RANBAXY : TIMELINE March 04-2012 - present

Updated: Sun, Mar 04 2012. 11 09 PM IST Mumbai: Foreign pharmaceutical companies may continue to fret over drugs going offpatent, but drug makers in India are not only raking in profits selling generic versions of such drugs but are also pushing up the growth rates of Indias pharma exports. Exports of the generic versions of Pfizer Inc.s Lipitor and Eli Lilly and Co.s Zyprexa alone by Ranbaxy Laboratories Ltd and Dr Reddys Laboratories Ltd, respectively, boosted the growth rate of Indias pharma exports by 4% in the third quarter of this fiscal year. Generic Lipitor recorded sales of $300 million for Ranbaxy and Dr Reddys generic drug, called Olanzapine, brought in $99 million in the third quarter ended 31 December, according to Ranjith Kapadia, senior vice-president of Centrum Broking Pvt. Ltd. The average quarterly exports growth rate for the pharma sector is 15-16%. But the launch of these two generic drugs boosted the growth rate of Indias $12 billion pharmaceutical exports market to 20% during the third quarter. The momentum is expected to continue in the fourth quarter, said analysts. Ranbaxy launched the generic Lipitor (chemical name is Atorvastatin) on 1 December in the US after getting approval to manufacture it from its US facility. Being the first to challenge the drugs patent in the US, the firm secured a 180 -day exclusivity, in line with the US Food and Drug Administrations (FDA) practice. Ranbaxy had almost lost the opportunity to exclusively market Lipitor, the worlds largestselling drug. In 2008, FDA placed an export ban on two of the companys India facilities that were to manufacture the drug.

But the day after the patent expired (30 November), Ranbaxy got approval to manufacture the drug from its facility in the US. Watson Pharmaceuticals is the only other firm that can sell an authorized generic Pfizer has given it the right to sell a copy version in return for a share of revenue during the 180day exclusivity period. Dr Reddys has a 180-day exclusivity for the schizophrenia drug it launched in October. The company, in a statement, attributed its 88% quarter-on-quarter jump in profit for the third quarter to the sale of the drug. The firms chief financial officer Umang Vohra in the statement said Dr Reddys will benefit from Olanzapines exclusivity in the fourth quarter as well. Ranbaxy declined to comment, while Dr Reddys did not respond to an email sent on Thursday. A sharply depreciating rupee also played a role in boosting profits from these sales, said analysts. The rupee depreciated 15.75% during the third quarter, according to Bloomberg. Although sales from these drugs will allow these firms and the exports market to end the year on a good note, the next year may not see similar gains, with both firms losing exclusivity. Once these drugs lose exclusivity, there will be a decline in their prices, with competitors entering the market. The prices may fall 85-90%, said Kapadia, adding that though there are a number of drugs going off-patent in the coming years, none of them will be as big as Lipitor. Surajith Pal, sector analyst at Elara Capital (India) Pvt. Ltd, said Indian firms have been actively pursuing first-to-files that would give them the 180-day exclusivity to sell generic versions of off-patent drugs and so will have an impact on the market in the coming years. Lupin Ltd, the fifth largest generic drug maker in the US market, said it expects 21 first-tofile opportunities to kick in over the next few years. While these opportunities are important and demand that pharma companies be well-prepared, both in terms of manufacturing and marketing capabilities, relying on them solely might not bode well in the long run, said a Lupin spokesperson, adding that due to severe competition that enters the space after the

exclusivity period, it was important to mitigate risk by spreading your drug portfolio across different segments. Till 2015, there are going to be a number of big opportunities for generic players, s aid Elara Capitals Pal, adding, If you look into the long-term strategy of the companies, on how they are planning to grow beyond the periods of market exclusivity, then you can separate the boys from the men. namrata@livemint.com

Updated: Mon, Apr 16 2012. 05 52 PM IST Mumbai: Indias drugs sector is heading into a year of fewer patent expiriescritical for an industry that thrives on selling copies of successful medicinesbut is set to end the previous fiscal year with a strong showing in the final quarter supported by growth in the domestic market and a favourable rupee movement. Local drug makers are expected to post a revenue growth of 15-34% for the fourth quarter, with the top companies, including Ranbaxy Laboratories Ltd, Sun Pharmaceutical Industries Ltd, Dr Reddys Laboratories Ltd and Lupin Ltd, set to gain significantly from the US and emerging markets, according to a Mint poll of five brokerages. The countrys largest drug maker Ranbaxy is expected to report a revenue growth of 67% for the fourth quarter, in large part because of its generic version of Pfizer Inc.s cholesterol lowering drug Lipitorthe worlds largest selling medicine todaythat it launched in the US and other markets in November, according to analysts. Sun Pharma is expected to see a 19% increase in sales following the integration of Israels Taro Pharmaceutical Industries Ltd, which it acquired recently. For GlaxoSmithKline Pharmaceuticals Ltd, Cipla Ltd and Glenmark Pharmaceuticals Ltd, their improved domestic formulations businesses is expected to boost revenue, analysts said.

The growth outlook for the sector was reflected in BSE Ltds healthcare index outperforming the exchanges bellwether index Sensex between January and March, Sarabjit Kaur Nangra, an analyst atAngel Broking Ltd, said in a report. The healthcare index rose 12.9% in that period, beating the Sensexs 12.6% gain. Nangra expects Ranbaxys generic Lipitor to increase the firms fourth-quarter sales by 133%, year-on-year. Mid-size drug firms such as Cadila Healthcare Ltd, Ipca Laboratories Ltd and Aurobindo Pharma Ltd, however, are expected to perform poorly. Cadila is expected to relatively underperform due to the base effect of healthy billion and lower contribution from Hospira joint venture, Manoj Garg and Perin Ali, analysts with Edelweiss Financial Services Ltd, said in a report. The Ahmedabad-based company supplies cancer drugs for the US market in a joint venture with US drug maker Hospira Inc. Aurobindos quarterly performance will be subdued because of operating issues and a higher cost base, Garg and Ali said. Analysts expect the higher operating profits to contribute significantly to quarterly net profits. Operating profitor earnings before interest, taxes, depreciation and amortization (Ebitda)is expected to grow at an average 32% for the sector, though higher taxes indicate a net profit growth of around 12% from a year earlier, Ravi Agrawal and Neha Kothari of Standard Chartered Securities said in a report released on Wednesday. Some companies could also expect bumper revenues from one-off opportunities. Two brokerages put average net profit growth for the healthcare sector at 41-67.5%, aided by foreign exchange gains and the launch of first to files in the US. Companies that are the first to file successfully for permission to make and sell a generic version of a drug get an exclusive marketing period, typically of six months. One-offs such as Lipitor launch is estimated to contribute $300 million to Ranbaxys earning, while the generic launches of Zyprexa (schizophrenia drug of Eli Lilly) and Lexapro (anti-depression drug of Forest Lab) (are expected) to add $45 million for Dr Reddys Lab

and $60 million for Cipla, respectively, Emkay Global Financial Services Ltd said in a report. Excluding such one-off opportunities, four brokerages still predicted net profits of 12-29% for the top drug makers. Excluding the one-time opportunities, we see double-digit growth in base business (growth of 22% in revenue and 20% in earnings) for leading companies led by strong traction in India and other emerging markets, the Edelweiss analysts said. The demand for cheap generics in the US is one of the biggest opportunities for Indian companies, said Sujay Shetty, partner and pharma and life sciences leader at consultant PricewaterhouseCoopers India. Also, developments in Japan and other regulated markets will bode well for the India drug makers. With the general growth, we expect 2012-13 to be positive for pharmaceuticals, he said. Japan is opening up its market to low-cost generic drugs, which will allow Indian pharma companies to leverage their capabilities in this space. Continued allowance for a 200% weighted deduction on research and development expenditure announced in the Union budget for 2012-13 will also benefit Indian drug companies, said Angel Brokings Nangra. The contract research and manufacturing services segment is witnessing some pressure, but is showing indications of gradual recovery and ramp up, she wrote in the report. Due to this revival, Divis Laboratories Ltd and Jubilant Life Sciences Ltd are expected to register good numbers, ICICI Securities Ltd analysts said in a report. Factors such as the number of off-patent opportunities and the strengthening Indian market put the pharma sector in a sweet spot over short-term, the Edelweiss analysts wrote. But going forward, they concluded, we are cautious on the sector as generic players are likely to face growth pressures from shrinking pipeline of patent expiries.

Updated: Wed, May 09 2012. 10 34 PM IST

Ranbaxy Laboratories Ltds results for the quarter ended March are a maze with so many exceptional items that its almost pointless trying to arrive at how the companys underlying business has done. Revenue fell 1.6% from the December quarter to Rs3,787 crore, but earnings before interest and tax (Ebit) jumped 62% to Rs935 crore. Ebit margin jumped 975 basis points, buoyed largely by the one-off items. A basis point is one-hundredth of percentage point. At the time of writing, most analysts were still trying to figure the level of core profit, a difficult taskgiven the selective disclosures made. For instance, Ranbaxy didnt disclose the amount it paid Teva Pharmaceutical Industries Ltd as part of its profit-sharing agreement on the sales of its generic version of Pfizer Inc.s blockbuster cholesterol-lowering drug Lipitor. Without these critical inputs, its almost as good as groping in the dark, and one will have to settle for the firms version that underlying profitability increased. The company said in a call with analysts that raw material costs reduced as a percentage of sales because of an improved product

mix and foreign exchange gains. Reported revenue and profit were higher than Street estimates, aided largely by sales of the generic Lipitor. Ranbaxy garnered the lions share of the market for the drug within the sixmonth exclusivity period after it went off-patent in December. Ranbaxys shares have yo-yoed since December, first falling after the firm disclosed it would be sharing profit with Teva, and then rising on the higherthan-expected sales of the generic product and the hope that its regulatory woes were coming to an end. In January, after further details of its consent decree with the US department of justice became public, the stock lost heavily, and then started rising again after the companys better-than-expected results for the December quarter. Ranbaxys shares have risen nearly 30% since mid-March in its most recent rally. The consensus view of analysts seems to be that the company is on a recovery path and that the margins of its base business can be expected to improve gradually. Results of the last two quarters give this view some credence. A report dated 22 April by Citigroup Research states, Over the last few quarters, Ranbaxy has demonstrated steady improvement in its base biz as well as its ability to monetize its first-to-file pipeline. There has been tangible improvement in emerging markets, which were under severe pressure at the beginning of the year and signs that Daiichi Sankyo sees a key role for Ranbaxy in its future strategy. The impact of the US Food and Drug Administrations action on Ranbaxys facilities (Dewas and Paonta Sahib) is also well understood and built into estimates and valuations.

Updated: Sun, Jun 03 2012. 10 52 PM IST Mumbai: Indias Rs 1 trillion drugs and pharmaceuticals industry reported a widely varied financial performance for the January-March quarter.
File Photo

The sector, considered defensive during economic downturns, performed well overall; the profits of many top companies dropped significantly, both due to operational and nonoperational reasons. The blame for poor performance fell on a changed tax regime, the volatile currency and regulatory hurdles, though many survived the impact of these through operational efficiency, better product mix and, in some instances, one-time opportunities. The combined net profit of the top 19 companies in the healthcare index on BSE rose nearly 57% to Rs 4,538 crore in the March quarter. Their combined revenue grew by about 30% to Rs 24,000 crore. Also See | Progress Card (PDF) Top drug makers, including Ranbaxy Laboratories Ltd, Sun Pharmaceutical Industries Ltd, GSK Pharma Ltd, Cipla Ltd, Strides Arcolab Ltd and Glenmark Pharma Ltd, posted significant growth ranging from 30% to 400% for the three months. But Dr Reddys Laboratories Ltd, the countrys second largest drug maker by income, posted only a 2 .5% increase in net profit, at Rs 343 crore, despite a 31% growth in sales, at Rs 2,658 crore, during the quarter. And seven other leading drug makersLupin Ltd, Biocon Ltd, Cadila Healthcare Ltd, Aurobindo Pharma Ltd, Orchid Chemicals and Pharmaceuticals Ltd,

Piramal Healthcare Ltd saw their profits fall, while the countrys sixth largest drug maker, Wockhardt Ltd, made a net loss during the quarter. Lupins quarterly net profit fell about 30% to Rs 156 crore despite a 25% growth in sales as its tax expenditure went up significantly. Two of its manufacturing plants that operated in special economic zones (SEZs) had to start paying taxes during the quarter as the tax-exemption period for SEZs ended in December. This new tax cost and a mandatory price reduction in the Japanese generic drug market mainly contributed to the drop in net profit, Nilesh Gupta, group president and an executive director at Lupin, said while announcing the results in May. But Lupin, with Rs 6,960 crore in revenue in fiscal 2012, improved its ranking among local drug makers, moving up to the fourth position in terms of sales, replacing Cipla after Ranbaxy, Dr Reddys and Sun Pharma. Ahmedabad-based Cadila Healthcare, or Zydus Cadila, reported a 4.52% drop in its quarterly consolidated net profit to Rs 170.88 crore, mainly on account of foreign exchange losses. Kiran Mazumdar Shaw-led Biocon posted a 3% decline in quarterly net profit at Rs 97.8 crore on account of a rise in research and development expenditure. And Orchid Chemicals reported lower-than-expected numbers for the fourth quarter on account of lower growth in sales and higher interest expenditure, Angel Broking Ltd said in a research report. Hyderabad-based Aurobindo Pharmas net profit fell almost 14% to Rs 108 crore. Aurobindos chief executive N. Govindarajan blamed the decline on the US Food and Drug Administrations alert on the companys factory in Hyderabad, high cost of materials, inflation and a notional loss related to restating foreign currency borrowings. Ciplas overall results were in line with expectations, with a 36% growth in net profit at Rs 292 crore during the January-March quarter. This was primarily led by extended seasonality, which boosted its respiratory franchise, mainly in anti-asthma sales. The segment was further benefited from the field force effectiveness, brokerage Proactive Universal Group Securities said in a report. Ciplas sales increased 8.7% to Rs 1,814 crore. Ranbaxy posted a significantly high growth in net profit for the January-March quarter mainly due to a one-time opportunity it had in the US market, where it launched a copy of

the worlds largest selling drug Lipitor. Ranbaxy posted a four fold increase in net profit at Rs 1,246 crore. The drug maker, which follows a January-December fiscal, launched the generic drug in the US in December under a six-month marketing exclusivity. It earned Rs 345 crore in foreign exchange gains during the quarter. Mumbai-based Sun Pharma also reported a high net profit growth, driven by significant growth in its domestic and international business and by the impressive profit posted by its Israel subsidiary Taro Pharmaceutical Industries Ltd. Indias generics-driven drugs industry maintained its annual growth at a compounded average rate of 16-17% during fiscal 2012. The local industry, which has about 15,000 active drug makers, including small, medium and large ingredients as well as formulation making units, also saw an impressive performance from mid-sized companies such as Ipca Laboratories Ltd, Indoco Remedies Ltd and Hikal Ltd during the quarter because of emerging opportunities in the domestic as well as international markets. The countrys drug industry is expected to sustain the growth, owing to its global competitiveness, according to Balaji Prasad, India healthcare and pharmaceuticals analyst, at Barclays. We do not share the general market apprehension of a steep dip in the revenue trajectory as the patent expiry opportunities recede post-2015, and we believe that growth opportunities abound in the US and other global pharma markets, Prasad said in his latest report. Graphic by Venkatesulu/Mint

Updated: Tue, Jul 10 2012. 10 09 PM IST New Jersey: The head of Indian drugmaker Ranbaxy Laboratories Ltd says hes charging ahead with plans to expand sales in the crucial US market, despite extra oversight from American regulators over quality questions that have blocked imports of 31 of its medicines.

Market focus:Ranbaxy Laboratories CEO Arun Sawhney. By Bloomberg

Ranbaxy, which almost exclusively makes generic pills, particularly is aiming to regularly be first on the US market with just-approved generic drugs, CEO Arun Sawhney told The Associated Press in an interview on Monday. His goal is to nab the six-month windfall period when theres usually only one generic version on sale, for roughly 25% less than the price of the brand-name drug whose patent just ended. Companies can make tens of millions of dollars then, as Ranbaxy just did in selling the first generic rival to cholesterol blockbuster Lipitor, whose US patent expired on 30 November. After that half-year stretch, five or more generic versions of the brand-name drug hit the market and prices plunge 90% or more. That leaves razor-thin profit margins for all the competing generic companies, Sawhney said, joking about the difference between brand-name and generic drug companies. They make profits. We make drugs, said Sawhney, who became CEO in August 2011. Discussing his plans during a visit to Ranbaxys US headquarters in central New Jersey, Sawhney noted his company has just launched its first brand-name drug, a malaria treatment called Synriam that is the first brand-name drug ever developed in India. Thats because the hundreds of drugmakers based in India all make inexpensive generic medicines, as most of the countrys 1.1 billion people cannot afford brand-name drugs that can cost thousands of dollars. Sawhney is hoping to sell some brand-name drugs in the US eventually and plans in about six months to start selling a recently approved generic version of acne drug Accutane. The US, as a total business, will remain the most important to us, he said. Ranbaxy, the top-selling pharmaceutical company in India, is just the 12th-largest generic drugmaker in the US by number of prescriptions filled. But in just a few years, its US sales have risen from about a quarter to a third of its total revenue, which was about $2.1 billion last year. In the first quarter of 2012, global sales jumped 55% to about $736 million. Thats partly because of strong US sales, particularly from new generic versions of Lipitor and a

combo pill containing Lipitor and blood-pressure medicine Norvasc. Its quite a turnaround after the black eye Ranbaxy suffered when the US Food and Drug Administration (FDA) in 2008 banned the import of 31 of its generic medicinesincluding generic versions of the popular antibiotic Cipro and the cholesterol pill Zocor. The FDA cited manufacturing quality concerns at two plants, in Dewas and Paonta Sahib, India, and months later it accused Ranbaxy of lying about some test results on its drugs. It hit our bottom line big-time, Sawhney said. It did slow down our growth plans in the US. The ban took away about half Ranbaxys sales in the US, but factories not affected were able to continue shipping other generic drugs here. However, a third factory involved in the probe, in Gloversville, New York, was shut down because it was too small to make a major investment there worthwhile, Sawhney said. Sawhney, who had just joined Ranbaxy when the scandal broke, said there were no problems with the safety or effectiveness of the drugs from those factories, just sloppiness in documentation. feedback@livemint.com

New Delhi: India has finally taken a call on rules governing acquisition of domestic pharma companies by multinational firms, and it is not one that foreign companies like. An inter-ministerial group on foreign direct investment (FDI) in pharmaceuticals has decided that investments resulting in an equity holding higher than 49% in an Indian pharma company will have to apply for the approval of the Foreign Investment Promotion Board (FIPB), a part of the ministry of finance.

Investments resulting in an equity holding lower than 49% as well as those made in subsidiaries will not need approval and will go through what is called the automatic route. The group has also decided that a multinational firm buying a stake higher than 49% in an Indian pharma company will maintain the same level of investment in research activities and production of essential medicines for five years. A finance ministry official, who spoke on condition of anonymity, said a consensus had been reached on the contentious issue. The ministries of health and commerce were earlier in favour of routing all proposals for foreign investment in Indian pharma companies through FIPB, while the finance ministry insisted that FIPB should only scrutinize proposals for investment that would result in an equity holding above 49%. The decision will adversely affect FDI, said Ranjit Shahani, president of the Organisation of Pharmaceutical Producers of India, the lobby group representing multinational firms. In a climate where India is already FDI-starved, any policy which restricts freedom of trade and investment will further restrict capital flows. This will not only have a chilling effect on FDI flows to the pharma industry, but will also have a serious knock-on effect in other industriesparticularly since it is a reversal of policy liberalization which took place only 10 years ago. Today, when the world is looking at India to kick-start the economy following changes at the Centre, this certainly is a retrograde step, he added. Still, the decision is likely to clear the logjam at FIPB. Proposals from foreign pharma companies such as Arch Pharmalabs Ltd, Pfizer Inc. and B Braun Singapore Pte. Ltd are stuck at the board due to a lack of clarity in the policy. A second finance ministry official, who also spoke on condition of anonymity, said FIPB will try and clear the pending proposals at its meeting on Friday.

A commerce ministry official, who is a part of the inter-ministerial group, had said on Monday that the group is likely to take a final decision on Tuesday. On 27 July, FIPB will take up some proposals, so before that, we would like to finalize the things, he added. The group also asked the department of industrial policy and promotion (DIPP), the commerce ministry arm that oversees FDI policy, to decide on a cap, in terms of size of the company in which the investment is being made, above which FIPB approval would be required. A senior health ministry official, who was a part of the group and did not want to be identified, said, Imposing norms on smaller investments would not be proper as it would make the (business) environment hostile to companies. The group also agreed to impose conditions on the continued production and sale of essential medicines by the companies in which the investments are made. Its draft report said, Production level of National List of Essential Medicines drugs and their supply to domestic market at the time of induction of FDI (to) be maintained over the next five years. It placed a similar condition on research and development spending. India has seen a number of big-ticket pharma deals in recent years. In June 2008, Japanese drug makerDaiichi Sankyo Co. Ltd acquired New Delhibased Ranbaxy Laboratories Ltd for nearly $5 billion (Rs 28,000 crore today). Two years later, US-based Abbott Laboratories bought the healthcare solutions business of Piramal
Healthcare Ltd for $3.72 billion.

Alarmed by such acquisitions and their possible impact on the availability of low-cost medicines, the health and commerce ministries demanded that foreign investment in domestic pharma companies be routed through FIPB. A panel set up under the chairmanship of Planning Commission member Arun Maira at the behest of the cabinet committee on economic affairs suggested a status quo in the FDI policy for the sector while recommending oversight by the Competition Commission of India (CCI) on pricing and competition issues. That recommendation was opposed by both DIPP and the health ministry. Finally, a meeting called by Prime Minister Manmohan Singh in October last year to resolve the differences decided that while 100% FDI in greenfield investments through the automatic route will continue to be allowed, brownfield investments in Indian pharma companies will be routed through FIPB for six months (from October) and that CCI will then take over the

job. That decision, however, left several unanswered questions that Tuesdays decision by the inter-ministerial group has addressed. vidya.krishnan@livemint.com

Updated: Thu, Aug 09 2012. 06 24 PM IST Mumbai: Ranbaxy Laboratories, Indias largest drug maker, posted an unexpected quarterly loss of Rs586 crore ($106 million) as foreign exchange losses ballooned although sales in its key US market more than doubled. Ranbaxy, controlled by Japans Daiichi Sankyo Co, recorded a loss of Rs 599 crore on foreign currency derivatives in the fiscal second quarter ended June, compared with a gain of Rs112 crore a year earlier, it said. Net sales rose 54.5% to Rs3,174 crore, Ranbaxy said. Analysts had forecast net profit at Rs321 crore on net sales of Rs2,906 crore, according to Thomson Reuters I/B/E/S.

The depreciation of the Indian rupee against the dollar, though favourable to Ranbaxys export business, had an adverse impact on the company, it said. Sales and profitability grew in the quarter with overall improvement across major regions, aided further by exclusivity sales in some of the key markets, Arun Sawhney, chief executive, said in a statement.

Sales in North America, Ranbaxys biggest market, grew 140% to Rs1,471 crore in AprilJune, primarily due to the generic version of Lipitor, Pfizers cholesterol-lowering blockbuster drug. Ranbaxy settled a compliance-related dispute with the US drug regulator early this year and can now ship products from its Indian factories to the worlds largest drug market. Indian drugmakers including Ranbaxy, Dr Reddys Laboratories and Sun Pharmaceutical Industries account for about a third of applications to sell generic drugs in the US and are expected to double their sales in that market to about $5 billion over the next five years. But they face intense competition, rising lawsuits from rival drugmakers and a stricter US health regulator in their race for the lucrative off-patent market. Valued at $3.9 billion, Ranbaxy stock dropped 2.7 % to Rs501.80 on Thursday. The stock is up about 24% this year, in line with the benchmark healthcare indexs 24.4% rise

Updated: Fri, Aug 10 2012. 01 06 AM IST

Ranbaxy Laboratories Ltds June quarter earnings do not come as a surprise, except for the

foreign exchange-related charges, which fluctuate every quarter. Sales rose 54.6% year-onyear (y-o-y), but it incurred a massive loss of Rs.580 crore, which was perhaps why its share declined 2.6% on Thursday. But the main reason for the loss is forex-related charges. While its operating performance deserves more importance, that, too, saw a decline on a sequential basis. The June quarter was the last one in which Ranbaxy earned revenue from selling generic Lipitor, in a six-month exclusivity window, in the US market. With just two competitors, it earned a windfall, part of which it had to share with Teva Pharmaceutical Industries Ltd. The exclusivity period started in end-November and ended in end-May. Thats why Ranbaxys sales declined 14.1% over the March quarter, as a number of firm s have jumped in after the exclusivity period ended. Ranbaxys North American market sales rose 140% y-o-y to $272 million; but in dollar terms, it declined from the $416 million figure seen in the March quarter. In India, it maintained growth at 13% y-o-y, matching the March quarters growth, which may come as

a disappointment. Other companies have posted higher growth, and its slower growth seems to be a function of the categories it is present in, as Ranbaxy said it grew faster than category growth. In Europe, sales rose 19% on constant currency basis, but were flat sequentially as sales in Romania were affected during the period. The foreign exchange impact was a dampener in the quarter as the companys operating profit rose 142% y-o-y (but declined 49% sequentially). On account of foreign exchange, it incurred a charge ofRs.250 crore taken as an expense, a Rs.600 crore mark-to-market loss on derivatives, and a Rs.116.5 crore loss added to interest costs. Thats a combined hit of Rs.966.5 crore. The September quarter results are expected to see US sales return to more normal levels as the exclusivity period for generic Lipitor has ended. Margins, too, are likely to fall further, and even if it gets a few good product launches, it may not be enough to fill the void created by the end of the exclusivity period for generic Lipitor. Next quarter onwards, investors will get a better idea of the shape the companys base business in the US is in. The key issue to watch out for would be if it announces progress in completing the requirements put forth in the consent decree, to which the approval of some first-to-file drugs are linked. Ranbaxy completed a key milestone by launching generic Lipitor; now it has to show investors it has more tricks up its sleeve, to deliver earnings triggers that investors covet so much.

Updated: Tue, Aug 14 2012. 12 55 AM IST Mumbai: The Rs.1 trillion pharmaceutical sector showed polarization in results for the AprilJune quarter despite healthy domestic sales as GlaxoSmithKline Pharmaceuticals Ltd and Pfizer Inc. concluded the earnings season for the countrys top drug makers on Monday. GSK Pharma, the Indian subsidiary of the UK drug maker, posted a 12% increase in net profit at Rs.163.52 crore as revenue rose 16% over a year ago to Rs.661.86 crore.

Pfizer, however, made a net loss of Rs.54 crore in its ordinary business that excludes onetime or exceptional items on the back of higher taxes, expenses on account of a change in inventory, and a voluntary retirement payout to employees, though it posted a 3% growth in its core pharmaceutical business. Sales came in at Rs.242.63 crore. Pfizers revenue and profits are not comparable with the year ago quarter as it sold its animal health business to a fully-owned subsidiary of its US parent in February. This resulted in a one-time income ofRs.382 crore in the three months ended June. GSK India results were just in line with expectations, brokerage Angel Broking Ltd said in a report on Monday. A 16.1% year-on-year (y-o-y) growth in its net sales to Rs.652 crore is in line with estimates, though its gross margin came in at 58.5%, a bit lower than our expectation of 59%. Indias drug sector has been growing with strong fundamentals, including domestic market growth and exports, and with a favourable currency position for exports, said Ranjit
Kapadia, senior vice-president, institutional research, at Centrum Broking Pvt. Ltd.

The local drug market is growing at 14% as per June data by drug market researcher IMSHealth, and exports grew to $2.1 billion during the three months, he said, adding that export growth is expected to be in the range of 19-20% this year, instead of the past average of 12%, considering the rupees depreciation. Foreign drug makers Novartis Ltd and Sanofi India Ltd (formerly Aventis Pharma Ltd) also had a bad June quarter in terms of profits, mainly because of the depreciating rupee and a couple of one-time expenses. Local rivals, though, benefited from the currency movement and strong growth in both domestic and international markets, resulting in significant sales and profit growth for Sun
Pharmaceutical Industries Ltd, Cipla Ltd, Wockhardt Ltd, Lupin Ltd and Torrent Pharmaceuticals Ltd.

Indias largest drug maker by value, Sun Pharmaceuticals, posted a 58.7% increase in net profit driven by the improved performance of its Israeli subsidiary Taro Pharmaceutical
Industries Ltd and a foreign exchange gain from the rupees depreciation against the dollar

(8.56% in the April-June quarter).

Net profit rose to Rs.795.5 crore from Rs.501 crore a year ago, the firm said in a release on Friday. Sales grew 63.9% to Rs.2,683 crore. Wockhardt last week reported a 95% increase in net profit to Rs.378 crore, led by robust sales growth in the US and Europe. Overall sales rose 35% to Rs.1,426 crore. Profit growth was also boosted by other income, and savings in employee costs and material consumption. However, the countrys largest drug maker by revenue, Ranbaxy Laboratories Ltd, posted a record loss of Rs.580 crore during the quarter due to forex loss and squeezed margin in the US. Ahmedabad-based Cadila Healthcare Ltd, also known as Zydus Cadila, posted a 16.41% drop in net profit at Rs.201 crore during the April-June quarter. Its profit was crimped by increased finance cost and interest payments. Revenue rose 30% to Rs.1,547 crore on account of higher sales in the domestic as well as export markets. Cadilas recent acquisition of the low-margin antibiotics business from Biochem Ltd was the main reason for the fall in profit and also it led to some finance costs. Interest cost has also gone up this quarter, said Centrums Kapadia. Drug makers Lupin and Torrent Pharmaceuticals beat market expectations in terms of revenue and profit growth. Lupin, Indias fourth largest drug maker by sales, posted a 33% growth in net profit to Rs.280.4 crore as revenue grew 44% to Rs.2,219 crore, the company said last week. Torrent Pharma, which announced its quarterly results in July, said y-o-y net profit and sales grew 7% and 19%, respectively, after dismal performances in the previous five consecutive quarters. Bangalore-based biotechnology and active pharmaceutical ingredient manufacturer Biocon
Ltd posted a 13% growth in net profit at Rs.79 crore though its sales rose 30% to Rs.571

crore as compared with the year-ago quarter. Operating margins for Biocon were extremely disappointing as it booked only Rs.13.9 crore of licensing income and saw a significant increase in other expenses, said a sector analyst, who did not want to be identified. Since the market potential has been proved strong for the drug makers despite the contradicting results, BSEs Healthcare Index continued its growth trend. The index, which grew 3.9% during the April-June quarter, has gained 5.9% since 9 July.

Mumbai: Indias top drug makers may see profit rise 20-30% in the quarter ended 30 September, boosted by selling new products in the US and a favourable currency movement. The companies may report 23-28% annual growth in revenue, analysts expect. The projected revenue growth is similar to the preceding two quarters ended June, although earnings have fluctuated because of foreign exchange losses, acquisitions and tax-related expenses. Analysts, however, forecast less variation in the September quarter, primarily because of the US drug launches, strong performance of foreign units and the rupee weakening 20% against the dollar, boosting exports.
Sun Pharmaceutical Industries Ltd, Glenmark Pharmaceuticals Ltd, Lupin Ltd and Cipla Ltd are likely to be among the top performers because they introduced new generic drugs in

the US for which they have exclusive marketing rights for 180 days. Sales and profit growth of the drug makers will average 22% and 50%, respectively, in the three months ended September, according to an 8 October forecast by Ranjit Kapadia, an analyst at Centrum Broking Pvt. Ltd. The 13 top pharmaceutical companies studied by the brokerage, which includes Ranbaxy
Laboratories Ltd, Sun Pharmaceutical Industries, Cipla, Lupin, Aurobindo Pharma Ltd and Dr. Reddys Laboratories Ltd, may post 22% growth in revenue during the quarter

because of growth in the local market and favourable foreign exchange fluctuations, Kapadia said. We expect Ranbaxy and Lupin to report revenue growth of 38% year-on-year and 34% net profit year-on-year, respectively due to good growth in the US market, said Kapadia. Overall, pharma companies should report excellent performance for the quarter, he said. Most drug companies, including Cipla, Divis Laboratories Ltd and Torrent
Pharmaceuticals Ltd, are expected to report an improvement in operating margins from a

year earlier because of low foreign-exchange hedging and US marketing exclusivity,

according to a 4 October prediction by Praful Bohra, analyst at brokerage Nirmal Bang

Securities Pvt. Ltd.

Sequentially, these companies may witness moderation in margins due to lower domestic sales, Bohra said in the report.
Krishna Kumar and Preeti Arora, analysts at Kotak Securities Ltd, said in a 10 October

report that they expected a strong quarter for large generic drug companies. Analysts, however, cautioned that domestic growth may be affected unless companies tweak their strategies to absorb the possible impact of a proposed price control policy and additional taxes. The Supreme Court on 3 October gave the government a week to come up with a timeline for implementing its new drug pricing policy, which proposes a national list of 348 essential medicines, the prices of which will be regulated. A group of ministers on 4 October linked the new drug price control formula to the weighted average of brands with over 1% market share in each segment. The policy requires cabinet approval. The drug pricing policy remains the key near-term monitorable. We believe the stocks are adequately reflecting near-term earnings growth while execution and pipeline visibility will hold the key for future stock performance, said the Kotak analysts. The domestic medicine market grew 15.6% and 13.6% in July and August, respectively, lower than the 17% gain reported in June, data from All India Organization of Chemists and Druggists shows. While a delayed monsoon was responsible for slower growth in acute therapies such as anti-infective, pain management and respiratory medicines that grew below 10%, growth in chronic therapies also dropped marginally to 16% in August compared with 18% and 20% in the preceding quarters. We believe this trend will reflect in the second quarter of 2013 fiscal performance and expect the domestic growth to moderate for Torrent Pharma and Cipla, said the Nirmal Bang report. Ahmedabad-based Cadila Healthcare Ltdalso known as Zydus Cadilais likely to report higher growth due to integration of Biochem Pharmaceutical Industries Ltd that was acquired in December, said the report.

Kotak analysts also expect growth in regions such as India and the US to remain healthy for

top pharma companies. They predict the September quarter sales growth to be more than 20%, except for Cipla. We expect Sun Pharma to deliver strong earnings for the quartercore sales and profit growth of 38% and 28%, respectively, on a year-on-year basis. Dr. Reddys Laboratories and Lupins margins are expected to improve sequentially, said the Kotak report, adding Lupin could see its operational profit improve by 220 basis points, driven by a moderation in research and development costs. One basis point is one-hundredth of a percentage point. For Cipla, the product mix holds the key; and for Glenmark Pharmaceuticals Ltd, its marketshare gain in the US helps, said the analysts.
Glenmarks core sales and net profit are expected to grow an annual 27% and 39%,

respectively. And for Cadila, we expect the Biochem consolidation and currency to be key factors for growth, the report predicted. Vidya Krishnan in New Delhi contributed to this story.

Mumbai: Indias top drug makers may see profit rise 20-30% in the quarter ended 30 September, boosted by selling new products in the US and a favourable currency movement. The companies may report 23-28% annual growth in revenue, analysts expect. The projected revenue growth is similar to the preceding two quarters ended June, although earnings have fluctuated because of foreign exchange losses, acquisitions and tax-related expenses. Analysts, however, forecast less variation in the September quarter, primarily because of the US drug launches, strong performance of foreign units and the rupee weakening 20% against the dollar, boosting exports.

Sun Pharmaceutical Industries Ltd, Glenmark Pharmaceuticals Ltd, Lupin Ltd and Cipla Ltd are likely to be among the top performers because they introduced new generic drugs in

the US for which they have exclusive marketing rights for 180 days. Sales and profit growth of the drug makers will average 22% and 50%, respectively, in the three months ended September, according to an 8 October forecast by Ranjit Kapadia, an analyst at Centrum Broking Pvt. Ltd. The 13 top pharmaceutical companies studied by the brokerage, which includes Ranbaxy
Laboratories Ltd, Sun Pharmaceutical Industries, Cipla, Lupin, Aurobindo Pharma Ltd and Dr. Reddys Laboratories Ltd, may post 22% growth in revenue during the quarter

because of growth in the local market and favourable foreign exchange fluctuations, Kapadia said. We expect Ranbaxy and Lupin to report revenue growth of 38% year-on-year and 34% net profit year-on-year, respectively due to good growth in the US market, said Kapadia. Overall, pharma companies should report excellent performance for the quarter, he said. Most drug companies, including Cipla, Divis Laboratories Ltd and Torrent
Pharmaceuticals Ltd, are expected to report an improvement in operating margins from a

year earlier because of low foreign-exchange hedging and US marketing exclusivity, according to a 4 October prediction by Praful Bohra, analyst at brokerage Nirmal Bang
Securities Pvt. Ltd.

Sequentially, these companies may witness moderation in margins due to lower domestic sales, Bohra said in the report.
Krishna Kumar and Preeti Arora, analysts at Kotak Securities Ltd, said in a 10 October

report that they expected a strong quarter for large generic drug companies. Analysts, however, cautioned that domestic growth may be affected unless companies tweak their strategies to absorb the possible impact of a proposed price control policy and additional taxes. The Supreme Court on 3 October gave the government a week to come up with a timeline for implementing its new drug pricing policy, which proposes a national list of 348 essential medicines, the prices of which will be regulated. A group of ministers on 4 October linked

the new drug price control formula to the weighted average of brands with over 1% market share in each segment. The policy requires cabinet approval. The drug pricing policy remains the key near-term monitorable. We believe the stocks are adequately reflecting near-term earnings growth while execution and pipeline visibility will hold the key for future stock performance, said the Kotak analysts. The domestic medicine market grew 15.6% and 13.6% in July and August, respectively, lower than the 17% gain reported in June, data from All India Organization of Chemists and Druggists shows. While a delayed monsoon was responsible for slower growth in acute therapies such as anti-infective, pain management and respiratory medicines that grew below 10%, growth in chronic therapies also dropped marginally to 16% in August compared with 18% and 20% in the preceding quarters. We believe this trend will reflect in the second quarter of 2013 fiscal performance and expect the domestic growth to moderate for Torrent Pharma and Cipla, said the Nirmal Bang report. Ahmedabad-based Cadila Healthcare Ltdalso known as Zydus Cadilais likely to report higher growth due to integration of Biochem Pharmaceutical Industries Ltd that was acquired in December, said the report.
Kotak analysts also expect growth in regions such as India and the US to remain healthy for

top pharma companies. They predict the September quarter sales growth to be more than 20%, except for Cipla. We expect Sun Pharma to deliver strong earnings for the quartercore sales and profit growth of 38% and 28%, respectively, on a year-on-year basis. Dr. Reddys Laboratories and Lupins margins are expected to improve sequentially, said the Kotak report, adding Lupin could see its operational profit improve by 220 basis points, driven by a moderation in research and development costs. One basis point is one-hundredth of a percentage point. For Cipla, the product mix holds the key; and for Glenmark Pharmaceuticals Ltd, its marketshare gain in the US helps, said the analysts.

Glenmarks core sales and net profit are expected to grow an annual 27% and 39%,

respectively. And for Cadila, we expect the Biochem consolidation and currency to be key factors for growth, the report predicted. Vidya Krishnan in New Delhi contributed to this story.

Mumbai: Ranbaxy Laboratories Ltd, Indias top drug maker by sales, beat estimates with a Rs.750 crore quarterly net profit as demand for its generic drugs stoked a sales surge in its key US market while foreign exchange gains boosted profitability.
Ranbaxy, controlled by Japans Daiichi Sankyo Co., said on Thursday sales grew

to Rs.2,650 crore in the third quarter ended September from Rs.2,020 crore a year earlier. The company gainedRs.393 crore in forex gains. Analysts, on average, estimated the net profit at Rs.292 crore on net sales of Rs.2,691 crore, according to Thomson Reuters.

Updated: Sun, Nov 25 2012. 10 16 PM IST Memories of Ranbaxy Laboratories Ltds long-drawn effort to end compliance-related issues with the US Food and Drug Administration (FDA) at some of its plants appear to be still fresh in investors minds. The company is complying with the terms of a consent decree signed with the US regulator to settle these issues and a formal closure is still awaited. But, something else grabbed investor attention on Friday, when the Ranbaxy stock fell by 3.3%. The scrip fell when Ranbaxy said it was recalling certain batches of cholesterol-lowering drug atorvastatin, or generic Lipitor, from the US market, and this would temporarily disrupt sales.

Investigations will take about two weeks, after which supplies are expected to resume. Now, drug recalls are not unusual in the US market, and companies are known to voluntarily do a recall, while keeping the FDA informed. If prompt preventive and remedial action is taken, and no harm to patients is found, then it should be possible to resume supplies.

Also, atorvastatin is no more a key driver of Ranbaxys sales, as it was when the company had exclusive sales and marketing rights in the US for six months that began in endNovember 2011. Several generic variants are now available, and the management had indicated that atorvastatins price had eroded by over 98.5%. The company management had said in a conference call that the companys quarterly US based revenue had risen to $100 million (aroundRs.553 crore today), and were about $7580 million without atorvastatin and a combination of atorvastatin and amplodipine, which is used to treat high cholesterol and blood pressure. Thus, the affected portfolio is significant for its US business. But supplies have been disrupted for two weeks, and Ranbaxys overall quarterly revenue in the September quarter was $480 million. A two-week stoppage will not cause a big dent in revenue or profits and should not worry investors. But their nervousness may be traced to Ranbaxy tripping on a high-profile drug, given the backdrop of its historical troubles with the US drug regulator and despite the care the company must have taken to prevent such incidents. The US subsidiarys website states that the recall is being done for certain batches of three strengths, as they may contain small glass particles. It is not known where the affected batches were manufactured. The recall may cause a shortage for the product, said a report by The Wall Street Journal, citing the FDA. There will be some negative publicity from this incident. Now, investors may still be overreacting and the issue may blow over in two weeks, just as the company has predicted, and it will be business as usual. But the odds, even if they appear slim, of the recall resulting in more material consequences, have made investors nervous.

Updated: Tue, Feb 26 2013. 08 07 PM IST

Ranbaxy Laboratories Ltd announced on Monday it had begun the process of resuming

generic Lipitor supplies to the US market. Its share went up. A day later, it announced disappointing results for the December quarter, and its share fell. The companys sales rose by just 0.1% on a sequential basis toRs.2,671 crore. Though the decline over the year-ago period at 29.1% seems dire, this was expected as the December 2011 quarter included exclusivity period sales of generic Lipitor, a cholesterol lowering drug, in the US market. The sequential performance is thus more comparable. In dollar terms, Ranbaxys sales in the North American market declined by 4.2% due to the stoppage of generic Lipitor sales since end-November. Ranbaxy also incurred an Rs.185.9 crore charge pertaining to this recall. Operating costs increased faster than sales growth did. Gross margin declined sequentially by 4.4 percentage points, while operating profit margin declined by 9.9 percentage points. After accounting for depreciation, other income and interest costs, it turned in a loss of Rs.58.5 crore, and at the net level, this figure increased to Rs.492.4 crore after deducting minority interest. This compares with a Rs.757.1 crore profit in the preceding quarter. It was no wonder that Ranbaxys share slipped by 3.7% on Tuesday, but its gain of 4.8% on Monday meant it was still in the positive after netting out both events. Investors are giving weight to the fact that the worst impact of the recall appears behind them. Ranbaxys performance in other markets such as India, East Europe and Commonwealth of Independent States and Africa were much better. The company has said it expects the base business to grow 10% in 2013. Investors will be looking to its US market performance in future quarters to see if it can win back lost market share in generic Lipitor. While its base business growth is one aspect, the real kicker to growth can come from a few big generic drug launches in the US market.

Updated: Tue, Feb 26 2013. 10 37 PM IST

Mumbai: Ranbaxy Laboratories Ltd, the countrys largest drug maker, said Decemberquarter loss widened to Rs.492.4 crore from Rs.298.2 crore a year earlier because of adverse foreign exchange fluctuations and declining sales. Sales fell 29% to Rs.2,711 crore in the three months ended 31 December, largely on account of expiry of market exclusivity in the US and also the recall of Lipitor generic. During the quarter, Ranbaxy incurred a foreign exchange loss of Rs.180 crore and a financial cost of Rs.186 crore on account of the recall of its much-touted generic copy of cholesterol drug Lipitor in the US. These and the drop in the prices of products for which market exclusivity expired contributed to the additional net loss for the December quarter. Pharma analysts had expected a difficult quarter for Ranbaxy mainly on account of the recall of its Lipitor version in the US. Ranbaxy, which follows a January-December financial year, swung to a net profit of Rs.922.8 crore for the full year from a net loss of Rs.2,899.8 crore in the previous year. Sales during the year rose 22.9% toRs.12,253 crore. 2012 was a mixed year for us, Arun Sawhney, chief executive and managing director of Ranbaxy, said in a statement on Tuesday. While we delivered our strongest -ever sales performance monetizing our major key product opportunities, we also faced challenges, primarily the recall of atorvastatin (Lipitor) in the US market at the end of the year. Shares of Ranbaxy dropped 3.66% to close at Rs.417.30 on BSE on Tuesday, while the benchmark Sensex fell 1.64% to 19,015.14 points. Ranbaxy has undertaken a consent decree with the US Food and Drug Administration seeking its approval to start exporting products from its Indian facilities after the US regulator banned two of those factories in 2009. We have made good progress on the consent decree honouring all our commitments till date. We continue to remain confident of monetizing our large ANDAs (abbreviated new drug application seeking approval for generic drugs) and we have also taken significant steps, which will position Ranbaxy to emerge stronger with a competitive edge, in the rapidly changing business climate, Sawhney added.

In the December quarter, emerging markets contributed Rs.1,362 crore in sales, accounting for 51% of Ranbaxys total revenue. Developed markets recorded Rs.1,093.8 crore, accounting for 41% of the total sales. Domestic sales during the quarter rose 12% from a year ago to Rs.541.8 crore.

Updated: Wed, Feb 27 2013. 03 09 PM IST Mumbai: Shares of Ranbaxy Laboratories Ltd fell for the second day after Indias largest drug maker announced dismal fourth-quarter earnings on Tuesday. On Wednesday, the stock dropped 4.51% to Rs.398.50 at 1.32pm on the BSE, after dropping 4.77% the previous day. Analysts tracking the stock said Ranbaxys December quarter earnings were disappointing and a rebound in the stock seemed difficult immediately. We have revised our target price down to Rs.488 from Rs.604...and we roll forward our estimates to fiscal 2014, analyst Hitesh Mahida at Fortune Equity Brokers (India) Ltd said in a report. Ranbaxys loss widened to Rs.492.4 crore in the December quarter from a loss of Rs.298.2 crore a year ago, mainly due to a 29% drop in sales and a foreign exchange loss. Sales suffered on account of the expiry of market exclusivity in the US for certain products and the recall of the companys generic version of cholesterol drug Lipitor (atorvastatin) tablets in November. Ranbaxys US formulations business posted sales degrowth of 64.4% and 8.6% year -onyear and quarter-to-quarter (in US dollar terms), respectively, due to high base (from atorvastatin exclusivity earlier), reduction in sales from Fenofibrate and atorvastatin (key generic products of the company in the US market) recall during the quarter, Mahida said in the report.

Atorvastatin would have contributed $40-45 million in the third quarter (ended 30 September) and sales during the current quarter would have been $10-15 million. We believe these two factors would have brought down the base US sales from $107 million in the third quarter 2012 to $66 million in the fourth quarter, Mahida said. After the November recall of the Lipitor generic, Ranbaxy said on Monday it had resumed sending drug materials to the US plant for manufacturing atorvastatin formulation. We however expect a better performance going forward as the company has exclusive launches of generics of Diovan and Valcyte in 2013. Companys branded drug Absorica is also consistently gaining share in that market, Mahida said in the report.

Updated: Tue, Mar 05 2013. 07 16 PM IST Mumbai: Ranbaxy Pharmaceuticals Inc., the US arm of Indias largest drug maker, said on Tuesday that it has entered into an in-licensing agreement with Alembic Pharmaceuticals
Ltd to exclusively sell the generic version of Pfizer Inc.s anti-depression drug Pristiq in the

US. Pristiq had total sales of $590 million in the 12 months ended January in the US, according to market researcher IMS Health.
Ranbaxy will sell the drug supplied by Alembic in the US, and both the companies will share

the profit, according to the licensing deal. Alembic has received the US Food and Drug Administrations approval to export the product to the US. Ranbaxy expects the drug to be available in the US from the ongoing quarter. On Tuesday, Alembic rose 15.2% to Rs.92.20 and Ranbaxy Laboratories Ltd gained 2.49% to close at Rs.391.05 on BSE, while the benchmark Sensex advanced 1.4% to end at 19,143.17 points.

Updated: Wed, May 08 2013. 09 53 PM IST Mumbai: Ranbaxy Laboratories Ltd, Indias largest drugmaker by sales, reported a 90% drop in first quarter net profit compared with the year-ago period, when it had exclusive rights to a generic version of cholesterol-lowering drug Lipitor in the US. Ranbaxy said consolidated net profit fell to Rs.126 crore in the fiscal first quarter ended March, from Rs.1,247 crore last year. Sales fell 34.2% to Rs.2,440 crore. Analysts, on an average, had estimated a net profit of Rs.141 crore on net sales of 2,648 crore, according to Thomas Reuters. Shares in Ranbaxy were down 2.6% at Rs.444.6 by 1:49pm. The stock is down nearly 11% this year as compared with 2.4% rise in the benchmark Sensex.

Updated: Tue, May 14 2013. 03 55 PM IST Mumbai: Indias largest drug maker by sales Ranbaxy Laboratories Ltd said on Tuesday that the US department of justice (DoJ) has concluded its investigation on data integrity and manufacturing processes at certain Ranbaxy facilities in India. The investigation was related to charges of non-complaince to drug manufacturing quality norms and related data falsification in filings to the US Food and Drug Administration which occurred at least six years ago. Following these charges, the US drug regulator had in 2008 banned products from two manufacturing facilities of Ranbaxy in India from being sold in that country. Under the terms of the final settlement agreement, Ranbaxy and its affiliates have agreed to settle alleged civil violations of the False Claims Act with all 50 states in the US and the District of Columbia. Separately, one of the companys US subsidiaries, Ranbaxy USA Inc., has agreed to plead guilty to violations of the Food, Drug and Cosmetic Act and other criminal statutes. Ranbaxys payments related to both the civil and criminal settlements total $500 million. On 20 December 2011, Ranbaxy announced that it had signed a consent decree with the US Food and Drug Administration, under which it committed to further strengthen

procedures and policies to ensure data integrity and to comply with current good manufacturing practice. In anticipation of the settlement with the DoJ announced on Tuesday, Ranbaxy had said at that time its intention was to make a financial provision of $500 million related to expected costs associated with resolving the DoJ investigation. The financial provision Ranbaxy established in December 2011 will be sufficient to cover all material financial obligations under the agreement, said a statement from Ranbaxy, which is currentlyowned by Japanese drug maker Daiichi Sankyo Group. Todays announcement marks the resolution of this past issue, said Arun Sawhney, chief executive officer and managing director of Ranbaxy, in a Tuesday statement. We are pleased to continue bringing safe, effective and quality medicines to market for the benefit of consumers in the US and other parts of the world. While we are disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxys stakeholders, he said. The company added that the conclusion of the DoJ investigation does not materially impact its current financial situation or performance. On Tuesday, Ranbaxys shares ended at Rs.455.50 apiece on BSE, up 3.63% from previous close, while Indias benchmark Sensex Index rose 0.16% to 19,722.29 points.

Updated: Tue, May 14 2013. 04 07 PM IST Mumbai: Ranbaxy Laboratories Ltd rose after opening lower following a disclosure that its US unit would pay a record $500 million to settle charges of non-compliance with drug manufacturing quality norms and related falsification of data in filings made to the US Food and Drug Administration that occurred at least six years ago. Ranbaxys shares ended at Rs.455.50 apiece on BSE, up 3.63% from previous close, on BSE on Tuesday, while Indias benchm ark Sensex rose 0.16% to 19,722.29 points. Ranbaxy said in December 2011 that it would set aside $500 million related to expected costs associated with resolving the investigation.

Updated: Thu, May 23 2013. 04 46 PM IST Mumbai: Shares of drug maker Ranbaxy Laboratories Ltd plunged as much as 9.3% in trade on BSE on Thursday. The companys Japanese parent Daiichi Sankyo Co. Ltd had on Tuesday said it is exploring legal action against the former promoters to recover the $500 million fine that it had to pay the US Food and Drug Administration to settle the civil and criminal charges against the company last week. Daiichi Sankyo had in a statement on Tuesday said for the first time after its acquisition of the Indian company in 2008 that the former shareholders concealed critical information about criminal investigation initiated by the US department of justice and the drug regulator against Ranbaxy from it at the time of the deal. Daiichi had also said that it had spent about $300 million to upgrade the companys compliance level and also to rectify the company from the wrong conduct of the past management. Shares of Ranbaxy Laboratories fell 8.80% to Rs.393.15 apiece on BSE, while the exchanges benchmark Sensex shed 1.93% to end at 19,674.33 points.

Updated: Fri, May 24 2013. 02 33 PM IST Mumbai/New Delhi: Malvinder Singh put forth a robust defence of his record at Ranbaxy Laboratories Ltd, which has come under a cloud after revelations of dodgy practices that had to be settled with the US Food and Drug Administration (FDA) through a $500 million payment. While the companys former chief executive officer (CEO) could be at the receiving end of a suit filed by Japans Daiichi Sankyo Ltd, which took control of Ranbaxy from Singhs family in a $4.6 billion deal in June 2008, the contagion could spread to other Indian generics manufacturers as they come under increased scrutiny as more skeletons come tumbling out of the closet.

Indian manufacturers are afraid they may all get smeared because of the transgressions of a few, handing ammunition to companies in developed markets that would like to see more stringent controls on cheaper generic imports. They cannot pass the blame on to previous shareholders and management, Singh said in an interview on Thursday. I dont think they (Daiichi Sankyo) have a case. There was absolutely no concealment on our part... They should be held accountable for destroying an Indian brand. The stock market is palpably nervousshares of some Indian generics companies have fallen in the past few days, most particularly after a 15 May Fortune story that detailed the extent of possible wrongdoing at Ranbaxy.
Wockhardt Ltd is the first Indian company thats said it faces FDA strictures since Ranbaxy

made details of its case public on 13 May, when it said it had agreed to pay $500 million to settle civil and criminal charges of making fraudulent statements to the FDA and selling adulterated drugs. The Wockhardt stock plunged 20% on Thursday after the FDA issued an import alert banning the import of products made at one of its plants at Aurangabad in Maharashtra. Chairman Habil Khorakiwalaconfirmed the development and said, The company expects a financial impact of $100 million in this financial year due to the import ban of products from this plant. The plant manufactures sterile injectables as well as solid oral drugs. Wockhardt called off a media conference on Monday (27 May) to announce its fourth-quarter results, citing no specific reasons. Wockhardt shares have declined 24.83% since the 15 May Fortune story, while the Ranbaxy stock has declined 11.11% in the same period. Malvinder Singh refuted all allegations against his family and said the current owners of the company were responsible for the troubles they were facing. They are the owners and they have to be accountable for what they do. They spent money and did their diligence. They were keen to buy and they ran it to the ground, he said. I am not here to discuss whether Ranbaxy is doing well or not. I am here because of the

allegations against my family. For the last many years, after I moved out of that space, I have not spoken on anything related to Ranbaxy or the industry. Indias pharmaceutical industry regulator meanwhile elaborated on the action it is considering against Ranbaxy. Drug controller general of India G.N. Singh said in an interview that all drug applications and dossiers filed by Ranbaxy as well as court documents presented in the US will be scrutinized to see if there have been any breaches of the Drugs and Cosmetics (D&C) Act. No one and no company is above rules, Singh said. We want companies operating in India to follow established procedures and will initiate necessary steps to ensure that. He said the regulators duty wasnt to companies but to patients and to ensuring that they have access to safe drugs. I want to assure people that the drugs currently allowed in the domestic market are of good quality and as per the D&C Act, he said. We have no reason to believe that the company has violated Indian laws. The matter, however, is currently being looked at. The drug regulator pointed out that Indias rules vary from those in other countries. However, he said, We export drugs to 218 countries and we are conscious of our responsibility towards health of all those who use Indian drugs. From time to time, we have put companies on alert and taken appropriate action against then when violations have been established. Indias image as a low-cost generic drugs manufacturer of high quality could get a beating in the wake of recent developments, said Tapan Ray, director general of the Organisation of Pharmaceutical Producers of India, the industry lobby that largely represents foreign drug makers operating in India. In the backdrop of such high decibel quality concerns raised by USFDA, the level of apprehension regarding effectiveness of generic drugs made in India may increase, unless some tangible remedial measures are taken forthwith, he said. These issues are company specific; it will not be appropriate to comment even remotely that all generic drugs manufactured in India are of dubious quality.

The Ranbaxy episode wont taint all domestic manufacturers of generics as the development is specific to one company, said Dilip G. Shah, secretary general, Indian Pharmaceutical Alliance, which represents the top Indian companies. We should admit that it was crude if Ranbaxy hasnt shown the documents regarding the non-compliance issues and the related investigation to Daiichi during the due diligence process, he said. If it is so, Daiichi has all the rights to raise legal remedies to recover the damage that it has caused the company post deal. Any impact on the overall industry will be short-lived, he said. I dont think quality is a concern as far as Indian generics are concerned as the country has several manufacturing plants which have been approved by many regulatory agencies including USFDA, and those are products are there in the market for so long. Singh added that Ranbaxy was built on professional principles. This company was built over generations based on talent and capability. It was one of the few companies that ran professionally which went global because it was forward looking with an international perspective. These aspects speak about the management capability amply, he said. Cases such as the Ranbaxy one will persuade deal makers and potential buyers to dig deeper during the due diligence phase, said Avinash Gupta, head, financial advisory, at corporate consultancy and audit firm Deloitte Touche Tohmatsu India Pvt. Ltd. Many deals have gone wrong in the past not only in India but globally too, as exuberant buyers or deal makers tend to discount the impact of certain issues or factor them lightly, he added. India exports generic drugs worth about Rs.60,000 crore to least 200 key markets in the US, Europe, Africa and Asia. Of this, about 40% is to the US, the largest drugs pharmaceutical market in the world in terms of value. India, the country which has the largest number of USFDA-approved manufacturing plants outside the US, has been the largest generic drug exporter to the US and Europe. Top Indian drug makers includingSun Pharmaceutiucal Industries Ltd, Dr Reddys
Laboratories Ltd, Lupin Ltd and Cadila Healthcare Ltd, besides Wockhardt and Ranbaxy,

also operate several manufacturing plants abroad, including the US, to cater to markets there. The local industry has faced several US regulatory issues in the past. Besides the import ban imposed on Ranbaxys manufacturing plants in Himachal Pradesh and Madhya Pradesh, other key instances include a 2009 ban on one of the sterile plants of Hyderabadbased Aurobindo Pharma Ltd, an import ban on Claris Lifesciences Ltds plant in 2008 and a four-year ban on the manufacturing plant of Sun Pharmas US subsidiary Caraco Pharma. The local drug industry also faced intellectual property related issues while exporting drugs. In recent years, several export consignments from companies such as Cipla Ltd and Dr Reddys were seized at European ports on charges of patent infringements, though many of them were released later after they were proved to be legal consignments to either Europe or other markets.

Updated: Sun, May 26 2013. 08 22 PM IST The US Food and Drug Administration (FDA) has been kind to Ranbaxy, too kind. The $500 million fine that the company has to pay is actually fairly light sentence for what it has done to the generics business out of India. The rapidly growing industry is now under a cloud. The first consequences of Ranbaxys actions are already being felt with the FDA issuing an alert banning import of products made at another pharma exporter Wockhardts plant in Aurangabad. It could be just the first of many more strictures against Indias generics companies. Ranbaxys is no ordinary misdemeanour. The US department of justice said the company had pleaded guilty today to felony charges relating to the manufacture of certain adulterated drugs. Felony is a serious criminal charge. By accepting to pay a criminal fine and forfeiture and agreeing to settle civil claims, Ranbaxy may have succeeded in effecting damage control. That does not, however, mitigate the seriousness of its actions.

The implications of its guilt cast serious doubts not just over the conduct of generics exporters from India, but over the way business is conducted in this country. First up, it proves beyond doubt that there is no monitoring, by an independent agency, of business practices of wannabe Indian multinationals. What was cooking in Ranbaxys labs over nearly five to six years was never under any supervision. That exposes the lack of teeth and, perhaps, even moral responsibility of the Indian Pharmaceutical Association (IPA), the association of drug companies. Whats worse, not till the FDAs actions did the Central Drugs Standard Control Organization, the designated Indian regulator, initiate any action against the company whose drugs are among the pricier and more popular ones in the Indian market. Expecting companies to voluntarily follow all the rules of the book is naivet. Through the 1990s, numerous Indian companies exploited loopholes in the global carbon trading opportunity. Our markets are riddled with companies in every industry segment flouting norms of ethical behaviour. Falsification of data submitted to regulators, is so common a practice that Ranbaxy must have wondered what the fuss was all about. And used to getting away with lax governance and ethics standards at home, no Indian company will automatically turn lily-white merely because it is selling in a developed market. The Ranbaxy affair also raises issues of executive conduct. The men, who were at the helm of the company in the days when it was growing rapidly on the back of such fraud, have mostly moved out now. But that does not absolve them. The company has acknowledged that in 2003 and 2005 it was informed of current good manufacturing practice (cGMP) violations by consultants it hired to conduct audits at its Paonta Sahib and Dewas facilities. That no action was taken exposes the executives of the day, including a board comprising eminent men of Delhi, to culpability. Nor does current Japanese owner Daiichi Sankyo, come out clean in all this. For a $4.6 billion deal (to buy a controlling interest in Ranbaxy), the due diligence it did in 2008 appears to have been rather skimpy and inadequate. Or, did it simply choose to turn a blind eye to what by then was publicly known? It is worth noting that US attorney for the District of Maryland, Rod J. Rosenstein, in his ruling held Ranbaxy accountable for a pattern of violations. Its three facilities in Paonta Sahib, Batamandi and Dewas have been on an FDA import alert since 2008.

Responsibility for this problem must be shared equally among the congregation of executives, owners and regulators. But the bitter truth is that we have been too elastic in condoning corruption all around so that it has become deeply and shamefully a part of the ethos of Indian firms. Not all the regulation in the world will stop fraud. Corporate integrity is about culture and sadly ours is a culture where unethical behaviour is condoned and rewarded. In the end, policing cannot win at the expense of self-policing; to act to avoid prosecution cannot win at the expense of acting ethically; pragmatism cannot win at the expense of responsibility. Finally, it is about building an ethisphere, which can come about by accountability to the citizenry and, in turn, having an honest citizenry. It again means going back to the drawing board and not tossing off ethics as an addendum taught in isolation but braiding it into actual and current decision-making. As Indian firms seek to do business abroad, their culture of deceit will come back to bite them. History is littered with examples of companies whose dubious ethical standards eventually led to their demise. The graves of Qwest, Tyco, Enron, WorldCom and Arthur Andersen are the stepping stones of the USs own exacting standards of corporate behaviour. Do Indian pharmaceutical companies operate in a lax regulatory environment? Tell us at views@livemint.com

Updated: Tue, Jun 18 2013. 04 32 PM IST Mumbai: Ranbaxy Laboratories Ltd shares tumbled to their lowest in nearly four years after reports that the Supreme Court will hear a petition seeking a probe against the drug maker for allegedly manufacturing and selling adulterated medicines on 24 June. They recouped some losses at the close. A bench of justices A.K. Patnaik and Ranjan Gogoi on Monday agreed to hear the public interest litigation (PIL) after the petitioner, advocate M.L. Sharma, sought an urgent hearing, Press Trust of India had reported on Monday.

The case was earlier heard by a different vacation bench that had on 10 June asked Sharma to substantiate his unfounded allegations that the Indian pharma company was allegedly manufacturing and selling adulterated medicines, the report added. Ranbaxy fell as much as 6.2% to Rs.342.75, its lowest since September 2009, before ending at 352.40, down 3.56%. The benchmark 30-share Sensex fell 0.5% to 19,223.28 points. The company said last month that it reached a $500 million settlement with the US Food and Drug Administration (USFDA) to settle charges that it had falsified data and sold substandard drugs. Ranbaxys valuations look attractive. However, in terms of problems the scene looks difficult with the issues related to USFDA and now even with the DCGI (Drug Controller General of India). On top of that, the base business profitability is low. It will take one-two years for the company to turn around, saidSarabjit Kour Nangra, vice-president of research at Angel Broking Ltd. It is a good buy from a long-term investors perspective. But, short-term investors do not stand to gain anything, Nangra said. The brokerage has a neutral rating on the stock. The stock has shed 19.8% since the 13 May Ranbaxy settlement with USFDA. In the year to date, Ranbaxy has dropped 29.9% while the Sensex has shed 1.1%.

Updated: Sun, Jun 23 2013. 09 10 PM IST Regulators in developed markets are turning on the screws for pay-for-delay settlements entered between innovator and generic companies. Last week, the US Supreme Court ruled that anti-trust authorities could scrutinize these deals. Last week also saw the European Commission fining an innovator pharmaceutical company and four generic firms (including Ranbaxy Laboratories Ltd) for a settlement it deemed anti-competitive. Increasing scrutiny of such deals poses some uncertainty for Indian

generic companies, marking an addition to the list of uncertainties investors contend with when investing in generic pharmaceutical companies. In the US market, a patent challenge by a generic company could lead to the innovator company suing for patent infringement. Subsequently, the two parties can either wait for the courts to get a final decision or settle the case. The Federal Trade Commissions (FTC) opposition is to those settlements where the generic company agrees to delay the launch of the drug, and is compensated either directly or more often indirectly for the same. Such settlements allow the innovator company to retain its patent, while the generic company gets rewarded for the effort and expense incurred in a patent challenge. Settlements do provide certainty in comparison to court battles that can last for years. But the FTCs opposition stems from a belief that pay-for-delay settlements deny consumer drugs at cheaper pricesa key cornerstone of the policy of facilitating entry for generic drug companies to the US market. The US Supreme Court has now ruled in the FTCs favour, saying that it has the power to apply the anti-trust laws to such cases. The court was ruling on appeal filed by the FTC in a case it had lost in a lower court against Actavis Inc. and other generic companies. These companies had settled with Solvay Pharmaceuticals (subsequently acquired by Abbott
Laboratories) and agreed to not launch a generic version of AndroGel, a testosterone

replacement product, for several years. Separately, it entered into a marketing agreement with the generic players for AndroGel in the US. Earlier, a lower court had ruled against the FTC, saying that the drugs patent anyway excluded competition till the patent expired, and the settlement did not create a new barrier to competition. This was not accepted by the Supreme Court. The court has also said that the FTC can investigate reverse payment cases to determine if they are anti-competitive in nature. But it has not declared pay-for-delay settlements as illegal and said that the facts of each case need to be considered. That means that the FTC will have to take legal recourse to halt a settlement that it deems anti-competitive. Next, one will see the FTC argue its case against the AndroGel settlement and that cases outcome will be watched with great interest.

The bigger worry is whether the FTC will target other settlements too. We also are studying the Courts decision and assessing how best to protect consumers interests in other pay for delay cases, says a statement from the FTC. Note that all settlements are not under threat. Only those where the anti-trust authorities believe that a generic company is foregoing a launch opportunity in return for compensation may come under scrutiny. The FTC estimates that consumers in America are paying $3.5 billion a year as higher drug prices due to these settlements. Companies may now structure settlements in a manner that alleviates anti-trust concerns. Investors are usually enamoured by such settlements because they bring in certain and healthy revenue streams for generic companies. If the FTC action were to block that, they would be disappointed for sure.

Mumbai: Asian markets are trading mixed. Concerns about the cash crunch in China and its eventual impact on the economy is weighing on shares of raw material suppliers. Read the Bloombergreport. Over the weekend, selling abated in the US markets. The S&P 500 gained 0.27% to 1,592 as investors reckoned the selling had been overdone. Read more. Back home, the dividends that state-owned companies paid the Indian government were significantly higher in fiscal year 2013. AMint analysis of 47 public sector undertakings, excluding banks, revealed that the aggregate dividend payout in 2012-13 rose 14.12% to Rs.36,441 crore from the year before. Good rains have spurred sowing across the country. Sowing area crossed 109 lakh hectares across the country, 11 lakh hectares more than is normal. Read more. Top customers of Indias information technology (IT) industry will send more work to the country if the US Senate approves a controversial immigration law, reports Mint. Increasing visa costs and restrictions on Indian technology firms will force some top buyers to send more work offshore to avoid the repercussions, research firms say.

Gearing up for robust business growth, HDFC Ltd is planning to seek shareholders approval for raising its borrowing limit to a whopping Rs.3 trillion. Presently, the company can borrow up to Rs.2 trillion. Read more.
Bharti Airtel Ltd is planning to cut 4G data charges by 31%, reports The Economic Times.

The company offers 4G services in Kolkata, Bangalore, Pune and Chandigarh.

Ranbaxy Laboratories Ltd may witness some action. The companys Mohali unit has come

under the US drug regulators scanner, reports Business Standard. According to the report, the US FDA has found some deviations from its norms there.
Legacy Iron Ore Ltd, the Australian arm of state-owned National Mineral Development Corp. Ltd plans to raise 25 million Australian dollars through a rights issue. NMDC is likely

to spend 12.5 million Australian dollars to acquire rights equivalent to its 49.6% stake in Legacy Iron Ore. Read more.
Zydus Wellness Ltd is looking to acquire more brands, reports Business Standard. The

company wants to fund the acquisitions through internal accruals and cash reserves. Keep an eye on the Alchemist group of companies. Sebi has asked the groups firm
Alchemist Infra Realty Ltdto wind up all collective investment schemes and refund the

money collected fro

Mumbai: Shares of Ranbaxy Laboratories Ltd. on Monday dipped by nearly 7% on reports that the companys manufacturing facility at Mohali has come under the US Food and Drug Administrations (USFDA) scanner. Shares of the drug firm in intra-day trade lost 7.56% to Rs323, its 52-week low on the BSE. The stock finally ended 6.85% lower at Rs325.50. On the NSE, the stock tanked 6.99% to close at Rs324.80. The stock has been under pressure due to charges levied by the USFDA. The reports which say that even other plant is being looked by the USFDA have brought more selling

pressure on the stock, said Milan Bavishi, head research, Inventure Growth and Securities. As per the media report, the USFDA is learnt to have issued a Form 483 to the companys manufacturing facility at Mohali a few months ago after finding deviations from norms during an inspection of the plant. A Form 483 is issued by the USFDA at the conclusion of an inspection to notify the company of objectionable conditions that might be in violation of the US Food, Drug and Cosmetic Act and related laws. However, it does not prevent a company from making regulatory filings from that unit, the report said. In the stock market, the BSE benchmark Sensex also saw selling pressure and settled the day with a loss of 233.35 points at 18,540.89.

Updated: Tue, Jun 25 2013. 12 21 PM IST New Delhi: The Supreme Court on Tuesday dismissed a PIL seeking a probe against Ranbaxy Laboratories Ltd for allegedly manufacturing and selling substandard medicines due to lack of evidence against the company. A bench of justices A.K. Patnaik and Ranjan Gogoi, however, allowed the petitioner advocate M.L. Sharma to file a fresh petition if he finds some evidence against the company in support of his allegation that the company is engaged in manufacturing and selling substandard drugs. The bench said that it cannot decide the plea against the company on the basis of a judgement passed by a US court against Ranbaxy. Your entire argument is based on proceedings in US. We have no jurisdiction over it. Show us material that things are happening in India and it adversely affects right to life of people here, the bench observed adding, Where is the material against Ranbaxy. No material has been placed to show that drugs manufactured by any unit of Ranbaxy are substandard, adulterated, spurious and that such drugs are prohibited under the law. In absence of such material, we cannot entertain the plea, the bench said.

Shares of Ranbaxy turned positive after earlier falling as much as 7.4% on Monday.

New Delhi: The image of Ranbaxy Laboratories Ltd, Indias largest drug maker, has taken a beating in recent weeks. The company agreed on 13 May to pay $500 million (around Rs.3,030 crore today) to settle charges of fraud, selling adulterated drugs in the US and lying to the Food and Drug Administration. This month, it was fined 10.3 million (around Rs.81 crore today) by the European antitrust watchdog for allegedly delaying the launch of an inexpensive generic antidepressant in the European market.Ranbaxys Mohali plant has now come under the scanner of the US regulator. Ranbaxy CEO and managing director Arun Sawhney spoke about the companys future plans in an interview on Wednesday. Edited excerpts: The companys reputation has taken a serious hit in the past month after the USFDA settlement. How is the company dealing with it? Over the past 52 years, Ranbaxy has grown by building trust among stakeholders. We have been the most globalized pharmaceutical brand from India. Despite recent setbacks, our stakeholders continue to patronize the company. Drug regulators have reposed faith in the company. What more can Ranbaxy ask for? Even now, hospitals and doctors by and large prescribe Ranbaxy drugs. The companys Mohali plant is now under the USFDAs scanner. Does it worry you? I want to categorically state that there is no inspection by USFDA in the Mohali plant in 2013. A 483 (FDA Form 483 notifies the companys management of objectionable conditions) is not going to hamper plant operations. We are making product submissions from Mohali. Some relief came from the Supreme Court dismissing the public interest litigation accusing Ranbaxy of selling sub-standard products in Indian markets. The apex court dismissed the case so there is very little for me to add to that.

Like I mentioned, Ranbaxy continues to enjoy patronage of all stakeholders. I have strong faith in the Indian system and drug regulators have backed us in this regard. Ranbaxys priority is and has always been, patient first. Ranbaxy is Indias leading pharmaceutical company, so with our team of experts and strategies for growth, the companys future is bright. We have recently invested nearly $300 million in our facilities which will pave way for our growth plans. What about the Rs.80 crore fine by the European Union (EU) for delaying launch of generic version of antidepressant drug Citalopram? We have played no role in delaying Citalopram. We will be appealing against the verdict in the EU court of justice. I think we have a strong case. It has been a difficult year for Ranbaxy. What are you targets for this year? We are hoping to end the current fiscal with Rs.120 billion (Rs.12,000 crore). There will be certain profit erosion but we are looking at developing a rich portfolio. Ranbaxy will continue investments in international markets like Malaysia, South Africa, Morocco, United States and of course, India. We have identified therapeutic areas to propel the companys growth and we will do it organically and inorganically. We will continue to invest in research and development. In addition to penalties imposed by USFDA and the European Union, there is a new pharmaceutical pricing policy that will erode the companys profits. How are you prepared for the policy change? The Indian pharmaceutical industry is growing in double digits and it will continue to grow for the next 10 years. The policy essentially removes uncertainties in the business environment and provides much needed stability. Certain erosion of profit is expected. The policy will be harder on a company like Ranbaxy because it is a brand leader but we have to take it in a stride as leaders do. The idea is to develop a more balanced portfolio of products in the future. We have a very able team which is working on these aspects.

New Delhi: The US state of Idaho has said it has received almost $420,000 from drug major Ranbaxy Laboratories Ltd as part of a $500 million settlement that the Indian firm had signed with the US authorities. Idaho has recovered nearly $420,000 in a legal settlement with pharmaceutical manufacturer Ranbaxy, Idaho attorney generalLawrence Wasden said in a statement. The settlement resolves civil and criminal allegations that Ranbaxy introduced adulterated drugs into interstate commerce, and, as a result, false or fraudulent claims were submitted to Idaho Medicaid, it added. This settlement reflects our resolve to address losses to the Idaho Medicaid program caused by individuals and companies, Wasden said. As part of the settlement with the US authorities, Ranbaxy had agreed to pay the states and the federal government $350 million in civil damages and penalties, the statement said. $266.73 million of this amount will go to the Medicaid programs, which are funded jointly by the states and the federal government. The remaining $83.27 million is designated for other federal healthcare programs affected by Ranbaxys conduct, according to the statement. Idahos share of the settlement is $419,914.45. Of that amount, $209,957.22 is restitution, which will be returned to Idaho Medicaid, it added. The additional recoveries and interest, totalling $218,462.37, will go to Idahos general fund. The general fund is the pool of money the legislature uses to fund the states share of Idaho Medicaid as well as other programs, it said. Additionally, Ranbaxy USA, a subsidiary, pleaded guilty to seven felony counts alleging violations of the US Food, Drug and Cosmetic Act and has agreed to pay $150 million in criminal fines and forfeitures, the statement said. Ranbaxy had entered into a consent decree with the US federal government to address outstanding current good manufacturing practice and data integrity issues at two manufacturing plants.

In May this year, Ranbaxy had agreed to pay $500 million to the US authorities after pleading guilty to felony charges over violation of manufacturing norms at its plants in Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh. In 2008, the US Food and Drug Administration (FDA) had banned the import of 30 generic drugs manufactured by the company at the two plants.

Many Indians are troubled by the warning letter issued to Wockhardt Ltd by the US Food and Drug Administration (FDA). Coming soon after the Ranbaxy Laboratories Ltd debacle, one starts to worry. Is this a US conspiracy to thwart the booming Indian pharmaceuticals companies? Are Western regulatory authorities overzealous in prosecuting companies of Indian origin? Indian pharma companies exporting to the US or the European Union have to play by their rules of the game. The rules in the US are interpreted by the FDA. You have to comply with the system and its referees. Period. Let us look at the track record of FDA with respect to regulatory action against pharma companies of non-Indian origin. If we look at the Inspections, Compliance, Enforcement, and Criminal Investigations section on the FDA website, it has more American companies indicted than non-American ones. In 2012, GlaxoSmithKline agreed to pay $3 billion for promoting its best-selling anti-depressants for unapproved uses and failing to report safety data about its top diabetes drug Rosiglitazone. Pfizer paid $2.3 billion in 2009 for off-label promotion and kickbacks. Abbott paid $1.5 billion in 2012, also for off-label promotion. All three were for violations of the US False Claims Act and had hired top legal talent to defend them. The only thing you could negotiate once you are fined is the settlement amount. Contrast this to India where two drugs suspended on 18 June had their suspension orders revoked within a month. If you read the letter of 18 July issued by the FDA to Wockhardt, the picture is one of fudging, hiding, providing inaccurate information, impeding investigators from the inspection site, and a general lack of data integrity with inadequate processes to prevent data manipulation. At one place, The uncontrolled documents indicate that up to 14% of vials

had defects including, but not limited to, black particles, fibres, glass particles, sealing defects, and volume variationshowever, a senior production officer at your firm stated that no investigations are performed when this occurs. And the ultimate Indian high caste indifference to bodily outputs: our investigators found that the washing and toilet facility located approximately twenty (20) feet (approximately 6 meters) from the entrance area to the Sterile Formulation (b)(4) manufacturing facility was found to have urinals that lacked drainage piping. The urine was found to fall directly onto the floor, where it was collected in an open drain. Stagnant urine was observed near the open drain. In addition, the investigators also observed what appeared to be mildew or other mold(s) in this toilet facility. The facilities used in the manufacture of drugs should be appropriately maintained and repaired, and remain in a clean condition. Witch hunting by FDA? Does not look like that to me. On the contrary, the letter to Wockhardt appears to be fair and suggests to Wockhardt ways to get out of the self-created mess. Companies exporting to countries with well-regulated agencies should have known better. If you did not expect the heat in the kitchen and cannot stand it, do not get into it. There will be short-term loss of face (and share price) but with disciplined compliance, pharma companies exporting to regulated markets can only flourish. Even if regulatory goalposts keep changing. Will this have a trickle down effect on Indias own regulators? One hopes so. Specify the standards for quality and good manufacturing practice compliance clearly. There should be no need for any setting thereafter, nor match fixing of inspections allowed. So is the FDA a white lily with perfect rules? No. It is like saying the umpire beats his dog, so overlook my ball-tampering. S. Srinivasan is a public health activist and managing trustee, Low Cost Standard Therapeutics (LOCOST), a non-profit and small-scale pharma firm in Vadodara, Gujarat.

Ranbaxy gains 34%: Five reasons why the stock was on a high
By ECONOMICTIMES.COM | 8 Aug, 2013, 05.00PM IST
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The surge comes on a day when Malaysia allotted its JV the site for a manufacturing unit, and a day after the firm reported Q2 earnings

Sun Pharmaceutical Industries Ltd.

BSE

507.10
-17.00(-3.24%)
Vol: 182430 shares traded

NSE

505.70
-16.35(-3.13%)
Vol: 3169712 shares traded

Prices | Financials | Company Info | Reports

NEW DELHI: Shares of Ranbaxy rallied 34 per cent in intraday trade on the BSE on Thursday, a day when Malaysia allocatedRMSB, its joint venture with Malaysian shareholders, space for setting up agreenfield manufacturing unit; and also a day after the company reported earnings for the second quarter of the calendar year 2013.

The pharma major finally ended 27.49 per cent higher at Rs 359.40, from

Wednesday's closing price of Rs 281.90. It hit a low of Rs 279 and a high of Rs 377.70 in the intraday trade on the Bombay Stock Exchange(BSE). Ranbaxy Labs posted a consolidated net loss of Rs 524.24 crore for the quarter ended June 30, 2013, mainly on account of foreign exchange losses and goodwill impairment in its operations in France. However, analysts at most brokerage firms are of the view that Ranbaxy is a 'good' buy with a limited risk given the fact the stock has already corrected a lot so far in 2013. We have collated top five reasons which could have aided the sharp rise in the stock price of Ranbaxy in today's trade: NOD FOR MANUFACTURING FACILITY IN MALAYSIA Ranbaxy Laboratories BSE 27.49 % said that Ranbaxy Malaysia Sdn Bhd (RMSB), its joint venture with Malaysian shareholders, has been allocated site for setting up a greenfield manufacturing facility in Malaysia. The JV company signed a 'letter of offer' agreement with Kulim Hi Tech Park (KHTP), a wholly owned state agency and industrial park that houses various other leading industries located at Kulim, Ranbaxy Laboratories said. Ranbaxy Laboratories holds a 71 per cent stake in the joint venture RMSB. MARGIN IMPROVEMENT With strong operating performance and sales especially in US showing some sort of uptick in the base business is a positive sign for the pharma major, say analysts.

Core OPM picked up sharply at 9.8 per cent as compared to 7.6 per cent reported in 1Q. The management expects to scale up margins in coming quarters led by led by market share gains on Isotretinoin (from c. 14%), Africa+India biz recovery and strengthening manufacturing processes. "Management guides gradual recovery in base margins, QoQ pick up in contractual payment from one time DOJ settlement related expense (nonrecurring), step down of consent decree expense from 1QC14," Sbicap Securities said in a report. ROBUST US SALES IN THE QUARTER "With healthy market share in generic Actos and Evoxac, along with scale up in Absorica, Ranbaxy's base business is strengthening," Elara Securities said in a report. "The company remains confident of monetizing generic Diovan and Valcyte (expecting launch in September 2013) this year. The company paid out US$ 500mn to the US FDA and DoJ during the quarter," added the report. US quarter run rate have further improved to $138mn from $110mn QoQ, led by MS gains in Absorica (14% vs. 10% qoq). "Further traction in Absorica along with potential launches in Diovan (4QC13), Valcyte (4QC13) and Nexium (2QC14) expects to result in $626/$922mn in Sales for C13/14e," say analysts.