Business Standard ND 27/02/2014 P-2

Business Standard ND 27/02/2014 P-2 Made-in-India drugs to be in dock at Capitol Hill SUSHMI DEY The concerns surrounding drug manufacturing practices in India appear to have reached foreign shores, beyond the international regulators' domain. Ranbaxy whistleblower Dinesh Thakur, along with a group of medical academicians and researchers, is set to address the US Congressional staff (of American legislators) on Wednesday at an event at Capitol Hill in Washington. The group is expected to raise issues about the quality of medicines available In the US, primarily those imported from India.

Apart from Thakur, the panellists for the much-hyped event include Amir Attaran, a professor of law and medicine at the University of Ottawa, Harry Lever, a senior cardiologist at the Cleveland Clinic and Preston Mason, a member of the cardiovascular division at Brigham and Women's Hospital and Harvard Medical School. The event will be moderated by Roger Bate, an expert on substandard and falsified medicines.

"Our aim is primarily educational, to explain there is a problem with some medicines, both domestically but more noticeably from imports from emerging markets India is the most important in terms of volume of imports, so is becoming the main focus," Bate told Business Standard, explaining the agenda of the Capitol Hill event. In the wake of US Food and Drug Administration (FDA) commissioner Margaret Hamburg's recent India visit, Thakur, Bate and Attaran have also published a working paper titled 'India's drug quality under the spotlight with FDA'. The working paper assumes significance as it has highlighted some key areas and concerns related to drug safety, regulatory mechanism in India as well as In the US and also the statement of intent signed between the American and Indian regulator during Hamburg's recent visit to India, enabling the Indian regulators to accompany US authorities during their inspections of facilities here as well as prior information about such activities.

These issues are also likely to be discussed with Congressional staff during the meeting at Capitol Hill.

Blaming Indian government for politicising FDA regulatory actions, the working paper said the government should "realise that its entire regulatory structures are a mess, and political tit for tats will do nothing to improve matters".

Referring to Drugs Controller General of India (DCGI) G N Singh's recent statement that the Indian regulator was mulling inspection of foreign facilities that supply to India, the paper said the regulator was making a "blatant political statement", as it does not have enough resources.

Raising questions over the integrity of the Indian regulatory system, the trio pointed to concerns on the intended regulatory collaboration between Indian and America. "...the FDA has to realise that it is engaging with a highly politicized organisation that does the bidding of powerful interests in the Indian pharma industry and where a culture of sensible even-handed regulation does not exist," the working paper said.

However, many in India feel the event as well as the paper is motivated with an idea to "malign the Indian generic drug manufacturing industry", which is spreading its wings worldwide and is posing a potential threat to multinational pharmaceutical companies, mainly in the US.

Of late, some of Indian manufacturing facilities of leading pharmaceutical companies such as Ranbaxy and Wockhardt have come under the FDA scanner for violating good manufacturing practices. The problems highlighted by the American regulator during its enforcements on these companies were mostly pertaining to manufacturing processes, data integrity and hygienic issues.

The event at Capitol Hill is being watched by many as it has the potential to add to troubles of Indian generic manufacturing industry, which is already struggling with a trust deficit world over following latest enforcements by FDA.

India, known as the 'pharmacy of the developing world', is one of the major low-cost generic drug suppliers to developed as well as emerging markets. With about 200 FDA factories, India is the largest exporter of generic drugs to the US, the world's largest pharmaceutical market. http://www.business-standard.com/article/companies/made-in-india-drugs-to-be-in- dock-at-capitol-hill-114022601116_1.html

Business Standard ND 27/02/2014 P-6 (Smart Investor) US sales rebound a boost for Cadila Analysts expect the company's earnings to more-than-double in FY13-FY16 UJJVAL JAUHARl The Cadila Healthcare stock has been gaining since November 2013, hitting an all-time high of Rs1,022 on Tuesday, before closing at Rs 999. The rise can be attributed to the company's improving prospects in the US business, led by a series of Food and Drug Administration (FDA) approvals for generic launches, including the one for clonidine HCI injections, an analgesic used to provide relief from severe pain.

The stock's recent performance is in contrast to the under-performance against the Sensex during the first half of 2013-14, owing to the slow rate of approvals from the US FDA and muted domestic sales growth, hit by the NLEM (New List of Essential Medicines). Cadila’s December quarter results have already started reflecting the positive impact of the new drug launches in the US, despite domestic growth remaining slow. Hitesh Mahida of KR Choksey Shares and Securities says the stock, primarily trading at a discount to its peers due to lack of new abbreviated new drug application (Anda) launches in the US, will continue to see re-rating, with niche approvals kicking in. On February 7, Nomura analysts had said the improvement in margins due to approvals and new launches implied the earnings-cut cycle had come to an end. On Monday, they raised their target price for Cadila from Rs 951 to Rs 1,103. They said the consensus FY14 earnings per share had fallen 24 per cent through the last 12 months and now, more approvals in the US would drive earnings.

The Bloomberg consensus target price of 35 analysts is Rs 1,024. Given the rally, investors with a medium-to-long-term view should consider the stock at dips, as Cadila’s prospects are improving and some events (product launch gains) are yet to be factored in. At Rs 1,009, the stock is trading at a price/earnings ratio of 22 times the FY15 estimated earnings.

US growth picking up

The company’s US sales (about 35 per cent of total) were almost flat during the period between December 2012 and June 2013, ranging at Rs 387-392 crore. However, sales have picked up since then. While the company recorded Rs 473 crore in the September 2013 quarter, US sales grew a strong 33.6 per cent sequentially to Rs 632 crore in the December 2013 quarter. The launch of the generics of migraine treatment drug Depakote ER (estimated to have contributed $25 million) was among the key contributors.

The company is expected to launch anti-depressant Cymbalta generics in this quarter and anti-hypertensive Toprol XL generics and lipid control drug Niaspan generics in the June and September quarters of FY15, respectively. What’s more, the market is looking forward to the generics launch of gastrointestinal drug Prevacid OD. Analysts at Nomura say this launch could add Rs 18 to the FY16 earnings per share, but given the uncertainty around the timing of the approval and exact extent of competition, they conservatively factor in a more sustained contribution of Rs 4.8 a share. http://www.business-standard.com/article/markets/us-sales-rebound-a-boost-for-cadila- 114022600664_1.html Financial Express ND 27/02/2014 P-2 Downgrade domestic pharma industry till India gets its act together: Ranbaxy whistleblower Jayati Chose

Dinesh Thakur, former Ranbaxy Laboratories Ltd executive who blew the whistle on manufacturing malpractices at the company, has hinted that an effective approach to enforce quality drug manufacturing and export from India would be to downgrade the domestic pharma industry and prevent it from exporting to US till regulators and companies get their act together.

In a working paper titled 'India's drug quality under the spotlight with FDA visit,' Thakur says that“if India wants its companies to export to US, then it should finance and equip its inspectors properly so as to build a cadre of talented, professional inspectors”.

He added that downgrading Indian aviation to category two by the US Federal Aviation Authority is a “good example to an effective approach to international enforcement”.

“The onus to take corrective action is wholly on the Indian authorities, and the sooner they demonstrate their competence, the sooner their carriers get to expand their operations in the US. This approach provides strong incentive to the Indian government and the industry to get its act together because the financial incentive is huge,” says Thakur.

The working paper is co-authored by Amir Attaran, law and medicine professor at Ottawa university and Roger Bate, author of 'Phake: The Deadly World of Falsified and Substandard Medicine'.Thakur, Attara and Bate are set to chair a session in Capitol Hill on Wednesday to discuss the threat of substandard and falsified medicines with a focus on India’s quality control failures.

The paper recommends that US Congress should impose severe penalties in the form of trade barriers on any country that repeatedly exports poor quality medicine to the US.

It also proposes that before FDA opens up its inspections dossiers, the Indian regulator should show how it inspects facilities today and ensure quality medicines for Indian patients.The US drug regulator (US FDA) over the past year has hauled up leading India-based firms, including Ranbaxy, Wockhardt, Strides Arcolab for failure to comply with good manufacturing practices, which impacts the quality of the finished product.

According to DG Shah, secretary-general, Indian Pharmaceutical Alliance, “The violations at a few manufacturing sites are now snowballing into harmful Indian medicines”. He added that this is an open and protracted attempt at maligning the entire generic industry of India which has helped contain the health expenditure of many governments.

During her maiden 10-day visit to India, Margaret Hamburg, commissioner of the United States Food and Drug Administration, said that Indian companies are not being targeted and are being put through routine regulatory scrutiny required to keep products safe for American consumers.US industry has also urged the Obama Administration to designate India as a Priority Foreign Country, a tag which is given to the worst offenders of patent rights. The only country on the list is Ukraine.

US-based pharma firms have also been putting pressure on India to make its patenting regime “more liberal.” India’s patent law has provisions that make it difficult to patent incremental pharmaceutical drugs that are not necessarily better than existing therapies in terms of efficacy.

The US is also sore over India not adopting a “data exclusivity” law that could prevent “unfair commercial use” of the information furnished by innovator drug companies with regulators by third parties. http://www.financialexpress.com/news/ranbaxy-laboratories-whistleblower-downgrade- pharma-industry-till-india-gets-its-act-together/1229707/0

Business Line ND 27/02/2014 Regulatory delays sending clinical trials abroad Testing of drugs on humans comes in for close scrutiny under apex court's orders PT JYOTHI DATTA Delays in permissions and regulatory clearances are resulting in companies taking clinical trials abroad, said Dilip Shanghvi, Chairman and Managing Director of Sun Pharma Advanced Research Company (SPARC), even as the company unveiled its research line-up and plans to license out some of its prospective products.

The first and second phase of clinical trials on several of SPARC's products are being done overseas, said Shanghvi’s, responding to a query on the domestic clinical trial environment.

Though companies can conduct equally good studies in India, trials were going abroad because getting permissions and regulatory clearance involved long and unjustified delays, he said. And though conducting trials overseas pushed up costs significantly, Shanghvi added, it gave companies an understanding of those markets.

SPARC is the de-merged research entity of Sun Pharma. Shanghvi's observations come even as several foreign and local companies complain of the glacial pace of getting regulatory approvals for clinical trials. Under the Supreme Court's watch after some tests went wrong, clinical trials (involving the testing of drugs on humans) have come in for close scrutiny.

Out-licensing

Speaking to analysts on SPARC's research pipeline, its top management said talks were on with partners to license out some under-research products to bring in funds for further study.

SPARC's products under research are in therapeutic areas such as ophthalmology, oncology, the respiratory system and central nervous system. Shanghvi said it would look to out-license the research product beyond the proof of concept at the pre- registration or close to market stage.

A key product in the SPARC basket, Paclitaxel Injection Concentrate for Nanodispersion (PICN), used to treat breast cancer, is scheduled for Phase III trials in the US in the third quarter of financial year 2014-15.

Shanghvi said PICN would start Phase III trials (to test for safety and efficacy) shortly, and it will be "fairly expensive".

If the company is not able to out-license some of these products, it would have to raise funds to support further research, he said, adding that it may out-license PICN, too.

The product has received patent protection in the US up to 2028. http://www.thehindubusinessline.com/companies/regulatory-delays-sending-clinical- trials-abroad/article5729995.ece

Indian Express ND 27/02/2014 (Express Newsline) P-1 CITY ANCHOR A 35-YEAR-OLD GREEK, CARRYING LSD WORTH Rs 15 LAKH, WAS ARRESTED RECENTLY USING DATABASE INPUT Database on LSD users helps police nab drug supplier ANANYA BHARDWAJ

A FOUR-MONTH effort on the part of the Crime Branch of the Delhi Police to keep track of habitual LSD users in the capital has resulted in a database on drug consumers.

The database, which was created by tracking the call detail records of known users and other intelligence inputs, has over 500 names on it. All consumers on the list are either university students or call centre employees. Police said the database will be helpful in tracking and identifying suppliers of drugs in the capital and elsewhere in the country.

The data was recently used to arrest a 35-year-old Greek who was carrying LSD worth Rs 15 lakh the first seizure of the drug in the capital in the last eight years.

"We identified habitual consumers through our intelligence, then put their phone numbers on surveillance. We then accessed their call detail records. We isolated patterns in their CDRs and identified the numbers they were frequently in touch with. Those numbers were then put on surveillance and most of them were found to belong to drug suppliers. This is how we identified the Greek drug supplier and arrested him," a police officer said.

Apart from the LSD, police also recovered passes to a rave party scheduled to be held in Kasol in Himachal Pradesh from the Greek, police said.

Police said they started thinking about developing a database to track drug suppliers after the death of 20-year-old NRI Anmol Sarna last year.

Sarna had died in Southeast Delhi's Kalkaji area in September last year hours after taking part hi party in which LSD was reportedly consumed, police said.

'After Sarna's death, we started concentrating on the LSD racket in the capital. We found that LSD was being widely used as a party drug in metropolitan cities," the officer said.

Sources revealed that the database has also helped them identify the route through which the drug reaches Delhi. http://indianexpress.com/article/cities/delhi/database-on-lsd-users-helps-police-nab- drug-supplier/

Times of India ND 27/02/2014 p-15 Cheaper drug-eluting stents save 100 lives Maha's Poor Gain after Price Halved To Rs 25k A Fortnight Ago Prafulla Marpakwar

The public health department's crucial decision to negotiate with leading firms to halve the price of drug-eluting stents has helped well over 100 poor patients in just a fortnight. The cheaper stents were launched on February 5.

Public health minister Suresh Shetty had taken a lead in launching the Rajiv Gandhi health scheme for below poverty line individuals on August 16, 2012. A few months after the project was made operational, Shetty found that they had not benefitted in real terms due to the prohibitive cost of such stents.

The scheme had a provision for Rs 18,000 to Rs 20,000 for angioplasty Quality stents were not available for Rs 20,000 though, as their prices ranged from Rs 45,000 to Rs 50,000. "Cardiologists brought to Shetty's notice that only bare metal stents were available for Rs 20,000. They added that considering advances in technology, the metal stent had become almost obsolete and immediate steps needed to be taken either to enhance the cost of treatment or reduce the cost of the stents," a senior bureaucrat told TOI.

Shetty swung into action immediately and held a series of meetings with leading cardiologists and bureaucrats of the public health and medical education department. Then it was proposed that if the government floats a tender for the purpose and signs a rate contract with a section of firms, then it will be beneficial for the poor people.

Accordingly ,a tender was floated where quite a large number of firms involved in the manufacture and supply of drug-eluting stents participated. http://timesofindia.indiatimes.com/city/mumbai/Cheaper-drug-eluting-stents-save-100- lives/articleshow/31071648.cms