The US Food and Drug Administration last month banned a facility in Punjab belonging to the Indian drug maker Ranbaxy from exporting to the US. Manan Vatsyayana / AFP
The US Food and Drug Administration last month banned a facility in Punjab belonging to the Indian drug maker Ranbaxy from exporting to the US. Manan Vatsyayana / AFP
The US Food and Drug Administration last month banned a facility in Punjab belonging to the Indian drug maker Ranbaxy from exporting to the US. Manan Vatsyayana / AFP
The US Food and Drug Administration last month banned a facility in Punjab belonging to the Indian drug maker Ranbaxy from exporting to the US. Manan Vatsyayana / AFP

India clamps down on clinical drug trials, at a cost


  • English
  • Arabic

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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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

1.

United States

2.

China

3.

UAE

4.

Japan

5

Norway

6.

Canada

7.

Singapore

8.

Australia

9.

Saudi Arabia

10.

South Korea

KEY%20DATES%20IN%20AMAZON'S%20HISTORY
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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

1. Fasting 

2. Prayer 

3. Hajj 

4. Shahada 

5. Zakat 

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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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

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Men
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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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