The Indian Pharmaceutical Industry
Regulatory, Legal and Tax Overview
May 03, 2023
 

The Indian pharmaceutical industry has been witnessing significant growth over the past few years and is expected to grow to USD 130 billion in value by the end of 2030.

For a global pharmaceutical company seeking to enter the Indian pharmaceutical market today, the opportunities are exciting, and the potential is tremendous. Several factors attract global pharmaceutical companies to India:

  • Low cost of production due to a variety of factors including relatively lower labour costs and raw material cost;

  • Big market not only for life saving drugs but also for lifestyle drugs;

  • Potential for conducting research and development activities in India – India has more than 300 medical colleges, over 20,000 hospitals;

  • Existing manufacturing capability to produce active pharmaceutical ingredients (APIs) as well as intermediates at lower cost while maintaining quality;

  • India has a maximum number of USFDA approved plants outside the US;

  • Ease of conducting clinical trials and bioavailability and bioequivalence studies due to India’s ability to provide speedier and less expensive trials without compromising quality and due to a vast patient pool.

In this paper we have outlined the entity structures, the tax regime, both direct and indirect, affecting the structuring of Indian operations, the regulatory aspects and the intellectual property issues that affect the pharmaceutical and life sciences industry.

Regards,

Varsha Rajesh, Eshika Phadke, Darren Punnen and Dr.Milind Antani

We hope you find this paper useful.

Please click here to access our paper.

For any help or assistance, please email us on concierge@nishithdesai.com.

Do visit us at www.nishithdesai.com.

 

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This Publication provides general information existing at the time of preparation. The Publication is intended as a news update and Nishith Desai Associates neither assumes nor accepts any responsibility for any loss arising to any person acting or refraining from acting as a result of any material contained in this Publication. It is recommended that professional advice be taken based on the specific facts and circumstances. This Publication does not substitute the need to refer to the original pronouncements.

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The Indian Pharmaceutical Industry

Regulatory, Legal and Tax Overview

May 03, 2023

 

 

The Indian pharmaceutical industry has been witnessing significant growth over the past few years and is expected to grow to USD 130 billion in value by the end of 2030.

For a global pharmaceutical company seeking to enter the Indian pharmaceutical market today, the opportunities are exciting, and the potential is tremendous. Several factors attract global pharmaceutical companies to India:

 

  • Low cost of production due to a variety of factors including relatively lower labour costs and raw material cost;

  • Big market not only for life saving drugs but also for lifestyle drugs;

  • Potential for conducting research and development activities in India – India has more than 300 medical colleges, over 20,000 hospitals;

  • Existing manufacturing capability to produce active pharmaceutical ingredients (APIs) as well as intermediates at lower cost while maintaining quality;

  • India has a maximum number of USFDA approved plants outside the US;

  • Ease of conducting clinical trials and bioavailability and bioequivalence studies due to India’s ability to provide speedier and less expensive trials without compromising quality and due to a vast patient pool.

In this paper we have outlined the entity structures, the tax regime, both direct and indirect, affecting the structuring of Indian operations, the regulatory aspects and the intellectual property issues that affect the pharmaceutical and life sciences industry.

Regards,

Varsha Rajesh, Eshika Phadke, Darren Punnen and Dr.Milind Antani

We hope you find this paper useful.

Please click here to access our paper.

For any help or assistance, please email us on concierge@nishithdesai.com.

Do visit us at www.nishithdesai.com.

 

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Disclaimer

The contents of this Publication should not be construed as legal opinion. View detailed disclaimer.

This Publication provides general information existing at the time of preparation. The Publication is intended as a news update and Nishith Desai Associates neither assumes nor accepts any responsibility for any loss arising to any person acting or refraining from acting as a result of any material contained in this Publication. It is recommended that professional advice be taken based on the specific facts and circumstances. This Publication does not substitute the need to refer to the original pronouncements.

This is not a Spam mail. You have received this mail because you have either requested for it or someone must have suggested your name. Since India has no anti-spamming law, we refer to the US directive, which states that a mail cannot be considered Spam if it contains the sender's contact information, which this mail does. In case this mail doesn't concern you, please unsubscribe from mailing list.
 
 

 

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