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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
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, Merck in pact for anti-infective drugs
Ranbaxy Laboratories on Monday announced it has signed a collaboration agreement with US-based Merck & Co for drug discovery and clinical development of products in the anti-infective field.
Both would work to develop clinically validated anti-bacterial and anti-fungal drug candidates, with Ranbaxy slated to get an undisclosed upfront sum and more than $100 million for each drug target, depending on successful development and regulatory approval. It will also be entitled to royalties under the five-year deal.
“Ranbaxy will carry out drug discovery and clinical development through phase II ‘a’ clinical trials, with Merck conducting development and commercialisation of drug candidates thereafter,” a company statement added. According to the agreement, the collaboration would begin this year with an initial term of five years and can be extended mutually thereafter by the parties.
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Ranbaxy Laboratories on Monday announced it has signed a collaboration agreement with US-based Merck & Co for drug discovery and clinical development of products in the anti-infective field.
Both would work to develop clinically validated anti-bacterial and anti-fungal drug candidates, with Ranbaxy slated to get an undisclosed upfront sum and more than $100 million for each drug target, depending on successful development and regulatory approval. It will also be entitled to royalties under the five-year deal.
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