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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COMPANY PROFILE
Founders: Alhaan Ahmed, Alyina Ahmed and Maximo Tettamanzi
Total funding: Self funded
If you go
Where to stay: Courtyard by Marriott Titusville Kennedy Space Centre has unparalleled views of the Indian River. Alligators can be spotted from hotel room balconies, as can several rocket launch sites. The hotel also boasts cool space-themed decor.
When to go: Florida is best experienced during the winter months, from November to May, before the humidity kicks in.
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COMPANY PROFILE
Name: HyperSpace
Started: 2020
Founders: Alexander Heller, Rama Allen and Desi Gonzalez
Based: Dubai, UAE
Sector: Entertainment
Number of staff: 210
Investment raised: $75 million from investors including Galaxy Interactive, Riyadh Season, Sega Ventures and Apis Venture Partners
How to keep control of your emotions
If your investment decisions are being dictated by emotions such as fear, greed, hope, frustration and boredom, it is time for a rethink, Chris Beauchamp, chief market analyst at online trading platform IG, says.
Greed
Greedy investors trade beyond their means, open more positions than usual or hold on to positions too long to chase an even greater gain. “All too often, they incur a heavy loss and may even wipe out the profit already made.
Tip: Ignore the short-term hype, noise and froth and invest for the long-term plan, based on sound fundamentals.
Fear
The risk of making a loss can cloud decision-making. “This can cause you to close out a position too early, or miss out on a profit by being too afraid to open a trade,” he says.
Tip: Start with a plan, and stick to it. For added security, consider placing stops to reduce any losses and limits to lock in profits.
Hope
While all traders need hope to start trading, excessive optimism can backfire. Too many traders hold on to a losing trade because they believe that it will reverse its trend and become profitable.
Tip: Set realistic goals. Be happy with what you have earned, rather than frustrated by what you could have earned.
Frustration
Traders can get annoyed when the markets have behaved in unexpected ways and generates losses or fails to deliver anticipated gains.
Tip: Accept in advance that asset price movements are completely unpredictable and you will suffer losses at some point. These can be managed, say, by attaching stops and limits to your trades.
Boredom
Too many investors buy and sell because they want something to do. They are trading as entertainment, rather than in the hope of making money. As well as making bad decisions, the extra dealing charges eat into returns.
Tip: Open an online demo account and get your thrills without risking real money.
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Company profile
Name: Back to Games and Boardgame Space
Started: Back to Games (2015); Boardgame Space (Mark Azzam became co-founder in 2017)
Founder: Back to Games (Mr Azzam); Boardgame Space (Mr Azzam and Feras Al Bastaki)
Based: Dubai and Abu Dhabi
Industry: Back to Games (retail); Boardgame Space (wholesale and distribution)
Funding: Back to Games: self-funded by Mr Azzam with Dh1.3 million; Mr Azzam invested Dh250,000 in Boardgame Space
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Juliet, Naked
Dir: Jesse Peretz
Starring: Chris O'Dowd, Rose Byrne, Ethan Hawke
Two stars
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Batti Gul Meter Chalu
Producers: KRTI Productions, T-Series
Director: Sree Narayan Singh
Cast: Shahid Kapoor, Shraddha Kapoor, Divyenndu Sharma, Yami Gautam
Rating: 2/5
Paatal Lok season two
Directors: Avinash Arun, Prosit Roy
Stars: Jaideep Ahlawat, Ishwak Singh, Lc Sekhose, Merenla Imsong
Rating: 4.5/5