In an evaluation of medicines approved by the European Medicines Agency 2000 to 2010, Ruben Duijnhoven and colleagues find that the number of patients evaluated for medicines approved for chronic use are inadequate for evaluation of safety or long-term efficacy.

Agovernment panel has proposed that prices of patented medicines be based on the country’s per capita income, a move that would substantially reduce prices of costly drugs made by global pharmaceutical firms.

The proposal, which seeks the input of other government agencies as well as industry groups, could provoke the ire of Big Pharma, which has clashed with India over protection of intellectual property, price regulations for generic drugs, and compulsory licenses for costly medicines.

Taking suo motu cognisance of a letter seeking action against renowned pharmaceutical companies for looting cancer patients by printing inflated maximum retail price (MRP) on medicines, the Punjab and Haryana High Court today put the state of Punjab on notice.

The Division Bench of Chief Justice Arjan Kumar Sikri and Justice Rakesh Kumar Jain issued the notice after taking cognisance of the letter by Faridkot-based Bhai Ghanaiya Cancer Roko Seva Society.

Man-made chemicals in everyday products are likely to be at least the partial cause of a global surge in birth deformities, hormonal cancers and psychiatric diseases, a U.N.-sponsored research team

Forms four expert panels to draft permission guidelines

Following more than 2,200 deaths in clinical trials in the past five years, the government has finally set up four expert committees to streamline approvals and evolve standard operating procedures for marketing of drugs in India, which are discovered abroad. The move comes following Supreme Court's observation that the Ministry of Health was watching meekly as the unregulated clinical trial sector played "havoc" with the people.

The National Human Rights Commission (NHRC) on Thursday issued a notice to the Union Health Ministry after receiving information that three government hospitals committed illegal drug trials on nea

The National Human Rights Commission (NHRC) on Thursday issued a notice to the Union Health Ministry after receiving information that three government hospitals committed illegal drug trials on nea

The rules notified by the government for compensating clinical trial victims have failed to address the concerns raised by patient groups and health activists.

Companies failing to pay up within the stipulated time may face suspension of trials and even a permanent ban

Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.
The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.

In a move that will go a long way in ensuring the safety of subjects who participate in clinical trials in India, the government has notified procedures whereby compensation will be awarded in case of death or injury suffered by persons participating in the trials.

Hitherto, there was no rule under the law to provide for compensation in case of serious adverse events or injuries to subjects in clinical trials. The Drug Controller General of India (DCGI), the highest drug regulator, approves the conduct of clinical trials under the Drugs and Cosmetics Rules. But these rules have no procedures or even a mention of compensation to be given in case a participant in a trial suffers injury, disability or death.

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