BioVoice News October 2022 Issue 1 Volume 3 | Page 10

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services and kits for biosimilars development , based on technology transferred from or co-developed with Somru . Collectively across Ingenuity , Somru and Bioneeds , we now offer end-to-end modular technical services , encompassing both pre-clinical and clinical development of biosimilars addressing global regulatory requirements .
What is your take on the clinical trial regulations in India ?
Over the years , India has established itself as one of the leading pharmaceutical hubs and a preferred destinations for outsourcing research , leveraging our strong industry ecosystem that includes scientifically skilled human resources , global quality infrastructure and compliances , and cost competitiveness . Within clinical research , India is a leading service provider supporting the global generic industry but we currently lag in global clinical trials for new and novel drug products .
Will the fast-track approvals for clinical trials and shortening of regulatory timelines for Covid vaccine development lead to any definitive changes ?
Progressive regulatory changes streamlining the approval process and oversight for studies has benefitted the CRO market . In March 2019 , the Ministry of Health and Family Welfare , India released the New Drugs and Clinical Trial Rules , 2019 , which provided clear
guidelines for the application and approval for clinical trials besides strengthening the ethical oversight and the responsibilities and obligations of the sponsors . It thereby provided a predictable , transparent and effective regulatory framework for clinical trials in India . These have supported the increase in clinical trials in India since then . There is further scope for developing the clinical research ecosystem , including regulatory pathways , to support more global clinical trials in India .

Veeda successfully completed a Phase II study for a phytochemical product for the treatment of mild to moderate COVID-19 . We see significant growth for preclinical and clinical research services in India over the medium to long term .
Why is the public perception about clinical trials in India mostly negative ? How can stakeholders create awareness on its role in drug discovery ?
The public perception about clinical trials in India has witnessed a drastic change . With the emergence of high quality CROs that operate in compliance with global safety , ethical and regulatory norms , the industry has significantly matured and the public perception thereof has definitely changed over the last several years . The stronger regulatory oversight on the industry and active industry forums are bringing together diverse stakeholders to enhance the operating ecosystem . It is also reflecting in the increasing volunteer participation in clinical research .
How are the CSR initiatives of the company making a difference to the society ?
Veeda is born out of a noble mission of preserving and safeguarding the quality of human life . We fulfil our mission of corporate social responsibility by collaborating with NGOs , voluntary organizations , institutions and working towards the upliftment of the under-privileged and promoting healthcare .
Your outlook for the clinical research market in India and Veeda respectively in FY 2022-23 ?
We see significant growth for preclinical and clinical research services in India over the medium to long term . With our comprehensive portfolio of drug development services , we are well positioned to be preferred partners for innovative pharmaceutical and biopharmaceutical clients globally for their critical drug development programs . We will continue to invest in infrastructure , people and processes to build new capabilities relevant to our clients .
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BioVoiceNews | October 2022