An orange book of India: The need of the hour

Milind Sathe, VP - IP and Tech, Themis Medicare explains why India's pharma sector urgently needs a transparent, publicly accessible database covering drug approvals, therapeutic equivalence, and patents, an Indian counterpart to the US FDA's Orange Book. He opines that this would enhance regulatory clarity, patient safety, and market competitiveness while supporting innovation and generic drug access

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For a transparent, reliable, and public-oriented pharma regulatory system, every nation needs a database covering the full cycle—from application to approval, along with manufacturing permissions and biopharma 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 US 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 US Orange book are listed below.

India currently lacks an authoritative and comprehensive reference comparable to the US FDA's Orange Book. As the nation rapidly advances toward becoming a global leader in pharma, such a resource is urgently needed—for the benefit of the Indian public, the pharma 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 pharma 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 pharma products approved for safety and efficacy. Its main functions include:

i) Identifying drugs approved after rigorous clinical trials.