What is Track & Trace System :
Track and Trace is the operation in which the past and current status information of each drug product is recorded. All the drugs in the market are tracked on the basis of packages using keys of GS1 (Global Standards One) standards. The ability to track each drug unit is provided by gathering the information of each unit in every single step and action and traceability is provided, thus the products can be traced at every phase from its manufacturing until their consumption. This system not only applicable to pharmaceuticals but also for Food, Beverages etc.
What is GS1 (Global Standards One) standards :
GS1 is a not-for-profit organisation that develops and maintains global standards for business communication. The well known of these standards is the barcode, a symbol printed on products that can be scanned electronically.
As per the global standards one (GS1) the manufacturer or exporter of drug formulations would have to print the barcode at different packaging levels – primary, secondary and tertiary – to facilitate tracking and tracing of their products.
Barcode helps in tracking and tracing origin of drugs, which minimises the chances of genuine medicines being considered spurious, sub-standard or counterfeit.
Track & Trace System is applicable to US & Falsified Medicines Directive (FMD) is applicable to European Union (EU)
Track & Trace System :
This system is proposed by the countries including Argentina, Brazil, china, EU, France, India, South korea, Turkey and USA to maintain supply chain integrity & ensure patient safety.This guide also provides information on mandate to be adhered by various stakeholders to ensure regulatory compliance.
US Federal Drug Quality and Security Act – H.R 3204 was introduced on September 27, 2013 . This bill was passed in the House on September 28, 2013 -also refereed as pharma track & trace bill is approved by US Senate as a US Federal law effective on Nov 27,2013. Below is the detailed mandate requirements of the same system.
- Manufacturers, wholesalers and repackages required to provide and/or receive pedigree for each transaction.
- Manufacturers required to include a product identifier number on each package and homogeneous case of prescription drug products.
- wholesalers required to accept or distribute only prescription drug products that include a product identifier.
- Dispensers required to accept or distribute only prescription drug products that include a product identifier.
- Mandates the full implementation of an inter operable electronic system.
After that Title 1-Compounding Quality Act & Title-2 Drug Supply Chain Security Act (DSCSA)came in US to protect Americans against counterfeit drugs.
Drug Supply Chain Security Act (DSCSA) Purpose & Requirements :
- Create a new framework for securing prescription drugs supply chain. The bill also establish a 10 year transition to a unit level tracking system for enhance security.
- The following data is required be collected for the DSCSA i.e The National Drug Code (NDC interchangeable with GTIN, FDA) ,The lot number, where the product originated, The expiry date & Serial number (S/N), randomization is NOT required.
- United States’ Track and Trace Regulations Overview In 2013, the Drug Supply Chain Security Act (DSCSA) was introduced, which requires all manufacturers to affix 2D barcodes on vaccine units of sale in the next couple of years.
- The Drug supply chain Security Act (DSCSA) mandates that manufactures begin serializing all drug products at the saleable unit and case level for the US market starting in Nov.2017, with repackager deadlines beginning in 2018.
- It is also called Track and Trace Act. DSCSA adds new sections in the Federal F & DC Act which include requirements for product tracing, identification and verification and standards for license of Third Party Logistic providers (3PLs).
- The full complement of US requirements phases in between 2015 and 2023, with challenges for all supply chain companies at different points along the way.
- The purpose of the DSCSA is to establish a nationwide drug track and trace system that would potentially eliminate counterfeit or illegitimate or fake medications to enter the market.
Track & Trace System Implementation Status in India :
In India Directive General of Foreign Trade (DGFT) made unique numbers and barcodes mandatory on Primary, Secondary & Tertiary packaging for all Pharmaceuticals exports from the country.
The law also requires incorporation of 2D barcodes (GS1 Datamatrix) on medicines at the strip/bottle/vials level as well as encoding GTIN and unique serial numbers by july 1 2014.
But due to the opposition from the industry the same was not fully implemented in India. The government of India has again extended the date for implementation of track and trace system for exports of drug formulations till July 1 2019 & date was extended earlier also from time to time & last extension was till November 15 2018 .
Track & Trace System Compliance Mandate in India :
Exporter of pharmaceutical products will adopt a track & trace system & incorporate its features for exported medicines using barcode technology as per GS1 global standards as details below….
- Primary level Packaging requirement : Incorporation of 2D (GS1 data matrix) barcodes on medicines at Stripe/ vial/bottle etc encoding unique product identification code & unique serial number of the Primary pack.
2. Secondary level Packaging requirement : Incorporation of barcodes (1D or 2D) encoding unique product identification code , Batch number, Expiry date and unique serial number of the secondary pack.
3. Tertiary level Packaging requirement : Incorporation of barcodes
(1D ) encoding unique product identification code, Batch number, Expiry date and unique serial number of the tertiary pack (shipper/carton).
Under the track & trace system manufacturers would be required to maintained serialized record of exported pharmaceutical product for a minimum period of 6 months after the expiry date of the product.
Counterfeiting is a growing threat to the patients and pharmaceutical industries globally. Therefore it is important for the pharmaceutical industries to use track and trace systems that are very advanced and designed in ensuring best quality print with high efficiency.
This allows the traceability of the products throughout the process and helps identifying the counterfeit or fake products by use of the stored database, serial number, expiry date and companies logo.