Wants cos to ensure early launch of new therapies here if trials prove successful This move is part of steps DCGI has taken last week to bring clarity in the clinical trials space and ensure patien

Drug regulator has set a range of . 4 lakh to . 74 lakh as payout, depending on age and health risks of volunteers

An expert panel set up by the drug regulator has recommended a minimum compensation of . 2 lakh for the family of ‘most serious, terminally ill’ patients who die because of drug study-related injuries.

The health ministry has suspended the sale of two drugs — painkiller Analgin and anti-diabetes drug Pioglitazone and all its combinations.

Panels meant to ensure safety & rights of volunteers must be registered with DCGI

Starting next week, all ethics panels that are meant to ensure the safety and rights of volunteers for clinical trials, must be registered with the Drug Controller General of India. The changes in the norms for ethics committees, that review and approve protocols of all clinical trials, are part of a clean-up act in the regulation of such trials initiated by the government after being rapped by the Supreme Court last month.“Even the existing ethics committees, which are part of ongoing trials would have to seek registration at the drug regulator’s office within 45 days of the notification,” said a health ministry official.

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.

New Delhi The laxness in branding medicines, a common practice for long but with serious implications for public health besides being an unhealthy business practice, might soon end.

A recent health ministry move to bar state drug regulators from granting manufacturing licences on brand names may force companies to queue up before the registrar of trademarks. In the process, several brands resembling popular brands and at times even misrepresenting their contents may get weeded out, too.

New Delhi The government has decided to stick to the new market-based formula for essential drugs.

New Delhi The International Cri-minal Police Organisation, popularly known as Interpol, wants to assist the Indian government in its effort to clamp down on the alleged ‘fake drugs’ network in the

New Delhi The government is planning to tighten the regulatory landscape of the R4,500-crore vitamins and neutraceuticals market in the country. Different arms of government — the drug regulator, Drug Controller General of India (DCGI), and the food regulator, Food Safety and Standards Authority of India (FSSAI) — are taking a series of steps to correct the anomaly of multivitamins getting marketed as dietary supplements.

First, DCGI may make it mandatory for all such vitamin manufacturers who use any drug as ingredients in their products to take a no-objection certificate from the government. This is likely to become compulsory for manufacturers who use medicinal ingredients for 'non medicinal use', which would include food supplements.

New Delhi A formula to determine the financial compensation that victims of clinical trials would be entitled to has been proposed by the health ministry.

In case of death resulting from clinicals trials, the deceased’s age, income, seriousness and severity of the disease he was suffering from at the time of enrolling into the trial is expected to be taken into account. In case of an injury that has resulted from clinical trials, an additional factor — the percentage of permanent disability — would be measured to arrive at the financial compensation that the clinical trial victim is entitled to.