Friday, 3 August 2012

CDSCO office has released the draft guidance related to Clinical Trials for feedback purpose

Dear All,

CDSCO office has released the draft guidance related to Clinical Trials for feedback purpose.

Please provide your comments and suggestions regarding these draft documents as the feedback needs to be submitted within 30 days of publication, to CDSCO, FDA Bhavan Kotla Road, New Delhi 110002

Draft Notification G.S.R.572(E) Regarding Inspection of Clinical Trial

Draft Notification G.S.R.573(E) Regarding Registration of Ethics Committee

Draft Guidance for calculation of compensation to be paid in case of clinical trial related injury or death

Wednesday, 1 August 2012

No reason to fear clinical trials

M. D. Nair
Hindu Business Line

It is wrong to argue that Indians are being used as guinea pigs in clinical trials.
The Supreme Court’s recent directives to the Government to deal with illegal clinical trials are timely and relevant, both for the development of medicine and the welfare of subjects participating in such trials.
Clinical research is an essential component of drug discovery and development, and cannot be substituted by any other credible method of validation of an experimental drug. Clinical trials are studies conducted in human volunteers (healthy or sick) to better prevent or treat diseases and determine whether the new treatment is both safe and effective.
Such trials are approved by the regulatory agency of the Government and undertaken only after there is adequate evidence from animal experiments for their safety and efficacy.
It is clear that medical research should continue as a cornerstone for making new drugs available for diseases for which no drugs are available, or when the available ones are not effective or safe.
Advances in drug research have substantially contributed to increase in life expectancy and a better quality of life. Over 90 per cent of the drugs available today have been discovered and developed by research-based pharmaceutical companies in U.S., Western Europe and Japan, even though much of the basic work which led to the discovery process may have been carried out in academic institutions.
Issues of concern in the conduct of human trials are: rights and privileges of the participants, their informed consent, assessment of the risk-to-benefit ratios, and ethical issues connected with the use of unknown drugs.


One of the first realisations that clinical research needs to be regulated came in the wake of a tragedy which killed over 100 people in the US, who consumed sulphanilamide elixir. This led to the Food & Drugs Act in the US in 1938.
The Nuremburg trials in 1947, when over 20 Nazi doctors were tried for unethical and immoral human experimentation, led to the Nuremburg Code for human experimentation in 1948.
The biggest tragedy in the history of medicine occurred in 1960 when over 10,000 children were born with malformed limbs (thalidomide babies) around the world as a consequence of their mothers taking the sedative thalidomide during the first trimester of their pregnancy.
That led to stringent controls on clinical trials as stipulated under the Kefauver-Harris amendment to the U.S. Drugs law. Over the years the laws have become more stringent with respect to clinical trials, and in 1990 the international Conference On Harmonisation of Clinical Trials (ICH) laid down strict Guidelines for Good Clinical Practice (GCP).
The Helsinki Declaration of 1964 provides the guiding principles for conducting biomedical research on humans. Article 11.3 of the Declaration mandates that all patients, whether in an active treatment group or control group should receive the best possible therapy, although it allows the use of a placebo when no such treatment exists.
Article 11.6 stipulates that research in patients is justified only if it is of potential value to the patient in the best judgment of the investigator and the Ethics Committee. (The Ethics Committee is a statutory body consisting of members of the public.) The Declaration also requires investigators to obtain subjects' freely given and non-coerced informed consent, in writing.
It forbids payment to the patients by way of incentives to participate. These well-laid out procedures are today the best possible safeguards against drug-related harm to patients.

Deficiencies In Trials

In spite of available guidelines, several deficiencies still plague clinical research.
Some of these are: whether of results of animal studies is relevant to human beings; human errors in planning and execution of the trials per se; fraudulent informed consent and even deliberate fraud on the part of the stake holders.
To ensure that clinical trials are carried out in a fair, ethical and transparent manner around the world, all sponsors of trials are required to register their trials in an International Clinical Trials Platform (ICTRP) set up under US Public Law 110-85 and managed by the National Institute Of Health. Voluntary and informed consent from every subject undergoing trials is mandatory.
In India, the medical profession, the drug manufacturers and the regulatory agencies have accepted international mandatory regulations as well as ethical standards embodied in the Hippocrates Oath, Helsinki Declaration and the ICH.
According to the international registry of clinical trials, the data bank maintained by the NIH in U.S. (clinical, around 129,599 trials are being carried out in 179 countries.
An Indian registry was set up under the aegis of WHO and the Indian Council of Medical Research (ICMR) in 2008 and registration of all trials was made mandatory from June 15 of 2009. At the last count, the number of clinical trials in India was 2010, representing only 1.6 per cent of the global trials.
At the same time China accounts for over 8 per cent, substantially higher than India. The fear that there is an avalanche of trials moving to India and risking our population is thus unfounded. India is by no means a preferred hub for clinical trials.
It is also a fact that the largest number of clinical trials in India are Phase III trials, which are multi-centric world-wide trials on well tested drugs with a common protocol, and hence risks are minimal.

Opportunity for India

Clinicians in India have a great opportunity to train themelves in this discipline, particularly at a time when several research organisations and pharmaceutical companies are developing skills in drug discovery and development.
The future of Indian capability in drug disovery will depend on our expertise in clinical research. In addition, for the many diseases which are endemic to India, such as tuberculosis, malaria, dengue, leptospirosis, chikungunya, and parasitic diseases, clinical trials can be carried out only where patients are available, and India offers major advantages.
The oft-repeated accusation that Indians are being used as ‘guinea pigs’ is baseless. Rules for ethical and high quality clinical research are laid out under Schedule Y of the Indian Drugs And Cosmetics Act, which is the ultimate authority for the registration, monitoring and approval of clinical trials.
Any attempt to bypass well-laid-out systems in the registration, monitoring and control of clinical trials should be dealt with utmost severity.
At the same time, properly conducted trials meeting highest quality standards should be encouraged for the sake of global medical progress.
(The author is a Chennai-based consultant to healthcare industry.)
(This article was published on August 1, 2012)

Business Line : Opinion : No reason to fear clinical trials

Business Line : Opinion : No reason to fear clinical trials

Friday, 6 July 2012

AXIS Clinicals announces successful completion of US FDA Audit

AXIS Clinicals announces successful completion of US FDA Audit for Patient Population Clinical Bioequivalence study
Friday, 08 June 2012

Hyderabad, INDIA : AXIS Clinicals Limited, India’s Premier Clinical Research Organization (CRO), announces today that it has successfully completed its 9th US FDA Audit for Patient Population Clinical Bioequivalence study.

AXIS Clinicals successful audits confirmed that the company's quality system was found to meet the requirements established by the US, Europe and other international regulatory authorities.

P. Sarath Chandra Reddy, Managing Director of AXIS Clinicals, said, "The successful US FDA Audit is a resounding success and we are delighted and proud of the achievement. Having a successful US FDA audit along with the US FDA, Brazil ANVISA, UK MHRA, France AFSSAPS, NABL and ISO 9001:2000 certification, means that AXIS Clinicals has attained the Quality Standards laid by regulatory bodies and we will ensure the Best Quality with Highest Standards - All The Time. These are very exciting times for all of us."
"We are proud to announce this FDA audit outcome for patient population clinical trial conducted by AXIS Clinicals, ensuring once again our commitment to the highest standards of quality," said P. Sarath Chandra Reedy, Managing Director of AXIS Clinicals Ltd. "We give the preference not only to the quality of our specialized services, but also on their continuous improvement for customer delightness. This achievement is the enduring result of a high level of dedication to achieve total customer satisfaction through unsurpassed service, on-time delivery, and report submissions that meet or exceed our customers and applicable regulatory expectations for quality and performance.

About AXIS Clinicals Limited

AXIS Clinicals Limited is a Clinical Contract Research Organization committed to serving the biotech, pharmaceutical and Generics industry with the global standards and most accurate results. AXIS has completed more than 1300 trials on various therapeutics classes of drugs, including; Lipid lowering agents, Anti-Diabetic, Anti-Depressants, Antibiotics, NSAIDs, anti-epileptic muscle relaxants, hormones, cardiac drugs, psychotropic & narcotics drugs, antiretroviral (ARVs), Oncology products, Ophthalmology products and oral contraceptives.
Within short span, AXIS Clinicals Limited has achieved the milestone of completing 1300+ clinical studies, 300+ ANDA study completions and 100+ product approvals from various regulatory agencies. Several regulatory audits from global competent authorities are the testament to the professionalism and dedication to quality studies.
AXIS Clinicals Limited has the state-of-art facilities for Bioequivalence / Bioavailability studies and also provides the Clinical Trials services like Phase II- IV services, Clinical Data Management, Project management, Site Management, Post-Marketing Surveillance.
AXIS Clinicals widen its global footprint with starting the Mexico operations for the Bioequivalence / Bioavailability studies and Clinical Trials services.

Please contact Business Development Team at or at +91 (40) 4040 8044

For any further information, please contact:

Corporate Communications
AXIS Clinicals Limited
1-121/1, Miyapur,
Hyderabad 500 049, INDIA
Phone +91 (40) 4040 8044

AXIS Clinicals Ltd is Clinical Research Organization committed to serving the global pharmaceutical and biotech industry

AXIS Clinicals Ltd is Clinical Research Organization committed to serving the global pharmaceutical and biotech industry with the global standards and most accurate results. In compliance with ICH/GCP/GLP guidelines, AXIS Clinicals is India’s premier Clinical Research Organization. We have completed 1300+ studies for all regulatory bodies like EU, US FDA, WHO, Canada, Brazil ANVISA, MCC South Africa, France, TGA Australia, Russia, Thailand and India.
AXIS facility has been successfully audited &/or accredited by US FDA, UK MHRA, Brazilian ANVISA, India (DCGI), AFSSAPS, NABL and ISO 9001:2000.

Audit details:

  • 8 US FDA Audits (recent audit in October 2011)
  • Recently completed US FDA audits with 'NO' 483’s
  • Turkey MOH Audit (Dec 2011)
  • 2 UK MHRA audits with NO major findings / observations (Recent audit Oct 2011)
  • France AFSSAPS audit - Sponsor received the product approval
  • Brazil ANVISA – 3 successful audits
  • ISO 900:2000
  • NABL approval for Clinical Investigational Unit
  • Product approvals (for sponsors) from Health Canada, WHO, AFSSAPS, US FDA, Europe, Australia, Brazil & DCGI Regulatory Agencies

In addition to BA/BE experience, we have a group of highly skilled clinical research professionals to conduct Clinical Bioequivalence studies and phase 2 to 4 clinical trials in India.

Our core clinical capabilities includes Ophthalmology (PK/PD studies), Oncology (lung, breast, and colorectal), orthopedic (chronic low back ache, arthritis, osteoporosis), cardiology (pulmonary arterial hypertension, essential hypertension, and acute myocardial infarction), and vaccine. The team has an experience of working with more than 360 clinical investigators across 110 research sites. Our services include medical writing, thorough project-, site- including monitoring and data-management.

Wednesday, 25 January 2012

AXIS Clinicals introduced the Mexico facility to boost global presence

Mexico City, Mexico - AXIS Clinicals widen its global footprint with starting the Mexico facility.

AXIS Clinicals Latina SA de CV, the one of the largest infrastructure for the Bioequivalence / Bioavailability facility in Mexico which houses 138 beds for the clinical unit and planning for 4 LC-MS/MS as the Phase I expansion. This facility has been designed using GCP and GLP requirements to meet the Global Regulatory Standards.

AXIS Clinicals Latina SA de CV received the facility approval in June 2011 for Clinical and Bionalytical facility from Cofepris, the Mexican Regulatory Agency.

The Bioanalytical Laboratory is equipped with the high-end instrumentation with dedicated areas as well-equipped sample processing zone, special precaution area where the controlled conditions will be maintained for the project specific requirement.  

P. Sarath Chandra Reddy, Managing Director mentions “Mexico BA / BE business is an important pie of our strategic expansion which will ensure the global drug development support for our business partners.”

Saturday, 21 January 2012

AXIS Clinicals : Summary of regulatory inspections and approvals

AXIS Clinicals facility has been successfully audited &/or accredited by US FDA, UK MHRA, Brazilian ANVISA, India (DCGI), AFSSAPS, NABL and ISO 9001:2000.

We would like to provide you the updates for the audits

  • 8 US FDA Audits (recent audit in October 2011)
  • Recently completed US FDA audits with 'NO' 483’s
  • Turkey Regulatory Audit (Dec 2011)
  • UK MHRA audit with NO findings / minor observation (Recent audit Oct 2011)
  • France AFSSAPS audit
  • Brazil ANVISA – 3 successful audits
  • ISO 900:2000
  • NABL approval for Clinical Investigational Unit
  • Product approvals (for sponsors) from Health Canada, WHO, AFSSAPS, US FDA, Europe, Australia, Brazil & DCGI Regulatory Agencies
For more updates, please click on or call on +91 (40) 4040 8044