A novel anti-diabetic drug that lowers blood glucose levels by acting on the kidneys, instead of the liver or the pancreas, has been approved by the USFDA.

The drug, Invokana (Canagliflozin), works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels in diabetics. Its safety and effectiveness were evaluated in nine clinical trials involving over 10,285 patients with type 2 diabetes.

“The court has recognised the right of patients to access affordable medicines over profits for big pharma companies”

It was celebration time for health activists and civil society groups after the Supreme Court delivered its judgment dismissing Swiss multinational company Novartis’ appeal for patent for its anti-cancer medicine imatinib mesylate or Gleevec. “We are happy that the apex court has recognised the right of patients to access affordable medicines over profits for big pharmaceutical companies through patents.

The Clinical Trials Registry - India (CTRI), an online system (www.ctri.nic.in) for the registration of clinical trials being conducted in India, has its secretariat at the National Institute of Medical Statistics of the Indian Council of Medical Research in New Delhi. The primary objective of the CTRI is to ensure that all clinical trials conducted in India are registered in order to bring transparency, accountability and access to clinical trials.

Supreme Court judgement dated 01-04-2013:in Appeal Civil No. 2706-2716/2013 @ SLP(C) 20539-20549/2009 Novartis AG Vs. Union of India and ors (Patent/Cancer Drug).

The Supreme Court will pronounce on Monday its verdict in a landmark patent case involving Swiss pharma giant Novartis AG.

The company has challenged the denial of patent to its blood cancer drug Glivec in India The verdict, which is crucial even for public health, is being watched closely by global pharmaceutical firms, who have been pushing for stronger patent protection in India to regulate the country's $26-billion generic drug industry.

Move comes in the wake of repeated slamming by the SC and the Parliamentary committee on health and family welfare

The government is considering framing a separate policy for the approval of medicines, as well as clinical trials conducted in India - in a move that is expected to strengthen regulation on the pharmaceutical industry and ensure patient safety in the country. The Union Ministry of Health and Family Welfare has constituted a committee, headed by Ranjit Roy Chaudhury, advisor in the health ministry, to formulate a policy "for approval of new drugs, clinical trials and banning of drugs".

INDORE: Madhya Pradesh government is all set to introduce a 'controversial' vaccine whose efficacy is still being debated in the country and elsewhere as some deaths of children were reported after they were administered the vaccine.

Much against caution by experts', Madhya Pradesh is mulling to launch pentavalent vaccine in National Immunisation Programme that targets five infections including diphtheria, pertussis, tetanus, hepatitis-B and HiB (haemophilius influenzae type B).

Health and Family Welfare Minister Aravinda Limbavali has invited pharmaceutical companies in Karnataka set up their plants across the State instead of focussing only on Bangalore.

Releasing the Karnataka Pharmaceutical Policy, 2012, here on Wednesday the minister said that many foreign pharmaceutical companies were willing to set up their plants in the State.

INDORE: While the Union government on Tuesday provided an updated list of 44 clinical trial victims compensated in between 2005 and 2012, experts have raised fingers over the institutional ethics c

Despite clinical trials coming under scrutiny, nothing much has changed on ground as many irregularities continue to exist. While the office of the Drugs Controller General of India (DCGI) is still struggling to accumulate data, compensation had been paid only in 50 per cent of the clinical trial death cases so far, sources said.

According to data from the drug controller's office, between January 2005 and June 2012, there were 80 deaths due to clinical trials. However, compensation has been paid in only 40 cases pertaining to 2008-2011. Pharmaceutical companies are yet to pay compensation to victims of trials during 2005-08, and for those who died in 2012.

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