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Life Sciences
Industry Focus

Life Sciences

Regulatory and tax advisory for pharma, biotech, and medical devices

50+

Pharma & biotech clients

CDSCO

Regulatory advisory

₹80Cr+

R&D tax benefits claimed

API/FDF

Full value chain coverage

Sector Overview

How JCA Serves Life Sciences

India's life sciences sector — spanning API manufacturers, formulation companies, biosimilar developers, CROs, and medical device firms — operates under an exceptionally complex regulatory and tax environment. Scientific R&D expenditure deductions, 100% weighted deduction history, transfer pricing for pharma CRO transactions, CDSCO compliance, and import duty on APIs are areas where specialist advice is critical. Our life sciences team combines CA expertise with understanding of pharma business models.

Key Challenges

Sector Issues We Resolve

Patent & IP tax treatment

Patent & IP tax treatment

Capital vs. revenue characterisation of patent purchase, royalty withholding, and IP transfer pricing.

API import classification

API import classification

CETA HS code disputes, basic customs duty exemptions, and IGST on life-saving drug imports.

CRO contract structures

CRO contract structures

Fee-for-service vs. risk-sharing CRO models and their GST, income tax, and TP implications.

CDSCO compliance costs

CDSCO compliance costs

Schedule M GMP compliance costs, medical device QMS audit findings, and regulatory penalty risk.

FAQ

Common Questions

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