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Drugmakers may lose product licence if govt labs flag quality failures
Drugmakers may lose product licence if govt labs flag quality failures

Business Standard

time6 days ago

  • Health
  • Business Standard

Drugmakers may lose product licence if govt labs flag quality failures

The Health Ministry is working with states to allow immediate suspension of licences for drugs declared substandard by labs, following a key recommendation from Drugs Technical Advisory Board Rimjhim Singh New Delhi The Ministry of Health is planning strict action against pharmaceutical companies if their medicines fail quality checks. The ministry is in talks with state authorities to allow immediate suspension of licences for drugs found to be 'Not of Standard Quality' (NSQ) by government laboratories, according to a report by The Economic Times. This move aims to ensure consistent drug quality and safeguard public health, especially after several cases of substandard medicines were reported across the country. Recommendation of drug advisory board The proposed action follows the recommendation of the Drugs Technical Advisory Board (DTAB), the apex body advising the Central Drugs Standard Control Organisation (CDSCO). The board, in its recent meeting, underlined the need for quick regulatory intervention once a drug is declared NSQ, the news report said. 'The board noted that it is very important that once a drug is declared NSQ, the license of such product shall be suspended immediately in public interest unless a satisfactory corrective action and preventive action (CAPA) is submitted by such manufactures. After detailed deliberation, DTAB recommended the appropriate amendment in the Drug Rules in this regard and the suspension product licence should be revoked only after root cause analysis and corresponding CAPA has been implemented,' said the minutes of the meeting. The CDSCO is currently holding discussions with pharmaceutical industry associations, many of which have raised objections to the proposed rule. 'The health ministry and the CDSCO is taking a step forward by taking views of the states and pharma bodies as it would require a notification,' said a senior government official, as quoted by The Economic Times. Pharma industry voices concerns Pharmaceutical industry representatives argue that NSQ declarations can stem from technical issues rather than deliberate negligence. The Federation of Pharma Entrepreneurs (FOPE) noted in its submission, 'NSQ is a global phenomenon, and most of the time, it is due to technical issues without any wrongful intent.' Industry groups also highlighted potential shortcomings in government laboratory practices. 'This has been a long-standing concern. It is also necessary that the NSQ investigation includes a review of records and data from government testing laboratories, as well as GLP compliance by the Drugs Inspector,' said a member of one such lobby group, as quoted by The Economic Times. Industry demands robust review and recall mechanisms Drugmakers emphasise that rather than immediately suspending licences, the focus should be on strengthening the drug recall mechanism and conducting thorough investigations before action is taken. FOPE has also called for a detailed impact assessment of the proposed rules. 'We fear it may lead to malpractices in the profession, and genuine manufacturers with investments of hundreds of crores in plant setup, product development, technical team development, brand development, business development, and goodwill, may be adversely impacted if actions like the suspension of product permission are taken without proper investigation,' the group said. Novo Nordisk launches Wegovy in India Danish drugmaker Novo Nordisk on Tuesday launched its weight-loss injection Wegovy in India. The once-a-week injectable, already available in the US and Europe, will reach Indian pharmacies by the end of June. Wegovy contains semaglutide, a compound that mimics a natural hormone to help control appetite, reduce cravings, and promote fullness — making it easier for users to adopt healthier habits. Approved for long-term weight management, it also lowers heart-related risks in overweight or obese individuals. Clinical trials suggest that around one in three users may lose up to 20 per cent of their body weight in just over a year, when combined with diet and exercise. In India, Wegovy is recommended for adults with a BMI of 30 or above, or over 27 with health issues like diabetes or high blood pressure. It is administered once weekly with a pre-filled pen, and the dose increases gradually. Monthly prices range from ₹17,345 to ₹26,015 depending on the dosage.

MakeMyTrip to raise $2.5 bn to slash Trip.com's stake and voting power
MakeMyTrip to raise $2.5 bn to slash Trip.com's stake and voting power

Business Standard

time18-06-2025

  • Business
  • Business Standard

MakeMyTrip to raise $2.5 bn to slash Trip.com's stake and voting power

MakeMyTrip to repurchase Class-B shares from reducing its voting power and board rights amid calls to limit Chinese investment following India-Pakistan conflict Rimjhim Singh New Delhi Indian travel booking platform MakeMyTrip has announced plans to raise over $2.5 billion through the sale of ordinary shares and convertible bonds. The move, disclosed in regulatory filings with Nasdaq, is aimed at substantially cutting down the ownership and influence of China-based Group in the company, news agency PTI reported. The Gurugram-based, NASDAQ-listed company said the funds raised through both the equity and the concurrent convertible notes offering will be used to buy back a portion of its Class-B shares previously held by 'As of March 31, 2025, beneficially owned 100 per cent of our issued and outstanding Class B Shares and 15.05 per cent of our aggregate ordinary shares and Class B shares, together representing an aggregate of 45.34 per cent of the total voting power in our company,' MakeMyTrip noted in its filings. Following the share repurchase, voting power will drop significantly — from 45.34 per cent to 19.99 per cent. As a result, its board nomination rights will be reduced from five directors to two, in line with the Terms of Issue governing the share structure, PTI reported. Broader geopolitical context The timing of this corporate move comes amid increasing scrutiny over investments from countries like China and Turkey, especially in the wake of heightened tensions following last month's India-Pakistan military clash. Public sentiment and political voices have urged companies to distance themselves from investors seen as aligned with Pakistan. Fuelling the debate, EaseMyTrip co-founder Nishant Pitti recently questioned MakeMyTrip's Chinese ties, alleging that five out of its ten board members are directly linked to China. Details of the capital raise MakeMyTrip revealed in its Nasdaq filing that it will issue 14 million ordinary shares, each with a par value of $0.0005. Additionally, the company announced a concurrent offering of $1.25 billion in aggregate principal amount of convertible senior notes, with an option for underwriters to purchase up to an additional $187.5 million, PTI reported. 'Concurrently with this offering, we are offering $1.25 billion aggregate principal amount of convertible senior notes, plus up to $187.5 million aggregate principal amount... if the initial purchasers... exercise in full their option,' the company said. Terms of repurchase agreement On Monday, MakeMyTrip entered into a share repurchase agreement with According to the agreement, the Chinese travel firm has agreed to sell a portion of its Class-B shares back to MakeMyTrip at the same price as the public offering, net of underwriting discounts and commissions. Generally, Class-B shares carry the same rights and preferences as ordinary shares, except as otherwise detailed in the company's terms of issue.

Shapoorji Group bags $3.35 bn in largest private deal led by Deutsche Bank
Shapoorji Group bags $3.35 bn in largest private deal led by Deutsche Bank

Business Standard

time31-05-2025

  • Business
  • Business Standard

Shapoorji Group bags $3.35 bn in largest private deal led by Deutsche Bank

The $3.35 billion financing was raised via 3-year NCDs at a 19.75 per cent annual yield, up from last year's 18.75 per cent when Goswami Infratech raised $1.7 billion in debt Rimjhim Singh New Delhi Deutsche Bank has planned the largest private credit transaction outside the United States by raising $3.35 billion for the Shapoorji Pallonji (SP) Group. The infrastructure conglomerate leveraged a portion of its Tata Sons stake as collateral, attracting commitments from major global investors, including BlackRock and Morgan Stanley, according to a report by The Economic Times. The financing was secured through three-year non-convertible debentures (NCDs) offering a 19.75 per cent yield, compounded annually and payable at maturity. This marks a rise from earlier debt issuances, which commanded yields approximately one percentage point lower. In 2023, SP Group's Goswami Infratech had raised $1.7 billion at an 18.75 per cent yield, the news report said. Deutsche Bank's significant commitment and syndication The $3.35 billion funding round brought together three distinct investor groups: existing bondholders of Sterling bonds, current investors in Goswami bonds, and a new cohort of private credit investors from the US, the UK, Hong Kong, Singapore, and India. Deutsche Bank spread its exposure across international credit funds, with BlackRock acquiring $70 million, Sona Capital investing $180 million, Morgan Stanley Investment Management putting in $60 million, and PIMCO contributing $45 million. This consortium totalled around $355 million, complemented by a separate $500 million investment from Ares Capital. Farallon Capital, a longstanding creditor to the SP Group, invested $596 million (approximately ₹5,100 crore). Other key participants included Davidson Kempner and Cerberus Capital, committing $401 million and $474 million respectively. Secured by stake in Tata Sons and real estate arms The debt is secured against SP Group's 9.2 per cent shareholding in Tata Sons, held through Sterling Investment, as well as assets in Shapoorji Pallonji Real Estate and SP Energy — the group's oil and gas business. This issuance, exclusively arranged by Deutsche Bank, represents the first large-scale corporate bond placement following changes in Foreign Portfolio Investor (FPI) norms, which now permit offshore investment under the general limit route instead of the more restrictive Voluntary Retention Route (VRR), the news report said. Regulatory changes and timing impact the deal Originally aiming for a March close, the transaction was completed six weeks later, delayed by geopolitical uncertainties. While part of the proceeds will refinance existing debt and support growth in SP Group's real estate and engineering, procurement, and construction (EPC) businesses, the deal is expected to transform capital access for large Indian conglomerates, the news report said.

Video: Massive glacier collapse crashes into Swiss village, buries homes
Video: Massive glacier collapse crashes into Swiss village, buries homes

Business Standard

time29-05-2025

  • Climate
  • Business Standard

Video: Massive glacier collapse crashes into Swiss village, buries homes

A glacier collapse buried most of Blatten after a preemptive evacuation; rescue teams are using drones to find a missing man as fears of flooding loom Rimjhim Singh New Delhi A massive glacier collapse in the Swiss Alps on Wednesday triggered a catastrophic landslide that buried most of the Alpine village of Blatten in the Lotschental valley. The collapse, caused by the disintegration of the Birch Glacier above the village, sent a deluge of ice, mud, and rock cascading through homes, infrastructure, and the Lonza River. INCREDIBLE !! Here we are... ???????????? After days of overloading and cracks propagating, Birch Glacier collapsed over Blatten today at 3:24 pm and dammed the Lonza river... Devastating! ???? — Melaine Le Roy (@subfossilguy) May 28, 2025 Officials had evacuated Blatten's 300 residents and livestock earlier this month after geologists warned that a 1.5 million cubic metre section of the glacier could collapse, news agency Reuters reported. About 90 per cent of the village is now buried or destroyed, said Stephane Ganzer, head of security for the Valais region. 'What I can tell you at the moment is that about 90 per cent of the village is covered or destroyed, so it's a major catastrophe that has happened here in Blatten,' Ganzer said. One missing as search teams deploy drones One person, a 64-year-old man, is missing. Search teams have deployed drones with thermal cameras in hopes of locating him, Euronews reported. Drone footage from Swiss national broadcaster SRF showed a vast plain of mud and debris stretching across the village, submerging houses and blanketing the wooded slopes of the valley. The Lonza River was also engulfed, raising fears of flooding from blocked water flows. 'We've lost our village,' said Matthias Bellwald, the mayor of Blatten. 'The village is under rubble. We will rebuild.' Climate change seen as key driver Officials said millions of cubic metres of material tumbled down when part of the mountain above the glacier collapsed, bringing the ice mass with it. 'An unbelievable amount of material thundered down into the valley,' said Matthias Ebener, a local spokesperson. Experts pointed to climate change as a factor behind the collapse. Christian Huggel, a professor of environment and climate at the University of Zurich, said that warming temperatures are melting permafrost and destabilising mountain slopes. 'Climate change had likely played a part in the deluge,' he said, noting that the extent of the destruction in Blatten was unprecedented in recent Swiss Alpine history. Switzerland, home to the most glaciers in Europe, lost 4 per cent of its total glacier volume in 2023 alone — its second-worst year on record after a 6 per cent loss in 2022. Government response and ongoing risk Swiss Environment Minister Albert Rosti described the disaster as 'extraordinary' and pledged support for affected residents. President Karin Keller-Sutter expressed solidarity, saying on X, 'It's terrible to lose your home.' Authorities have closed the main road into the valley and urged the public to avoid the area due to ongoing risks. 'There's a risk that the situation could get worse,' Ganzer warned, noting that blocked water flows remain a threat. The army has also been mobilised in response to earlier signs of glacier instability, underscoring the scale and seriousness of the crisis. (With Reuters inputs)

Viral manga revives quake fears, Japan tourism hit ahead of summer peak
Viral manga revives quake fears, Japan tourism hit ahead of summer peak

Business Standard

time24-05-2025

  • Business Standard

Viral manga revives quake fears, Japan tourism hit ahead of summer peak

Bookings to Japan from key Asian markets like Hong Kong and Taiwan drop sharply as viral posts revive a comic book prediction of a July 2025 quake, prompting airlines to cut flights Rimjhim Singh New Delhi Holiday bookings to Japan from major Asian markets have plummeted ahead of the peak summer season, driven by a resurgence of online rumours predicting a catastrophic earthquake. The speculation stems from a decades-old manga by artist Ryo Tatsuki, which has recently gone viral once again, Bloomberg reported. Tatsuki's graphic novel, The Future I Saw, originally published in 1999 and reissued in 2021 with new content, includes a prediction of a massive earthquake in July 2025. The work portrays Japan being engulfed by tsunami waves and mentions impacts on neighbouring regions such as Hong Kong, Taiwan and the Philippines. Claims that Tatsuki foresaw the devastating 2011 quake have given new fuel to social media speculation, leading to widespread unease among potential travellers. Viral posts drive travel slump An analysis by Bloomberg Intelligence, using ForwardKeys data, shows a notable drop in airline bookings from markets such as Taiwan, South Korea and particularly Hong Kong. Since April, average bookings from Hong Kong are down by 50 per cent year-on-year, with reservations for late June through early July plunging by as much as 83 per cent. In response to waning demand, Greater Bay Airlines and Hong Kong Airlines have reduced flight frequencies to Japan. Authorities push back on quake speculation Officials in Japan have urged the public to remain calm and ignore unverified predictions. Miyagi prefecture Governor Yoshihiro Murai warned last month that the rumours were beginning to damage the region's tourism sector. The Japan Meteorological Agency also reiterated via its website that no technology currently exists to pinpoint the timing of earthquakes. Japan, situated along the Pacific Ring of Fire, is among the most earthquake-prone nations in the world. The memory of the 2011 disaster — when a powerful quake triggered a tsunami and nuclear crisis in Fukushima — continues to heighten public sensitivity to seismic threats. Airlines brace for impact While overall tourism to Japan remains strong, with a record 3.9 million foreign visitors in April driven largely by the weaker yen, industry analysts warn that the quake rumours are casting a shadow over short-term prospects, the news report said. 'The quake speculations are definitely having a negative impact on Japan tourism and it will slow the boom temporarily,' said Eric Zhu, an aviation and defence analyst at Bloomberg Intelligence. 'Travellers are taking a risk-averse approach given the plethora of other short-haul options in the region.' Zhu predicts more airlines could suffer in the coming months as a result of declining bookings and lower passenger loads. He identified Cathay Pacific Airways Ltd — which includes Hong Kong Express — as particularly vulnerable, given that nearly 20 per cent of its planned seat capacity through the autumn is allocated to Japanese routes, the news report said. Myth meets science — and fear Further increasing the anxiety is commentary from a well-known feng shui master in Hong Kong, who recently advised followers to steer clear of Japan this summer. Social media users have also cited a February report by a Japanese government task force, which raised the probability of a major earthquake along the Nankai Trough occurring within the next 30 years to approximately 80 per cent. However, scientists emphasise that this does not imply an event is imminent or tied to a specific date. Tatsuki, now retired and residing in Japan, responded to the renewed attention by urging a focus on preparedness rather than panic. 'I, myself, would like to take precautions such as stockpiling supplies in preparation for disasters and confirming evacuation routes when going out,' she told Bloomberg in a statement. 'I intend to remain vigilant on a daily basis as we approach July 2025.'

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