India

About

CRO in India, cultural insight, market overview, medical system, and more

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pharmaceutical production by volume globally

share of global clinical trial activity

billion pharmaceutical sector worth

average annual growth rate of the hospital industry

GCT in India

Country manager

Umakanta Sahoo

MBA, PhD

Office information

Tel: +91 22 42369729

Email: bd@gctrials.com

Vatika Business Center, Supreme Business Park, Hiranandani Gardens, Powai, Mumbai 400076, India

Country manager

Umakanta Sahoo

MBA, PhD

Office information

Tel: +91 22 42369729

Email: bd@gctrials.com

Vatika Business Center, Supreme Business Park, Hiranandani Gardens, Powai, Mumbai 400076, India

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Regulatory

Under the Ministry of Health and Family Welfare, Govt. of India, the Central Drugs Standard Control Organization (CDSCO), headquartered in New Delhi, is the National Regulatory Authority in India. The Drugs Controller General of India (DCGI), an official of the CDSCO, is the final regulatory authority for the approval of clinical trials in the country. The Indian regulatory framework allows concurrent submission of applications for regulatory and institutional ethics committee (IEC) approval. Clinical trials for a new drug can only be initiated after DCGI has granted permission, and the approval has been obtained from the registered Institutional ethics committee of the site.

A single regulatory dossier is prepared containing application for permission to undertake clinical trials, for importation of new drugs (Test License) and to export blood samples (Export License) in the prescribed formats. The regulatory dossier is uploaded through Sugam, an e-Governance system under CDSCO for online submission of CTA and obtaining no objection certificates (NOC), Licenses and approvals. After online submission, Subject Expert Committee (SEC) reviews clinical trial application. If SEC reviews and accepts the application without any query, DCGI issues NOCs for the conduct clinical trial. This process takes 12-16 weeks in total.

The Clinical Trials Registry – India (CTRI), hosted at the ICMR’s National Institute of Medical Statistics, is a free and online public record system for registration of clinical trials launched in 2007. Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the DCGI.

Official links

https://cdsco.gov.in/opencms/opencms/en
http://icmr-nims.nic.in
www.ctri.nic.in

Pharmaceutical Industry & Clinical Trials Market

The Indian clinical trials market is growing at a rapid rate. Indian pharmaceutical sector supplies over 50% of global demand for vaccines, 40% of the US demand for generics and 25% of all medicine in the UK. Over 80% of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) are supplied by Indian pharmaceutical firms. Moreover, India ranks 3rd in terms of pharmaceutical production by volume and 14th by value worldwide. The domestic pharmaceutical industry includes a network of 3,000 drug companies and ~10,500 manufacturing units.

India holds an influential position in the global pharmaceuticals sector. Furthermore, the country has a large pool of scientists and engineers with a potential to steer the industry to greater heights.

India is one of the most preferred destination for global clinical trials because of significant cost and other resource advantages. The 3 ‘P’s— Population, Patients and Physicians make India uniquely attractive for sponsors. When pharma and biotech companies choose to conduct clinical trials in India, they can utilize:

1) the largest and most diverse pool of patients.
2) mandatory CTRI registration of clinical trials facilitating transparency of the process
3) highly skilled doctors, professionals, and experienced scientists

Medical System in India

Healthcare is one of India’s largest sectors, both in terms of revenue and employment. The Indian healthcare sector is growing at a brisk pace due to its strengthening coverage, services and increasing expenditure by public as well private players. Medical devices, clinical trials, outsourcing, telemedicine, medical tourism, health insurance and medical equipment are developing rapidly.

Indian healthcare delivery system is categorized into two major components — public and private. The Government, i.e., the public healthcare system, comprises limited secondary and tertiary care institutions in key cities and focuses on providing basic healthcare facilities in the form of primary healthcare centers (PHCs) in rural areas. The private sector provides the majority of secondary, tertiary, and quaternary care institutions with major concentration in metropolitan areas and tier I and tier II cities.