Rebecca Bundhun, foreign correspondent, reports from Mumbai
India has introduced restrictions on clinical trials following concerns about the safety of test patients, and it has become a much more complex and lengthy process to secure permission for trials.
It has reached the point where some Indian companies are moving trials abroad to locations in Europe and the US, at a much higher cost.
Bangalore-based Biocon is one company to have done so.
"The situation is becoming more and more difficult in India," Kiran Muzumdar-Shaw, the managing director of Biocon, said last month, according to the Indian newspaper Business Standard. "Several programmes have been stalled and we have also moved the trials offshore, to ensure the work on the development does not stop."
Sujay Shetty, a partner and the pharma leader at the consultancy PwC India, says the restrictions come at a cost.
“There’s clinical trials which the government has put a stop on due to a lot of issues, which is stopping new product launches and innovation,” he says.
“The government of India has almost stopped giving permission for new trials for a number of reasons – there are issues around informed consent, there are issues around compensation paid to patients who are under clinical trial treatment. At the moment it is all at a standstill.”
A report by PwC and the Confederation of Indian Industry published last year said India needed to create a clearer regulatory framework for trials.
That is not the only area where the standards of Indian drug makers have come under scrutiny.
An external watchdog has also waded in, with the US Food and Drug Administration (FDA) having banned products from several pharmaceutical factories in India.
Last month, the FDA banned a facility in Punjab belonging to the Indian drug maker Ranbaxy from exporting to the US. It was the company’s fourth plant to face action from the FDA. Ranbaxy last year had to pay a record fine of US$500 million in the US for making false statements about methods of testing medicine and for manufacturing substandard drugs. The FDA has also banned two factories operated by the Indian company Wockhardt from exporting drugs to the US.
The head of the FDA, Margaret Hamburg, this month met officials from the Central Drug Standard Control Organisation in New Delhi to discuss standards of safety and quality.
India has the largest number of pharma factories approved by the FDA outside of the US. The US is India’s largest export market for medicines.
“While the need is more pronounced in case of export-driven companies, there are numerous Indian manufacturing units which too need to shore up their quality standards,” says Utkarsh Palnitkar, a partner and head of life sciences at the consultancy KPMG in India. “The Indian regulatory set-up is complicated and under-equipped ... Ensuring that companies meet regulatory norms is especially relevant in light of the increasing competition that India faces from China.”
He says a culture of regulatory compliance must emerge so that the Indian drugmakers are, as a whole, viewed as “globally competent”.
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UAE currency: the story behind the money in your pockets
How England have scored their set-piece goals in Russia
Three Penalties
v Panama, Group Stage (Harry Kane)
v Panama, Group Stage (Kane)
v Colombia, Last 16 (Kane)
Four Corners
v Tunisia, Group Stage (Kane, via John Stones header, from Ashley Young corner)
v Tunisia, Group Stage (Kane, via Harry Maguire header, from Kieran Trippier corner)
v Panama, Group Stage (Stones, header, from Trippier corner)
v Sweden, Quarter-Final (Maguire, header, from Young corner)
One Free-Kick
v Panama, Group Stage (Stones, via Jordan Henderson, Kane header, and Raheem Sterling, from Tripper free-kick)
Global state-owned investor ranking by size
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United States
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China
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UAE
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Japan
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Norway
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Canada
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Singapore
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Australia
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Saudi Arabia
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South Korea
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KEY%20DATES%20IN%20AMAZON'S%20HISTORY
%3Cp%3E%3Cstrong%3EJuly%205%2C%201994%3A%3C%2Fstrong%3E%20Jeff%20Bezos%20founds%20Cadabra%20Inc%2C%20which%20would%20later%20be%20renamed%20to%20Amazon.com%2C%20because%20his%20lawyer%20misheard%20the%20name%20as%20'cadaver'.%20In%20its%20earliest%20days%2C%20the%20bookstore%20operated%20out%20of%20a%20rented%20garage%20in%20Bellevue%2C%20Washington%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3EJuly%2016%2C%201995%3A%3C%2Fstrong%3E%20Amazon%20formally%20opens%20as%20an%20online%20bookseller.%20%3Cem%3EFluid%20Concepts%20and%20Creative%20Analogies%3A%20Computer%20Models%20of%20the%20Fundamental%20Mechanisms%20of%20Thought%3C%2Fem%3E%20becomes%20the%20first%20item%20sold%20on%20Amazon%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E1997%3A%3C%2Fstrong%3E%20Amazon%20goes%20public%20at%20%2418%20a%20share%2C%20which%20has%20grown%20about%201%2C000%20per%20cent%20at%20present.%20Its%20highest%20closing%20price%20was%20%24197.85%20on%20June%2027%2C%202024%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E1998%3A%3C%2Fstrong%3E%20Amazon%20acquires%20IMDb%2C%20its%20first%20major%20acquisition.%20It%20also%20starts%20selling%20CDs%20and%20DVDs%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2000%3A%3C%2Fstrong%3E%20Amazon%20Marketplace%20opens%2C%20allowing%20people%20to%20sell%20items%20on%20the%20website%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2002%3A%3C%2Fstrong%3E%20Amazon%20forms%20what%20would%20become%20Amazon%20Web%20Services%2C%20opening%20the%20Amazon.com%20platform%20to%20all%20developers.%20The%20cloud%20unit%20would%20follow%20in%202006%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2003%3A%3C%2Fstrong%3E%20Amazon%20turns%20in%20an%20annual%20profit%20of%20%2475%20million%2C%20the%20first%20time%20it%20ended%20a%20year%20in%20the%20black%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2005%3A%3C%2Fstrong%3E%20Amazon%20Prime%20is%20introduced%2C%20its%20first-ever%20subscription%20service%20that%20offered%20US%20customers%20free%20two-day%20shipping%20for%20%2479%20a%20year%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2006%3A%3C%2Fstrong%3E%20Amazon%20Unbox%20is%20unveiled%2C%20the%20company's%20video%20service%20that%20would%20later%20morph%20into%20Amazon%20Instant%20Video%20and%2C%20ultimately%2C%20Amazon%20Video%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2007%3A%3C%2Fstrong%3E%20Amazon's%20first%20hardware%20product%2C%20the%20Kindle%20e-reader%2C%20is%20introduced%3B%20the%20Fire%20TV%20and%20Fire%20Phone%20would%20come%20in%202014.%20Grocery%20service%20Amazon%20Fresh%20is%20also%20started%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2009%3A%3C%2Fstrong%3E%20Amazon%20introduces%20Amazon%20Basics%2C%20its%20in-house%20label%20for%20a%20variety%20of%20products%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2010%3A%3C%2Fstrong%3E%20The%20foundations%20for%20Amazon%20Studios%20were%20laid.%20Its%20first%20original%20streaming%20content%20debuted%20in%202013%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2011%3A%3C%2Fstrong%3E%20The%20Amazon%20Appstore%20for%20Google's%20Android%20is%20launched.%20It%20is%20still%20unavailable%20on%20Apple's%20iOS%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2014%3A%3C%2Fstrong%3E%20The%20Amazon%20Echo%20is%20launched%2C%20a%20speaker%20that%20acts%20as%20a%20personal%20digital%20assistant%20powered%20by%20Alexa%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2017%3A%3C%2Fstrong%3E%20Amazon%20acquires%20Whole%20Foods%20for%20%2413.7%20billion%2C%20its%20biggest%20acquisition%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3E2018%3A%3C%2Fstrong%3E%20Amazon's%20market%20cap%20briefly%20crosses%20the%20%241%20trillion%20mark%2C%20making%20it%2C%20at%20the%20time%2C%20only%20the%20third%20company%20to%20achieve%20that%20milestone%3C%2Fp%3E%0A
Labour dispute
The insured employee may still file an ILOE claim even if a labour dispute is ongoing post termination, but the insurer may suspend or reject payment, until the courts resolve the dispute, especially if the reason for termination is contested. The outcome of the labour court proceedings can directly affect eligibility.
- Abdullah Ishnaneh, Partner, BSA Law
Benefits of first-time home buyers' scheme
- Priority access to new homes from participating developers
- Discounts on sales price of off-plan units
- Flexible payment plans from developers
- Mortgages with better interest rates, faster approval times and reduced fees
- DLD registration fee can be paid through banks or credit cards at zero interest rates
The five pillars of Islam
Race 3
Produced: Salman Khan Films and Tips Films
Director: Remo D’Souza
Cast: Salman Khan, Anil Kapoor, Jacqueline Fernandez, Bobby Deol, Daisy Shah, Saqib Salem
Rating: 2.5 stars
THE DETAILS
Kaala
Dir: Pa. Ranjith
Starring: Rajinikanth, Huma Qureshi, Easwari Rao, Nana Patekar
Rating: 1.5/5
The White Lotus: Season three
Creator: Mike White
Starring: Walton Goggins, Jason Isaacs, Natasha Rothwell
Rating: 4.5/5
Living in...
This article is part of a guide on where to live in the UAE. Our reporters will profile some of the country’s most desirable districts, provide an estimate of rental prices and introduce you to some of the residents who call each area home.
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ESSENTIALS
The flights
Emirates flies from Dubai to Phnom Penh via Yangon from Dh2,700 return including taxes. Cambodia Bayon Airlines and Cambodia Angkor Air offer return flights from Phnom Penh to Siem Reap from Dh250 return including taxes. The flight takes about 45 minutes.
The hotels
Rooms at the Raffles Le Royal in Phnom Penh cost from $225 (Dh826) per night including taxes. Rooms at the Grand Hotel d'Angkor cost from $261 (Dh960) per night including taxes.
The tours
A cyclo architecture tour of Phnom Penh costs from $20 (Dh75) per person for about three hours, with Khmer Architecture Tours. Tailor-made tours of all of Cambodia, or sites like Angkor alone, can be arranged by About Asia Travel. Emirates Holidays also offers packages.
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Director: Jafar Panahi
Stars: Vahid Mobasseri, Mariam Afshari, Ebrahim Azizi, Hadis Pakbaten, Majid Panahi, Mohamad Ali Elyasmehr
Rating: 4/5
The bio
Favourite food: Japanese
Favourite car: Lamborghini
Favourite hobby: Football
Favourite quote: If your dreams don’t scare you, they are not big enough
Favourite country: UAE
Dust and sand storms compared
Sand storm
- Particle size: Larger, heavier sand grains
- Visibility: Often dramatic with thick "walls" of sand
- Duration: Short-lived, typically localised
- Travel distance: Limited
- Source: Open desert areas with strong winds
Dust storm
- Particle size: Much finer, lightweight particles
- Visibility: Hazy skies but less intense
- Duration: Can linger for days
- Travel distance: Long-range, up to thousands of kilometres
- Source: Can be carried from distant regions
MATCH INFO
Rugby World Cup (all times UAE)
Final: England v South Africa, Saturday, 1pm
Company Profile
Name: Thndr
Started: 2019
Co-founders: Ahmad Hammouda and Seif Amr
Sector: FinTech
Headquarters: Egypt
UAE base: Hub71, Abu Dhabi
Current number of staff: More than 150
Funds raised: $22 million
RESULTS
Men
1 Marius Kipserem (KEN) 2:04:04
2 Abraham Kiptum (KEN) 2:04:16
3 Dejene Debela Gonfra (ETH) 2:07:06
4 Thomas Rono (KEN) 2:07:12
5 Stanley Biwott (KEN) 2:09:18
Women
1 Ababel Yeshaneh (ETH) 2:20:16
2 Eunice Chumba (BRN) 2:20:54
3 Gelete Burka (ETH) 2:24:07
4 Chaltu Tafa (ETH) 2:25:09
5 Caroline Kilel (KEN) 2:29:14
The specs
AT4 Ultimate, as tested
Engine: 6.2-litre V8
Power: 420hp
Torque: 623Nm
Transmission: 10-speed automatic
Price: From Dh330,800 (Elevation: Dh236,400; AT4: Dh286,800; Denali: Dh345,800)
On sale: Now
The specs
- Engine: 3.9-litre twin-turbo V8
- Power: 640hp
- Torque: 760nm
- On sale: 2026
- Price: Not announced yet
Company%20Profile
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GROUPS
Group Gustavo Kuerten
Novak Djokovic (x1)
Alexander Zverev (x3)
Marin Cilic (x5)
John Isner (x8)
Group Lleyton Hewitt
Roger Federer (x2)
Kevin Anderson (x4)
Dominic Thiem (x6)
Kei Nishikori (x7)
EXPATS
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