Anti-Counterfeiting Regulations

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Be Updated with the latest Global Anti-Counterfeiting / Traceability Regulations & Notifications

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HEALTH AND PHARMACEUTICALS

INDIA: 

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).

USA:

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). 

Nov 2019: Falsified Medicines: Aide-Memoire for Good Distribution Practices (GDP) inspections

Feb 2019: Falsified medicines: new rules to enhance patients' safety: From February 2019, the industry will have to affix a 2-D barcode and an anti-tampering device on the box of prescription medicines. The pharmacies – including on-line pharmacies – and hospitals will have to check the authenticity of medicines before dispensing to patients. This is the final step in the implementation of the Falsified Medicines Directive, adopted in 2011, aiming at guaranteeing the safety and quality of medicines sold in the EU (Click here for more information). 
 
2016: Commission Delegated Regulation (EU) 2016/161: Details the characteristics of the safety features, how medicine authenticity should be verified and by whom. 
 
2011: Falsified Medicines Directive (FMD): Following adoption by the European Council and the European Parliament, the Falsified Medicines Directive (Directive 2011/62/EU) was published on 1 July 2011 and applies since 2 January 2013. It amended Directive 2001/83/EC. This Directive introduces harmonised European measures to fight medicine falsifications and ensure that medicines are safe and that the trade in medicines is rigorously controlled. Measures include:
  • 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). 

TOBACCO AND ALCOHOL

 

EUROPEAN UNION

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

 
WORLD HEALTH ORGANISATION (WHO), FRAMEWORK CONVENTION TOBACCO CONTROL 
 
WHO, FCTC protocol to eliminate illicit trade in tobacco products: The Protocol to Eliminate Illicit Trade in Tobacco Products is the first protocol to the WHO Framework Convention on Tobacco Control (WHO FCTC), and a new international treaty. It was adopted by consensus on 12 November 2012 at the fifth session of the Conference of the Parties (COP) to the WHO FCTC (Seoul, Republic of Korea, 12–17 November 2012). The Protocol builds upon and complements Article 15 of the WHO FCTC, which addresses means of countering illicit trade in tobacco products, a key aspect of a comprehensive tobacco control policy.

UK (HMRC): The Tobacco Products (Traceability and Security Features) Regulations 2019 

Automotive Components

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