NishithDesai-印度制药工业-监管、法律和税务概述（英）

© Nishith Desai Associates 2024www.nishithdesai.comMUMBAI SILICON VALLEY BENGALURU SINGAPORE NEW DELHI NEW YORK GIFT CITYResearchThe Indian Pharmaceutical IndustryRegulatory, Legal and Tax OverviewAugust 2024© Nishith Desai Associates 2024www.nishithdesai.comResearchThe Indian Pharmaceutical IndustryRegulatory, Legal and Tax OverviewAugust 2024DMS Code: 30670.1© Nishith Desai Associates 2024www.nishithdesai.comRanked as the ‘Most Innovative Indian Law Firm’ in the prestigious FT Innovative Lawyers Asia Pacific Awards for multiple years. Also ranked amongst the ‘Most Innovative Asia Pacific Law Firm’ in these elite Financial Times Innovation rankings. The Indian Pharmaceutical Industry — Regulatory, Legal and Tax Overview © Nishith Desai Associates 2024Provided upon request only DisclaimerThis report is a copyright of Nishith Desai Associates. No reader should act on the basis of any statement contained herein without seeking professional advice. The authors and the firm expressly disclaim all and any liability to any person who has read this report, or otherwise, in respect of anything, and of consequences of anything done, or omitted to be done by any such person in reliance upon the contents of this report.ContactFor any help or assistance please email us on concierge@nishithdesai.com or visit us at www.nishithdesai.com.AcknowledgementsTanya Kukade tanya.kukade@nishithdesai.comVarsha Rajeshvarsha.rajesh@nishithdesai.comEshika PhadkeEshika.phadke@nishithdesai.comDr. Milind AntaniMilind.antani@nishithdesai.com The Indian Pharmaceutical Industry — Regulatory, Legal and Tax Overview © Nishith Desai Associates 2024Provided upon request only ContentsExecutive Summary 1Introduction 3India Entry Strategies 5A. Investment Climate in India 5B. Government Production Linked Incentives 6C. India’s Post-Trips Intellectual Property Environment 6D. Form of The Indian Entity 6E. Corporate Governance in India 9F. Anti-Corruption Framework 10Legal and Regulatory Regime in India 11A. Outline of Legal and Regulatory Framework 11B. Regulatory Framework 11C. Proposed Law on Regulation of Pharmaceutical Products 14D. Manufacturing a Drug in India 14E. Importing a Drug into India 15F. Manufacture/Import of New Drugs 16G. Clinical Trials 16H. Product Standards 18I. OTC and Prescription Drugs 18J. Pharmacy 19K. E-Pharmacy 19L. Labeling 20M. Shelf Life 20N. Good Manufacturing Practices (GMP) 21O. Pricing of Drugs and Drug Price Control Order, 2013 22P. Advertisement and Sales Promotion 23 The Indian Pharmaceutical Industry — Regulatory, Legal and Tax Overview © Nishith Desai Associates 2024Provided upon request only The Anti-Trust Regulatory Framework 27Intellectual Property Landscape 29A. Patent Protection 29B. Trademarks 32Tax Regime 36A. Direct Taxes 36B. Indirect Taxes 48Key Issues and Challenges in Indian Pharma Industry 50A. Promotion and advertisement 50B. Price Control 50C. Labelling 50D. Env