La Liga: Real Madrid and Atletico warm up for city derby with victories

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India vs South Africa: Will Rohit Sharma's red-ball dream get a top-up?

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League Cup: Manchester United survive shoot-out, West Ham crash out

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GSK to recall Ranitidine from India after regulator alert

NEW DELHI: British drugmaker GlaxoSmithKline on Wednesday said it is recalling heartburn drug Ranitidine from India, a day after the country’s drug regulator asked pharma companies to check their products for carcinogen.“As a precautionary action, GSK has made the decision to initiate a voluntary recall (pharmacy/retail level recall) of Zinetac Tablets 150 mg and 300 mg products manufactured in India using API sourced from Saraca Laboratories Ltd,” a GSK spokesperson said in a statement.Earlier this month, the US FDA had raised a global alarm over the presence of a probable cancer causing substance—NDMA or N-Niteosodimethylamine—in some Ranitidine medicines.GSK manufactures Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg (Zinetac) using API from Hyderabad-based Saraca Laboratories and another supplier, SMS Lifesciences India Ltd, for supply to the Indian market.Subsequently, Saraca Laboratories was notified by the European Directorate for the Quality of Medicines (EDQM) that its certificate of suitability for Ranitidine Hydrochloride has been suspended with immediate effect.GSK has been contacted by the Indian drug regulatory authority regarding the detection of genotoxic nitrosamine NDMA in Ranitidine products.“Based on the information received and correspondence with regulatory authorities, GSK made the decision to suspend the release, distribution and supply of all dose forms of Ranitidine Hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations,” added the spokesperson, clarifying that the product manufactured using API from SMS Lifesciences will not be recalled from the market at this point of time. However, all such products will remain on hold and they will not be released to the market till they receive test results.“GSK is continuing with investigations into the potential source of the NDMA. These investigations include continued engagement with our API suppliers. Patient safety remains our utmost priority and we are taking this issue very seriously,” the spokesperson further said.Ranitidine is a commonly prescribed medicine for countering acidity and is on the World Health Organisation’s Model List of Essential Medicines. In India, a host of companies including GalxoSmithKline, JB Chemicals, Cadila Pharma, Zydus Cadila, Dr Reddy’s and Sun Pharmaceuticals sell over 180 versions of the drug.The market size for Ranitidine brand in India is Rs 688.6 crore, as per data shared by AIOCD PharmaTrac.

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Gold gains ground on bargain hunting, strong dollar caps gains

US gold futures were up 0.2 per cent at $1,515.9 per ounce.

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Side effects of medical devices: Panel chalks out formula for compensation

By Teena ThackerNEW DELHI: Indian manufacturers and importers of medical devices will soon have to compensate patients for serious side effects of their products. On Wednesday, an experts’ panel set up by the government finalised the terms of a legally binding compensation formula which will be recommended to the health ministry for incorporation in the Drugs and Cosmetics (D&C) Act, people aware of the matter told ET.India so far did not have legal provisions to compensate patients who suffer serious side effects due to use of medical devices. The law mandates compensation only when something goes wrong during a clinical trial.According to the formula finalised by the nine-member medical devices sub-committee, compensation will be determined on the basis of parameters like the base amount, loss of wages, and the degree of disability, the persons cited earlier said, requesting not to be named. The panel is headed by former director general of health services (DGHS), BD Athani.“If the disability is higher, permanent and the patient is young, the compensation is higher,” said one of the persons cited earlier.The experts have suggested a composition of “causality assessment committee” to determine if the adverse event happened due to the manufacturing defect of the medical device or otherwise.In case of imported devices, the liability to pay compensation will fall on the Indian agent licensed to sell the product. Once the formula is approved and notified by the government, all devices regulated under the Drugs and Cosmetics Act will fall under the ambit of the amended legislation.71303716 The proposal to chalk out a formula for compensation in case of medical devices was part of the government’s 100-day agenda. The sub-committee was formed after investigations were started into problems due to hip implants manufactured by a subsidiary of Johnson & Johnson (J&J) which required some patients to undergo revision surgery. While some of the affected patients received compensation this year after court intervention, the gap in the law prodded the government to put in place a structure for future compensations.Before finalising their recommendation, the experts’ committee had examined the terms of the Motor Vehicles Act, the compensation formula used for awarding subjects who suffer injury in medical clinical trials, the formula prescribed for patients who suffered in the Johnson & Johnson hip implant case, among others.The expert committee consists of representatives of Indian and multi-national device makers along with state drug controllers and public health experts. “The manufacturers who are part of the committee have come to the conclusion that the patient should be entitled to a decent compensation in case any untoward incident happens. However, cases of medical negligence by doctors will not be covered under this formula,” the person quoted earlier said.Among other suggestions, the panel has said that state-level expert committees should be formed to investigate compensation claims.

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Here’s why you must try the Diwali flavours in Dubai this festive season

From Michelin-starred venues to family-friendly eateries, try a taste of Diwali in Dubai.

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