The Saffron book: An orange book of India

For a transparent, reliable, and public-oriented pharmaceutical regulatory system, every nation needs a database covering the full cycle—from application to approval, along with manufacturing permissions and biopharmaceutical regulatory details. This could take the form of two publicly accessible, mutually exclusive databases: one dedicated to regulatory application and submission management, and the other to drug approvals, therapeutic equivalence, and patent or exclusivity periods. The U.S. FDA’s Orange Book can serve as a reference point—with the aim of building an even better version.

India’s Sugam portal serves as a reference database for the former category of database mentioned above. The differences between SUGAM and intended Saffron Book which is customised version of U.S. Orange book are listed below.

Feature	SUGAM Portal (India) administrative tool for regulatory processes	US FDA Orange Book “Approved Drug Products with Therapeutic Equivalence Evaluations.”
Main Purpose	Regulatory application/ submission management	A public database listing all FDA-approved small molecule drugs (not biologics) and providing information about equivalence, patents.
Primary Users	CDSCO regulators, Pharmaceutical companies seeking approval to manufacture, import, or sell drugs and biological products in India	Healthcare providers, pharma industry, legal professionals/experts, Physicians, pharmacists, and the public seeking to verify drug approvals, identify interchangeable generics, and check relevant patents.
Information Provided	Application status, licenses, NOCs, permissions	Drug approval and related documentation, therapeutic equivalence, patent/exclusivity periods
Drug Types	Both chemical and biological (for registration/approval)	Small molecule drugs (FDA-approved generics and brands)
Public Access	Limited (not a directory of approved drugs for public browsing)	Freely accessible, searchable database, with facility to export data indexed on different parameters.
Substitution Data	Not Provided.	Yes—therapeutic equivalence codes to support substitution
Scope	Focused on workflow management for regulatory applications; not as a comprehensive public reference on drug approvals or equivalence.	Central reference for drug safety, efficacy, patent and exclusivity details, and generic substitution in the US regulatory system, critical for clinical, legal, and commercial decision-making in the drug sector

 

India currently lacks an authoritative and comprehensive reference comparable to the U.S. FDA’s Orange Book. As the nation rapidly advances toward becoming a global leader in pharmaceuticals, such a resource is urgently needed—for the benefit of the Indian public, the pharmaceutical industry, and the national regulatory framework i.e. Indian Food and Drug Administration (FDA). Such a resource would greatly assist the FDA by dramatically enhancing regulatory transparency, strengthening patient safety, and boosting market competitiveness in India. This article explores the necessity for such a resource, an Indian equivalent of the Orange Book, examining its potential benefits and far-reaching sector-wide impacts across the healthcare and pharmaceutical sectors.

 

What Is the Orange Book and why is it important? 

The Orange Book—formally known as Approved Drug Products with Therapeutic Equivalence Evaluations—is a freely accessible database published by the US FDA. It lists all pharmaceutical products approved for safety and efficacy. Its main functions include: 

1. i) Identifying drugs approved after rigorous clinical trials.
2. ii) Providing therapeutic equivalence evaluations for generic drug substitution.

iii) Listing drug patent and exclusivity data.

1. iv)  Supporting healthcare providers, patients, and industry stakeholders in evidence-based selection and substitution of medicines.

This compendium plays a vital role in facilitating generic drug approval, aiding competitive intelligence, fostering patent transparency, and ensuring ongoing public and professional trust in drug regulation.

Gaps in prevailing system

India is one of the world’s leading pharmaceutical producers, known for its expertise in generics and active pharmaceutical ingredients. However, the absence of a single, authoritative, and continuously updated public reference for approved drugs, therapeutic equivalence, and patent data results in several persistent challenges:

1. Inconsistent drug information among regulators, prescribers, and manufacturers and public.
2. Obstacles to efficient evaluation and approval of generics and biosimilars.
3. Increased risk of medication errors due to confusion about substitutions.
4. Limited transparency on drug patent status and exclusivity, affecting both innovation and generic entry.

If a central, comprehensive database is created, it would plug these gaps and benefit India in several ways.

Key benefits of an Indian Saffron Book

• Enhanced regulatory transparency

A national Saffron Book would publicise up-to-date lists of all drugs approved by Indian regulators for safety and effectiveness. This supports:

1. Rapid verification of a drug’s approval status.
2. Greater public trust in regulatory decisions.
3. Every stakeholder (healthcare providers, pharmacists, researchers, and patients i.e. member of the public) having access to the same, accurate information.

• Facilitating safe and effective generic drug substitution

One of the defining features of the Orange Book is its system for evaluating therapeutic equivalence—confirming which generics can be confidently substituted for branded drugs at the pharmacy level.

For India, with its large market for affordable generics, such a framework would standardise substitution rules.

Reduces confusion and risk associated with switching between brands, reinforcing patient safety.

• Promoting competition and lower drug costs

By listing generic equivalents and their approval status, the Orange Book enables fair market competition:

1. Encourages manufacturers to develop safe, bioequivalent generics.
2. Streamlines the drug approval process for generics, potentially lowering development costs. 
3. Increases downward price pressure, making medicines more accessible to the Indian public.

• Strengthening patent clarity and innovation 

1. The US Orange Book lists patents and its type, expiry dates, and exclusivity details, supporting both originator and generic manufacturers to make informed decisions about market entry and IP strategy.
2. Indian innovators would benefit from clear public information on patent life and exclusivity, incentivising high-value R&D investments.
3. Generic makers could better plan launches, balancing patent respect with public demand for affordable drugs.

• Boosting India’s international standing

A rigorously maintained Orange Book-like repository would demonstrate India’s commitment to global regulatory standards.

1. Facilitate international trust and acceptance of Indian drug approvals.
2. Support export ambitions, as international partners value reliable regulatory infrastructure.
3. Enable alignment with US and European systems, smoothing international collaboration and mutual recognition paths.

Practical features of an Indian Orange Book

Based on global best practices, a Saffron book i.e. Indian Orange Book should include:

• A searchable list of all approved drugs, by active ingredient, trade name, manufacturer, and dosage form, provide access to related documentation such as CMC, Labels etc.

• Clear marking of innovator and approved generic products.

1. 1. Therapeutic equivalence ratings—showing which drugs can be safely substituted.
   2. Patent and exclusivity database, including expiry dates and description of protection.

• Real-time updates and open digital access for the public, medical professionals, researchers, and the industry.

Addressing potential concerns and implementation challenges.

1. Data Integrity: Requires rigorous vetting and regular updating and uploading CMC and other documents by an empowered executive giving identity, traceability of executives and time.
2. Patent Disputes: Well-defined criteria and transparency in listing patents help reduce conflict and litigation. Need to create rules to govern the listing of patents and its types i.e. Product or process patent etc.
3. Integration with State Regulations: Should coordinate with state-level authorities for nationwide applicability and uniform interpretation of Drugs and Cosmetic Act and Rule and provisions of other related legislations.
4. Industry Participation: Continuous input from the pharmaceutical sector ensures accuracy and broad acceptance.
5. Inherent Freedom and flexibility being a territorial regulatory endeavor: No global interference. 
6. Brain teasing activity: It provides scope to creativity to boost national performance, healthy competition in pharmaceutical industry.

 

Game changer for generic entry

It may prompt a provision like patent declaration or certification by generic applicant. As it would be publicly accessible, innovator would know it faster and seek appropriate remedies. On the other hand, generic manufacturer would first study patents protecting the product and inadvertent infringements would be eliminated.

 

Contents and verticals in proposed Saffron book   

Building a comprehensive database based on existing model is straightforward. However, its design should actively involve input from industry, the public, healthcare professionals, and experts in legal, administrative, technical, and biopharmaceutical fields—ensuring it addresses the information they need to perform their duties and meet currently unmet needs. Above all, the database must be structured around user requirements, not solely the regulator’s vision.

Conclusion: A call to action for Indian regulators and industry

India’s pharmaceutical sector stands at a pivotal crossroads. The establishment of a Saffron book, an Orange Book-style reference is not just desirable—it is essential for:

1. Enabling sophisticated pharmaceutical market analysis, long-term pricing strategy, and smarter R&D allocation through transparency and real-time access.
2. Assisting in fulfilling Indian dream of becoming a global leader in both innovation and generics, while securing patient safety and promoting free-market competition.
3. Safeguarding patient welfare through reliable information and safe generic substitution. 
4. Fostering innovation with clear patent and exclusivity data.
5. Enhancing trust, efficiency, and competitiveness in both domestic and global markets.

Regulatory policymakers, industry stakeholders, and public health advocates must work together to create, implement, and continuously update this vital resource. Only then will India realise its full potential as a pharmaceutical powerhouse—with benefits for its citizens and the world.