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US halts import of drugs from Ranbaxy’s Ropar unit
FDA cites violations of manufacturing norms; shares dive 20%
New Delhi, January 24
A view of Ranbaxy’s Mohali plant. In yet another setback for Ranbaxy, the US health regulator, FDA, has banned the import of products from its fourth plant, halting the shipment of all the company's drugs to the US from India. The US is the biggest market for generic products.


A view of Ranbaxy’s Mohali plant. Tribune file photograph

I-T Dept restrains Cairn Energy from selling India stake
New Delhi, January 24
The Income Tax Department, which is probing Cairn Energy plc's transfer of India assets, has asked the UK-based company not to dispose of its 10.3% holding in Cairn India.



EARLIER STORIES


Rajan’s remarks pull Sensex down 240 pts
Mumbai, January 24
Snapping four days of gains, the BSE benchmark Sensex today tumbled 240.10 points from record high to close at one-week low of 21,133.5 after RBI Governor Raghuram Rajan's comments on inflation dashed hopes of a rate cut in next week's monetary policy review.

Maruti to launch automatic small car Celerio at Auto Expo
New Delhi, January 24
Maruti Suzuki India Ltd (MSIL) today announced that bookings for its new automatic small car Celerio have been opened. The vehicle, which could prove to be a game changer in the small car segment, will be launched at the 2014 Auto Expo that begins on February 5.

 





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US halts import of drugs from Ranbaxy’s Ropar unit
FDA cites violations of manufacturing norms; shares dive 20%
Tribune News Service

New Delhi, January 24
In yet another setback for Ranbaxy, the US health regulator, FDA, has banned the import of products from its fourth plant, halting the shipment of all the company's drugs to the US from India. The US is the biggest market for generic products.

In the latest order, the US regulator has banned the import of drugs from Ranbaxy Laboratories’ plant at Toansa (Ropar), Punjab.

The Toansa plant is Ranbaxy’s fourth plant to be banned by the USFDA and would mean a major disruption in the company’s operations. This marks a series of setbacks for Indian pharma companies exporting to the US such as Wockhardt that have come under the scanner in recent months.

The US regulator cited manufacturing norm violations to ban Ranbaxy from distributing drugs produced at the Toansa unit, including medicines made by the company's Ohm Laboratories facility in New Jersey. Ranbaxy’s other plants at Paonta Sahib, Mohali and Dewas are already facing an import alert.

Japanese pharma MNC, Daiichi Sankyo and its erstwhile promoters, Malvinder and Shivinder Singh have been involved in a spat earlier regarding the US Department of Justice and FDA investigations.

In its reaction to the USFDA decision, Ranbaxy said it would investigate the matter. "This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation," Ranbaxy CEO and managing director Arun Sawhney said.

Expressing disappointment, the company said, it "would like to apologise to all its stakeholders for the inconvenience caused by the suspension." Ranbaxy will cooperate with the USFDA and comply with the consent decree in letter and spirit, it said.

Ranbaxy’s shares plunged 19.54% to Rs 335.65 at the close on the BSE today. Analysts said the move would hurt the company’s operations. "With this import alert, the operations of the company in US business, which contributes around 40%, could come under impact unless it can compensate for the same at the earliest and manage a smooth supply of key raw material. While the management has not indicated, the plant is said to manufacture around 70-75% of its API requirements," said Sarabjit Kour Nangra, VP, Research (Pharma), Angel Broking.

An inspection of Ranbaxy’s facility by the USFDA in Toansa revealed significant violations of the current good manufacturing practices (CGMP). The FDA concluded that staff at the company’s Toansa facility was guilty of retesting raw materials and intermediate drug products and finishing API that had previously failed analytical testing and specifications.

"We are taking swift action to prevent substandard quality products from reaching the US consumers," said Carol Bennett, acting director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research.

The USFDA said it exercised its authority under a provision in a January 2012 consent decree, which permits the agency to extend those terms to any Ranbaxy-owned or operated facility if an FDA inspection finds it in violation of the Federal Food, Drug, and Cosmetic Act or FDA regulations, including current good manufacturing practice requirements. 

Another setback

* The Toansa (Ropar) plant is Ranbaxy’s 4th plant to be banned by the USFDA and would mean a major disruption in the company’s operations

* Ranbaxy’s other plants at Paonta Sahib, Mohali and Dewas are already facing an import alert

* An inspection of Ranbaxy’s facility by the USFDA in Toansa revealed significant violations of the current good manufacturing practices

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I-T Dept restrains Cairn Energy from selling India stake

New Delhi, January 24
The Income Tax Department, which is probing Cairn Energy plc's transfer of India assets, has asked the UK-based company not to dispose of its 10.3% holding in Cairn India.

Cairn Energy was widely seen as a likely participant in the Indian firm's share buyback, which opened yesterday.

The I-T Department had started an investigation on January 15 to establish if capital gains tax was due from Cairn Energy's transfer of shares of Indian assets that were held in a subsidiary set up in the tax haven of Jersey to newly incorporated Cairn India in 2006.

"Cairn (Energy) has been contacted by the Income Tax Department of India to discuss income-tax assessments for the year ending March 31, 2007. Cairn is cooperating to provide the necessary documentation and information as requested," the Edinburgh-based company said.

The Department had 'surveyed' Cairn India's Gurgaon office on January 15. It is investigating the asset transfer under Section 9 of the Income-Tax Act, which deals with income deemed to accrue or arise in India.

Cairn India profit dips 14%

Cairn India has reported a 14% drop in its December quarter net profit after record revenue from highest ever production was negated by a foreign-exchange loss.

Profit in October-December fell to Rs 2,884 crore, or Rs 16.9 a share, from Rs 3,345 crore, or Rs 15.9 per share, a year earlier, Cairn said.

Revenue rose 17% to Rs 5,000 crore as output touched a record 224,493 barrels of oil and oil-equivalent gas a day. — PTI 

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Rajan’s remarks pull Sensex down 240 pts

Mumbai, January 24
Snapping four days of gains, the BSE benchmark Sensex today tumbled 240.10 points from record high to close at one-week low of 21,133.5 after RBI Governor Raghuram Rajan's comments on inflation dashed hopes of a rate cut in next week's monetary policy review.

A plunge in rupee value also hit investor sentiment.

Traders also said weak global cues due to poor Chinese manufacturing data put pressure on markets.

The 30-share barometer resumed weak and was in the negative territory for the entire day.

The key index settled at 21,133.56, a fall of 240.10 points or 1.12%, recording the biggest drop in more than three weeks. On January 2, it declined 252 points.

Jignesh Chaudhary, Head of Research, Veracity Broking Services, said: "Equity markets traded in the red today after closing at an all time high yesterday eroding maximum of their gains accumulated over the last four trading sessions."

In the previous 4 days, the bellwether index had gained 310 points to set new closing peaks on rate cut hopes after wholesale and retail inflation softened. The barometer rose by 87 points to close at all-time high of 21,337.67 yesterday.

Brokers said Rajan's comment that inflation was a "destructive disease" killed rate cut hopes. Rupee weakness also added to worries of investors who pressed the selling button, they added.

BHEL at 3.39% was the biggest Sensex loser, followed by Tata Steel at 3.26%. Tata Motors was down 3.26% and Sesa Sterlite 2.92%.

SBI, ICICI Bank and HDFC lost 2.12%, 1.96% and 1.31%, respectively. Maruti Suzuki (1.25%), Cipla (1.08%) and Sun Pharma (1%) were other big losers.

All the 12 sectoral indices closed with losses in the range of 0.28% and 3.19%. Interest rate sensitive realty, banking and auto ended lower by 3.19%, banking 1.88% and auto 1.57% in that order. — PTI 

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Maruti to launch automatic small car Celerio at Auto Expo
Tribune News Service

New Delhi, January 24
Maruti Suzuki India Ltd (MSIL) today announced that bookings for its new automatic small car Celerio have been opened. The vehicle, which could prove to be a game changer in the small car segment, will be launched at the 2014 Auto Expo that begins on February 5.

The Celerio has 'EZ Drive' (an automated manual transmission). It has a fuel efficiency of 23.1 km per litre.

MSIL expects that the revolutionary technology, which allows manual gears to be used like automatic transmission without engaging the clutch, would catch the eye of customers and its low pricing would provide a major push to the company’s sales.

Maruti’s chief operating officer (marketing and sales) Mayank Pareekh said the improved technology will not affect fuel efficiency or the price of the car.

Maruti will be the first company in India to debut this automatic manual transmission (AMT), which is expected to be a turning point in the small-car segment, thereby improving the overall driving experience.

The technology allows the driver to directly change gears without engaging the clutch. 

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