Be Updated with the latest Global Anti-Counterfeiting / Traceability Regulations & Notifications
- World Health Organisation (WHO) Framework Convention Tobacco Control (FCTC)
- European Union, Tobacco Products Directive (TPD)
- USA, Drug Supply Chain Security Act (DSCSA)
- European Union, Falsified Medicines Directive (FMD)
- India, Drugs Authentication and Verification Application (DAVA)
- India, Notification allowing Motor Vehicles & their parts to be affixed with Microdots
HEALTH AND PHARMACEUTICALS
2020: Drug marketers to be held responsible for quality: Pharmaceutical companies that market medicines made by third parties in the country will now be held responsible for drug product quality with the health and family welfare ministry on Thursday issuing a notification to this effect (Click here to view notification).
2019: Pharma API packaging: CDSCO mandate every active pharmaceutical ingredient (API) packaging should bear Quick Response (QR) code on its label to facilitate tracking and tracing (Click here to view notification).
2019: DGFT Update: iVEDA portal to replace DAVA portal: As per the new directive, Pharmaceutical exporters in India will now have to implement the Track and Trace system. The Central system will be changed from DAVA to iVEDA (Integrated validation of exports of drugs from India and its authentication) portal from 01.10.2020. To register in the central portal (IVEDA), Manufacturers and Merchant exporters need to visit the IVEDA website (click here to visit iVEDA) and register.
2011: Drugs Authentication and Verification Application (DAVA): In India, the Directorate General of Foreign Trade passed a regulation in 2011 requiring all drug exporters to implement serialization and track-and-trace on primary, secondary and tertiary levels of packaging. This regulation has already been implemented on the tertiary level in 2011, the secondary level in 2013, and is slated to be in effect on the primary level in 2015. Track and trace and government reporting requirements are expected to follow in the coming years. The Indian Government have made a portal for Indian Drugs Authentication, Track and Trace called Drugs Authentication and Verification Application (DAVA).
Nov 2013: Drug Supply Chain Security Act (DSCSA): The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA's ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve the detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Read the Drug Supply Chain Security Act. Find a list of DCSCA policy documents and the FDA's implementation plan. Additionally, read the key provisions of the law and find out if you are ready for DSCSA's requirements.
EUROPEAN UNION FALSIFIED MEDICINES DIRECTIVES (FMD):
Feb 2020: Safety features for medicinal products for human use: This documents sets out frequently-asked 'questions and answers' regarding the implementation of the rules on the safety features for medicinal products for human use (Click here for more information).
- Obligatory safety features – a unique identifier and an anti-tampering device – on the outer packaging of medicines
- A common, EU-wide logo to identify legal online pharmacies
- Tougher rules on import of active pharmaceutical ingredients
- Strengthened record-keeping requirements for wholesale distributors.
WORLD HEALTH ORGANISATION (WHO) POLICY ON FALSIFIED AND SUB STANDARD MEDICINES:
WHO publishes its draft Policy brief on traceability of health products for comments: In the context of the 2030 target for UHC for all, the World Health Organization recognizes that traceability systems and technologies could be leveraged to ensure the integrity and efficiency of supply chains. However, outstanding questions remain for WHO Member States on the implementation of existing standards and approaches, as well as on an appropriate governance in terms of data (use and ownership).
- Review WHO recommended available authentication technologies for the prevention and detection of Substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products
TOBACCO AND ALCOHOL
January 2020: Summary record - Subgroup on Traceability and Security Features established by the Expert Group on Tobacco Policy (Click to view the document)
May 2019: The systems became operational on 20 May 2019. Articles 15 and 16 of the Tobacco Products Directive 2014/40/EU (TPD) provide for EU-wide systems of traceability and security features for tobacco products to address the issue of illicit trade. To read press release, click here, To download FAQ on Tobacco traceability and security features: Questions and Answers (Click to view the document)
2014: European Union, Tobacco Products Directive (TPD): The Tobacco Products Directive (2014/40/EU) entered into force on 19 May 2014 and became applicable in EU countries on 20 May 2016. The Directive lays down rules governing the manufacture, presentation and sale of tobacco and related products. These include cigarettes, roll your own tobacco, pipe tobacco, cigars, cigarillos, smokeless tobacco, electronic cigarettes and herbal products for smoking. For detail, click here
India, Notification allowing Motor Vehicles & their parts to be affixed with Microdots: The Ministry of Road Transport & Highways has issued a draft notification GSR 521(E) dated 24thJuly 2019, amending Central Motor Vehicle Rules, allowing motor vehicles and their parts, components, assemblies, sub-assemblies to be affixed with permanent and nearly invisible microdots that can be read physically with a microscope and identified with ultra violet light source.
Chemicals and Fertilizers
India: Government is likely to introduce seed traceability by June 2020: Department of Agricultural, Cooperation & Farmers Welfare wishes to put in place a Digital Traceability System, for traceability based on Global Traceability System (GTS) framework for the movement of seed across existing supply chain. Click here to download EOI