GUJPHARM
· Projects are invited from Pharma Academic and Research Centers.
· As Individual send your interest as I – Individuals / M - Team-group member / V-volunteers.
· Pharma companies needed for any services as a part of Gujpharm IIPC can be done are invited.
· For any further information and suggestions contact Dr Shrikalp Deshpande, 9427774447 shrikalp@gmail.com
GUJPHARM IIPC - GUJARAT PHARMA INSTITUTE INDUSTRY PARTNERSHIP CELL
Name of the Institute and contact persons
Code Title
A Animal (Pre-clinical)
A.1 Toxicity Studies
A.2 Evaluation Studies
A.3 Specific studies
A.4 Others
B Biotechnology
B.1 Non regulatory
B.2 Regulatory
B.3 others
C Clinical Research
C.1 BA
C.2 BE
C.3 Clinical Trials
C.4 PMS
C.5 Others
D Formulation & Development
D.1 Formulation problem
D.2 Stability studies
D.3 Platform Technology
D.4 Others
E Educational Certificate Courses
E.1 Regulatory Affairs
E.2 Biostatistics
E.3 GCP
E.4 GMP
E.5 GLP
E.6 IPR
E.7 Marketing
F Project Reports
G Regulatory Affairs & Documentation
G.1 Indian Regulatory
G.2 Documentation Preparation (CTD,
G.3 Others
H Herbal drugs
H.1 Formulation development & manufacturing
H.2 Formulation queries
H.3 Evaluation of drugs with marketed formulation
H.4 Others
I Marketing Research and Survey
I.1 Marketing projects
I.2 Marketing field survey
I.3 Special survey with Physicians, Experts…
I.4 Pharma segment survey in Gujarat
J Analytical Research
J.1Estimation method
J.2 Analytical method development (UV-Visible, HPLC /LC-MS etc )
J.3 Validation methods and study
J.4 others
K Event management
K.1 Seminar
K.2 Workshop
K.3 Symposium
K.4Conference
K.5 Others
Note:
Ethics Committee Permission
Animal Ethics Committee from IAEC
Clinical Ethics Committee from IRB / IEC
Many projects can be plan at Academic (Institute), Research Centre and Pharma Industry.
IAEC (CPCSEA) permission can be done at Institute having facilities of conducting research projects and CPCSEA registered animal house.
IRB/IEC approval is applicable for Clinical Research.
Sunday, November 8, 2009
Friday, September 4, 2009
Tuesday, April 21, 2009
4th News Letter
NEWS
ACADEMICS
KSV’s – K. B. Institute of Pharmaceutical Education and Research
Workshop on “Quality and Relevance in Research” was organized at KSV- Kadi Sarva Vishvavidyalaya on 14th April 2009 for Pharmacy and Biotechnology faculty and PhD students. The Key note address was given by Prof. R. K. Goyal, Vice Chancellor, M S University, Baroda. Other speakers were Dr Bhatt, Sun Agrigenetics P. Ltd., Baroda and Dr M. C. Sharma, Director, Biotecnology Dept. KSV
Anand Pharmacy College, Anand
Ms. Avani P.Shah student of M.Pharm pharmacology - Anand Pharmacy College, Anand has been the 1st student of Gujarat to be conferred with 54th Indian Pharmaceutical Congress(IPC) Award as " Outstanding Student of the year 2007-08 given by IPA- Indian Pharmaceutical Association.
Saurashtra University, Rajkot
The MOU between Saurashtra University and New Mexico University Workshop was organized by Saurashtra University, Rajkot on 11th April, 2009. On this occasion, a one day Workshop on RECENT ADVANCES IN GLOBAL HEALTHRESEARCH AND TELEMEDICINE was jointly organizing by Department Pharmaceutical Sciences and Faculty of Medicine of Saurashtra University, Rajkot (Gujarat). Dr. Pratap C. Shah, Urologist, and Faculty, Global Health, Univ. of New Mexico. Dr. Kamleshbhai Joshipura, Hon.Vice-Chancellor, Saurashtra University preside the function. Dr. D. K. shah, Dean, Faculty of Medicine and Prof. (Dr.) Navin Sheth, Head, Department of Pharma. Sciences welcome all the dignitaries and guests.Dr. Ravi Durvasula, Associate Professor and Chief of Medicine at the New Mexico Health Care System and Director, Global Health, Univ. of New Mexico., U.S.A.Dr. Dale Alverson, President of American Telemedicine Associaton, Professor of pediatrics at the Univ. of New Mexico, U.S.A. Dr. D. J. Perkins, director, Global and Geographic Medicine Program at Univ.of New Mexico, U.S.A. More than 100 delegates as dignitaries from health, research scientists, academicians from reputed medical and pharmacy colleges and medical personnel grace the occasion with their esteemed presence.
PHARMA INDUSTRY
The Economics Times April 16, 2009
Pharma cos have it tough this quarter
WEAK OVERSEAS DEMAND, HIGH INTEREST COSTS LIKELY TO PULL PROFITS DOWN
THE pharma sector is expected to be an underperformer during the fourth quarter of FY09. The growth in revenues and earnings is likely to be lower than that observed in the previous three quarters of the fiscal. High base-year effect for some companies, delay in US FDA approvals, lower demand in the exports market, increase in the receivable days and high interest cost for companies in debt are likely to adversely affect companies’ profits. Some respite is likely to come from the rupee depreciation of around 5% and easing off of raw material costs. With AS11 no longer mandatory, drug makers are not expected to report MTM loss on their foreign exchange borrowings. Average estimates of leading seven pharma companies by ETIG and five brokerages indicate 43% drop in net profits during the quarter ended March 2009, against the corresponding quarter in the previous year. Revenues are expected to increase by a modest 6% y-o-y. The net profit margin is estimated to drop by 957 bps to 11.4% for the quarter ended March 2009. While Ranbaxy is estimated to report a loss due to its ongoing issues with US FDA, companies like Sun Pharma, Piramal Healthcare and Dr Reddy’s are likely to report a significant drop in their profits. In absence of exclusivities that were enjoyed during the fourth quarter last year, Sun Pharma is likely to report a drop in revenues and earnings. DRL’s profits are likely to be dented on account of writeoffs by its German subsidiary. Piramal Healthcare is expected to report a drop in profit due to one-time writeback of NCE research expenses in Q4 FY08. While the pricing pressures in overseas markets of Europe and North America continued, the quarter also witnessed increase in US FDA’s scrutiny of the regulatory compliance practices followed by domestic pharma companies. Many Indian companies are now facing increased inspection and enquiries by the US healthcare agency.
The Economics Times April 15, 2009
Breach of clinical trial norms may invite 10 years in jail
Govt May Amend Law; Violation May Also Attract Cancellation Of Licence
THE government plans to amend the Drugs & Cosmetics Act to slap up to 10 years’ imprisonment and cancellation of licence for violating norms for testing drugs on humans in India, a government official said. “The new set of guidelines would ensure that those who do not follow the norms approved by the Drug Controller General of India (DCGI) for conducting clinical trials on humans are brought to book and punished,” Dr Vishwa Mohan Katoch, secretary in the department of health research and director general of the Indian Council of Medical Research (ICMR), told ET. The move comes in the wake of the drug regulator’s failure to take action against several companies even after finding gaps in their clinical trials during audits, due to the absence of legal provisions. The proposed guidelines for conducting clinical trials of experimental drugs in India, framed by ICMR, have been approved by the ministries of law and health. The move is intended to improve the country’s image in this area, which has been sullied by some cases of alleged unethical and sub-standard practices. India has become a hub for clinical trials of drugs with a clinical research market estimated at $389 million, which is forecast to touch $1 billion by 2010. Having a tough, credible regulatory set-up is crucial to enable the growth of this industry while protecting the rights of Indians who volunteer to become test subjects. India does not allow Phase 1 trials, or initial experimentation on human subjects after a drug is found effective on laboratory animals, for molecules developed abroad. This prevents Indians from being the initial guinea pigs for foreign drug companies. Recently, DCGI conducted the first audit of a clinical trial for Wyeth’s advanced pneumonia vaccine after an infant’s death was reported during the trial last October. It turned out that the child had been administered not the experimental vaccine but an already licensed, widely distributed vaccine in the double-blind study. Health ministry wants separate provision to check offenders BUT the child should not have been enrolled in the study at all on account of a cardiac condition it suffered from, the drug regulator’s audit had found. However, in the absence of legal provisions, the regulator is still weighing future action in this case. In another incident last year, 49 children died during clinical trials at the country’s premier medical institution All India Institute of Medical Sciences. Later, a high-level committee found that none of the drugs had been tested on healthy children and rather they were suffering from highrisk illnesses and were also in a serious condition. “Even as the DCGI prescribes certain protocols while allowing any company to conduct clinical trial, it does not have statutory powers to punish companies that do not follow these guidelines or violate any norms,” said a health ministry official who asked not to be named. The most important part of these guidelines is that the person undergoing the experiment is informed about the risks involved while giving consent. The norms also specify the eligibility of a human subject to participate in the experiment. The health ministry now plans to bring in a separate provision in the Drugs and Cosmetics Act to deal with offenders to check unethical human experiments in India. So far, India has established only voluntary guidelines for testing experimental drugs on humans. Drugmakers as well as companies which do such experiments for a fee may choose to register themselves with the ICMR or with the World Health Organisation (WHO). But this is not yet mandatory. According to critics like All India People’s Science Network secretary Amit Sengupta, the government move is too little too late. The government relaxed earlier laws to allow clinical trials of drugs developed in foreign countries and now Indians are treated as guinea pigs to promote clinical research organisations who are sub-contractors of foreign multinationals, he said. “In this background, if the government wants to safeguard public interest, this is bolting the door after the horse has run away,” Mr Sengupta said. Experts also say very few pathology laboratories in India follow good laboratory practices and the data they generate are often fake. There is also a lack of adequate infrastructure and expertise for conducting clinical trial.
ACADEMICS
KSV’s – K. B. Institute of Pharmaceutical Education and Research
Workshop on “Quality and Relevance in Research” was organized at KSV- Kadi Sarva Vishvavidyalaya on 14th April 2009 for Pharmacy and Biotechnology faculty and PhD students. The Key note address was given by Prof. R. K. Goyal, Vice Chancellor, M S University, Baroda. Other speakers were Dr Bhatt, Sun Agrigenetics P. Ltd., Baroda and Dr M. C. Sharma, Director, Biotecnology Dept. KSV
Anand Pharmacy College, Anand
Ms. Avani P.Shah student of M.Pharm pharmacology - Anand Pharmacy College, Anand has been the 1st student of Gujarat to be conferred with 54th Indian Pharmaceutical Congress(IPC) Award as " Outstanding Student of the year 2007-08 given by IPA- Indian Pharmaceutical Association.
Saurashtra University, Rajkot
The MOU between Saurashtra University and New Mexico University Workshop was organized by Saurashtra University, Rajkot on 11th April, 2009. On this occasion, a one day Workshop on RECENT ADVANCES IN GLOBAL HEALTHRESEARCH AND TELEMEDICINE was jointly organizing by Department Pharmaceutical Sciences and Faculty of Medicine of Saurashtra University, Rajkot (Gujarat). Dr. Pratap C. Shah, Urologist, and Faculty, Global Health, Univ. of New Mexico. Dr. Kamleshbhai Joshipura, Hon.Vice-Chancellor, Saurashtra University preside the function. Dr. D. K. shah, Dean, Faculty of Medicine and Prof. (Dr.) Navin Sheth, Head, Department of Pharma. Sciences welcome all the dignitaries and guests.Dr. Ravi Durvasula, Associate Professor and Chief of Medicine at the New Mexico Health Care System and Director, Global Health, Univ. of New Mexico., U.S.A.Dr. Dale Alverson, President of American Telemedicine Associaton, Professor of pediatrics at the Univ. of New Mexico, U.S.A. Dr. D. J. Perkins, director, Global and Geographic Medicine Program at Univ.of New Mexico, U.S.A. More than 100 delegates as dignitaries from health, research scientists, academicians from reputed medical and pharmacy colleges and medical personnel grace the occasion with their esteemed presence.
PHARMA INDUSTRY
The Economics Times April 16, 2009
Pharma cos have it tough this quarter
WEAK OVERSEAS DEMAND, HIGH INTEREST COSTS LIKELY TO PULL PROFITS DOWN
THE pharma sector is expected to be an underperformer during the fourth quarter of FY09. The growth in revenues and earnings is likely to be lower than that observed in the previous three quarters of the fiscal. High base-year effect for some companies, delay in US FDA approvals, lower demand in the exports market, increase in the receivable days and high interest cost for companies in debt are likely to adversely affect companies’ profits. Some respite is likely to come from the rupee depreciation of around 5% and easing off of raw material costs. With AS11 no longer mandatory, drug makers are not expected to report MTM loss on their foreign exchange borrowings. Average estimates of leading seven pharma companies by ETIG and five brokerages indicate 43% drop in net profits during the quarter ended March 2009, against the corresponding quarter in the previous year. Revenues are expected to increase by a modest 6% y-o-y. The net profit margin is estimated to drop by 957 bps to 11.4% for the quarter ended March 2009. While Ranbaxy is estimated to report a loss due to its ongoing issues with US FDA, companies like Sun Pharma, Piramal Healthcare and Dr Reddy’s are likely to report a significant drop in their profits. In absence of exclusivities that were enjoyed during the fourth quarter last year, Sun Pharma is likely to report a drop in revenues and earnings. DRL’s profits are likely to be dented on account of writeoffs by its German subsidiary. Piramal Healthcare is expected to report a drop in profit due to one-time writeback of NCE research expenses in Q4 FY08. While the pricing pressures in overseas markets of Europe and North America continued, the quarter also witnessed increase in US FDA’s scrutiny of the regulatory compliance practices followed by domestic pharma companies. Many Indian companies are now facing increased inspection and enquiries by the US healthcare agency.
The Economics Times April 15, 2009
Breach of clinical trial norms may invite 10 years in jail
Govt May Amend Law; Violation May Also Attract Cancellation Of Licence
THE government plans to amend the Drugs & Cosmetics Act to slap up to 10 years’ imprisonment and cancellation of licence for violating norms for testing drugs on humans in India, a government official said. “The new set of guidelines would ensure that those who do not follow the norms approved by the Drug Controller General of India (DCGI) for conducting clinical trials on humans are brought to book and punished,” Dr Vishwa Mohan Katoch, secretary in the department of health research and director general of the Indian Council of Medical Research (ICMR), told ET. The move comes in the wake of the drug regulator’s failure to take action against several companies even after finding gaps in their clinical trials during audits, due to the absence of legal provisions. The proposed guidelines for conducting clinical trials of experimental drugs in India, framed by ICMR, have been approved by the ministries of law and health. The move is intended to improve the country’s image in this area, which has been sullied by some cases of alleged unethical and sub-standard practices. India has become a hub for clinical trials of drugs with a clinical research market estimated at $389 million, which is forecast to touch $1 billion by 2010. Having a tough, credible regulatory set-up is crucial to enable the growth of this industry while protecting the rights of Indians who volunteer to become test subjects. India does not allow Phase 1 trials, or initial experimentation on human subjects after a drug is found effective on laboratory animals, for molecules developed abroad. This prevents Indians from being the initial guinea pigs for foreign drug companies. Recently, DCGI conducted the first audit of a clinical trial for Wyeth’s advanced pneumonia vaccine after an infant’s death was reported during the trial last October. It turned out that the child had been administered not the experimental vaccine but an already licensed, widely distributed vaccine in the double-blind study. Health ministry wants separate provision to check offenders BUT the child should not have been enrolled in the study at all on account of a cardiac condition it suffered from, the drug regulator’s audit had found. However, in the absence of legal provisions, the regulator is still weighing future action in this case. In another incident last year, 49 children died during clinical trials at the country’s premier medical institution All India Institute of Medical Sciences. Later, a high-level committee found that none of the drugs had been tested on healthy children and rather they were suffering from highrisk illnesses and were also in a serious condition. “Even as the DCGI prescribes certain protocols while allowing any company to conduct clinical trial, it does not have statutory powers to punish companies that do not follow these guidelines or violate any norms,” said a health ministry official who asked not to be named. The most important part of these guidelines is that the person undergoing the experiment is informed about the risks involved while giving consent. The norms also specify the eligibility of a human subject to participate in the experiment. The health ministry now plans to bring in a separate provision in the Drugs and Cosmetics Act to deal with offenders to check unethical human experiments in India. So far, India has established only voluntary guidelines for testing experimental drugs on humans. Drugmakers as well as companies which do such experiments for a fee may choose to register themselves with the ICMR or with the World Health Organisation (WHO). But this is not yet mandatory. According to critics like All India People’s Science Network secretary Amit Sengupta, the government move is too little too late. The government relaxed earlier laws to allow clinical trials of drugs developed in foreign countries and now Indians are treated as guinea pigs to promote clinical research organisations who are sub-contractors of foreign multinationals, he said. “In this background, if the government wants to safeguard public interest, this is bolting the door after the horse has run away,” Mr Sengupta said. Experts also say very few pathology laboratories in India follow good laboratory practices and the data they generate are often fake. There is also a lack of adequate infrastructure and expertise for conducting clinical trial.
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