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Govt hospitals to be restructured in Andhra
Andhra Pradesh chief minister Y S Rajasekhara Reddy on Wednesday agreed for restructuring the government hospitals in the state in tune with the requirements of the Aarogyasri scheme, which provides cashless treatment to the poor.
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The health department prepared a blueprint for revamping the policies, support services, infrastructure and restructuring the staff of government hospitals.
The government proposed to increase the participation of government hospitals in the Aarogyasri programme from the present 9 per cent to 30 per cent in a year by creating better infrastructure and staff.
New definition of fake drugs could save the day for local companies
The risk of India’s generic drugs being labelled counterfeit under the new definition proposed by WHO has receded, a government represe
ntative concerned with the issue said. This would ensure that India’s manufacturers continue to sell their drugs in foreign markets.
The WHO-funded International Medical Products Anti-Counterfeiting Taskforce (IMPACT) had proposed a new definition of counterfeit drugs as medical products with a “false representation about their identity, history or source”.
How safe are our clinical trials?
The way the actual testing works is that the sponsor clears every project with the Drug Controller General of India (DCGI) and, as part of the process, has to have a Management Committee, an Ethics Committee and a Data Safety Management Board; there are then various monitoring committees and the DCGI is training people to ensure these guidelines are being followed. The structures are all there and the larger trials, by the Bill and Melinda Gates Foundation for instance, are being done under these rules. But much of this is self-regulatory and there will be lapses. The rules and their implementation are being strengthened and as the support eco-system gets better, the chances of regulatory failure also decline. In another five years, India will have a very strong clinical trials environment in place.
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The way the actual testing works is that the sponsor clears every project with the Drug Controller General of India (DCGI) and, as part of the process, has to have a Management Committee, an Ethics Committee and a Data Safety Management Board; there are then various monitoring committees and the DCGI is training people to ensure these guidelines are being followed. The structures are all there and the larger trials, by the Bill and Melinda Gates Foundation for instance, are being done under these rules. But much of this is self-regulatory and there will be lapses. The rules and their implementation are being strengthened and as the support eco-system gets better, the chances of regulatory failure also decline. In another five years, India will have a very strong clinical trials environment in place
Peace on patents to boost Ranbaxy
Ranbaxy expects the settlement with Astrazeneca on Nexium, the world's second largest selling drug with annual global sales of around $5.5 billion, to fetch $1.5 billion in exclusive sale of its generic version and supply of raw materials. The out of court settlement with Pfizer on Lipitor is expected to generate even more revenues in the coming years.
By doing out of court settlements, Ranbaxy has opened multiple revenue streams from these products. Apart from generic clones, it can supply authorized generics as well as bulk drugs to some of these innovator companies.
Settlement of patent litigations, said the source, has brought certainty to the company's cash flows, besides saving it millions of dollars in legal fees. Ranbaxy still has 14 patent challenges going on at the moment. However, the source said, it may not settle all of these out of court.
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Ranbaxy expects the settlement with Astrazeneca on Nexium, the world's second largest selling drug with annual global sales of around $5.5 billion, to fetch $1.5 billion in exclusive sale of its generic version and supply of raw materials. The out of court settlement with Pfizer on Lipitor is expected to generate even more revenues in the coming years.
By doing out of court settlements, Ranbaxy has opened multiple revenue streams from these products. Apart from generic clones, it can supply authorized generics as well as bulk drugs to some of these innovator companies.
Settlement of patent litigations, said the source, has brought certainty to the company's cash flows, besides saving it millions of dollars in legal fees. Ranbaxy still has 14 patent challenges going on at the moment. However, the source said, it may not settle all of these out of court.
Babies'death in AIIMS trials open Pandora's box
Bangalore:The death of 49 babies in clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi may have opened a Pandora's box as two of the trial drugs have never been tried on patients below 18 years, an expert said.
How many of the children died because of the trial drugs will be known only when an enquiry committee submits its report this month, but doctors have already raised questions of ethics.
In reply to a Right to Information (RTI) query, the AIIMS said that 49 babies had died during clinical trials over the past two-and-a-half years.
The AIIMS paediatrics department conducted 42 sets of trials on 4,142 babies - 2,728 of them below the age of one - since Jan 1, 2006.
Two of the trial drugs - olmesartan and valsartan, meant for reducing blood pressure - have never been tried on patients below the age of 18 years, said Chandra M. Gulhati, editor of the Monthly Index of Medical Specialties and a keen obserger of the clinical trials in India.
Ranbaxy buyout awaits CCEA nod
Japan's Daiichi Sankyo's proposal to acquire Ranbaxy will go to the Cabinet Committee on Economic Affairs (CCEA) for approval. Any foreign deal exceeding Rs 600 crore has to be approved by the CCEA under the existing policy.
Industry secretary Ajay Shanker told reporters that he does not see any problems related to the Tokyo-based Daiichi Sankyo's controlling bid on Ranbaxy Laboratories. The takeover is valued at $ 4.6 billion (Rs 19,780 crore).
The open offer by Daiichi to acquire upto 20 per cent of Ranbaxy's shares will close on September 4
Phase I prime-boost vaccine trial to be conducted in Chennai, Pune
Chennai: Next year may see the start of a Phase I prime-boost AIDS vaccine trial at the National AIDS Research Institute (NARI), Pune, and the Tuberculosis Research Centre (TRC), Chennai.
Prime-boost vaccine strategies are adopted to produce stronger and
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The final results of the Phase I AIDS vaccine trial using Modified Vaccinia Ankara (MVA) vector indicated good response in the volunteers at both low and high doses. However, the level of immune responses was only modest and the persistence of the responses was not very encouraging.
“It may be possible to boost the [level of] immune responses when the vaccine is used in combination with other candidate AIDS vaccines. This is what the prime-boost trial aims to determine,” Patricia Fast, Executive Director (Medical Affairs) of the International AIDS Vaccine Initiative (IAVI) told this correspondent over telephone from New York.
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“Thirty-two volunteers will be recruited. It will be 16 volunteers each at the NARI and the TRC,” said Dr. Fast. The proposal is to split the 16 volunteers at the NARI and the TRC into two groups of eight each. One arm would get only MVA while the other one would get ADVAX and MVA. Each arm would have two volunteers who would get a placebo (dummy).
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Separate department for pharma sector on anvil
In view of the robust growth of the pharmaceutical sector, the Government has decided in-principle to create a separate department dedicated to the sector, Union Minister of Chemicals and Fertilisers Ram Vilas Paswan said on Tuesday.
Addressing the media, the Minister said the proposed department for the pharma sector would be carved out from the existing chemical and fertilizer department, which is now also taking care of the sector.
Responding to a question on the demand of the Indian Drug Manufacturers Association (IDMA) for revising the ceiling prices of 33 bulk drugs in the wake of the appreciating dollar against the rupee, the Minister said, “In a situation where the profit margins are as high as 200 per cent, there is no possibility of any company closing its manufacturing business due to the price control mechanism of the government.
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In view of the robust growth of the pharmaceutical sector, the Government has decided in-principle to create a separate department dedicated to the sector, Union Minister of Chemicals and Fertilisers Ram Vilas Paswan said on Tuesday.
Addressing the media, the Minister said the proposed department for the pharma sector would be carved out from the existing chemical and fertilizer department, which is now also taking care of the sector.
Responding to a question on the demand of the Indian Drug Manufacturers Association (IDMA) for revising the ceiling prices of 33 bulk drugs in the wake of the appreciating dollar against the rupee, the Minister said, “In a situation where the profit margins are as high as 200 per cent, there is no possibility of any company closing its manufacturing business due to the price control mechanism of the government.
Financial Express : Patent Trials
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With drugs worth $60 billion going off patents in the US pharma market by 2011, Indian firms known for their expertise in copycat making are moving away from patent offices and aggressively taking the litigation route to get exclusive marketing rights in different parts of the world. Indian majors like Dr Reddy’s Labs, Sun Pharma, Glenmark and Ranbaxy have already entered into patent litigation with US-based MNCs to get the major chunk of the revenue from the sales of blockbuster drugs (having sales over $1 billion) in the US.
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The number of Paragraph IV abbreviated new drug applications (ANDA) submitted by Indian firms in the US has increased manifold in the last few years and what makes this more attractive is the chance for getting 180-day marketing exclusivity. “As part of building a large generics business through Glenmark Generics Limited (GGL), our Paragraph IV strategy would offer significant value,” says Glenn Saldanha, MD & CEO, Glenmark Pharmaceuticals Ltd.
According to the US FDA, a Paragraph IV certification begins a process in which the question of whether the listed patent is valid or will be infringed by the proposed generic product may be answered by the courts prior to the expiration of the patent. Paragraph III ANDAs can be submitted before the patent expiry, seeking marketing approval for the drug once the patent expires. Paragraph IV ANDA submission enables the applicant to prove that such patent is invalid or will not be infringed by the generic drug, for which approval is being sought.
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