide believe that counterfeiting by organized crime can be reduced significantly by implementing product serialization and a considerable number of countries are taking steps in this regard.


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J D Gandhi Jun 16, 2018 4:55 PM
Dear sir,

Can you tell me what is the current notification regarding track and trace .
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