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CoS reviews state of preparedness on H1N1
The Cabinet Secretary Ajit Kumar Seth chaired a Committee of Secretaries meeting to review the state of preparedness to contain the incidence of H1N1 virus. Secretaries from Ministry of Health and Family Welfare, Biotechnology, Pharmaceuticals were among those who attended the meeting.
The Cabinet secretary was apprised that a central team was deputed to Pune on April 8, 2012 to investigate the outbreak of Influenza A H1N1 and their preliminary report shows that the cases and deaths reported from Pune and Pimpri-Chinchiwad are sporadic in nature. A central stockpile of Oseltamivir tablets (anti viral drug) is being maintained and D/o Pharmaceuticals is monitoring availability of raw ingredient for making the drug. There is adequate stock of drugs and vaccines for treatment of people affected by the illness and immunization of health care personnel and whosoever may require it. Vaccine manufactured by indigenous manufacturers is also available.
The medical response system has been put on a state of preparedness. Forty five laboratories are testing samples (26 in Government sector and 19 in Private Sector). The test is done free of cost in Government laboratories/Integrated Disease Surveillance Project supported private laboratories (KMC, Manipal and CMC, Vellore). A nationwide network of laboratories in the private sector are also available for rapid diagnosis.
It was also stated that at the time of the early warning of the cases in Pune itself, an advisory was sent to all the States/UTs about the possibility of sporadic outbreaks of H1N1 influenza. Owing to reports circulating in the media regarding mutation in the virus, expert opinion was sought from the Director, National Institute of Virology, Pune who has stated that there is no mutation to suggest change of virus to ‘dangerous form’ and that the present strain of H1N1 pandemic virus are susceptible to Oseltamivir and the currently available vaccine can be used for protection against the virus. In the first week of March almost 30% of referred samples were positive for H1N1 in Pune which has now come down to approximately 10%.
During the period from March 1, 2012 to April 9, 2012, 689 cases of H1N1 have been reported from Maharashtra (392 cases), Karnataka (104), Andhra Pradesh (66), Rajasthan (84), Tamil Nadu (28), Delhi (6), Gujarat (5) and in Punjab, Haryana, Himachal Pradesh and Madhya Pradesh (one each). During the same period, 35 deaths have been reported, of which 15 were from Maharashtra, nine from Rajasthan, six from Andhra Pradesh, two from Gujarat and one each from Tamil Nadu, Himachal Pradesh and Madhya Pradesh.
M/o Health & Family Welfare has been asked to monitor the situation on a day to day basis and take all possible steps to ensure that the drug and vaccine are available in sufficient stock.
No cause for panic on H1N1 virus: Govt
The situation with respect to instances of H1N1 is well under control and is being monitored. As reported in some section of the press, the virus has not mutated to a more virulent form or changed its character. Director, National Institute of Virology, Pune has clarified that the presently circulating strain of H1N1 pandemic virusbelongs to clade 6 and 7. (Clade is the medical terminology used to describe related organisms descended from a common ancestor).
These clades are circulating in many countries. All are treatable with Oseltamivir (an antiviral drug which slows the spread of influenza (flu) virus). The currently available vaccine can be used, as antigenic (antigen is a substance that when introduced into the body stimulates the production of an antibody. Antigens include toxins, bacteria, foreign blood cells, and the cells of transplanted organs) differences are not significant. There is no mutation to suggest change of virus to `dangerous form`.
World Health Organisation while declaring the Pandemic to be over in August 2010, had conveyed that the influenza H1N1 pandemic virus would take on the behaviour of seasonal influenza virus and continue to circulate for some years to come. Hence, in the post-pandemic period, localized outbreaks of varying magnitude with significant level of H1N1 transmission are expected.Subsequent to this declaration, our country had experienced major outbreaks during the period August to October, 2010 and again from May, 2011 to July 2011.
Now, in March-April, 2012, there is increased number of cases of Pandemic Influenza A H1N1 reported from the State of Andhra Pradesh, Maharashtra, Rajasthan, Karnataka and Tamil Nadu. Small pockets of population who remained unexposed to the pandemic and susceptible would be affected. In first week of March almost 30% of referred samples were positive for H1N1 in Pune which has come down to approx. 10% now.
A large number of these cases would be presenting with mild influenza like illness and as such requires no testing or anti viral drug treatment. However, it is important to get oneself examined at the nearest hospital in the initial part of illness to detect moderate illness and other associated risk factors/ diseases that require hospitalization.
The anti viral drug Oseltamivir is available free of cost through the State public health system. They are also available with retail chemists licensed to keep Schedule X drugs. A central stockpile of about 8 million doses of Oseltamivir is also maintained. As the virus is circulating with in the country, there is no need to impose any travel restrictions or screening at inter-state point of entry, railway stations etc.
In Focus Stories
Kidville held a workshop on “Think Prevention & First Aid”
Kwakids Learning Pvt. Ltd., the master franchisee for Kidville, a well-known US enrichment facility for children aged seven and below, held a workshop on “THINK PREVENTION & FIRST AID” at their facility in Atria Mall on Sunday, April 8th, 2012. The workshop, in association with Safe Baby, was held under the guidance of Dr. Rashid Merchant, Consulting Pediatrician - Nanavati Hospital.
Dr. Rashid Merchant, speaking at the workshop said, “The first five minutes after any mishap are the most crucial moments for any child. The immediate first aid administered by the person present on the scene decides how the child fares. It is necessary that every parent with a small child understands basic first aid techniques to be able to tackle any situation that they may face.”
Dr. Rashid Merchant shared the incidents of treating kids in the city that enumerated the various emergency situations that parents can face with children. He pointed out that coins, pencil points, electrical sockets, doors are among the most common injury causing objects and one needs to be well prepared to be able to administer first aid.
Shalini Agarwal, CEO – Safe Baby while conducting the workshop and the demos said, “Play is the work of childhood and we should let children be children. Our job is to make it safe for them to explore their world and taking some basic precautions and measures can reduce the risk to a large extent.”
A choking child’s airway may be completely or partially blocked. A complete blockage is an urgent medical emergency. A partial obstruction can quickly become life threatening if the child loses the ability to breathe in and out sufficiently. Without oxygen, permanent brain damage can occur in as little as 4 minutes. Rapid first aid for choking can save a life.
Shalini, in the course of the workshop, demonstrated the Heimlich maneuver used to remove object because of which a child could be choking. She also demonstrated the technique to be used if the child is below one year.
Rosenyn Kapur, Managing Director & CEO, Kwakids Learning Pvt. Ltd. speaking about the need for this workshop, said, ““Children are meant to be children. It is important that parents and caregivers are educated to know all possible correct and immediate first-aid response to common accidents such as cuts, burns, poisoning and choking.”
Kidville also has a wide range of classes for children which include Music & Art (an interactive music program), Enrichment Classes etc. Kidville, additionally, offers a wide range of services for families such as birthday celebrations, special events and workshops for families as well as products at the boutique and a children’s salon. Kidville is dedicated to safety security and cleanliness to ensure that children could learn and play in hygienic, safe and clean environment.
Domestic News
Piramal Healthcare announces approval for regenerative medicine, BST-CarGeI
Piramal Healthcare Limitedannounced that it has received the European CE mark approval for its innovative bio-orthopaedic product for cartilage repair, BST-CarGel.
This European regulatory approval enables the company to commercialize BST-CarGel in all of the countries in the European Union. Furthermore, this approval will serve as the basis to obtain commercial authorization for the product in other geographic areas of the world such as the Middle East, the Asia Pacific region, South America and other countries including India.
“We are excited with the approval of Piramal’s first innovative product for regenerative medicine and we are looking forward to launch BST-CarGel to treat patients with cartilage injuries of the knee around the world. The approval of this product is a testimony of Piramal Healthcare’s commitment to become an innovation-led healthcare company”, said Dr Swati Piramal, Director, Piramal Healthcare.
BST-CarGel, a EU class III medical device, is a novel natural polysaccharide based liquid scaffold which, combined with the patient’s whole blood, is then implanted into a debrided cartilage lesion prepared with bone marrow access. As demonstrated in a controlled clinical trial, this procedure results in a superior cartilage repair volume and quality compared to the standard of care treatment with the goal of offering a more durable longer term treatment.
Commenting on the development, Ajay Piramal, Chairman, Piramal Group said, “BST-Cargel provides us with a superior way to address significant unmet medical needs in the global knee cartilage repair market. The current European approval provides access to a USD 200 million market in Europe with the potential for a larger market with greater penetration of treatment in Europe. As we obtain commercial approval in other geographic areas, this will give us access to additional markets.”
Piramal Healthcare plans to launch BST-CarGel for commercial sale in the fourth quarter of the 2012 calendar year after completing user studies with key opinion leaders.
Piramal Healthcare originally invested into the BST-CarGel® technology in 2006 and subsequently in 2010, acquired the assets relating to BST-CarGel® from BioSyntech Technologies Inc, a company located in Montreal, Canada.
Omkar Speciality Chemicals acquires LASA Laboratory
Omkar Speciality Chemicals Limited, one of the leading manufacturers of speciality chemicals, such as selenium derivatives, iodine derivatives, molybdenum derivatives, cobalt bismuth derivatives and pharma intermediates for life saving drugs has recently forayed into pharmaceutical business with its recent acquisition of LASA Laboratory Private Limited.
Located at Mahad in Raigad district, south west of Maharashtra has been an established player in the anthelmintic / veterinary API segment with state-of-the-art API manufacturing facility.
Talking to the media, Pravin S. Herlekar, Chairman & Managing Director, Omkar Speciality Chemicals Limited (OSCL) said, "There is a colossal demand in the API manufacturing space, and with Indian drug manufacturing sector gaining international prominence, the acquisition of LASA Laboratory was the right move for our group to venture into the pharma business. It is also a part of our group's forward integration strategy "
"The acquisition will enable us to focus on manufacturing Anthelmintics, such as Albendazole EP, Albendazole IP/USP, Cyromazine, Fenbendazole BP VET/ EP, Nitroxynil BP Vet, Ricobendazole, Toldimphos Sodium and Triclabendazole," informed Herlekar.
"Our new API division is already in operations and will initially focus on continuing the existing API business of LASA Laboratory, which has massive demand in India and abroad. The products are used as Anthelmintics or deworming agents for veterinary," informed Mr. Herlekar.
"Currently, our product portfolio comprises 10 products in the Veterinary Anthelmentics segment, mainly Benzimidazoles and other active pharma ingredients," he added.
Glenmark Generics receives USFDA nod for Norgestimate and Ethinyl Estradiol Tablets
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Ind-Swift Laboratories gets USFDA nod for 5 APIs for its Derabassi facility
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International News
Offer for Illumina fair and attractive: Roche
Roche released the following statement regarding its pending offer for Illumina, Inc.):
“We continue to believe that on the basis of the public information that has been available to us, our offer price of US$51 per share is full, fair and extremely attractive by every conceivable financial metric.
Illumina has to date not provided any quantitative support for their aggressive growth assumptions. We believe that their long term growth expectations are unrealistic and ignore the inherent and significant market and technology risks,” said Severin Schwan, CEO of Roche Group.
Schwan continued, “As we have said earlier, if Illumina were to engage with us, we would consider any information supporting Illumina’s contention that our offer undervalues the company and its prospects. However, because Illumina has refused to enter into negotiations with us,
our current analysis is by necessity based solely on publicly available information, and that information does not justify a price in excess of $51 per share. Our goal has always been to enter into a negotiated transaction with Illumina and we firmly believe that our present offer is more than adequate to serve as a basis to begin that negotiation with Illumina.”
USFDA approves Eli Lilly's Amyvid for Alzheimer's Disease
Eli Lilly and Company and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, on Monday announced that the US Food and Drug Administration (FDA) has approved Amyvid, a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. Amyvid binds to amyloid plaques, a hallmark characteristic of Alzheimer's Disease,,, and is detected using PET scan images of the brain.
A negative Amyvid scan indicates sparse to no amyloid plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer's Disease and reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's Disease.
A positive Amyvid scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer's Disease, but may also be present in patients with other types of neurologic conditions and in older people with normal cognition.
It's important to note that Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scan does not establish a diagnosis of Alzheimer's Disease, or other cognitive disorder. Additionally, the safety and effectiveness of Amyvid have not been established for predicting development of dementia or other neurologic condition, or monitoring responses to therapies.
Alzheimer's Disease is one of several possible causes of cognitive decline. Alzheimer's Disease and other causes of cognitive impairment share many overlapping symptoms including memory, visuospatial ability, executive function, behavior and language deficiencies.4, Because a definitive diagnosis of Alzheimer's Disease is usually determined upon autopsy, physicians rely on medical history, clinical examination and a variety of diagnostic tools when evaluating patients.
"It's estimated that one in five patients clinically diagnosed with probable Alzheimer's Disease during life do not end up having Alzheimer's Disease pathology upon autopsy,", said Daniel Skovronsky, M.D., Ph.D., president and CEO of Avid, and global brand development leader for Amyvid at Lilly. "The approval of Amyvid offers physicians a tool that, in conjunction with other diagnostic evaluations, can provide information to help physicians evaluate their patients."
Amyvid was evaluated in three clinical studies that examined images from healthy adult patients as well as patients with a range of cognitive disorders, including some terminally ill patients who had agreed to participate in a postmortem brain donation program.
"Florbetapir gives patients with cognitive decline, their families and the physicians who treat them, more information about the amyloid plaques that may be found in their brain," said R. Edward Coleman, M.D., professor of radiology, Duke University Medical Center. "This approval marks a great advancement in nuclear medicine practice, as it enables us to evaluate the presence or absence of moderate to frequent levels of amyloid plaques in a patient's brain. In conjunction with other tests, florbetapir may help give physicians additional information when evaluating patients for the cause of their cognitive decline."
Because Amyvid loses over half of its radioactivity every two hours, Amyvid must be distributed directly from a radiopharmacy to the imaging centers where it will be administered within several hours. Beginning in June, a limited number of radiopharmacies will be distributing Amyvid with the goal of making the product available in more areas as soon as possible.
"The approval of Amyvid exemplifies Lilly's commitment to discovering and developing innovative products for many of the world's unmet medical needs," said Alex Azar, president, Lilly USA. "We are working hard with our manufacturing partners to increase production of Amyvid and will notify the community as it becomes available in more markets."