Clinical Trials in India
August 13, 2022
 

Clinical trials form an integral part of the drug discovery process worldwide. They aid pharmaceutical companies and medical practitioners to evaluate the efficacy of new treatments on humans. Clinical trials in India has been a buzzing topic in the pharmaceutical industry for decades. With a variety of factors in its favour, such as a diverse large population, availability of medical professionals and cost effectiveness India is a promising hub for clinical trials.

With the passage of the New Drugs and Clinical Trial Rules in 2019, India is progressing towards a favourable regulatory ecosystem for clinical trials. In the backdrop of this new law, in this research paper we discuss the scope regulatory life cycle of clinical trials, modes of entry, emerging trends and challenges to clinical trials in India.

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

This Hotline provides general information existing at the time of preparation. The Hotline 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 Hotline. It is recommended that professional advice be taken based on the specific facts and circumstances. This Hotline does not substitute the need to refer to the original pronouncements.

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Clinical Trials in India

August 13, 2022

 

 

Clinical trials form an integral part of the drug discovery process worldwide. They aid pharmaceutical companies and medical practitioners to evaluate the efficacy of new treatments on humans. Clinical trials in India has been a buzzing topic in the pharmaceutical industry for decades. With a variety of factors in its favour, such as a diverse large population, availability of medical professionals and cost effectiveness India is a promising hub for clinical trials.

With the passage of the New Drugs and Clinical Trial Rules in 2019, India is progressing towards a favourable regulatory ecosystem for clinical trials. In the backdrop of this new law, in this research paper we discuss the scope regulatory life cycle of clinical trials, modes of entry, emerging trends and challenges to clinical trials in India.

We hope you find this paper useful.

Please click here to access our paper.

For any help or assistance, please email us on [email protected].

Do visit us at www.nishithdesai.com.

 

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Disclaimer

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

This Hotline provides general information existing at the time of preparation. The Hotline 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 Hotline. It is recommended that professional advice be taken based on the specific facts and circumstances. This Hotline 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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Chambers and Partners Asia-Pacific: Band 1 for Employment, Lifesciences, Tax and TMT, 2022

AsiaLaw Asia-Pacific Guide 2022: Ranked ‘Outstanding’ for Media & Entertainment, Technology & Communications, Labor & Employment, Regulatory, Private Equity, Tax

Who's Who Legal: Thought Leaders India 2022: Nishith M Desai (Corporate Tax - Advisory, Corporate Tax - Controversy and Private Funds – Formation), Vikram Shroff (Labour & Employment and Pensions & Benefits) and Vyapak Desai (Arbitration)

Benchmark Litigation Asia-Pacific: Tier 1 for Tax, Labour and Employment, International Arbitration, Government and Regulatory, 2021

Legal500 Asia-Pacific: Tier 1 for Tax, Data Protection, Labour and Employment, Private Equity and Investment Funds, 2021

IFLR1000: Tier 1 for Private Equity and Tier 2 for Project Development: Telecommunications Networks, 2021

FT Innovative Lawyers Asia Pacific 2019 Awards: NDA ranked 2nd in the Most Innovative Law Firm category (Asia-Pacific Headquartered)

RSG-Financial Times: India’s Most Innovative Law Firm 2019, 2017, 2016, 2015, 2014