Pharmacovigilance Risk Assessment Committee concludes review of Valdoxan/Thymanax United Kingdom
The Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its regular benefit-risk assessment (known as a periodic safety update report or PSUR) of Valdoxan/Thymanax (agomelatine), two identical medicines used to treat major depression in adults.
As part of this assessment, the PRAC looked at cumulative data on severe side effects on the liver with Valdoxan/Thymanax and recommended further measures to minimise this risk, particularly in vulnerable populations.
The PRAC recommended that the warnings in the product information regarding liver injury be strengthened to further clarify that liver function tests should be performed before and regularly during treatment. As patients aged 75 years and above may be at an increased risk of severe side effects on the liver and beneficial effects have not been documented in these patients, the Committee recommended that Valdoxan/Thymanax should now be contraindicated in patients aged 75 and above. The Committee further recommended that a letter be sent to healthcare professionals to inform them of these changes.
The PRAC recommendations will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) which will issue the Agency’s final opinion with clear guidance to patients and healthcare professionals at its next meeting of 22-25 September 2014.
The PRAC was established in July 2012. Over its first two years the Committee’s central role in patient safety has been demonstrated.
Proactivity in pharmacovigilance is key, and as such, risk management planning constitutes an important part of the PRAC’s work. The Committee assesses risk-management plans (RMPs), submitted by companies before a medicine can be authorised. These include measures to be taken in order to prevent or minimise the medicine's risks in patients and are regularly updated as new information becomes available. It also looks at the design and results of post-authorisation safety studies of authorised medicines, which are carried out to obtain further information on their safety. In its first two years the Committee conducted more than 600 reviews of risk management plans and 150 reviews of protocols for post-authorisation safety studies.
Overseeing the safety of a medicine once it is used to treat patients in the European Union (EU) is a core task of the PRAC. The Committee evaluates periodic safety update reports (PSURs) to re-assess the benefit-risk balance of a medicine throughout its lifecycle on the basis of new data collected. More than 650 PSUR reviews have been carried out by the PRAC since it was established.
Another important part of the PRAC’s work is the Committee’s involvement in referral procedures. Referrals are started because of concerns over the safety or the benefit-risk balance of a medicine or a class of medicines. In such procedures, the PRAC evaluates all available data to make a recommendation for a harmonised position across the EU on whether marketing authorisations should be maintained, varied, suspended or withdrawn. Over the last two years, following triggers from Member States and the European Commission, the Committee has started 31 referrals to assess safety concerns of medicines, and issued 23 recommendations on their safe and effective use.
The assessment and management of safety signals is also a key pharmacovigilance function performed by the PRAC. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. In its first two years of operation, 163 signals have been managed by the Committee, the majority resulting in recommendations for changes to product information for patients and healthcare professionals.
The EMA has launched a public consultation on draft rules of procedures for public hearings to be held by the PRAC. Comments are invited until 15 October 2014 and should be sent to public-hearings@ema.europa.eu using the comments submission form.
The rules of procedures describe the process and practical arrangements for the preparation, conduct and follow-up of public hearings.
Public hearings are a new tool for the EMA to engage EU citizens in the regulatory process of the supervision of medicines and to listen to their views and experiences. The contributions made by the public during a public hearing will be considered by the PRAC and inform the Committee’s decision-making.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84047&sid=2
As part of this assessment, the PRAC looked at cumulative data on severe side effects on the liver with Valdoxan/Thymanax and recommended further measures to minimise this risk, particularly in vulnerable populations.
The PRAC recommended that the warnings in the product information regarding liver injury be strengthened to further clarify that liver function tests should be performed before and regularly during treatment. As patients aged 75 years and above may be at an increased risk of severe side effects on the liver and beneficial effects have not been documented in these patients, the Committee recommended that Valdoxan/Thymanax should now be contraindicated in patients aged 75 and above. The Committee further recommended that a letter be sent to healthcare professionals to inform them of these changes.
The PRAC recommendations will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) which will issue the Agency’s final opinion with clear guidance to patients and healthcare professionals at its next meeting of 22-25 September 2014.
The PRAC was established in July 2012. Over its first two years the Committee’s central role in patient safety has been demonstrated.
Proactivity in pharmacovigilance is key, and as such, risk management planning constitutes an important part of the PRAC’s work. The Committee assesses risk-management plans (RMPs), submitted by companies before a medicine can be authorised. These include measures to be taken in order to prevent or minimise the medicine's risks in patients and are regularly updated as new information becomes available. It also looks at the design and results of post-authorisation safety studies of authorised medicines, which are carried out to obtain further information on their safety. In its first two years the Committee conducted more than 600 reviews of risk management plans and 150 reviews of protocols for post-authorisation safety studies.
Overseeing the safety of a medicine once it is used to treat patients in the European Union (EU) is a core task of the PRAC. The Committee evaluates periodic safety update reports (PSURs) to re-assess the benefit-risk balance of a medicine throughout its lifecycle on the basis of new data collected. More than 650 PSUR reviews have been carried out by the PRAC since it was established.
Another important part of the PRAC’s work is the Committee’s involvement in referral procedures. Referrals are started because of concerns over the safety or the benefit-risk balance of a medicine or a class of medicines. In such procedures, the PRAC evaluates all available data to make a recommendation for a harmonised position across the EU on whether marketing authorisations should be maintained, varied, suspended or withdrawn. Over the last two years, following triggers from Member States and the European Commission, the Committee has started 31 referrals to assess safety concerns of medicines, and issued 23 recommendations on their safe and effective use.
The assessment and management of safety signals is also a key pharmacovigilance function performed by the PRAC. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. In its first two years of operation, 163 signals have been managed by the Committee, the majority resulting in recommendations for changes to product information for patients and healthcare professionals.
The EMA has launched a public consultation on draft rules of procedures for public hearings to be held by the PRAC. Comments are invited until 15 October 2014 and should be sent to public-hearings@ema.europa.eu using the comments submission form.
The rules of procedures describe the process and practical arrangements for the preparation, conduct and follow-up of public hearings.
Public hearings are a new tool for the EMA to engage EU citizens in the regulatory process of the supervision of medicines and to listen to their views and experiences. The contributions made by the public during a public hearing will be considered by the PRAC and inform the Committee’s decision-making.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84047&sid=2
SRL Diagnostics imparts Msc, PhD courses in biotechnology in collaboration with Mumbai University Our Bureau, Mumbai
With an objective to provide a platform for innovation in the diagnostics, SRL Diagnostics has been conducting MSc and PhD courses in biotechnology in collaboration with Mumbai University. Interestingly, their research and development division which drives all the academic programmes at SRL is recognised by DSIR for research and for academic courses by Mumbai University and Maharashtra University of Health Sciences
The fellowship programme in molecular pathology is recognised by the Maharashtra University of Health Sciences and has been covered under their curriculum for several years.
In fact SRL is the only diagnostic centre that offers MSc by research and PhD degrees recognised by the Mumbai University and the fellowship course in molecular pathology (FMP) which is conducted exclusively by them.
Through this initiative their objective is to introduce academic courses so that students understand the value of thinking beyond discovery and innovation, sustain the culture of continuing education (CE) amongst the faculties and scientific officers. It also aims to give back to the society the learning SRL has gained through its existence and create evidenced based information through research publications in various peer reviewed journals.
SRL is by far the largest clinical diagnostic laboratory network in India and has an enormous strength in terms of diagnostic know how, expert faculty and a strong R&D push-unmatched in the private diagnostic sector in India. The R&D of SRL diagnostics have published 55 research papers in peer reviewed journals, in which many break through ideas like unique prediction of heart failure and non- invasive tools for liver fibrosis were introduced. The R&D department of SRL Diagnostics also coordinates with continued medical education (CME) programs for clinicians to increase awareness about advances in diagnostics and its impact on the management of health conditions
http://www.pharmabiz.com/NewsDetails.aspx?aid=84046&sid=2
The fellowship programme in molecular pathology is recognised by the Maharashtra University of Health Sciences and has been covered under their curriculum for several years.
In fact SRL is the only diagnostic centre that offers MSc by research and PhD degrees recognised by the Mumbai University and the fellowship course in molecular pathology (FMP) which is conducted exclusively by them.
Through this initiative their objective is to introduce academic courses so that students understand the value of thinking beyond discovery and innovation, sustain the culture of continuing education (CE) amongst the faculties and scientific officers. It also aims to give back to the society the learning SRL has gained through its existence and create evidenced based information through research publications in various peer reviewed journals.
SRL is by far the largest clinical diagnostic laboratory network in India and has an enormous strength in terms of diagnostic know how, expert faculty and a strong R&D push-unmatched in the private diagnostic sector in India. The R&D of SRL diagnostics have published 55 research papers in peer reviewed journals, in which many break through ideas like unique prediction of heart failure and non- invasive tools for liver fibrosis were introduced. The R&D department of SRL Diagnostics also coordinates with continued medical education (CME) programs for clinicians to increase awareness about advances in diagnostics and its impact on the management of health conditions
http://www.pharmabiz.com/NewsDetails.aspx?aid=84046&sid=2
Aware launches INQUIRE software for text-based identity data management & analytics Bedford, Massachusetts
Aware, Inc, leading global provider of biometrics software and services, introduced a new software development kit product called INQUIRE, an acronym for "Information Quality and Identity Resolution Engine."
INQUIRE uses advanced text-based filter, search, match, and link algorithms to provide a variety of useful identity data processing and analysis functions that are complementary to biometric search and match operations. Capabilities enabled by INQUIRE include data integration, data quality analysis, identity resolution, fuzzy text search and match with similarity scoring, name and address matching, link analysis, and biometric pre-and post-search filtering. INQUIRE is not a platform, but rather a lightweight SDK that can be incorporated by developers into the workflows of their client- and server-based applications. Alternatively, INQUIRE may be deployed as a software module with Aware's Biometric Services Platform (BioSP).
"Aware's introduction of INQUIRE reflects the usefulness of text-based identity data in biometric systems," commented David Benini, VP of marketing at Aware. "The ability to interpret textual identity data adds a dimension of analysis that is powerful not only for discovery of insightful identity information, but also towards characterizing identity data and optimising its effectiveness. By bundling these algorithms in an SDK form factor, INQUIRE gives developers the flexibility to apply them in a highly customisable fashion towards enhancing and optimising end-user solutions."
Aware will provide demonstrations of INQUIRE and other software products in its booth at the Global Identity Summit, formerly known as the Biometrics Consortium Conference and Technology Expo, taking place September 16-18 in Tampa.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84045&sid=2
INQUIRE uses advanced text-based filter, search, match, and link algorithms to provide a variety of useful identity data processing and analysis functions that are complementary to biometric search and match operations. Capabilities enabled by INQUIRE include data integration, data quality analysis, identity resolution, fuzzy text search and match with similarity scoring, name and address matching, link analysis, and biometric pre-and post-search filtering. INQUIRE is not a platform, but rather a lightweight SDK that can be incorporated by developers into the workflows of their client- and server-based applications. Alternatively, INQUIRE may be deployed as a software module with Aware's Biometric Services Platform (BioSP).
"Aware's introduction of INQUIRE reflects the usefulness of text-based identity data in biometric systems," commented David Benini, VP of marketing at Aware. "The ability to interpret textual identity data adds a dimension of analysis that is powerful not only for discovery of insightful identity information, but also towards characterizing identity data and optimising its effectiveness. By bundling these algorithms in an SDK form factor, INQUIRE gives developers the flexibility to apply them in a highly customisable fashion towards enhancing and optimising end-user solutions."
Aware will provide demonstrations of INQUIRE and other software products in its booth at the Global Identity Summit, formerly known as the Biometrics Consortium Conference and Technology Expo, taking place September 16-18 in Tampa.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84045&sid=2
Fortis Healthcare, NDTV collaborates to launch NDTV Fortis Health4U campaign Our Bureau, Mumbai
With a view to address raising concerns due to non-communicable diseases which has almost doubled in the last decade compared to communicable diseases, Fortis healthcare in partnership with NDTV recently launched the NDTV Fortis Health4U initiative, urging people to take control of their health. Since cardiovascular diseases amongst Indians have greatly increased, through this campaign they aim to promote healthy living as a way of life, raise awareness about taking health precautions to avoid adverse health issues by acting in time.
The campaign will also educate people about the importance of precautionary measures and train them in cardiopulmonary resuscitation (CPR), so that they can be prepared to handle cardiac emergencies which can occur at any time.
It is understood that cardiac diseases are claiming 3.5 times more lives than cancer and are responsible for three times more deaths than tuberculosis in India. NDTV Fortis Health4U campaign will not only focus on prevention and lifestyle modifications but will also educate people about how timely diagnosis and CPR training can help save lives.
As a part of the initiative and lead up to the World Heart Day on September 29, cardiopulmonary resuscitation (CPR) training sessions would be organised across multiple cities. These on-site camps will train and impart a life-saving skill that is essential for people to save a life.
NDTV Fortis Health4U campaign will also showcase stories of the myriad problems arising from neglecting early signs, ignoring routine check-ups; highlight stories of patients suffering from coronary heart disease and of those born with congenital heart defects. Success stories of recovery aimed at encouraging and counselling others would also be showcased.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84048&sid=2
The campaign will also educate people about the importance of precautionary measures and train them in cardiopulmonary resuscitation (CPR), so that they can be prepared to handle cardiac emergencies which can occur at any time.
It is understood that cardiac diseases are claiming 3.5 times more lives than cancer and are responsible for three times more deaths than tuberculosis in India. NDTV Fortis Health4U campaign will not only focus on prevention and lifestyle modifications but will also educate people about how timely diagnosis and CPR training can help save lives.
As a part of the initiative and lead up to the World Heart Day on September 29, cardiopulmonary resuscitation (CPR) training sessions would be organised across multiple cities. These on-site camps will train and impart a life-saving skill that is essential for people to save a life.
NDTV Fortis Health4U campaign will also showcase stories of the myriad problems arising from neglecting early signs, ignoring routine check-ups; highlight stories of patients suffering from coronary heart disease and of those born with congenital heart defects. Success stories of recovery aimed at encouraging and counselling others would also be showcased.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84048&sid=2
Gilead partners with 7 Indian pharma cos to expand its access to hep C drugs in developing countries Our Bureau, Mumbai
Gilead Sciences entered into an non-exclusive licencing agreements with seven India-based generic pharma manufacturers to expand access to its chronic hepatitis C medicines in developing countries. The countries within the agreement account for more than 100 million people living with hepatitis C, representing 54 per cent of the total global infected population.
The agreements allows Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab- to manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries.
"Hepatitis C is a significant public health issue worldwide, and Gilead is working to make its accessible to as many patients, in as many places, as quickly as possible. In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries," said, Gregg H. Alton, executive vice president, corporate and medical affairs, Gilead Sciences.
Under the licensing agreements, the Indian companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible. The licensees also set their own prices for the generic product they produce, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities. The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.
Sofosbuvir was approved under the trade name Sovaldi by the US Food and Drug Administration (FDA) in December 2013 and by the European Commission in January 2014. The FDA and the European Medicines Agency are currently reviewing the company's applications for a single tablet regimen of ledipasvir/sofosbuvir; which is an investigational agent with its safety and efficacy not established.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84050&sid=2
The agreements allows Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab- to manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries.
"Hepatitis C is a significant public health issue worldwide, and Gilead is working to make its accessible to as many patients, in as many places, as quickly as possible. In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries," said, Gregg H. Alton, executive vice president, corporate and medical affairs, Gilead Sciences.
Under the licensing agreements, the Indian companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible. The licensees also set their own prices for the generic product they produce, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities. The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.
Sofosbuvir was approved under the trade name Sovaldi by the US Food and Drug Administration (FDA) in December 2013 and by the European Commission in January 2014. The FDA and the European Medicines Agency are currently reviewing the company's applications for a single tablet regimen of ledipasvir/sofosbuvir; which is an investigational agent with its safety and efficacy not established.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84050&sid=2
Yashoda Hospitals ties up with Jeevandan to sensitise people about organ donation Our Bureau, Mumbai
Yashoda Group of Hospitals in association with government institution named Jeevandan initiated an organ donation drive recently in Hyderabad. Through this initiative they aimed at driving home the fact, that organ donation can comfort and heal millions of grieving families as donors can actually save and improve lives of many.
This timely initiative got a grand success with an overwhelming response and participation from over 4,600 people. Despite India being the world's second most populous country, it has a donation rate of just 0.26 per million population compared to 26 in the US, 35 in Spain and 36.5 in Croatia: the highest organ donation rate in the world. In fact, poor awareness levels and superstitious beliefs are the major hurdles.
It is estimated that over 5,00,000 people die every year in India awaiting organ donors and 3 per cent of patients awaiting a kidney transplant actually get only one. 1,00,000 people are on the waiting list for corneal transplants at any given time, while almost 2,00,000 patients die every year for want of donor livers.
It is understood that a single donor can save up to seven lives so everyone should proudly come forward, participate and pass on the gift of life to many, which is the vision for this entire initiative.
According to Dr G S Rao, managing director, Yashoda Group of Hospitals, 'This is truly an important event as we endeavour to increase the awareness level, dispel superstitious beliefs and to make it clear that there is an ever increasing demand for organ donors. The waiting-list for patients with heart, lung, pancreas and liver failure requiring transplants is growing all the time as well.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84052&sid=2
This timely initiative got a grand success with an overwhelming response and participation from over 4,600 people. Despite India being the world's second most populous country, it has a donation rate of just 0.26 per million population compared to 26 in the US, 35 in Spain and 36.5 in Croatia: the highest organ donation rate in the world. In fact, poor awareness levels and superstitious beliefs are the major hurdles.
It is estimated that over 5,00,000 people die every year in India awaiting organ donors and 3 per cent of patients awaiting a kidney transplant actually get only one. 1,00,000 people are on the waiting list for corneal transplants at any given time, while almost 2,00,000 patients die every year for want of donor livers.
It is understood that a single donor can save up to seven lives so everyone should proudly come forward, participate and pass on the gift of life to many, which is the vision for this entire initiative.
According to Dr G S Rao, managing director, Yashoda Group of Hospitals, 'This is truly an important event as we endeavour to increase the awareness level, dispel superstitious beliefs and to make it clear that there is an ever increasing demand for organ donors. The waiting-list for patients with heart, lung, pancreas and liver failure requiring transplants is growing all the time as well.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84052&sid=2
Yashoda Hospitals ties up with Jeevandan to sensitise people about organ donation Our Bureau, Mumbai
Yashoda Group of Hospitals in association with government institution named Jeevandan initiated an organ donation drive recently in Hyderabad. Through this initiative they aimed at driving home the fact, that organ donation can comfort and heal millions of grieving families as donors can actually save and improve lives of many.
This timely initiative got a grand success with an overwhelming response and participation from over 4,600 people. Despite India being the world's second most populous country, it has a donation rate of just 0.26 per million population compared to 26 in the US, 35 in Spain and 36.5 in Croatia: the highest organ donation rate in the world. In fact, poor awareness levels and superstitious beliefs are the major hurdles.
It is estimated that over 5,00,000 people die every year in India awaiting organ donors and 3 per cent of patients awaiting a kidney transplant actually get only one. 1,00,000 people are on the waiting list for corneal transplants at any given time, while almost 2,00,000 patients die every year for want of donor livers.
It is understood that a single donor can save up to seven lives so everyone should proudly come forward, participate and pass on the gift of life to many, which is the vision for this entire initiative.
According to Dr G S Rao, managing director, Yashoda Group of Hospitals, 'This is truly an important event as we endeavour to increase the awareness level, dispel superstitious beliefs and to make it clear that there is an ever increasing demand for organ donors. The waiting-list for patients with heart, lung, pancreas and liver failure requiring transplants is growing all the time as well.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84052&sid=2
This timely initiative got a grand success with an overwhelming response and participation from over 4,600 people. Despite India being the world's second most populous country, it has a donation rate of just 0.26 per million population compared to 26 in the US, 35 in Spain and 36.5 in Croatia: the highest organ donation rate in the world. In fact, poor awareness levels and superstitious beliefs are the major hurdles.
It is estimated that over 5,00,000 people die every year in India awaiting organ donors and 3 per cent of patients awaiting a kidney transplant actually get only one. 1,00,000 people are on the waiting list for corneal transplants at any given time, while almost 2,00,000 patients die every year for want of donor livers.
It is understood that a single donor can save up to seven lives so everyone should proudly come forward, participate and pass on the gift of life to many, which is the vision for this entire initiative.
According to Dr G S Rao, managing director, Yashoda Group of Hospitals, 'This is truly an important event as we endeavour to increase the awareness level, dispel superstitious beliefs and to make it clear that there is an ever increasing demand for organ donors. The waiting-list for patients with heart, lung, pancreas and liver failure requiring transplants is growing all the time as well.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84052&sid=2
PCI to expedite all existing registration tribunals into state pharmacy councils soon Shardul Nautiyal, Mumbai
Against the backdrop of recent cases of fake pharmacy registrations in UP, Maharashtra, Assam, Pharmacy Council of India (PCI) is planning to expedite the evolution of existing registration tribunals into councils. As per the PCI official, states in the North East like Sikkim and newly formed states like Jharkhand are working towards forming state pharmacy councils.
While Sikkim does not have a state pharmacy council, Jharkhand is having a Registration Tribunal. Manipur Pharmacist Registration Tribunal has recently evolved into a full fledged council.
Says Dr B Suresh, president, PCI, "Pharmacy Council of India (PCI) has decided to expedite the evolution of existing registration tribunals in Sikkim and Jharkhand into full fledged councils. Ever since the country got its independence, there were no state pharmacy councils and it was mandated by the Pharmacy Act, 1948 to first form a registration tribunal which would gradually evolve into a council. Many of the states did not try to do the same initially but most of the states today have pharmacy councils except a few in the North East and newly divided states. It has got delayed and we are now putting pressures on the states to do the same."
The growing cases of fake registrations, explains an official, is the outcome of the misuse of powers by the registration tribunals which were actually constituted to bifurcate the register of pharmacists for administrative purpose as provisioned under the law.
As per section 30 of the Pharmacy Act, 1948, for the purpose of preparing the first register, the State Government shall by notification in the official gazette constitute a Registration Tribunal consisting of three persons, and shall also appoint a Registrar who shall act as Secretary of the Registration Tribunal.
The Registrar shall amend the register in accordance with the decisions of the authority appointed under sub section (4) of section 30 and shall thereupon issue to every person whose name is entered in the register a certificate of registration in the prescribed form.
The Assam Pharmacy Council (APC) is in the process of scrutinising 1500 documents related to a fake registration racket involving 2900 pharmacists in the state. These pharmacists were earlier registered with the Registration Tribunals of other states. As per official records, APC today has 9000 registrations of which 2500 pharmacists are working in the government sector alone.
Informs Munindra Deka, registrar, APC, "After scrutinising documents related to the fake registration racket, the state government would be consulted on the matter to take appropriate action for curbing the malpractices. Drug licences will also be cancelled subsequent to cancelling of the registrations."
http://www.pharmabiz.com/NewsDetails.aspx?aid=84033&sid=1
While Sikkim does not have a state pharmacy council, Jharkhand is having a Registration Tribunal. Manipur Pharmacist Registration Tribunal has recently evolved into a full fledged council.
Says Dr B Suresh, president, PCI, "Pharmacy Council of India (PCI) has decided to expedite the evolution of existing registration tribunals in Sikkim and Jharkhand into full fledged councils. Ever since the country got its independence, there were no state pharmacy councils and it was mandated by the Pharmacy Act, 1948 to first form a registration tribunal which would gradually evolve into a council. Many of the states did not try to do the same initially but most of the states today have pharmacy councils except a few in the North East and newly divided states. It has got delayed and we are now putting pressures on the states to do the same."
The growing cases of fake registrations, explains an official, is the outcome of the misuse of powers by the registration tribunals which were actually constituted to bifurcate the register of pharmacists for administrative purpose as provisioned under the law.
As per section 30 of the Pharmacy Act, 1948, for the purpose of preparing the first register, the State Government shall by notification in the official gazette constitute a Registration Tribunal consisting of three persons, and shall also appoint a Registrar who shall act as Secretary of the Registration Tribunal.
The Registrar shall amend the register in accordance with the decisions of the authority appointed under sub section (4) of section 30 and shall thereupon issue to every person whose name is entered in the register a certificate of registration in the prescribed form.
The Assam Pharmacy Council (APC) is in the process of scrutinising 1500 documents related to a fake registration racket involving 2900 pharmacists in the state. These pharmacists were earlier registered with the Registration Tribunals of other states. As per official records, APC today has 9000 registrations of which 2500 pharmacists are working in the government sector alone.
Informs Munindra Deka, registrar, APC, "After scrutinising documents related to the fake registration racket, the state government would be consulted on the matter to take appropriate action for curbing the malpractices. Drug licences will also be cancelled subsequent to cancelling of the registrations."
http://www.pharmabiz.com/NewsDetails.aspx?aid=84033&sid=1
Gujarat FDCA act against 1400 chemists for not having pharmacists out of 7000 shops in state Suja Nair Shirodkar, Mumbai
In a massive drive aimed at checking the presence of pharmacists in retail chemists shops, Gujarat Food and Drug Control Administration (FDCA) has till now scoured around 7000 plus chemists shops across Gujarat. Following the ongoing probe, the state drug regulatory body has already busted around 1400 chemists shops found to be flouting the rules and regulations of the Drugs and Cosmetics Act that requires presence of pharmacists in the chemist shops.
It is understood that from the detected 1400 cases, around 141 cases have been found to be of gross violation wherein the chemist shops did not have the presence of pharmacists at all at any given time at their premises, which is a grave contravention of law. Dr H G Koshia, Gujarat FDCA informed that to put a stop to such incidence and to ensure that strict action is taken against the wrong doers the Gujarat FDCA has alerted canceled the licenses of these chemists shops.
While, he added that, stern directive have been given to the assistant commissioners to pursue this matter on an urgent basis with the Gujarat Pharmacy Council of India (PCI) to tackle with the pharmacists found to be leasing their licenses to these chemist shops. “We found that in this select cases the chemist shops where operating without having a pharmacists at all, which is completely against the law. Not only where they putting the life of patients at risk they were also making a mockery of the law and order situation. Severe steps have been taken against the wrong doers to discourage them from doing the same in future and we hope that it will stand as a deterrent for others as well if they want to see themselves doing business in the state,” Dr Koshia warned.
He further stressed that in the other 600 cases, it was found that there was irregularity in the presence of pharmacists in the chemist shops, which is also against the law. To keep a tab on them and warn them against repeating the same in the future the Gujarat FDCA have suspended the licenses of these 600 chemists shops till further proceedings, while the rest have been left off with stern warnings.
Dr Koshia stressed that the state drug regulatory body is going to further strengthen their measure by more surprise drives and checks as they want to ensure that no chemist shop in the state flout the rules. He added, “We have been successfully able to check the multiple and illegal enrollment in the state through our XLN software. However, there have been incidence where absence of pharmacists have become a growing cause of concern for us, which we plan to solve soon enough through our dedicated drive, which we plan to carry on in the coming months too.”
http://www.pharmabiz.com/NewsDetails.aspx?aid=84034&sid=1
It is understood that from the detected 1400 cases, around 141 cases have been found to be of gross violation wherein the chemist shops did not have the presence of pharmacists at all at any given time at their premises, which is a grave contravention of law. Dr H G Koshia, Gujarat FDCA informed that to put a stop to such incidence and to ensure that strict action is taken against the wrong doers the Gujarat FDCA has alerted canceled the licenses of these chemists shops.
While, he added that, stern directive have been given to the assistant commissioners to pursue this matter on an urgent basis with the Gujarat Pharmacy Council of India (PCI) to tackle with the pharmacists found to be leasing their licenses to these chemist shops. “We found that in this select cases the chemist shops where operating without having a pharmacists at all, which is completely against the law. Not only where they putting the life of patients at risk they were also making a mockery of the law and order situation. Severe steps have been taken against the wrong doers to discourage them from doing the same in future and we hope that it will stand as a deterrent for others as well if they want to see themselves doing business in the state,” Dr Koshia warned.
He further stressed that in the other 600 cases, it was found that there was irregularity in the presence of pharmacists in the chemist shops, which is also against the law. To keep a tab on them and warn them against repeating the same in the future the Gujarat FDCA have suspended the licenses of these 600 chemists shops till further proceedings, while the rest have been left off with stern warnings.
Dr Koshia stressed that the state drug regulatory body is going to further strengthen their measure by more surprise drives and checks as they want to ensure that no chemist shop in the state flout the rules. He added, “We have been successfully able to check the multiple and illegal enrollment in the state through our XLN software. However, there have been incidence where absence of pharmacists have become a growing cause of concern for us, which we plan to solve soon enough through our dedicated drive, which we plan to carry on in the coming months too.”
http://www.pharmabiz.com/NewsDetails.aspx?aid=84034&sid=1
Health ministry issues draft documents for implementation of Clinical Establishments Act Ramesh Shankar, Mumbai
The Union health ministry has issued draft documents for the implementation of the Clinical Establishments Act, which was enacted by the central government in 2010 to provide for registration and regulation of all clinical establishments in the country with a view to prescribe the minimum standards of facilities and services provided by them.
After the enactment of the Act, the Union health ministry had notified the “National Council for Clinical Establishments” and ‘The Clinical Establishments (Central Government) Rules, 2012” under the Act vide government Gazette. This Act is applicable to all kinds of clinical establishments from the public and private sectors, of all recognized systems of medicine including single doctor clinics. The only exception will be establishments run by the Armed forces.
The draft documents for the implementation of the Clinical Establishments Act was prepared by the National Council for Clinical Establishments under the chairmanship of Director General of Health Services (DGHS), in consultation with various stakeholders for its implementation in the country.
The draft documents issued by the ministry are Application format for Permanent Registration of Clinical Establishments; Minimum Standards; Formats for Collection of information and Statistics; Template for Display of Rates; and Standard Treatment Guidelines of Ayurveda.
The ministry has invited comments, suggestions, objections, including deletions/additions if required on the draft documents from public at large, including the stakeholders like hospitals and other clinical establishments, consumer groups, etc by October 9, 2014.
It has set minimum standards for clinical establishments like allied health executive, allied health wellness center, behaviourial health integrated counselling, dental center, dental hospital, dietetics, hospital (level 1), hospital (level 2), hospital (level 3), lab, lab-collection center, mobile clinic only consultation, mobile clinic with procedure, nephrology dialysis center, physiotherapy center, polyclinic only consultation, polyclinic with diagnostic support, polyclinic with dispensary, polyclinic with observation, radiology, imaging and ultrasound and stem cell laboratory.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84035&sid=1
After the enactment of the Act, the Union health ministry had notified the “National Council for Clinical Establishments” and ‘The Clinical Establishments (Central Government) Rules, 2012” under the Act vide government Gazette. This Act is applicable to all kinds of clinical establishments from the public and private sectors, of all recognized systems of medicine including single doctor clinics. The only exception will be establishments run by the Armed forces.
The draft documents for the implementation of the Clinical Establishments Act was prepared by the National Council for Clinical Establishments under the chairmanship of Director General of Health Services (DGHS), in consultation with various stakeholders for its implementation in the country.
The draft documents issued by the ministry are Application format for Permanent Registration of Clinical Establishments; Minimum Standards; Formats for Collection of information and Statistics; Template for Display of Rates; and Standard Treatment Guidelines of Ayurveda.
The ministry has invited comments, suggestions, objections, including deletions/additions if required on the draft documents from public at large, including the stakeholders like hospitals and other clinical establishments, consumer groups, etc by October 9, 2014.
It has set minimum standards for clinical establishments like allied health executive, allied health wellness center, behaviourial health integrated counselling, dental center, dental hospital, dietetics, hospital (level 1), hospital (level 2), hospital (level 3), lab, lab-collection center, mobile clinic only consultation, mobile clinic with procedure, nephrology dialysis center, physiotherapy center, polyclinic only consultation, polyclinic with diagnostic support, polyclinic with dispensary, polyclinic with observation, radiology, imaging and ultrasound and stem cell laboratory.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84035&sid=1
Karnataka pharma cos complies with July 10 order of NPPA, prices of many drugs cut by 15-35% Nandita Vijay, Bengaluru
Karnataka drugs control department has prepared a list of companies which have drugs coming under the National List of Essential Medicines (NLEM) to have a database of information at one go. The pharma companies in the state are in total compliance mode and adhering to the ceiling prices notified by the National Pharmaceutical Pricing Authority (NPPA). The tabulated data indicates that price fall is between 15-35 per cent.
From Bal Pharma to Biocon and Micro Labs in the state have ensured that there is no violation of NPPA order of July 10,2014 listing the 108 drugs under ceiling prices.
The state drugs control department has a readymade information on manufacturers of NLEM and information of previous and past drug prices, said Raghurama Bhandary, drugs controller, government of Karnataka.
While companies are ready with the revised pricing, the issue is the prevalence of existing stocks at the over 22,000 pharmacy outlets in the 30 districts of the state. There is a challenge to withdraw the existing stocks. “However we are ensuring that for the new batch of products entering into the market, the revised drug prices are implemented. For instance in the case of GlaxoSmithKline’s Augmetine which is a penicillin injection is a fresh batch and therefore it is a new price”, he added.
The drugs coming under the NPPA list cover conditions like blood pressure cardiovascular, cholesterol diabetes and infectious diseases. These include atorvastatin for cholesterol manufactured by Micro Labs, Sun Pharma, Torrent, gliclazide by Dr. Reddy’s, Indoco, IPCA, glimepiride for diabetes by Unichem, Micro Labs, Glenmark, Sanofi, Pancea, Torrent, Abbot to name a few, heparin by Biocon and Gland Pharma used to prevent blood clot and metolazone used in cardiovascular diseases by Zydus Cadila. Atenol , Olmesartan and Telmisartan are some of the blood pressure drugs which report fall in prices by half. Telmisartan was priced at Rs.8.33 per tablet will now cost Rs.4.38 per tablet. Diabetic drugs are reported to see a fall by 35 per cent per tablet.
Companies in Karnataka said that there is no questions of violating NPPA even if there is a fall of drug prices spanning between 15 and 35 per cent. The state pharmacy outlets said that revised prices are being implemented on new stocks.
The NPPA order is creating an impact on the small and medium players, said Shailesh Siroya, managing director, Bal Pharma. According to Biocon, very few of its products fall into new list of products put under price control, hence the company views that there will be a very marginal impact.
According to doctors from the Karnataka government, hospitals like Victoria and Bowring Lady Curzon, the benefit to the lower and middle class patients are immense. Many of the life style disorder drugs were discontinued by bread winners of the family because of the high prices. Therefore, the July 10 notification came in as a big relief to patients as it brought down the hospitalisation costs, they said.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84036&sid=1
From Bal Pharma to Biocon and Micro Labs in the state have ensured that there is no violation of NPPA order of July 10,2014 listing the 108 drugs under ceiling prices.
The state drugs control department has a readymade information on manufacturers of NLEM and information of previous and past drug prices, said Raghurama Bhandary, drugs controller, government of Karnataka.
While companies are ready with the revised pricing, the issue is the prevalence of existing stocks at the over 22,000 pharmacy outlets in the 30 districts of the state. There is a challenge to withdraw the existing stocks. “However we are ensuring that for the new batch of products entering into the market, the revised drug prices are implemented. For instance in the case of GlaxoSmithKline’s Augmetine which is a penicillin injection is a fresh batch and therefore it is a new price”, he added.
The drugs coming under the NPPA list cover conditions like blood pressure cardiovascular, cholesterol diabetes and infectious diseases. These include atorvastatin for cholesterol manufactured by Micro Labs, Sun Pharma, Torrent, gliclazide by Dr. Reddy’s, Indoco, IPCA, glimepiride for diabetes by Unichem, Micro Labs, Glenmark, Sanofi, Pancea, Torrent, Abbot to name a few, heparin by Biocon and Gland Pharma used to prevent blood clot and metolazone used in cardiovascular diseases by Zydus Cadila. Atenol , Olmesartan and Telmisartan are some of the blood pressure drugs which report fall in prices by half. Telmisartan was priced at Rs.8.33 per tablet will now cost Rs.4.38 per tablet. Diabetic drugs are reported to see a fall by 35 per cent per tablet.
Companies in Karnataka said that there is no questions of violating NPPA even if there is a fall of drug prices spanning between 15 and 35 per cent. The state pharmacy outlets said that revised prices are being implemented on new stocks.
The NPPA order is creating an impact on the small and medium players, said Shailesh Siroya, managing director, Bal Pharma. According to Biocon, very few of its products fall into new list of products put under price control, hence the company views that there will be a very marginal impact.
According to doctors from the Karnataka government, hospitals like Victoria and Bowring Lady Curzon, the benefit to the lower and middle class patients are immense. Many of the life style disorder drugs were discontinued by bread winners of the family because of the high prices. Therefore, the July 10 notification came in as a big relief to patients as it brought down the hospitalisation costs, they said.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84036&sid=1
DRL, Ranbaxy yet to reduce drug prices after July10 order, many other cos cut prices Shardul Nautiyal, Mumbai
Following Ranbaxy's refusal to cut prices in anti-diabetic and cardio-vascular segments in compliance with the July 10 NPPA order, Dr Reddy's Laboratories Ltd (DRL) has also refused to cut prices of the 13 specific products covered as per the NPPA notification. Both the companies are supplying drugs at the old prices citing the High Court stay granted to them till the next hearing on February 24, 2015.
DRL and Ranbaxy in their letters to all the stockists have made it amply clear that the stay granted by the High Court continues to be in effect till the next hearing. As per sources, Cipla, Pfizer, Abbott and Sanofi have started supplying drugs capped in the anti-diabetic and cardio-vascular segments as per the July 10 NPPA notification
The copy of the letter of DRL to the stockists which is with Pharmabiz states -"In continuation to our aforesaid letter, we would like to confirm to you that the stay granted by the High Court continues to be in effect till it is cancelled. We will inform you in case if the stay is cancelled. Kindly note that only 13 products are covered under the aforesaid notification for DRL."
Informs Rajiv Singhal, general secretary, Madhya Pradesh Chemists and Druggists Association (MPCDA), the state unit of AIOCD, "We have issued a circular to all 22000 retailers across the 51 districts of the state to return back the old stocks as per the NPPA order and replenish with the new stocks at the revised prices."
Ranbaxy had issued a letter to the stockists with reference to the subject of notification by NPPA dated July 10, 2014. The copy of the letter which is with Pharmabiz states - "We draw kind attention of stockists to our circular dated August 26, 2014 on the above subject and wish to share the update on the matter pending before Bombay High Court. The matter which was initially fixed for hearing on August 28, 2014 got postponed to September 2, 2014. On 2nd September, 2014 also, the matter could not be heard and next hearing is fixed for February 24, 2015.
The Indian Pharmaceutical Alliance (IPA) and the Organisation of Pharmaceutical Producers of India (OPPI), had challenged the order in the Bombay and Delhi high courts, respectively. While the Delhi High Court has refused to entertain the OPPI petition seeking a stay on the DPCO, the Bombay HC is yet to hear the IPA plea.
The Delhi High Court had on August 1 refused to stay NPPA's July 10 order fixing prices of 108 non-scheduled drugs, but sought responses from the pricing authority by September 29, when it will hear the petition.
Significantly, the Delhi HC observed that paragraph 19 of the 2013 DPCO does not restrict price fixation to only essential drugs. Paragraph 19 of DPCO, 2013, authorises the NPPA in extraordinary circumstances, if it considers necessary so to do in public interest, to fix the ceiling price or retail price of any drug for such period as it deems fit, the court had said.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84037&sid=1
DRL and Ranbaxy in their letters to all the stockists have made it amply clear that the stay granted by the High Court continues to be in effect till the next hearing. As per sources, Cipla, Pfizer, Abbott and Sanofi have started supplying drugs capped in the anti-diabetic and cardio-vascular segments as per the July 10 NPPA notification
The copy of the letter of DRL to the stockists which is with Pharmabiz states -"In continuation to our aforesaid letter, we would like to confirm to you that the stay granted by the High Court continues to be in effect till it is cancelled. We will inform you in case if the stay is cancelled. Kindly note that only 13 products are covered under the aforesaid notification for DRL."
Informs Rajiv Singhal, general secretary, Madhya Pradesh Chemists and Druggists Association (MPCDA), the state unit of AIOCD, "We have issued a circular to all 22000 retailers across the 51 districts of the state to return back the old stocks as per the NPPA order and replenish with the new stocks at the revised prices."
Ranbaxy had issued a letter to the stockists with reference to the subject of notification by NPPA dated July 10, 2014. The copy of the letter which is with Pharmabiz states - "We draw kind attention of stockists to our circular dated August 26, 2014 on the above subject and wish to share the update on the matter pending before Bombay High Court. The matter which was initially fixed for hearing on August 28, 2014 got postponed to September 2, 2014. On 2nd September, 2014 also, the matter could not be heard and next hearing is fixed for February 24, 2015.
The Indian Pharmaceutical Alliance (IPA) and the Organisation of Pharmaceutical Producers of India (OPPI), had challenged the order in the Bombay and Delhi high courts, respectively. While the Delhi High Court has refused to entertain the OPPI petition seeking a stay on the DPCO, the Bombay HC is yet to hear the IPA plea.
The Delhi High Court had on August 1 refused to stay NPPA's July 10 order fixing prices of 108 non-scheduled drugs, but sought responses from the pricing authority by September 29, when it will hear the petition.
Significantly, the Delhi HC observed that paragraph 19 of the 2013 DPCO does not restrict price fixation to only essential drugs. Paragraph 19 of DPCO, 2013, authorises the NPPA in extraordinary circumstances, if it considers necessary so to do in public interest, to fix the ceiling price or retail price of any drug for such period as it deems fit, the court had said.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84037&sid=1
Industry urges NPPA to keep differentiated/modified dosage forms out of DPCO 2013 Ramesh Shankar, Mumbai
The pharmaceutical industry in the country has urged the NPPA to keep the differentiated/modified dosage forms out of the ambit of DPCO 2013, as these dosage forms are patient-friendly and involve huge investments in R&D to develop them.
According to experts, the pharmaceutical industry is a differentiated/modified technology driven industry, wherein new technology is introduced for administration of drugs to the patient, with an objective of providing patient-friendly dosages along with therapeutic dosage compliance, anti-counterfeiting measures to provide patients with a genuine product, better therapeutic value, superior quality dosage forms combined with benefit of better safety profile.
Driving home the point that it involves a huge investment in manufacturing differentiated/modified dosage forms, sources said that dosage forms like SR/CR; gelatin coated tablets, gelatin enrobed tablets; effervescent, dispersible, soluble tablets; soft gelatin capsules (soft gels); etc, formulations developed by companies investing large sum in R&D, plant, specialised equipments, intellectual property and development of processes and technologies.
Differentiated/modified dosage forms are patient-friendly and involve huge investment in R&D. The manufacturing process is also different compared to normal dosage forms. The materials used in manufacture of such dosage forms are also often distinct. Thus considering the superiority of the differentiated/modified dosage forms, same should not be clubbed with normal dosage forms for arriving at the ceiling price, the industry pleaded with the government.
The DPCO 1995 recognised different formulations and prices were fixed according to the technical category. However, since DPCO 2013 does not recognise cost, the ceiling price fixed under DPCO 1995 for a certain formulation on actual cost basis, has got reduced substantially due to averaging out the prices.
Even though the differentiated/modified dosage forms should have been outside the ambit of the price control, the industry sources said that in a number of cases, the differentiated dosage forms have been included in the list of products while calculating the average prices for setting ceiling prices for molecules in the basic dosage forms. Even if it is the department's thought that the differentiated dosage forms should have been under price control, these products are different to the conventional dosage forms and even if averaging was to be done, it should have been done separately for each molecule in each specific dosage forms separately, sources said.
Cautioning the government about the need to resolve the issue immediately, the industry said that otherwise it will result in non-availability of products to patients who are already on the product thereby impacting their lives, lay-offs of workers and will kill the innovation dependent upon such differentiated/modified technologies and will also lead to closure of operations.
According to experts, the pharmaceutical industry is a differentiated/modified technology driven industry, wherein new technology is introduced for administration of drugs to the patient, with an objective of providing patient-friendly dosages along with therapeutic dosage compliance, anti-counterfeiting measures to provide patients with a genuine product, better therapeutic value, superior quality dosage forms combined with benefit of better safety profile.
Driving home the point that it involves a huge investment in manufacturing differentiated/modified dosage forms, sources said that dosage forms like SR/CR; gelatin coated tablets, gelatin enrobed tablets; effervescent, dispersible, soluble tablets; soft gelatin capsules (soft gels); etc, formulations developed by companies investing large sum in R&D, plant, specialised equipments, intellectual property and development of processes and technologies.
Differentiated/modified dosage forms are patient-friendly and involve huge investment in R&D. The manufacturing process is also different compared to normal dosage forms. The materials used in manufacture of such dosage forms are also often distinct. Thus considering the superiority of the differentiated/modified dosage forms, same should not be clubbed with normal dosage forms for arriving at the ceiling price, the industry pleaded with the government.
The DPCO 1995 recognised different formulations and prices were fixed according to the technical category. However, since DPCO 2013 does not recognise cost, the ceiling price fixed under DPCO 1995 for a certain formulation on actual cost basis, has got reduced substantially due to averaging out the prices.
Even though the differentiated/modified dosage forms should have been outside the ambit of the price control, the industry sources said that in a number of cases, the differentiated dosage forms have been included in the list of products while calculating the average prices for setting ceiling prices for molecules in the basic dosage forms. Even if it is the department's thought that the differentiated dosage forms should have been under price control, these products are different to the conventional dosage forms and even if averaging was to be done, it should have been done separately for each molecule in each specific dosage forms separately, sources said.
Cautioning the government about the need to resolve the issue immediately, the industry said that otherwise it will result in non-availability of products to patients who are already on the product thereby impacting their lives, lay-offs of workers and will kill the innovation dependent upon such differentiated/modified technologies and will also lead to closure of operations.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84038&sid=1
Health department will help Private hospitals to set up organ transplantation facilities
JAIPUR: There is a golden opportunity for the private hospitals willing to introduce organ transplant in their hospitals.
The health department will accept private hospitals' applications for introducing organ transplant facilities in their hospitals.
"It is necessary for private hospitals to take permission from the health department to introduce organ transplant facility," health department director (health) Dr B R Meena said.
He said that they have constituted various committees necessary at the state level, including an advisory committee, to start organ transplant in the state.
Meena said, "A committee, which has already been formed at Sawai Man Singh hospital, will inspect private hospitals to check for the infrastructure available for organ transplant. Only after ensuring that the hospitals have all required infrastructure in place, will they be give permission for conducting organ transplantation."
Private hospitals too have started showing interest in such an idea. The health department has already received more than three applications from the private hospitals, which are willing to start organ transplant facilities.
So far, hospitals in the state have the facility for live organ transplant like eyes and kidneys but there is a requirement of organ donation from brain dead persons (with consent from the relatives) for other organs including heart, lungs and liver.
The health experts claimed that there are a lot of patients, whose life can be saved if there is a donor.
The health department has already constituted an organ donation registry, in which donors and receivers could both register. The receiver will mention what organ he requires and donor will register, which organ he is willing to donate. The health department and hospitals will help them in the process.
However, the infrastructure for organ transplant will be developed as institute of organ donation would come up soon. The health department has asked for requirements from SMS medical college for developing infrastructure at the hospital for organ transplantation.
The health department will accept private hospitals' applications for introducing organ transplant facilities in their hospitals.
"It is necessary for private hospitals to take permission from the health department to introduce organ transplant facility," health department director (health) Dr B R Meena said.
He said that they have constituted various committees necessary at the state level, including an advisory committee, to start organ transplant in the state.
Meena said, "A committee, which has already been formed at Sawai Man Singh hospital, will inspect private hospitals to check for the infrastructure available for organ transplant. Only after ensuring that the hospitals have all required infrastructure in place, will they be give permission for conducting organ transplantation."
Private hospitals too have started showing interest in such an idea. The health department has already received more than three applications from the private hospitals, which are willing to start organ transplant facilities.
So far, hospitals in the state have the facility for live organ transplant like eyes and kidneys but there is a requirement of organ donation from brain dead persons (with consent from the relatives) for other organs including heart, lungs and liver.
The health experts claimed that there are a lot of patients, whose life can be saved if there is a donor.
The health department has already constituted an organ donation registry, in which donors and receivers could both register. The receiver will mention what organ he requires and donor will register, which organ he is willing to donate. The health department and hospitals will help them in the process.
However, the infrastructure for organ transplant will be developed as institute of organ donation would come up soon. The health department has asked for requirements from SMS medical college for developing infrastructure at the hospital for organ transplantation.
http://timesofindia.indiatimes.com/City/Jaipur/Health-department-will-help-Private-hospitals-to-set-up-organ-transplantation-facilities/articleshow/42509651.cms
Biospleen cleans bad blood with magnets Mumbai Mirror
A new dialysis-like device inspired by the human spleen could eradicate sepsis, the leading cause of hospital deaths, killing at least eight million people every year.
Things can go downhill fast when a patient has sepsis, a lifethreatening condition in which bacteria or fungi multiply in a patient's blood - often too fast for antibiotics to help. A new device inspired by the human spleen and developed by a team at Harvard's Wyss Institute may radically transform the way doctors treat sepsis.
"Even with the best current treatments, sepsis patients are dying in intensive care units at least 30 per cent of the time," said Mike Super, Scientist at the Wyss Institute. "We need a new approach." Sepsis kills at least eight million people worldwide each year and it's the leading cause of hospital deaths.
The device, called a "biospleen," exceeded the team's expectations with its ability to cleanse human blood tested in the lab and increase survival in animals with infected blood, as reported in Nature Medicine. In a matter of hours, it can filter live and dead pathogens from the blood, as well as dangerous toxins that are released from the pathogens.
What is Sepsis?
Sepsis occurs when a patient's immune system overreacts to a bloodstream infection, triggering a chain reaction that can cause inflammation, blood clotting, organ damage, and death. It can arise from a variety of infections, including appendicitis, urinary tract infections, lung infections, as well as contaminated IV lines and catheters.
Identifying the specific pathogen responsible for sepsis can take several days, and in most patients the causative agent is never identified. If doctors are unable to pinpoint which types of bacteria or fungi are causing the infection, they treat sepsis patients empirically with broad-spectrum antibiotics - but these often fail in many cases and they can have devastating side-effects. The sepsis treatment challenge continues to grow more complex as the prevalence of drug-resistant bacteria increases while the development of new antibiotics lags.
"This is setting the stage for a perfect storm," said Super, who was part of a team led by Don Ingber, that also included Joo Kang.
Kang set out with the team to build a fluidic device that works outside the body like a dialysis machine, and removes living and dead microbes of all varieties - as well as toxins. They modeled it after the microarchitecture of the human spleen, an organ that removes pathogens and dead cells from the blood through a series of tiny interwoven blood channels.
The biospleen
The biospleen is a microfluidic device that consists of two adjacent hollow channels that are connected to each other by a series of slits: one channel contains flowing blood, and the other has a saline solution that collects and removes the pathogens that travel through the slits. Key to the success of the device are tiny nanometer-sized magnetic beads that are coated with a genetically engineered version of a natural immune system protein called mannose binding lectin (MBL).
In its innate state, MBL has a branch-like "head" and a stick-like "tail." In the body, the head binds to specific sugars on the surfaces of all sorts of bacteria, fungi, viruses, protozoa and toxins, and the tail cues the immune system to destroy them.
However, sometimes immune system proteins also bind to the MBL tail and activate clotting and organ damage - so Super used genetic engineering tools to lop off the tail and graft on a similar one from an antibody protein that does not cause these problems.
They then attached the hybrid proteins to nano magnetic beads to create beads that could be added to blood of an infected patient to bind to the pathogens. The device has a magnet that pulls the beads through channels to clean it.
The team tested the system using human blood spiked with pathogens. They were able to filter blood much faster than ever before, and the magnets efficiently pulled the beads - coated with the pathogens - out of the blood.
In fact, more than 90 per cent of key sepsis pathogens were bound and removed when the blood flowed through asingle device at one liter per hour.
http://www.mumbaimirror.com/others/sci-tech/Biospleen-cleans-bad-blood-with-magnets/articleshow/42555329.cms
Things can go downhill fast when a patient has sepsis, a lifethreatening condition in which bacteria or fungi multiply in a patient's blood - often too fast for antibiotics to help. A new device inspired by the human spleen and developed by a team at Harvard's Wyss Institute may radically transform the way doctors treat sepsis.
"Even with the best current treatments, sepsis patients are dying in intensive care units at least 30 per cent of the time," said Mike Super, Scientist at the Wyss Institute. "We need a new approach." Sepsis kills at least eight million people worldwide each year and it's the leading cause of hospital deaths.
The device, called a "biospleen," exceeded the team's expectations with its ability to cleanse human blood tested in the lab and increase survival in animals with infected blood, as reported in Nature Medicine. In a matter of hours, it can filter live and dead pathogens from the blood, as well as dangerous toxins that are released from the pathogens.
What is Sepsis?
Sepsis occurs when a patient's immune system overreacts to a bloodstream infection, triggering a chain reaction that can cause inflammation, blood clotting, organ damage, and death. It can arise from a variety of infections, including appendicitis, urinary tract infections, lung infections, as well as contaminated IV lines and catheters.
Identifying the specific pathogen responsible for sepsis can take several days, and in most patients the causative agent is never identified. If doctors are unable to pinpoint which types of bacteria or fungi are causing the infection, they treat sepsis patients empirically with broad-spectrum antibiotics - but these often fail in many cases and they can have devastating side-effects. The sepsis treatment challenge continues to grow more complex as the prevalence of drug-resistant bacteria increases while the development of new antibiotics lags.
"This is setting the stage for a perfect storm," said Super, who was part of a team led by Don Ingber, that also included Joo Kang.
Kang set out with the team to build a fluidic device that works outside the body like a dialysis machine, and removes living and dead microbes of all varieties - as well as toxins. They modeled it after the microarchitecture of the human spleen, an organ that removes pathogens and dead cells from the blood through a series of tiny interwoven blood channels.
The biospleen
The biospleen is a microfluidic device that consists of two adjacent hollow channels that are connected to each other by a series of slits: one channel contains flowing blood, and the other has a saline solution that collects and removes the pathogens that travel through the slits. Key to the success of the device are tiny nanometer-sized magnetic beads that are coated with a genetically engineered version of a natural immune system protein called mannose binding lectin (MBL).
In its innate state, MBL has a branch-like "head" and a stick-like "tail." In the body, the head binds to specific sugars on the surfaces of all sorts of bacteria, fungi, viruses, protozoa and toxins, and the tail cues the immune system to destroy them.
However, sometimes immune system proteins also bind to the MBL tail and activate clotting and organ damage - so Super used genetic engineering tools to lop off the tail and graft on a similar one from an antibody protein that does not cause these problems.
They then attached the hybrid proteins to nano magnetic beads to create beads that could be added to blood of an infected patient to bind to the pathogens. The device has a magnet that pulls the beads through channels to clean it.
The team tested the system using human blood spiked with pathogens. They were able to filter blood much faster than ever before, and the magnets efficiently pulled the beads - coated with the pathogens - out of the blood.
In fact, more than 90 per cent of key sepsis pathogens were bound and removed when the blood flowed through asingle device at one liter per hour.
http://www.mumbaimirror.com/others/sci-tech/Biospleen-cleans-bad-blood-with-magnets/articleshow/42555329.cms
Mild hypertension can be treated without drugs — By FPJ Bureau
London : For people with mild hypertension, encouraging lifestyle changes should be the first line of recommendations for physicians rather than putting them on drugs, suggest experts, reports IANS.
Lead researcher Stephen Martin and colleagues argue that the current strategy is failing patients and wasting healthcare resources.
“Over-emphasis on drug treatment risks adverse effects such as increased risk of falls and misses opportunities to modify individual lifestyle choices,” they noted.
They called for a re-examination of the threshold and urge clinicians to be cautious about treating low risk patients with blood pressure lowering drugs. Up to 40 percent of adults worldwide have hyper-tension, over half of which is classified as mild.
Low risk indicates that an individual does not have existing cardio-vascular diseases, diabetes or kidney diseases. Over the years, hyper-tension has been treated with drugs at progressively lower blood pressures.
“We urge clinicians to share the uncertainty surrounding drug treatment of mild hypertension with patients, measure blood pressure at home, improve accuracy of clinic measurements and encourage lifestyle changes,” Martin concluded.
They were scheduled to discuss the findings at the 2014 Preventing Overdiagnosis Conference hosted by the Centre for Evidence-based Medicine at the University of Oxford.
http://freepressjournal.in/mild-hypertension-can-be-treated-without-drugs/
US FDA approves Contrave ER tablets for chronic weight management Deerfield, Illinois
Takeda Pharmaceuticals USA, Inc. and Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, jointly announced that the US Food and Drug Administration (FDA) has approved Contrave (naltrexone HCI and bupropion HCI) extended-release tablets as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition.
"Some individuals seeking to manage their weight may require a treatment plan that includes more than lifestyle modification with diet and exercise," said Dr Ken Fujioka, director, Center for Weight Management, Division of Diabetes and Endocrinology at Scripps Clinic. "Clinical trial data for Contrave demonstrates that this new treatment, when used as an adjunct to a reduced-calorie diet and increased physical activity, is a therapeutic option for some adults who are either overweight with a comorbidity, or obese. In my clinic, I often treat patients who fit these criteria, and now, with the approval of Contrave, I am excited to have a new treatment option to consider for my patients."
Contrave is an important addition to Takeda's portfolio of cardiometabolic products. Takeda is committed to providing patients with obesity with treatment options that help address their needs, and the company is planning to commercially launch Contrave in the fall of 2014.
The effect of Contrave on cardiovascular morbidity and mortality has not been established. In addition, the safety and effectiveness of Contrave in combination with other medications intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
The exact neurochemical effects of Contrave leading to weight loss are not fully understood. Contrave has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system).
"The FDA approval of Contrave is a significant milestone in Takeda's and Orexigen's commitment to leading innovation in medicine for patients and physicians dealing with chronic conditions and diseases, such as obesity," said Douglas Cole, president, Takeda Pharmaceuticals USA, Inc. "It's important that physicians and appropriate patients have options when discussing weight management, especially when you look at the prevalence of obesity in today's society. We're excited about the addition of Contrave to our Cardiovascular and Metabolic Disease Portfolio."
"We are extremely proud of our team's work and commitment to the research and development efforts that have charted our path to Contrave approval," said Michael Narachi, CEO of Orexigen. "Takeda has been a great, contributing partner throughout this endeavor, and we at Orexigen now look forward to doing everything possible to support them as they bring Contrave to the U.S. market."
According to National Health and Nutrition Examination Survey (NHANES) 2012 estimates, approximately 35 per cent, or one out of three, adults age 20 years or older were classified as obese based on a BMI of 30 kg/m2 or greater. Obesity has been recognized by the American Medical Association, as well as other medical and government organizations, as a chronic disease.
Four 56-week multicenter, double-blind, placebo-controlled obesity trials (CONTRAVE Obesity Research, or COR-I, COR-II, COR-BMOD, and COR-Diabetes) were conducted to evaluate the effect of Contrave in conjunction with lifestyle modification in 4,536 patients randomized to Contrave or placebo. The COR-I, COR-II, and COR-BMOD trials enrolled patients with obesity (BMI 30 kg/m2 or greater) or overweight (BMI 27 kg/m2 or greater) and at least one comorbidity (hypertension or dyslipidemia). The COR-Diabetes trial enrolled patients with BMI greater than 27 kg/m2 with type 2 diabetes with or without hypertension and/or dyslipidemia.
COR I and COR II included a program consisting of a reduced-calorie diet resulting in an approximate 500 kcal/day decrease in caloric intake, behavioral counseling, and increased physical activity. COR-BMOD included an intensive behavioral modification program consisting of 28 group counseling sessions over 56 weeks as well as a prescribed diet and exercise regimen. COR-Diabetes evaluated patients with type 2 diabetes not achieving glycemic goal of a HbA1c less than 7 percent either with oral antidiabetic agents or with diet and exercise alone. Co-primary efficacy endpoints were percent change from baseline in body weight and proportion of participants who achieved a decrease in body weight of 5 percent or more. In these studies, the most common adverse reactions (=5 percent) seen in patients taking Contrave included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
The clinical trial programme also includes an ongoing, double-blind, placebo-controlled cardiovascular outcomes trial known as the LIGHT study. The primary objective of this study is to evaluate the occurrence of major adverse cardiovascular events in overweight and obese adults with cardiovascular risk factors receiving Contrave.
As part of the approval of Contrave, Takeda and Orexigen agreed to several post-marketing requirements, including studies to assess the safety and efficacy of Contrave for weight management in obese pediatric patients. There will also be a new randomized double-blind, placebo-controlled study to evaluate the effects of long-term treatment with Contrave on the incidence of major adverse cardiovascular (CV) events in overweight and obese subjects with CV disease or multiple CV risk factors.
Contrave is a trademark of Orexigen Therapeutics, Inc. registered with the US Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.
Takeda Pharmaceuticals USA, Inc. is a subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. TPUSA markets oral diabetes, CNS, rheumatology and gastroenterology treatments.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84019&sid=2
"Some individuals seeking to manage their weight may require a treatment plan that includes more than lifestyle modification with diet and exercise," said Dr Ken Fujioka, director, Center for Weight Management, Division of Diabetes and Endocrinology at Scripps Clinic. "Clinical trial data for Contrave demonstrates that this new treatment, when used as an adjunct to a reduced-calorie diet and increased physical activity, is a therapeutic option for some adults who are either overweight with a comorbidity, or obese. In my clinic, I often treat patients who fit these criteria, and now, with the approval of Contrave, I am excited to have a new treatment option to consider for my patients."
Contrave is an important addition to Takeda's portfolio of cardiometabolic products. Takeda is committed to providing patients with obesity with treatment options that help address their needs, and the company is planning to commercially launch Contrave in the fall of 2014.
The effect of Contrave on cardiovascular morbidity and mortality has not been established. In addition, the safety and effectiveness of Contrave in combination with other medications intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
The exact neurochemical effects of Contrave leading to weight loss are not fully understood. Contrave has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system).
"The FDA approval of Contrave is a significant milestone in Takeda's and Orexigen's commitment to leading innovation in medicine for patients and physicians dealing with chronic conditions and diseases, such as obesity," said Douglas Cole, president, Takeda Pharmaceuticals USA, Inc. "It's important that physicians and appropriate patients have options when discussing weight management, especially when you look at the prevalence of obesity in today's society. We're excited about the addition of Contrave to our Cardiovascular and Metabolic Disease Portfolio."
"We are extremely proud of our team's work and commitment to the research and development efforts that have charted our path to Contrave approval," said Michael Narachi, CEO of Orexigen. "Takeda has been a great, contributing partner throughout this endeavor, and we at Orexigen now look forward to doing everything possible to support them as they bring Contrave to the U.S. market."
According to National Health and Nutrition Examination Survey (NHANES) 2012 estimates, approximately 35 per cent, or one out of three, adults age 20 years or older were classified as obese based on a BMI of 30 kg/m2 or greater. Obesity has been recognized by the American Medical Association, as well as other medical and government organizations, as a chronic disease.
Four 56-week multicenter, double-blind, placebo-controlled obesity trials (CONTRAVE Obesity Research, or COR-I, COR-II, COR-BMOD, and COR-Diabetes) were conducted to evaluate the effect of Contrave in conjunction with lifestyle modification in 4,536 patients randomized to Contrave or placebo. The COR-I, COR-II, and COR-BMOD trials enrolled patients with obesity (BMI 30 kg/m2 or greater) or overweight (BMI 27 kg/m2 or greater) and at least one comorbidity (hypertension or dyslipidemia). The COR-Diabetes trial enrolled patients with BMI greater than 27 kg/m2 with type 2 diabetes with or without hypertension and/or dyslipidemia.
COR I and COR II included a program consisting of a reduced-calorie diet resulting in an approximate 500 kcal/day decrease in caloric intake, behavioral counseling, and increased physical activity. COR-BMOD included an intensive behavioral modification program consisting of 28 group counseling sessions over 56 weeks as well as a prescribed diet and exercise regimen. COR-Diabetes evaluated patients with type 2 diabetes not achieving glycemic goal of a HbA1c less than 7 percent either with oral antidiabetic agents or with diet and exercise alone. Co-primary efficacy endpoints were percent change from baseline in body weight and proportion of participants who achieved a decrease in body weight of 5 percent or more. In these studies, the most common adverse reactions (=5 percent) seen in patients taking Contrave included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
The clinical trial programme also includes an ongoing, double-blind, placebo-controlled cardiovascular outcomes trial known as the LIGHT study. The primary objective of this study is to evaluate the occurrence of major adverse cardiovascular events in overweight and obese adults with cardiovascular risk factors receiving Contrave.
As part of the approval of Contrave, Takeda and Orexigen agreed to several post-marketing requirements, including studies to assess the safety and efficacy of Contrave for weight management in obese pediatric patients. There will also be a new randomized double-blind, placebo-controlled study to evaluate the effects of long-term treatment with Contrave on the incidence of major adverse cardiovascular (CV) events in overweight and obese subjects with CV disease or multiple CV risk factors.
Contrave is a trademark of Orexigen Therapeutics, Inc. registered with the US Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.
Takeda Pharmaceuticals USA, Inc. is a subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. TPUSA markets oral diabetes, CNS, rheumatology and gastroenterology treatments.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84019&sid=2
Hospira voluntary recalls one lot of Heparin sodium, 1,000 USP Heparin units/500 mL, in 0.9% sodium chloride injection, 500 mL, due to particulate matter Lake Forest, Illinois
Hospira, Inc., a leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, is initiating a voluntary nationwide user-level recall of one lot of Heparin sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% sodium chloride injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair, sealed between the tube and the film at the round seal of the unused Administrative Port on the non-print side of the container.
In the unlikely event that the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Capillaries which may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.
Heparin sodium injection in 0.9% sodium chloride at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. The root cause has not been determined and is under investigation.
The affected lot was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals and pharmacies.
Anyone with an existing inventory should stop use and distribution and quarantine the product immediately. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84018&sid=2
In the unlikely event that the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Capillaries which may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.
Heparin sodium injection in 0.9% sodium chloride at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. The root cause has not been determined and is under investigation.
The affected lot was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals and pharmacies.
Anyone with an existing inventory should stop use and distribution and quarantine the product immediately. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle.
http://www.pharmabiz.com/NewsDetails.aspx?aid=84018&sid=2