Source:The Economic Times
Thursday, October 23, 2008
Convention's Initiative:Update Professionals In Regulatory Agency
The FDA Class I Officers Association and Drugs Inspectors' Welfare Association, Maharashtra State, hosted the AIDCOC Convention 2008. The convention was an interactive platform to update professionals in regulatory agencies and pharmaceutical industry to share their views and distribution network about advances in the area of Pharmacotherapeutics. The theme 'Better healthcare through innovations in pharmaceuticals' was in line with AIDCOC's endeavour of achieving professional excellence through self-initiative and providing better services to the consumer. The program began with the keynote address on the theme by Dr Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon. The experts from various field shared their knowledge with the delegates on various subjects such as incentives to innovations through intellectual property rights, stem cell-emerging therapy, innovations in packaging, quality risk management, supply chain management and international regulatory harmonisation. Along with this, there was a panel discussion on 'Indian healthcare scenario-vision 2020' and 'Acquiring competitive edge through innovations'. Two hundred drugs control officers covering all states and two hundred professionals from pharmaceutical industry, blood banks, and clinical research organisations were registered as delegates.
AIDCOC Convention 2008 addressed key issues before the pharmaceutical industry and the concerns about the availability, affordability and rational use of medicines. It also focused on the benefits of innovations to the consumers and the need to concentrate resources and R&D efforts on specific disease pattern in India. S R Salunkhe, Organising Secretary and his team in the Organising Committee under the guidance of Dhanraj Khamatkar, Commissioner, FDA and Sandeep Bishnoi, Joint Commissioner, (Vig) as Patron and Co-Patron ensured the success of the event. The Organising Committee was guided and supported by SA Momin, Chairperson; Ravi Kant, President, AIDCOC; Ravi Uday Bhaskar, Secretary General, AIDCOC and S W Deshpande, Director General, AIDCOC. The conference brought together great emissaries from the field of pharma and biotech industry who shared their views on the current trends and needs of the industry.
Source:Express Pharma
AIDCOC Convention 2008 addressed key issues before the pharmaceutical industry and the concerns about the availability, affordability and rational use of medicines. It also focused on the benefits of innovations to the consumers and the need to concentrate resources and R&D efforts on specific disease pattern in India. S R Salunkhe, Organising Secretary and his team in the Organising Committee under the guidance of Dhanraj Khamatkar, Commissioner, FDA and Sandeep Bishnoi, Joint Commissioner, (Vig) as Patron and Co-Patron ensured the success of the event. The Organising Committee was guided and supported by SA Momin, Chairperson; Ravi Kant, President, AIDCOC; Ravi Uday Bhaskar, Secretary General, AIDCOC and S W Deshpande, Director General, AIDCOC. The conference brought together great emissaries from the field of pharma and biotech industry who shared their views on the current trends and needs of the industry.
Source:Express Pharma
Wednesday, October 22, 2008
ISCR Awards for Excellence in Clinical Research
Source: Biospectrum
The Indian Society for Clinical Research has instituted first ever awards for clinical research in India. The awards will promote meritorious work in the areas of clinical trials. “The ISCR Awards 2008” is India’s first industry-wide event exclusively for clinical research that aims to recognize the achievements and contributions to science and the advancement of drug research and healthcare. The event was celebrated in Mumbai, India on the October 16, 2008.
The Lifetime Achievement Award went to Dr A S Nanivadekar, a distinguished professional in medical & clinical research. Dr Narges Mahaluxmivala of Quintiles received the special Award “Notable Contribution to Clinical Research Fraternity” and Seth GS College & KEM Hospital, Mumbai received the other special award, “Notable Initiative to shape clinical research environment in India.”
Besides, there were four categories - CRA of the year, Study Manager of the year, Study coordinator of the year and Investigator of the year awards in which 8 winners received trophies and certificates - aimed at bringing wider recognition to the clinical research fraternity.
Nomination for the awards were invited from across the country that went through a rigorous review process by the jury panel consisting of Dr. Nilima Kshirsagar, Dr. S.M.Sapatnekar, Dr.Purvish M.Parikh and Dr Ferzaan N Engineer before selection of the winners.
The Indian Society for Clinical Research has instituted first ever awards for clinical research in India. The awards will promote meritorious work in the areas of clinical trials. “The ISCR Awards 2008” is India’s first industry-wide event exclusively for clinical research that aims to recognize the achievements and contributions to science and the advancement of drug research and healthcare. The event was celebrated in Mumbai, India on the October 16, 2008.
The Lifetime Achievement Award went to Dr A S Nanivadekar, a distinguished professional in medical & clinical research. Dr Narges Mahaluxmivala of Quintiles received the special Award “Notable Contribution to Clinical Research Fraternity” and Seth GS College & KEM Hospital, Mumbai received the other special award, “Notable Initiative to shape clinical research environment in India.”
Besides, there were four categories - CRA of the year, Study Manager of the year, Study coordinator of the year and Investigator of the year awards in which 8 winners received trophies and certificates - aimed at bringing wider recognition to the clinical research fraternity.
Nomination for the awards were invited from across the country that went through a rigorous review process by the jury panel consisting of Dr. Nilima Kshirsagar, Dr. S.M.Sapatnekar, Dr.Purvish M.Parikh and Dr Ferzaan N Engineer before selection of the winners.
Monday, October 20, 2008
Alliance:Between US FDA And Indian Drug Regulator
America’s Drug regulator US FDA is in talks with Indian drug regulator-The Drug Controller General Of India for co-operation on various regulatory parameters.
This alliance between Indian and American drug regulator reveals the global influence that Indian drug manufacture have.The world’s most stringent regulatory authority US FDA is in alliance plans with Drug Controller General Of India to work on most important issues considering drug investigative parameters.
More than 200 Indian drug units presently supplying generic category medicines to the Indian states which are already authorized by USFDA. Moreover Indian drug regulation is to be deeply understood by US regulator consequently better equipped US FDA will supervise Indian manufacturing units.
It furthers helps DCGI’S office in getting full exposure to current features of investigation, drug evaluation and approval processes.
USFDA is planning a risk evaluation and mitigation plans for several vital drugs globally in turn Indian drug regulators are being benefitted from such keen moves.
This alliance between Indian and American drug regulator reveals the global influence that Indian drug manufacture have.The world’s most stringent regulatory authority US FDA is in alliance plans with Drug Controller General Of India to work on most important issues considering drug investigative parameters.
More than 200 Indian drug units presently supplying generic category medicines to the Indian states which are already authorized by USFDA. Moreover Indian drug regulation is to be deeply understood by US regulator consequently better equipped US FDA will supervise Indian manufacturing units.
It furthers helps DCGI’S office in getting full exposure to current features of investigation, drug evaluation and approval processes.
USFDA is planning a risk evaluation and mitigation plans for several vital drugs globally in turn Indian drug regulators are being benefitted from such keen moves.
India as a base for Clinical Trials
Source: The Economic Times, 14th october'08
The investigational new drug (IND) filing process in the Indian regulatory system needs to change drastically to meet competitive challenges from China and Eastern Europe, geographies that are becoming powerhouses in clinical trials. India has made a mark in the low-end bio-equivalence testing for generic drugs, and western regulators are accepting Indian dossiers. It is, however, the more skill-based and high-tech process of doing phase I to III trials which are proving to be much more difficult.
In the past, Phase I trials were allowed only for Indian discovery molecules . This was done to stop Indians becoming “guinea pigs” for foreign companies. Phase II and onwards was allowed for other MNCs wanting to do a clinical study in India. Foreign companies did begin to do Phase 3 trials in India where this country became a part of the worldwide trials. Phase III and the other bio-equivalence work formed the bulk of the revenue of most of the CROs in India. India proved to be adept at following worldwide GCP (Good Clinical Practice ) methods and many scientists from abroad returned home to provide international methodology.
Bio-analytical work is also another lucrative technology process. Here, the Indian skill base is low and the cost of equipment is a few crores each. This kind of expensive equipment is not available in academic institutions and companies have to train fresh young recruits on these million-dollar machines. Eventually, the scientists are poached by other CROs and the cycle starts again. The government should start training bioanalytical scientists to fill this crucial and unmet need.
Recently, the drug regulator announced that the ban on Phase I studies by foreign companies is to be lifted . This makes eminent sense in the globalised world as it is becoming hard to determine what is “Indian.”
Many Indian companies may do parts of the research on foreign shores in their own subsidiaries and today’s NCE is being researched across the globe from Taiwan to Toronto. The expertise for approval of Phase I studies needs to be built whether the molecule is Indian or global.
The real hurdle is that the time taken to constitute the IND committee for a Phase I molecule is 6-8 months. From the time a proposal is made to the drug regulator, and it passes through the various health secretarial desks and an office order, it takes 6 months just for a committee to be formed. After this, the committee deliberates on the approval. In sharp contrast, the time taken for Phase I approval is just 28 days in Canada, Europe , the UK and other countries. India is lagging behind. At least 10 sitting committees must be formed by therapeutic areas (cardiology, oncology etc).
They can call on international skilled and experienced scientists to assist them. If we are to become the medicine maker to the world we must build world-class skills, quality and experience to provide affordable drugs not just for India but for the whole world. What is required is to ensure the key tenets of care, backed by solid, dynamic action, in turn rooted in deep knowledge. These are critical to the democratisation of healthcare and the reduction of disparities.
(The author is director, Piramal Healthcare)
The investigational new drug (IND) filing process in the Indian regulatory system needs to change drastically to meet competitive challenges from China and Eastern Europe, geographies that are becoming powerhouses in clinical trials. India has made a mark in the low-end bio-equivalence testing for generic drugs, and western regulators are accepting Indian dossiers. It is, however, the more skill-based and high-tech process of doing phase I to III trials which are proving to be much more difficult.
In the past, Phase I trials were allowed only for Indian discovery molecules . This was done to stop Indians becoming “guinea pigs” for foreign companies. Phase II and onwards was allowed for other MNCs wanting to do a clinical study in India. Foreign companies did begin to do Phase 3 trials in India where this country became a part of the worldwide trials. Phase III and the other bio-equivalence work formed the bulk of the revenue of most of the CROs in India. India proved to be adept at following worldwide GCP (Good Clinical Practice ) methods and many scientists from abroad returned home to provide international methodology.
Bio-analytical work is also another lucrative technology process. Here, the Indian skill base is low and the cost of equipment is a few crores each. This kind of expensive equipment is not available in academic institutions and companies have to train fresh young recruits on these million-dollar machines. Eventually, the scientists are poached by other CROs and the cycle starts again. The government should start training bioanalytical scientists to fill this crucial and unmet need.
Recently, the drug regulator announced that the ban on Phase I studies by foreign companies is to be lifted . This makes eminent sense in the globalised world as it is becoming hard to determine what is “Indian.”
Many Indian companies may do parts of the research on foreign shores in their own subsidiaries and today’s NCE is being researched across the globe from Taiwan to Toronto. The expertise for approval of Phase I studies needs to be built whether the molecule is Indian or global.
The real hurdle is that the time taken to constitute the IND committee for a Phase I molecule is 6-8 months. From the time a proposal is made to the drug regulator, and it passes through the various health secretarial desks and an office order, it takes 6 months just for a committee to be formed. After this, the committee deliberates on the approval. In sharp contrast, the time taken for Phase I approval is just 28 days in Canada, Europe , the UK and other countries. India is lagging behind. At least 10 sitting committees must be formed by therapeutic areas (cardiology, oncology etc).
They can call on international skilled and experienced scientists to assist them. If we are to become the medicine maker to the world we must build world-class skills, quality and experience to provide affordable drugs not just for India but for the whole world. What is required is to ensure the key tenets of care, backed by solid, dynamic action, in turn rooted in deep knowledge. These are critical to the democratisation of healthcare and the reduction of disparities.
(The author is director, Piramal Healthcare)
INDIA CHEM 2008
Department of Chemicals & Petrochemicals, India & FICCI has organised 5th International Exhibition & Conference " INDIA CHEM 2008".
Following are the details for exhibition & conference:
Duration: October 20-22, 2008
Venue: Bombay Exhibition Centre, Mumbai
The exhibition and conference is inaugrated on 20th october, 2008 at Hotel Intercontinental The Grand, Mumbai
The exhibition and conference has 4 concurrent focussed shows:
* Chemicals
* Petrochemicals
* Pharmaceuticals
* Technologies, Process Plant Machinery, Control & Automation Systems
Highlights of INDIA CHEM 2008
Over 250 Companies expected to participate
Active participation from potential PCPIR states
Buyer - seller meet by chemexcil & Pharmexcil
Chemexcil Pavilion and REACH Registration Facility
Conclave of International Chemical Councils organized by ICC
for further details contact:
Manoj Mehta
Federation House
tansen Marg
New Delhi - 110001
Tel: 011 - 32910411
Mob: 9891098772
Email: manoj105@rediffmail.com
Following are the details for exhibition & conference:
Duration: October 20-22, 2008
Venue: Bombay Exhibition Centre, Mumbai
The exhibition and conference is inaugrated on 20th october, 2008 at Hotel Intercontinental The Grand, Mumbai
The exhibition and conference has 4 concurrent focussed shows:
* Chemicals
* Petrochemicals
* Pharmaceuticals
* Technologies, Process Plant Machinery, Control & Automation Systems
Highlights of INDIA CHEM 2008
Over 250 Companies expected to participate
Active participation from potential PCPIR states
Buyer - seller meet by chemexcil & Pharmexcil
Chemexcil Pavilion and REACH Registration Facility
Conclave of International Chemical Councils organized by ICC
for further details contact:
Manoj Mehta
Federation House
tansen Marg
New Delhi - 110001
Tel: 011 - 32910411
Mob: 9891098772
Email: manoj105@rediffmail.com
Friday, October 17, 2008
bioLOGIC India 2008: Global Biopharmaceutical Conference
Terrapinn (B2B media ) is organizing 6th Global biopharmaceutical conference on the growing biopharmaceutical sector in India . Following are the details about the conference:
Venue : Marriott Hyderabad, India
Dates: : 17th – 20th November, 2008
The conference is the platform where international and Indian biopharmaceutical industry leaders convene to discuss biopharmaceutical manufacturing trends, opportunities, best manufacturing & operational practices & methodologies and where:
• International biopharmaceutical manufacturers share their outsourcing and partnership needs, and discuss different partnership models
• Indian and international biopharmaceutical production gurus gather to discuss the best manufacturing practices and operational strategies to achieve higher efficiency and profitability
• Indian biotech and biopharma leaders showcase their newest biopharmaceutical innovation to international licensors and investors
• Indian CMOs to showcase their manufacturing capability and capacity to global outsourcing partners
For more information on the conference programme or to register contact:
Mr. Amit Singh
Tel: (65) 6322 2772
Fax: (65) 6223 3554
Email: amit.singh@terrapinn.com
Venue : Marriott Hyderabad, India
Dates: : 17th – 20th November, 2008
The conference is the platform where international and Indian biopharmaceutical industry leaders convene to discuss biopharmaceutical manufacturing trends, opportunities, best manufacturing & operational practices & methodologies and where:
• International biopharmaceutical manufacturers share their outsourcing and partnership needs, and discuss different partnership models
• Indian and international biopharmaceutical production gurus gather to discuss the best manufacturing practices and operational strategies to achieve higher efficiency and profitability
• Indian biotech and biopharma leaders showcase their newest biopharmaceutical innovation to international licensors and investors
• Indian CMOs to showcase their manufacturing capability and capacity to global outsourcing partners
For more information on the conference programme or to register contact:
Mr. Amit Singh
Tel: (65) 6322 2772
Fax: (65) 6223 3554
Email: amit.singh@terrapinn.com
Thursday, October 16, 2008
Wednesday, October 15, 2008
Friday, October 10, 2008
BII At genzyme
BII organized a seminar for it's (Advance PG Programe in clinical trials,Research And Data Management) students at genzyme at its only facility at gurgoan.Purpose of seminar was to give exposure to a clinial research organization
Student's Feedback
- Session with Mr.himanshu was very constructive and helped us to get the insight of clinical trials and the management.
.It was very interactive session cum presentation.
We got to know lot about the prospects and application of clinical trials .We are looking forward for more such interactions with him.
I,from the behalf of students of BII,NOIDA(Advance PG Programe in clinical trials,Research And Data Management) Thanks for such knowledgeable and interactive sessions with him.
This was really a nice experience at genzyme.The Senior Programe coordinator of BII helps us a lot in having a full exposure of a clinical research organization
Tuesday, October 7, 2008
November 2008 Examinations
Dear Students of BII,
November 2008 examinations will be held on 8th and 9th November'08 i.e. Saturday and Sunday from 10 a.m to 2 p.m
Dispatching of Hall Tickets will begin from mid of October'08
For any query contact:
BII Support
0120-4320801/02
9818473366, 9810535368
All the Best for Examinations !
November 2008 examinations will be held on 8th and 9th November'08 i.e. Saturday and Sunday from 10 a.m to 2 p.m
Dispatching of Hall Tickets will begin from mid of October'08
For any query contact:
BII Support
0120-4320801/02
9818473366, 9810535368
All the Best for Examinations !
Monday, October 6, 2008
Why TO Join A Distance Participation Programe In Pharma Regulatory Affairs Only At BII ?
1. BII is regularly providing currently updated contents for its various modules in pharma regulatory affairs such as
· Pharma regulatory regime in US, EU and INDIA.
· Biomedical intellectual property management.
· Pharma regulation practices and procedures.
· Regulatory compliance for pharma and biotech products.
· Clinical trials and regulations.
· Good manufacturing practices,quality assurance and regulation.
· Reports on Indian patent law and pharmaceutical industry
2. Moreover the institute has its blog, BII blog. The Blog focuses and provides relevant and current news,technical and non technical articles and presentations whitepapers,various notification not only for pharma regulatory affairs but for its other regular and distance participation programe in clinical trials, bioinformatics any many more.
3. At BII students are supposed to write compulsory assingnments and research study. This exercise will enable them to think and innovate,so that they can grow and excel in the particular field.
4. One can view the representative list of our current and former pharma regulatory affairs students who are successfully placed and currently working at http://www.bii.in/
· Pharma regulatory regime in US, EU and INDIA.
· Biomedical intellectual property management.
· Pharma regulation practices and procedures.
· Regulatory compliance for pharma and biotech products.
· Clinical trials and regulations.
· Good manufacturing practices,quality assurance and regulation.
· Reports on Indian patent law and pharmaceutical industry
2. Moreover the institute has its blog, BII blog. The Blog focuses and provides relevant and current news,technical and non technical articles and presentations whitepapers,various notification not only for pharma regulatory affairs but for its other regular and distance participation programe in clinical trials, bioinformatics any many more.
3. At BII students are supposed to write compulsory assingnments and research study. This exercise will enable them to think and innovate,so that they can grow and excel in the particular field.
4. One can view the representative list of our current and former pharma regulatory affairs students who are successfully placed and currently working at http://www.bii.in/
Wednesday, October 1, 2008
Who Heads the Global Regulatory Authorities ?
| INDIA | DCG(I) Center and State Drugs Controllers States |
| USA | FDA Commissioner |
| CANADA | Director General |
| BRAZIL | President Director |
| AUSTRALIA | Therapeutic Good Administration (TGA) Director |
| MALAYSIA | Director, Drug Control Authority |
| CHINA | Director-SDA |
SOUTH AFRICA . | Registrar Medicines Control Council which is an independent body appointed by the Minister for Health |
| SOUTH KOREA | Director-Korea Food & Drugs Administration |
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