![banner-image](https://www.tracelink.com/sites/default/files/2024-02/India%20Pharmaceuticals_0.png) Products ## Breadcrumb 1. [Home](/) 2. [Country Compliance](/products/product-orchestration/country-compliance) # India Pharmaceuticals Advanced compliance data management and reporting solutions to meet India traceability compliance requirements blue Product overview ## Comply with India’s serialization and reporting requirements TraceLink India Pharmaceuticals enables marketing authorization holders, manufacturers, and exporters to meet the requirements in India for serializing and reporting serialized product information, as well as certain traceability transactions for exported medicines to the India Integrated Validation of Export of Drugs and its Authentication (iVEDA) platform. Contact Us Contact Us document.addEventListener("DOMContentLoaded", function() { // Delay the execution by 2 seconds (2000 milliseconds) setTimeout(function() { (function() { 'use strict'; // Load Marketo form MktoForms2.loadForm("//go.tracelink.com", "776-BAW-230", 2259); })(); // Wait until the Marketo form is loaded MktoForms2.whenReady(function(form) { var formElement = document.getElementById('mktoForm_2259'); if (!formElement) { console.error("Form with id 'mktoForm_2259' not found."); return; } var formLocation = formElement.querySelector("input[name=formLocation]"); // Get the current URL and set the formLocation field if (formLocation) { var currentURL = window.location.href; formLocation.value = currentURL; } // Add onSuccess handler form.onSuccess(function(values, followUpUrl) { var formElem = form.getFormElem()[0]; if (formElem) { formElem.style.display = 'none'; } else { console.warn("Form element could not be found to hide it."); } var confirmMessage = document.getElementById('confirmform'); if (confirmMessage) { confirmMessage.style.display = 'block'; } else { console.warn("Confirmation message with id 'confirmform' not found."); } return false; // Prevent the form from submitting normally }); }); }, 2000); // Delay for 2 seconds }); **Thank you for contacting us; we’ll be in touch shortly.** ##### With India Pharmaceuticals, you can: Confidently meet India traceability requirements Streamline regional compliance operations and processes Insulate internal enterprise systems from country-specific compliance demands #### Industry challenges ### New compliance requirements demand new compliance solutions Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges managing regulatory compliance and navigating evolving requirements in India. These challenges include: ##### Complex product identification and traceability regulations India has been developing new regulations for several years, primarily focused on medicines produced in India and exported to foreign markets. ##### Complex product identification and traceability regulations ##### Compliance report preparation and submission to the iVEDA system India’s new regulations require significant acquisition and management of product master data, product identification information, and supply chain participant information that inform these reports. ##### Compliance report preparation and submission to the iVEDA system ##### Constant changes to requirements and reporting procedures India has frequently updated and changed both the requirements and the target reporting system, requiring companies to stay agile and innovative when meeting requirements for export medicines. ##### Constant changes to requirements and reporting procedures Product benefits ## How TraceLink India Pharmaceuticals drives efficiency ## Accelerate integration with ready-to-go supply partners ## Support a wide range of business use cases ## Ensure continuous compliance as requirements evolve ## Scale compliance across multiple markets and regulatory standards ## Ease integration with other third-party enterprise solutions ![india compliance](https://www.tracelink.com/sites/default/files/styles/vertical_drawer_desktop_600px_x_336px_/public/2024-02/For%20Internal%2041.png.webp?itok=J9sqgKGS) Product benefits ## Accelerate integration with ready-to-go supply partners Companies can leverage TraceLink's extensive network of pre-existing integrations with CMOs and 3PLs to speed access to key product and transaction compliance information needed for reporting. ![use cases](https://www.tracelink.com/sites/default/files/styles/vertical_drawer_desktop_600px_x_336px_/public/2024-02/For%20Internal%2082_0.png.webp?itok=MZWj_28_) Product benefits ## Support a wide range of business use cases The flexible TraceLink global compliance platform supports a wide range of business and operational use cases for marketing authorization holders and pharmaceutical manufacturers producing product in India for export to other global markets. ![compliance](https://www.tracelink.com/sites/default/files/styles/vertical_drawer_desktop_600px_x_336px_/public/2024-02/For%20Internal%2033.png.webp?itok=Qj91QvZG) Product benefits ## Ensure continuous compliance as requirements evolve The TraceLink compliance platform is constantly updated to ensure compliance, regardless of whether companies are producing their own medicines, leveraging third-party CMOs, or taking a hybrid approach across their portfolio. ![multiple markets](https://www.tracelink.com/sites/default/files/styles/vertical_drawer_desktop_600px_x_336px_/public/2024-02/For%20Internal%2065_1.png.webp?itok=NK6QSfz_) Product benefits ## Scale compliance across multiple markets and regulatory standards The India Pharmaceuticals solution provides a common global platform for compliance reporting and compliance data management to meet unique India compliance reporting requirements while serving other global traceability regulations. ![Alex](https://www.tracelink.com/sites/default/files/styles/vertical_drawer_desktop_600px_x_336px_/public/2024-02/For%20Internal%2045_0.png.webp?itok=GKANtVb2) Product benefits ## Ease integration with other third-party enterprise solutions Leverage TraceLink serialization applications for India serialization management and creation of product identifiers, while easily integrating with other existing third-party solutions already in place and in use. Capabilities ### TraceLink India Pharmaceuticals The India Pharmaceuticals solution provides the intelligent compliance data management and reporting system needed for the product data and export shipment reports documented in India compliance regulations. #### Manage workflows & data #### Automate and customize reports #### Analyze compliance data and reports ![For Internal 40](https://www.tracelink.com/sites/default/files/styles/tabs_component_desktop_574_x_380_/public/2024-02/For%20Internal%2040.png.webp?itok=ehu4bHIZ) Utilize flexible workflows, business rules, and data configuration capabilities needed to support complex operational and supply chain requirements. Read More Read Less ![serial](https://www.tracelink.com/sites/default/files/styles/tabs_component_desktop_574_x_380_/public/2024-02/For%20Internal%2088_0.png.webp?itok=L4m3a-rQ) Generate XML-formatted India compliance reports for the Product Report and Export Tertiary Packaging Report. Automate or manually generate reports. Read More Read Less ![network](https://www.tracelink.com/sites/default/files/styles/tabs_component_desktop_574_x_380_/public/2024-02/For%20Internal%2089.png.webp?itok=VykM0fua) Search, view, and and analyze compliance data and current and historical reports including in-depth information on: Report Type Aggregation Hierarchy Lot Numbers Serial Numbers Shipment Information Packaging Codes and other Product Information Utilize audit trailing of submitted reports and system responses Read More Read Less ### Explore related products [ See all products ](/products/product-explorer) [ Serialization ](/category/serialization) [ Serial Number Manager ](/products/product-orchestration/serialization/serial-number-manager) [ Serialization ](/category/serialization) [ Serial Number Exchange ](/products/product-orchestration/serialization/serial-number-exchange) [ Serialization ](/category/serialization) [ Serialized Operations Manager ](/products/product-orchestration/serialization/serialized-operations-manager) [ OPUS Digital Network Platform ](/solution-suite/opus-platform-enabling-products) [ Master Data Exchange ](/products/network-platform-enabling-applications/master-data-exchange) ### Related resources [ See more resources ](/resources/resource-center) ![](/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/solutions/global-compliance/thumbnail/india-multicolumn.png.webp?itok=esevS6Mz) ##### India Regulatory Updates View a compilation of the most recent track and trace regulations for the healthcare supply chain in… [Get Details](/resources/resource-center/regulatory-updates/india-regulatory-updates "Get Details") ![](/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/edge-scanner-tracelink-tn.jpg.webp?itok=64A4Ibc5) ##### Leading India Pharma Co. Gains Edge in Operational Efficiency, Compliance Download this PDF to learn how an Edge solution can improve your operational efficiency. [Get Details](/resources/resource-center/leading-india-pharma-co-gains-edge-in-operational-efficiency-compliance "Get Details") Countries ### Compliance around the globe Explore specific country compliance solutions offered by TraceLink. [ See all countries ](/products/product-orchestration/country-compliance) ![](/sites/default/files/styles/resize_image_style_640_480/public/2024-02/DSCSAPharmaceuticals.png.webp?itok=OeNGTuie) ##### U.S. Drug Supply Chain Security Act (DSCSA) TraceLink DSCSA Compliance solutions provide life sciences and healthcare companies with a complete… [Get Details](/products/product-orchestration/country-compliance/us-compliance "Get Details") ![](/sites/default/files/styles/resize_image_style_640_480/public/2024-02/eufmd.png.webp?itok=StAeM2H6) ##### European Union Falsified Medicines Directive European Union Compliance provides a comprehensive compliance reporting and product data management… [Get Details](/products/product-orchestration/country-compliance/european-union-compliance "Get Details") ![](/sites/default/files/styles/resize_image_style_640_480/public/2024-02/China%20Pharmaceuticals.png.webp?itok=gEg8xUbK) ##### China Pharmaceuticals Learn what you need to do to comply with the serialization and traceability requirements for… [Get Details](/products/product-orchestration/country-compliance/china-compliance "Get Details") ![](/sites/default/files/styles/resize_image_style_640_480/public/2024-02/Indonesia%20Compliance_0.png.webp?itok=ye9GFPZo) ##### Indonesia Pharmaceuticals Advanced compliance data management and reporting solution for Indonesia pharmaceutical… [Get Details](/products/product-orchestration/country-compliance/indonesia-compliance "Get Details") ![Country Compliance for Pharmaceuticals](https://www.tracelink.com/sites/default/files/styles/recovery_banner_desktop_1224_x_386/public/2024-02/Country%20Compliance_2.png.webp?itok=dY4teYr8) ### Join the global compliance special interest group Inform your global compliance strategy through this monthly tour of track-and-trace developments throughout the world. Discover what's new in the current traceability regulations and keep an eye on the future. [ Join the community ](/resources/community/global-compliance-sig)