Indian pharmaceutical companies need to step up their efforts to avoid falling foul of regulations in the United States, according to leaders in the sector.
The US is a major export market for Indian pharmaceuticals, for generic medicines, but there have been a series of incidents surrounding the compliance of Indian companies with safety standards set in the US.
“The industry has taken this as a challenge and is working closely with the US FDA [United States Food and Drug Administration] and addressing the issues,” said D G Shah, the secretary general of the Indian Pharmaceutical Alliance, speaking at a conference in Mumbai this week.
He said that in some cases Indian pharma companies had faced issues because of cultural differences and because they had not kept up to date with changing regulations.
Every third pill in the US is manufactured in India and India is the second largest supplier of medicine to the US, after Canada, he said.
“For all of us in India, the US is very important,” said Habil Khorakiwala, the founder chairman of Wockhardt, one of India’s biggest pharma firms. “Irrespective of what are the FDA requirements, we need to create organisation which meets whatever is the requirement of the FDA. I can tell you from our own experience that the standard they expect outside the US is much higher than in the US.
“I think in two, three, four years, you will find state of the art manufacturing facilities in India, so I think it is a blessing in disguise, whatever has happened.”
Mr Shah said that 102 warning letters were issued by the US FDA between August 2013 and August 2016, with 51 letters being issued within the US and 26 letters being sent to Indian companies.
“Considering the volume of medicine that we supply to the US, it’s just natural that some of the warning letters come to Indian companies,” said Mr Shah.
The Indian drugs firm Ranbaxy Laboratories three years ago had to pay a record fine of US$500 million for lying about its methods of testing medicine and for manufacturing substandard drugs in a settlement agreement with the US department of justice.
The FDA in 2013 placed bans on two factories in India operated by Wockhardt, because of concerns over production quality. These were the drugmaker’s main plants for exports to the US.
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If you go
Flights
Emirates flies from Dubai to Phnom Penh with a stop in Yangon from Dh3,075, and Etihad flies from Abu Dhabi to Phnom Penh with its partner Bangkok Airlines from Dh2,763. These trips take about nine hours each and both include taxes. From there, a road transfer takes at least four hours; airlines including KC Airlines (www.kcairlines.com) offer quick connecting flights from Phnom Penh to Sihanoukville from about $100 (Dh367) return including taxes. Air Asia, Malindo Air and Malaysian Airlines fly direct from Kuala Lumpur to Sihanoukville from $54 each way. Next year, direct flights are due to launch between Bangkok and Sihanoukville, which will cut the journey time by a third.
The stay
Rooms at Alila Villas Koh Russey (www.alilahotels.com/ kohrussey) cost from $385 per night including taxes.
SPECS
%3Cp%3E%3Cstrong%3EEngine%3A%3C%2Fstrong%3E%20Two-litre%20four-cylinder%20turbo%3Cbr%3E%3Cstrong%3EPower%3A%20%3C%2Fstrong%3E235hp%3Cbr%3E%3Cstrong%3ETorque%3A%20%3C%2Fstrong%3E350Nm%3Cbr%3E%3Cstrong%3ETransmission%3A%3C%2Fstrong%3E%20Nine-speed%20automatic%3Cbr%3E%3Cstrong%3EPrice%3A%20%3C%2Fstrong%3EFrom%20Dh167%2C500%20(%2445%2C000)%3Cbr%3E%3Cstrong%3EOn%20sale%3A%20%3C%2Fstrong%3ENow%3C%2Fp%3E%0A
Manikarnika: The Queen of Jhansi
Director: Kangana Ranaut, Krish Jagarlamudi
Producer: Zee Studios, Kamal Jain
Cast: Kangana Ranaut, Ankita Lokhande, Danny Denzongpa, Atul Kulkarni
Rating: 2.5/5
MEDIEVIL%20(1998)
%3Cp%3E%3Cstrong%3EDeveloper%3A%3C%2Fstrong%3E%20SCE%20Studio%20Cambridge%3Cbr%3E%3Cstrong%3EPublisher%3A%3C%2Fstrong%3E%20Sony%20Computer%20Entertainment%3Cbr%3E%3Cstrong%3EConsole%3A%3C%2Fstrong%3E%20PlayStation%2C%20PlayStation%204%20and%205%3Cbr%3E%3Cstrong%3ERating%3A%3C%2Fstrong%3E%203.5%2F5%3C%2Fp%3E%0A
The specs: 2018 Infiniti QX80
Price: base / as tested: Dh335,000
Engine: 5.6-litre V8
Gearbox: Seven-speed automatic
Power: 400hp @ 5,800rpm
Torque: 560Nm @ 4,000rpm
Fuel economy, combined: 12.1L / 100km
MATCH INFO
Schalke 0
Werder Bremen 1 (Bittencourt 32')
Man of the match Leonardo Bittencourt (Werder Bremen)
The specs
Engine: Long-range single or dual motor with 200kW or 400kW battery
Transmission: Single-speed automatic
Max touring range: 620km / 590km
Price: From Dh250,000 (estimated)
COMPANY%20PROFILE%20
%3Cp%3E%3Cstrong%3EName%3A%3C%2Fstrong%3E%20Haltia.ai%0D%3Cbr%3E%3Cstrong%3EStarted%3A%3C%2Fstrong%3E%202023%0D%3Cbr%3E%3Cstrong%3ECo-founders%3A%3C%2Fstrong%3E%20Arto%20Bendiken%20and%20Talal%20Thabet%0D%3Cbr%3E%3Cstrong%3EBased%3A%3C%2Fstrong%3E%20Dubai%2C%20UAE%0D%3Cbr%3E%3Cstrong%3EIndustry%3A%3C%2Fstrong%3E%20AI%0D%3Cbr%3E%3Cstrong%3ENumber%20of%20employees%3A%3C%2Fstrong%3E%2041%0D%3Cbr%3E%3Cstrong%3EFunding%3A%3C%2Fstrong%3E%20About%20%241.7%20million%0D%3Cbr%3E%3Cstrong%3EInvestors%3A%3C%2Fstrong%3E%20Self%2C%20family%20and%20friends%26nbsp%3B%3C%2Fp%3E%0A
Dhadak
Director: Shashank Khaitan
Starring: Janhvi Kapoor, Ishaan Khattar, Ashutosh Rana
Stars: 3
The specs
Engine: 2.7-litre 4-cylinder Turbomax
Power: 310hp
Torque: 583Nm
Transmission: 8-speed automatic
Price: From Dh192,500
On sale: Now
A Cat, A Man, and Two Women
Junichiro Tamizaki
Translated by Paul McCarthy
Daunt Books
The specs
Engine: 2.0-litre 4-cyl, 48V hybrid
Transmission: eight-speed automatic
Power: 325bhp
Torque: 450Nm
Price: Dh359,000
On sale: now
Company%20Profile
%3Cp%3E%3Cstrong%3EName%3A%3C%2Fstrong%3E%20HyveGeo%3Cbr%3E%3Cstrong%3EStarted%3A%3C%2Fstrong%3E%202023%3Cbr%3E%3Cstrong%3EFounders%3A%3C%2Fstrong%3E%20Abdulaziz%20bin%20Redha%2C%20Dr%20Samsurin%20Welch%2C%20Eva%20Morales%20and%20Dr%20Harjit%20Singh%3Cbr%3E%3Cstrong%3EBased%3A%20%3C%2Fstrong%3ECambridge%20and%20Dubai%3Cbr%3E%3Cstrong%3ENumber%20of%20employees%3A%3C%2Fstrong%3E%208%3Cbr%3E%3Cstrong%3EIndustry%3A%20%3C%2Fstrong%3ESustainability%20%26amp%3B%20Environment%3Cbr%3E%3Cstrong%3EFunding%3A%20%3C%2Fstrong%3E%24200%2C000%20plus%20undisclosed%20grant%3Cbr%3E%3Cstrong%3EInvestors%3A%20%3C%2Fstrong%3EVenture%20capital%20and%20government%3C%2Fp%3E%0A
TRAP
Starring: Josh Hartnett, Saleka Shyamalan, Ariel Donaghue
Director: M Night Shyamalan
Rating: 3/5
The specs
Engine: 1.5-litre 4-cylinder petrol
Power: 154bhp
Torque: 250Nm
Transmission: 7-speed automatic with 8-speed sports option
Price: From Dh79,600
On sale: Now
Building boom turning to bust as Turkey's economy slows
Deep in a provincial region of northwestern Turkey, it looks like a mirage - hundreds of luxury houses built in neat rows, their pointed towers somewhere between French chateau and Disney castle.
Meant to provide luxurious accommodations for foreign buyers, the houses are however standing empty in what is anything but a fairytale for their investors.
The ambitious development has been hit by regional turmoil as well as the slump in the Turkish construction industry - a key sector - as the country's economy heads towards what could be a hard landing in an intensifying downturn.
After a long period of solid growth, Turkey's economy contracted 1.1 per cent in the third quarter, and many economists expect it will enter into recession this year.
The country has been hit by high inflation and a currency crisis in August. The lira lost 28 per cent of its value against the dollar in 2018 and markets are still unconvinced by the readiness of the government under President Recep Tayyip Erdogan to tackle underlying economic issues.
The villas close to the town centre of Mudurnu in the Bolu region are intended to resemble European architecture and are part of the Sarot Group's Burj Al Babas project.
But the development of 732 villas and a shopping centre - which began in 2014 - is now in limbo as Sarot Group has sought bankruptcy protection.
It is one of hundreds of Turkish companies that have done so as they seek cover from creditors and to restructure their debts.
Blackpink World Tour [Born Pink] In Cinemas
Starring: Rose, Jisoo, Jennie, Lisa
Directors: Min Geun, Oh Yoon-Dong
Rating: 3/5
Abaya trends
The utilitarian robe held dear by Arab women is undergoing a change that reveals it as an elegant and graceful garment available in a range of colours and fabrics, while retaining its traditional appeal.