Terms of Use

Welcome to OrphanDrug (“OrphanDrug,” “Platform,” “Website,” “we,” “our,” or “us”), a digital knowledge and intelligence platform operated by GNH India Pharmaceuticals Limited.

These Terms of Use (“Terms”) govern your access to and use of the Website, APIs, databases, tools, dashboards, content, and related services provided through OrphanDrug. By accessing, browsing, or using the Website, you acknowledge that you have read, understood, and agreed to be legally bound by these Terms and all applicable laws and regulations.

If you do not agree with any part of these Terms, you must immediately discontinue use of the Website.

1. About OrphanDrug

OrphanDrug is a global informational and research platform focused on:

• Orphan and rare disease drugs
• Rare disease intelligence
• Regulatory pathways and approvals
• Named Patient Programs (NPP)
• Compassionate use and expanded access programs
• Market availability and access status across jurisdictions
• International drug availability mapping
• Disease classifications and epidemiological references
• Pharmaceutical commercialization insights
• Public regulatory and market-access information

The Platform aggregates, structures, curates, enriches, and presents publicly available data sourced from regulatory authorities, public databases, manufacturer disclosures, scientific literature, healthcare publications, and other publicly accessible resources.

The Website is intended for informational, educational, analytical, and research purposes only.

2. Eligibility

By using this Website, you represent and warrant that:

• You are at least 18 years of age or the legal age of majority in your jurisdiction;
• You possess the legal authority to enter into binding agreements;
• Your use of the Platform complies with all applicable local, national, and international laws and regulations;
• You will not use the Website for unlawful, fraudulent, harmful, or unauthorized purposes.

If you are accessing the Platform on behalf of an organization, institution, company, or government body, you represent that you are authorized to bind such entity to these Terms.

3. No Medical, Clinical, Pharmaceutical, or Legal Advice

Nothing on this Website should be interpreted as a substitute for consultation with qualified healthcare professionals, pharmacists, physicians, legal advisors, regulatory consultants, or governmental authorities.

Users must not rely solely on information available through the Platform for:

• Patient treatment decisions
• Prescribing decisions
• Drug procurement
• Import/export compliance
• Regulatory submissions
• Clinical trial participation
• Commercial launch strategies
• Market authorization decisions
• Reimbursement determinations

Drug approvals, market availability, labeling requirements, safety warnings, import permissions, compassionate access schemes, and regulatory pathways vary significantly by jurisdiction and may change without notice.

Always verify information directly with:

• Official regulatory agencies
• Product manufacturers
• Marketing authorization holders
• Licensed healthcare professionals
• Legal or regulatory experts

Use of the Website is entirely at your own risk.

4. Informational Nature of Data

The Platform contains aggregated and curated information derived from publicly available sources. While we strive to maintain accurate and current information, we do not guarantee that:

• All information is complete;
• Data is current or continuously updated;
• Regulatory statuses remain unchanged;
• Product availability is accurate in real time;
• Country-specific information is exhaustive;
• Access pathways are currently operational;
• Third-party references are error-free.

Information may become outdated due to:

• Regulatory changes
• Market withdrawals
• Safety advisories
• Commercial discontinuations
• Patent disputes
• Government restrictions
• Import/export policy updates
• Manufacturer decisions

The Platform should therefore be used as a supplementary research and reference tool only.

5. Permitted Use

Subject to compliance with these Terms, users are granted a limited, non-exclusive, non-transferable, revocable license to access and use the Website for lawful informational and research purposes.

You may:

• Browse and search the Platform;
• Access publicly available informational content;
• Use the public API for lawful non-commercial research purposes;
• Cite factual information with appropriate attribution;
• Use the Platform internally within your organization for informational purposes.

6. Prohibited Activities

You agree not to:

• Reproduce, republish, redistribute, or commercially exploit substantial portions of the Website without prior written permission;
• Copy or mirror the Platform's structure, taxonomy, editorial formatting, or database architecture;
• Use automated scraping tools, bots, spiders, crawlers, or data-harvesting technologies in a manner that disrupts or burdens the Platform;
• Circumvent rate limits, authentication systems, or technical safeguards;
• Reverse engineer or attempt unauthorized access to systems or infrastructure;
• Introduce malicious software, malware, ransomware, or harmful code;
• Use the Platform to violate applicable pharmaceutical, healthcare, privacy, trade, sanctions, or export-control laws;
• Misrepresent the source, ownership, or accuracy of information obtained from the Website;
• Impersonate another individual or organization;
• Use the Platform in connection with unlawful marketing, spam, misinformation, or fraudulent healthcare activities.

We reserve the right to suspend or terminate access for users engaging in prohibited conduct.

7. API Access and Fair Use

OrphanDrug may provide API access through endpoints including, but not limited to /api/v1.

API access is provided on an “as available” basis and may be modified, restricted, rate-limited, suspended, or discontinued at any time without notice.

Unless expressly authorized in writing, API usage is limited to:

• Non-commercial research
• Educational use
• Internal analytics
• Academic and informational applications

Users must comply with reasonable fair-use limits and must not:

• Abuse system resources;
• Generate excessive automated requests;
• Resell API data;
• Build competing commercial datasets using the API;
• Attempt unauthorized extraction of proprietary structured content.

Commercial licensing may require separate written agreements.

8. Intellectual Property Rights

Ownership

The OrphanDrug Platform, including but not limited to:

• Website design
• User interface
• Branding
• Logos
• Editorial structure
• Data organization
• Taxonomies
• Search architecture
• Database compilation
• Content enrichment methodology
• Proprietary categorization systems
• Software and source code

are owned by or licensed to GNH India Pharmaceuticals Limited and are protected under applicable intellectual property laws.

Third-Party Intellectual Property

Drug names, brand names, logos, trademarks, regulatory identifiers, and manufacturer references remain the property of their respective owners. Their appearance on the Platform does not imply:

• Ownership by OrphanDrug;
• Endorsement;
• Affiliation;
• Sponsorship;
• Commercial partnership.

Such references are used solely for informational, educational, research, and identification purposes.

Public Facts

Certain factual information — including International Nonproprietary Names (INNs), disease nomenclature, ATC classifications, regulatory statuses, and publicly disclosed market data — may not independently qualify for copyright protection.

However, the structured compilation, editorial enhancement, organization, normalization, presentation, and integration of such information within the Platform constitute proprietary intellectual property.

9. User-Generated Content and Submissions

If users submit inquiries, corrections, comments, suggestions, or other materials to OrphanDrug:

• You grant us a non-exclusive, worldwide, royalty-free license to use, modify, publish, reproduce, and distribute such submissions for operational and editorial purposes;
• You represent that your submissions do not infringe third-party rights;
• You agree not to submit confidential or unlawful material.

We reserve the right, but not the obligation, to review, edit, or remove submissions at our discretion.

10. Third-Party Websites and External Sources

The Website may contain references or links to third-party websites, regulatory agencies, journals, databases, manufacturers, distributors, healthcare institutions, or external resources. These links are provided solely for convenience and informational purposes.

We:

• Do not control external websites;
• Do not guarantee the accuracy of third-party content;
• Are not responsible for external policies, practices, or security;
• Do not endorse third-party services unless explicitly stated.

Access to third-party sites is entirely at your own risk.

11. Privacy and Data Handling

Your use of the Website may involve the collection and processing of limited technical and usage data, including:

• IP address
• Browser information
• Device metadata
• API usage logs
• Analytics and usage metrics

Use of such information is governed by our Privacy Policy.

Users are responsible for ensuring that any information they provide complies with applicable privacy and data-protection laws.

12. Availability of Service

We do not guarantee uninterrupted or error-free operation of the Platform. The Website may occasionally become unavailable due to:

• System maintenance
• Infrastructure upgrades
• Technical failures
• Cybersecurity events
• Third-party service disruptions
• Regulatory or operational requirements

We reserve the right to modify, suspend, discontinue, or restrict any aspect of the Platform at any time without liability.

13. Disclaimer of Warranties

To the fullest extent permitted by law, the Website and all content are provided on an “AS IS,” “AS AVAILABLE,” and “WITH ALL FAULTS” basis without warranties of any kind, whether express, implied, statutory, or otherwise.

We expressly disclaim all warranties relating to:

• Accuracy
• Completeness
• Reliability
• Availability
• Merchantability
• Fitness for a particular purpose
• Non-infringement
• Regulatory suitability
• Commercial viability

We do not warrant that:

• The Website will meet your requirements;
• The Platform will be uninterrupted or secure;
• Errors will be corrected;
• The Website is free from viruses or harmful components.

14. Limitation of Liability

To the maximum extent permitted by applicable law, GNH India Pharmaceuticals Limited, OrphanDrug, their affiliates, directors, employees, contractors, licensors, and operators shall not be liable for:

• Direct damages
• Indirect damages
• Incidental damages
• Consequential damages
• Special damages
• Regulatory losses
• Commercial losses
• Procurement losses
• Data loss
• Business interruption
• Loss of profits
• Loss of goodwill

arising out of or relating to:

• Use of the Website;
• Reliance on information from the Platform;
• Errors or inaccuracies;
• Unavailability of services;
• Third-party conduct;
• API usage;
• Security incidents.

This limitation applies even if we were advised of the possibility of such damages.

15. Indemnification

You agree to indemnify, defend, and hold harmless GNH India Pharmaceuticals Limited and its affiliates, officers, employees, and operators from and against any claims, liabilities, damages, losses, costs, or expenses arising from:

• Your use of the Platform;
• Violation of these Terms;
• Violation of applicable laws;
• Infringement of third-party rights;
• Misuse of Website data or APIs.

16. Regulatory and Jurisdictional Compliance

Users are solely responsible for ensuring compliance with all applicable laws and regulations in their jurisdiction, including but not limited to:

• Pharmaceutical regulations
• Drug import/export laws
• Healthcare advertising restrictions
• Clinical regulations
• Sanctions and trade laws
• Data privacy regulations
• Intellectual property laws

The availability of information regarding a drug or access pathway does not imply legality, authorization, or commercial availability in any jurisdiction.

17. Termination and Restriction of Access

We reserve the right, at our sole discretion and without prior notice, to:

• Suspend access;
• Restrict API usage;
• Block IP addresses;
• Remove content;
• Terminate user access;

for violations of these Terms or for operational, security, legal, or regulatory reasons.

18. Changes to These Terms

We may revise these Terms periodically.

Updated versions will be posted on this page with a revised “Effective Date.” Continued use of the Website after changes become effective constitutes acceptance of the revised Terms.

Users are encouraged to review these Terms periodically.

19. Governing Law and Jurisdiction

In accordance with applicable Indian laws, users may submit privacy-related complaints or grievances to the designated Grievance Officer.

Any dispute or difference which may arise, first will be resolved by the Parties amicably through consultation between the Parties. In case such dispute or difference is not resolved within thirty (30) days of such dispute or difference, the same shall be referred to and finally resolved by arbitration administered by Mumbai Centre for International Arbitration (MCIA) in accordance with the MCIA Arbitration Rules for the time being in force, which rules are deemed to be incorporated by reference into this clause.

The tribunal shall consist of a sole arbitrator mutually appointed by the Parties in accordance with the said Rules. The seat and venue of arbitration shall be Mumbai, India. The language of arbitration shall be English. The arbitral award shall be final and binding on both Parties.

Details of the Grievance Officer:
Ms. Shweta Dudeja – [email protected]

20. Severability

If any provision of these Terms is found to be invalid, unlawful, or unenforceable, the remaining provisions shall remain in full force and effect.

21. Entire Agreement

These Terms constitute the entire agreement between users and OrphanDrug regarding use of the Platform and supersede any prior agreements, understandings, or communications relating to the subject matter herein.

22. Contact Information

For legal, compliance, licensing, or policy-related inquiries, please contact:

GNH India Pharmaceuticals Limited
Email: [email protected]