CII organizes its first National Conference on Clinical Trial
“Opportunities and Challenges for Contract Research Organisations”

The first two day National Conference on Clinical Trial was organized in Mumbai on 24-25 November by CII Institute of Quality and the Technology Division of CII in association with Department of Science and Technology, Government of India and supported by Association of Clinical Research Organization [ACRO], Institute of Clinical Research (India) (ICRI), Quintiles Research [I ] Pvt. Ltd and Quality Council of India.

Clinical research and trials form a crucial segment of the pharmaceutical industry as it is an indispensable part of any drug discovery process to ensure the safety and efficacy of any new drug. Based on robust guidelines which govern the conduct of Clinical Trials, it is the mainstay for bringing newer and better drugs to market.

Speaking at the conference Dr. A B Ramteke, Joint Drugs Controller General of India emphasised that, “The drug control department has formed norms on Clinical Research Trials as per International guidelines since clinical research has come under public scrutiny due to extensive media involvement leading to its bar being raised. Its bio-medical guidelines have also been recognized by US FDA and Health Canada”.

Mr. Kewal Handa, Managing Director, Pfizer Ltd., presided over the inaugural session. Commenting on the clinical research industry, he said, “There is great future potential in this field and by 2015 it will be a $1.5bn industry. Focus has to on Backward integration, Capacity building and Business Culture.”

Mr Kewal Handa, MD, Pfizer Ltd, delivering the Inaugural address. Others from left: Mr Ferzaan N Engineer, CEO, Quintiles Research [I ] Pvt Ltd., Mr A B Ramteke, Joint Drugs Controller of India, GOI, Dr S P Vasireddi, CMD, Vimta Labs Ltd. & Chairman, ACRO, Dr GJ Samathanam ,Technology Transfer , DST, GOI and Dr R N Chowdhury, Principle Counselor, TQM, CII

The other eminent speaker at the inaugural session was Dr. G J Samathanam, Advisor – Technology Transfer, Department of Science and Technology, Govt. of India, who stressed upon the importance of product development, infrastructure, public private partnership, societal awareness in clinical research trials. “Although drug development is not a mandate of the Department of Science and Technology, it provides soft grants out of its annual funding to the tune of 100 crores at 3% interest to pharmaceutical companies for research and development. Some beneficiaries of this grant have been Lupin, Ranbaxy, Cadilla etc” he said. He also spoke about the great interest of the US pharma industries in the Indian Contract Research Organizations (CRO). Touching on a very sensitive issue, he mentioned about the concern about the decrease in the animal colonies because of the use of animals in testing medicines. Enumerating some of India’s advantage in this segment, he underscored its English speaking capabilities as also the Genomic conservation due of the caste system prevalent in India.

The conference and the accompanying exhibition, attended by over 100 delegates, helped create widespread sensitization and knowledge creation about clinical trial methodologies among the various stakeholders dealing directly or indirectly in this area. A high point was the various scientific sessions on different streams of Clinical Research operations, Pharmaco vigilance, Regulatory Affairs, Qualification Validation QC/QA and Safety Audit.

Dr. S K Gupta, Dean and Director of The Institute of Clinical Research with his expertise in the field of Clinical Research and training added that, “India is considered as the global hub for Clinical Research and its success lies in making the regulatory environment very friendly”. He said, “The problems faced by India are with regards to the scarce human resources and few laws for IP protection”. He also stressed on the fact that Contract Research Organizations (CRO) play a very important role in the booming Clinical Research Industry.

With growing problems relating to cosmetic use, pharmaco vigilance has come under the scanner. Speaking on the toxicity and the availability of spurious cosmetic elements in the market, Dr. S S Agrawal, Director of Delhi Institute of Pharmaceutical Sciences and Research said that, “Pharmaco-Vigilance is required to be implemented aggressively and regulatory amendments will help to make the public aware of the disadvantages of toxicity of cosmetics thus making the public cautious”.

The concurrent exhibition provided an opportunity to all the stakeholders dealing directly or indirectly in this area to explore all new and existing methodology and techniques of Clinical Research. The Amristart Pavilion showcased the scope of obtaining more projects from USA and the European Union.

CII continues to play an important role to bring about the much needed change in the Pharma Clinical Research Industry. It plans to conduct many more of such conferences to shed more light on various aspects of Clinical Research Industry which will immensely help the CRO industry to boost their prospects, nationally and internationally


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