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Indian government outlines policies on drug pricing to favor poorer patients, and increase clinical trials
The Indian government is looking to review the existing drug price control measures in order to make medicines more affordable in the country, and at increasing the number of clinical trials taking place in the country, reports The Pharma Letter's India correspondent.
In a parallel move, the Health Ministry is also preparing a framework for public private partnership to tackle the menace of non-communicable diseases in the country, In a move that could potentially result in affordable Medicare and health security moving to a larger section of the population, the government is considering a rash of policy measures in favor of poor patients.
Talks are also on in government circles to abolish clinical trials on proven drugs that have been approved and marketed for at least two years in the European Union, United States, UK, Australia, Canada and Japan.
A draft proposal in this regard has been prepared by the Health Ministry. If instituted, it would reduce the time taken to introduce new drugs in India to just 45 days from five-six years.
Making medicines more affordable
The government has constituted a panel comprising joint secretaries from the Department of Pharmaceuticals (DoP), Health and Family Welfare Ministry, National Pharmaceutical Pricing Authority (NPPA) member secretary and Drugs Controller General of India (DGCI), among others, to recommend steps to make medicines more affordable.
FDA Decides Not to Ban Avandia, but Puts Restrictions on How It’s Used.
By Daniel J. DeNoon
WebMD Health News
Sept. 23, 2010 -- The FDA will not ban Avandia -- but stringent restrictions will make it far harder for doctors to prescribe the safety-troubled diabetes drug.
The European Medicines Agency took harsher action. European sales of Avandia-containing drugs will be suspended over the next few months, although the agency did not formally withdraw approval.
The 600,000 U.S. patients currently taking Avandia can continue to take the drug only if their doctors officially attest that their patients understand the risks, that the drug is helping them, and that no other diabetes drug can keep their blood sugar under control.
New Avandia prescriptions can only be written for patients who, for medical reasons, cannot take Actos. Actos, a diabetes medication in the same class as Avandia, does not cause the heart problems linked to Avandia.
Isotretinoin in India: A tragedy in the offing Wednesday, March 28, 2007 08:00 IST Seema Thakral
Isotretinoin is the drug of choice for severe calcitrant cystic acne vulgaris, which often causes scarring and depression from disfigurement. Isotretinoin has been called "the greatest medical advance of the 1980's." A majority of patients with acne are permanently cleared after a four to five months course of treatment. It has also been used off-label for a variety of oncology uses including: cervical cancer, head and neck cancer, squamous cell cancer of the skin, juvenile chronic myelogenous leukemia (CML), and neuroblastoma. However, the drug is a proved teratogen and carries a significant risk of birth defects, if it taken during pregnancy. Birth defects, which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. There is an increased risk …
 Various methods are used to obtain specimens for hematocritdetermination in neonates. We evaluated arterial sampling andfound this method to be acceptable. Arterial values correlatedclosely with simultaneously obtained venous samples. Venousblood obtained with a tourniquet had a significantly higherhematocrit than that obtained without a tourniquet. Influence of tourniquet application on venous blood sampling for serum chemistry, hematological parameters, leukocyte activation and erythrocyte mechanical propertiesBackground: Venous blood sampling is usually performed using a tourniquet to help locate and define peripheral veins to achieve successful and safe venipuncture. Despite widespread usage of tourniquets for venipuncture by medical and laboratory staff, very few are aware of the effects of tourniquet application on laboratory parameters. In addition, definitive guidelines regarding when and how to use a tourniquet for blood sampling are lacking. The aim of the present stu…