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DCGI Dispels False Allegations Against Axis Clinicals

The Drug Controller General of India and an independent expert cleared Axis Clinicals of any wrongdoing after investigating allegations against the company. The investigation found that Axis Clinicals was not involved in the death of a tribal woman, as she had never enrolled or participated in any of the company's trials. Clinical research organizations in India must follow strict laws and regulations to ensure safety and ethics in clinical trials.

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122 views2 pages

DCGI Dispels False Allegations Against Axis Clinicals

The Drug Controller General of India and an independent expert cleared Axis Clinicals of any wrongdoing after investigating allegations against the company. The investigation found that Axis Clinicals was not involved in the death of a tribal woman, as she had never enrolled or participated in any of the company's trials. Clinical research organizations in India must follow strict laws and regulations to ensure safety and ethics in clinical trials.

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aashnak_1
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© Attribution Non-Commercial (BY-NC)
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DCGI dispels false allegations against Axis Clinicals

Axis Clinical has been cleared of any wrongdoing by the Drug Controller General of India (DCGI) and an independent expert. Both DGCI and the expert are convinced that Axis Clinical had nothing to do with the tribal womans death.

Hyderabad, 8th February 2013: The Drugs Controller General (India) dispelled the recent allegations on Axis Clinicals of various irregularities committed by the lab in conducting the clinical studies following health-related complaints from a group of rural women. The Drugs Controller General (India)s South Zone Office, Chennai and Sub-zonal office, Hyderabad has conducted investigations in the matter of recent reports about certain irregularities in conduct of clinical study by Axis Clinicals Ltd., Hyderabad. The investigations have revealed that Axis Clinicals had nothing to do with the tribal womans death. The complaint against Axis Clinical Ltd is based upon unsubstantiated allegations from the deceaseds womans husband despite the fact that the woman had never enrolled nor participated in the trial. according to official statement here. Dr. Yati Chugh, CEO, Axis Clinicals said, We have extended our full support during the investigation. Axis Clinical has always ensured at every point that all the requisite rules and regulations are adhered to strictly in its trials. The deceased woman was never part of our trial. Clinical research plays a key role in speeding up the market arrival of life-saving new medicines. The Clinical Research industry strongly believes that every human life is precious and cannot be compromised at any cost. Accordingly, safety norms are always adhered to in every trial by all members of the industry. ACRO India the representative body of the Clinical Research Organizations industry in India has been at the forefront of advocating ethical practices for clinical trials and will continue to do so. Clinical research organizations in India need to follow established norms based upon ethical testing and volunteer safety guidelines. We work continuously with the DCGI to streamline the process and ensure that unethical practices, if any, are weeded out immediately as and when they occur. India has stringent laws and regulations for clinical research and we are working to further align them with global standards of safety and efficacy for clinical trials conducted in India.

About Axis Clinicals Limited AXIS Clinicals Limited is one of the most experienced and fastest growing Clinical Research Organization incorporated in September 2004. Their state-of-the-art facilities houses 500+ dedicated full-time professionals to ensure the quick turnaround time with high quality. Their facilities are accredited by DCGI (Drugs Controller General,India), NABL (National Accreditation Board for Testing and Calibration Laboratories - ISO 15189:2003) and inspected by US-FDA, UK-MHRA, Brazil-ANVISA and France AFSSAPS and conforms to ICH and CDSCO-GCP & GLP Guidelines.

Within short span, they have achieved the milestone of completing 1200+ clinical studies, 300+ ANDA study completions and 50+ product approvals from various regulatory agencies. Ten plus (10+) regulatory audits from global competent authorities is testament to their professionalism and dedication to quality studies.

About ACRO The Association of Clinical Research Organizations (ACRO) represents the world's leading clinical research organizations (CROs). Their members provide specialized services that are integral to the development of drugs, biologics and medical devices. ACRO advances clinical outsourcing to improve the quality, efficiency and safety of biomedical research. Each year, ACROs members conduct thousands of clinical trials and provide related drug development services in more than 115 countries while ensuring the safety of nearly 2 million research participants. Since their founding in 2002, ACRO has been committed to strengthening public understanding and confidence in clinical research and to highlighting CRO expertise in all aspects of the clinical research enterprise. ACRO represents the CRO industry globally to pharmaceutical, biotech and medical device companies, regulators and legislators, peer associations, academic organizations, patient groups, the media and the public. ACRO is a leading voice for safe and ethical clinical trials, working with stakeholders globally to explore new paradigms for research and development and to promote a better and more efficient clinical trial process. The association looks to demonstrate the strategic value of clinical outsourcing and the important contribution CROs make as partners in the development of new medicines and new treatments.

For further information, please contact: Association of Clinical Research Organization Axis Clinicals Limited

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