DGCI, G N Singh is in talks with international agencies like USDFA, PMDA and European agencies to overlook how they control online sale of medicine, writes Arshad KhanThe Drugs Controller General of India (DGCI) will be formulating a new regulatory framework for online sales of medicines to bring the controversial e-pharmacy under its sphere and ensure safety of consumers. "The role, responsibilities and liabilities of e-commerce marketplace and the product sellers need to be clearly defined. It becomes even more critical to have a framework in place when the intermediary is selling drugs where the safety and health of the consumer is of paramount importance," said DCGI, G N Singh. Speaking at the Ficci’s consultative meeting on 'Pharma Guidelines for Reinforcing Due Diligence for Intermediaries’ Singh said the industry needs a new regulatory framework to effectively bring e-pharmacy under its ambit since The Drugs and Cosmetics Act does not have any guidelines for e-commerce players in pharmaceuticals sector. Drugs Controller General (India) appointed Ficci as the nodal agency for consolidating the guidelines and for seeking views from All India Chemists and Druggists Association, States Chemists and Druggists Associations, OPPI (Organisation of Pharmaceutical Producer of India), Indian Medical Association, CIPI, BDMA, PHD Chamber of Commerce and Industry and consumer forums. Singh said that he is in talk with international agencies like USDFA, PMDA and European agencies to overlook how they control online sale of medicine. It is important for us to over from conventional to modern system of governance which a place for e-pharmacy. Hence, it is essential to create guidelines for e-pharmacy that checks the use of technology as safety of patient, quality of drugs and robust supply chain. To resolve these issues complaints being filed against e-commerce players for online sale of prescription based drugs, Singh suggested that it would be beneficial for the regulator to engage with stakeholders in constructive brainstorming deliberations to reach a consensus. Singh assured that the interest of small retailers will be protected and it would be ensured that e-pharmacy does not disturb the existing supply chain system in place. The aim would be to integrate e-pharmacy in the existing system On the issue of complaints filed against e-commerce players for online sale of prescription drugs, Singh suggested that it be beneficial for the regulator to engage with the stakeholders in constructive to reach a final conclusion He added that the government was forthcoming in adopting industry's recommendations and the Drugs Controller General would assist in providing a legal status to implementable suggestions of industry. He also assured that the interest of small retailers will be protected and it would be ensured that e-pharmacy does not disturb the existing supply chain system in place. Backgroud In April, Maharashtra's Food and Drugs Administration (FDA) conducted raid on the premises of Snapdeal.Com for allegedly selling medicines, including prescription drugs. Post this incident, several state FDAs have cracked down on such e-retailers that were selling prescription drugs in their jurisdiction. For example, the Gujarat Food and Drug Control Administration(FDCA) had cracked down on a Surat-based firm Prowisor Pharma, an online pharmacy last month. More recently, Indian Pharmacist Association (IPA) wrote to the Drugs Controller General of India (DCGI) for not allowing online pharmacies in India. All India Organisation of Chemists and Druggists (AIOCD) too urged the government to put a ban on the same.
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The Supreme Court has barred Glenmark Pharmaceuticals from making and selling copies of US drugmaker Merck's diabetes drugs Januvia and Janumet, according to a court document released on Friday. The court has, however, allowed Glenmark to continue to sell existing inventory, according to the document posted on the Supreme Court's website after a hearing.The decision against Glenmark comes two years after Switzerland's Novartis AG was denied patent protection for its cancer treatment Glivec in a landmark decision by India's Supreme Court that was widely seen as boosting the local generic drugs industry. Anti-diabetes drugs are the top-selling therapy area in India, where about 65 million people live with the disease and that number is expected to reach 100 million by 2030. Merck sued Glenmark in 2013 for infringing a patent it has on sitagliptin, the chemical compound in Januvia and Janumet, both of which the company has been selling in India since 2008. A month's dose of Merck's drugs costs about Rs 1,300 Indian and Rs 1,900 ($30), respectively. Merck has licensed the drugs to Sun Pharmaceutical Industries Ltd for sale in India. Glenmark sells the medicines under the brand names Zita and Zita-met at a nearly 30 per cent discount to Merck's price. Glenmark is barred from producing sitagliptin until the next hearing on the case, the order said. Spokespersons for Glenmark and Merck declined to comment. "This is an interim sort of measure taken by the court, and the decision on the patent of sitagliptin is subject to final orders," said Ameet Hariani, managing partner at Mumbai-based law firm Hariani & Co. (Reuters)
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Generic drugmaker Ranbaxy Laboratories Ltd has been sued in a district court in the United States for allegedly manipulating U.S. Food and Drug Administration rules for years to keep rival generic drugs out of the market. Ranbaxy filed "grossly inadequate" applications seeking approval for its drugs and deceived the FDA into granting approvals and giving the company market exclusivity, the class action lawsuit asserts. It was filed by U.S. retailer Meijer Inc on Tuesday in the U.S. District Court in Massachusetts. The suit also names India's largest drugmaker Sun Pharmaceutical Industries Ltd, which completed a $3.2 billion deal to buy Ranbaxy in March and is now helping Ranbaxy fix its manufacturing problems. A Sun Pharma spokesman declined to comment. Ranbaxy did not immediately respond to a request for comment outside of regular business hours. Ranbaxy repeatedly made misstatements to the FDA about the compliance status of its manufacturing plants, the lawsuit says. The FDA has banned import of drugs from all of Ranbaxy's India-based plants under a wider scrutiny of the country's $15 billion pharmaceutical industry, which is the largest supplier of generic medicines to the United States. In 2013, Ranbaxy pleaded guilty to felony charges related to drug safety and agreed to civil and criminal fines of $500 million in a settlement with the United States to resolve claims that it sold substandard drugs and made false statements to the FDA about manufacturing practices at its plants. The lawsuit says customers overpaid for Roche's antiviral Valcyte and Novartis's hypertension drug Diovan because the release of generic versions of both drugs was delayed due to Ranbaxy having wrongfully gained market exclusivity. Drugmakers that are first to file with the FDA to make a generic version of a brand name drug are entitled to a six-month market exclusivity, a huge revenue-generating opportunity that many companies like Ranbaxy compete for. The FDA in November last year stripped Ranbaxy of a tentative approval and six-month exclusivity it gave the company in 2008 for launching a Valcyte generic. Meijer has sought damages and monetary relief on behalf of all direct purchasers of drugs for which the release of cheaper copies was delayed due to market exclusivity secured by Ranbaxy, according to the lawsuit.
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Talks between the European Free Trade Association and India over a free trade pact are stuck due to intellectual property rights issues but the Swiss government is hopeful that discussions could soon resume. Switzerland's economic affairs department said that free trade negotiations between the EFTA states - Iceland, Liechtenstein, Norway and Switzerland - and India are stuck due to intellectual property rights issues. "The negotiations on certain issues like tariffs and non-tariff measures were promising. Unfortunately, concerning other important issues like intellectual property and data security the positions diverge widely," Isabel Herkommer, spokesperson for State Secretariat for Economic Affairs (SECO) told PTI. "We hope to resume negotiations as soon as possible. We still have a very good relationship with our Indian partners," she said. The free trade negotiations that were launched between the EFTA and India in 2008 for trade in goods, services and investments have been stalled primarily due to strong objections from the Swiss pharmaceutical industries. The talks came to a halt 18 months ago due to elections in India. The SECO chief Marie-Gabrielle Ineichen-Fleisch told a Swiss daily that chances of a free trade accord being signed between India and Switzerland were "low" because it is not just about patents, but also to brand protection. "The main outstanding issues remain intellectual property protection and data security," Ineichen-Fleisch said. She said India had provided very good terms for the Swiss machine industry but if the deal is to go through, a satisfactory solution will have to be found for all industries. The Swiss economics minister Johann Schneider-Ammann is expected to visit India in mid-May. The total Indo-Swiss trade went down by 36.5 per cent last year, though India's exports to Switzerland increased while the imports, which primarily includes pharmaceuticals, machinery, transport equipments, chemical products and watches, decreased. The balance of payments, however, is still heavily skewed in favour of Switzerland. According to the Ministry of Commerce data, India's exports to Switzerland was $1.8 billion in 2013-14 and imports were $19.3 billion for the same period. Many multinationals, especially pharmaceutical companies in the US and the Switzerland, have been lobbying against India's "weak IP regime", especially over a provision for compulsory licensing to meet public health requirements and absence of a period of exclusive marketing rights when a new drug gets regulatory approval in the Indian patent laws. The Swiss pharmaceutical giant Novartis lost a case in April 2013 in India's Supreme Court which denied a patent to the multinational for its cancer drug Glivec. Developing countries like India have the support of the World Health Organisation that encourages member states to make use of the flexibilities in the WTO-administered Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities in view of maintaining public health. India's IPR policy affects billions of people globally as it is the largest supplier of low-cost generic medicines.
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Mexico has approved bio-pharmaceutical major Biocon's insulin Glargine. Mexican health authority COFEPRIS,, through its partner PiSA Farmaceutica (PiSA), approved the insulin, it was announced on Friday (10 April). Mexico has been a very important market for Biocon since 2006, where it has been playing a significant role in enabling access to affordable rh-Insulin. Insulin Glargine will augment the affordable insulins therapy for diabetes management. ‘GALACTUS’ by PiSA is the first Insulin Glargine to be approved in Mexico as per the biocomparable approvals pathway defined in 2012. Biocon is as Asia’s largest insulins producer and has been committed to affordable diabetes management through rh-Insulin (Insugen ®) and Insulin Glargine (Basalog ®) in India and several emerging markets. The company currently has marketing approvals in over 60 countries for rh-Insulin and in over 20 countries for Insulin Glargine. Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said: “We are committed to make global impact with our affordable insulins therapy. Our Insulin Glargine, will now enable access to a basal insulin which will further expand the diabetes management therapy for patients in Mexico.” Diabetes is a major health risk in Mexico, over 70 per cent of the Mexican population is overweight thus prone to developing diabetes. With over 9 million cases of diabetes, it poses a huge disease burden for the government with per capita expenditure on diabetes being as high as $892.5. Biocon’s presence in Mexico, over the last eight years, has expanded the insulins market substantially by initiating many more patients onto insulin therapy. The increasing affordability of Insulin Glargine will now enable Biocon and PiSA to expand this reach further. The combined market for Insulin Glargine in Mexico is estimated to be in excess of $40 million.
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India's universal health plan that aims to offer guaranteed benefits to a sixth of the world's population will cost an estimated 1.6 trillion rupees ($26 billion) over the next four years, a senior health ministry official said.Under the National Health Assurance Mission, Prime Minister Narendra Modi's government would provide all citizens with free drugs and diagnostic treatment, as well as insurance cover to treat serious ailments.The proposed plan would be rolled out in phases from April 2015 and will cover the entire population by March 2019, C.K. Mishra, an additional secretary at the health ministry, told Reuters. When the entire population is covered, it would cost an estimated $11.4 billion annually."If you want to deliver the service, that is what it will take," Mishra said, disclosing for the first time an expert group's cost estimates that will be considered by the finance ministry for inclusion in the government's spending plans.Healthcare experts caution that it could take decades before India's 1.2 billion people are adequately covered and that the costs of provision could face significant upward pressure.If approved, India would need to drastically raise its healthcare spending. In the current financial year, the federal budget allocated about $5 billion to healthcare."We are not in a position to implement it across the regions, states (right now). It's impossible. So we are choosing number of districts each year," said Mishra.Despite rapid economic growth in the last 20 years, the Indian government spends only about 1 percent of gross domestic product on healthcare. That compares to 3 per cent in China and 8.3 percent in the United States.More newborns die in India than in poorer neighbours such as Bangladesh, and preventable illnesses such as diarrhoea kill more than a million children every year.Government hospitals are overcrowded and lack resources to meet the growing demand, while access to basic health services in rural areas and smaller towns remains poor."I can say that you are covered, but your closest facilities are 100 kilometres away. You are limited by that fact," said Rana Mehta, leader of healthcare at consultants PwC India."To build infrastructure and then provide care over a period of time would obviously take decades."A 2012 study by Indian business lobby FICCI and consultants EY estimated that universal health cover in India was feasible in a decade and would require government health spending to rise to 3.7-4.5 percent of GDP.PLAN STRUCTUREThe new plan will focus on improving preventive healthcare services by ensuring adequate availability of medical practitioners in rural areas, while new infrastructure will be created under existing welfare programmes, Mishra said.Tertiary care services would be provided through an insurance-based model and the government will offer more than 50 drugs free to all its citizens.Along with the drugs, about 12-15 diagnostic treatments will be offered in the package.Mishra said states will be encouraged to enter into outsourcing agreements for the provision of treatment.In recent years, thousands of small private hospitals and test centres have flourished, betting on high demand created by lack of adequate public facilities. Such providers opened 80 percent of India's new hospital beds during 2002-2012, according to a PwC-NatHealth report.While private players will be involved in the ambitious programme, the government will need to ensure speedy payments for the partnership to work, said Harish Pillai, chief operating officer at private healthcare group Indus Health."Private providers can definitely help and execute it better, but the government should not only see us as commercially-driven entities," said Pillai.The World Bank and Britain's health cost-effectiveness agency NICE are also assisting India, providing technical assistance and advice on treatments the government should offer in the package, the bank said last week. (1 US dollar = 61.4200 Indian rupee) (Reuters)
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Ever wondered why Gilead Sciences, the US pharmaceutical company, chose seven India-based drugmakers last month to sign non–exclusive licensing agreements to produce low cost versions of its new hepatitis C drug sofosbuvir?The obvious reason could be that Gilead, as part of its humanitarian programme, desires to make “its chronic hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible” and Indian companies - Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab - with their large-volume generic manufacturing and distribution capabilities -- are the preferred choice. Gilead has allowed its Indian partners to sell the medicine in India and 90 other developing countries, which together account for more than 100 million people living with hepatitis C, or 54 per cent of the total infected population globally. India, the world’s third largest producer of generic drugs by volume, and the base for the largest number of US drug regulator (FDA) approved drug manufacturing facilities outside the US, certainly has the capacity to take up such a challenge. It has proven this on an earlier occasions, by selling AIDS medicines in large volumes at a fraction of innovator’s price, to the entire developing world. It could thus be argued that India is best fit for taking up the Gilead assignment.That is not the only reason, though.In addition to humanitarian considerations, Gilead has commercial reasons as well for choosing Indian generic companies over others for the specific licensing agreement.By making the generic players its partners (for a royalty, of course!) for some countries, Gilead has made them accept the intellectual property rights (IPRs) it holds over the drug in all jurisdictions. Even in countries such as India, where the patent status of sofosbuvir remains undecided (Gilead’s claim is being examined by the Indian Patent Office), the agreement helps avoid potential patent challengers. Thus, in addition to the goodwill generated by agreeing to share its patented technology to produce low cost medicines for markets that cannot afford its high cost drug, Gilead will now gain exclusive marketing opportunities in the developed world and thereby maintain its potential windfall revenue generation opportunities. India, Not Indian CompaniesIndia is different from most of the countries with similar or better drug manufacturing capabilities because of its unique IPR law. And that’s again the reason for Gilead’s attraction towards companies based in India.India’s patent law limits the patentability criteria to real innovation. Hence, all patent claims that are found to be on incremental innovations get rejected.Even in the case Gilead, there are pre-grant patent oppositions filed against sofosbuvir in India. The agreement with generic drug makers will help Gilead limit the generic threat in the eventuality of an adverse ruling. Though, most foreign global multinationals do not consider partnerships as their first option, and are trying to pressurize India to change its patent laws to better suit their interests.Modi VisitGiven the high decibel opposition against India’s patent regime from the US companies, Narendra Modi government has been indicating the possibility of a review of India’s IPR rules. With Modi planning his first US visit next week, the move has gained strength now.The development of Indian generic industry was itself driven by an earlier IPR policy of the Indian government. The Patents Act 1970 had limited patent protection to process innovations and hence allowed companies to develop generic products through processes different than that of the innovator company. The entire production capability of Indian pharmaceutical industry was developed during the three decades that followed. The 2005 amendment to the Patent Act brought product patent protection back to the country, though with certain public interest safeguards, which is allowed under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO). A day after the announcement of the partnership agreement, on September 16th , the Gilead team had visited Nirmala Sitharaman, the Minister of State (Independent Charge) for Commerce and Industry to share the details of the partnership. They informed the minister that no price limitations have been fixed in the licensing deal in order to ensure adequate competition amongst the licensees resulting in competitive prices for the patients. Welcoming the development, as it expands the access of drugs, Sitharaman pointed out that the “pharmaceutical industry has a very pronounced human aspect and such a sector cannot be governed by the commercial considerations alone”. The minister also said that India appreciates the value of innovation and partnerships to improve access of medicines through transparent, non restrictive voluntary licensing and hopes that it will help in technology transfer in front-end technologies in healthcare. As Prime Minister Narendra Modi visits US next week, the significance of India’s current IPR policy will be tested against its ability to remain a credible source of low cost, high quality medicines to the entire world and to help shape Gilead like partnerships. Joe@businessworld.injoecmathew@gmail.com@joecmathew
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Preventive healthcare, including national awareness programmes promoting healthy lifestyle will get more focus under the Modi government, according to Dr Harsh Vardhan, Union Health Minister. “The priority would be to emphasise prevention over cure in India’s National Health Policy”, the minister points out. Speaking to the media after taking charge on Tuesday (27 May) afternoon, Dr Vardhan said the government would address the growing menace of lifestyle diseases such as diabetes, heart diseases, occupational diseases and ailments through preventive care programmes. “The problem of over consumption of fast foods, trans-fat food etc is assuming menacing proportion among the young. This must be checked through medical as well as multi-media offensives”, the minister says. The ministry is planning to evolve an action plan and consult the state governments on how they could contribute to a campaign to promote safe, nutritious and locally available foods. Promoting yoga and physical exercises is also there on Dr Vardhan’s agenda. The minister also stressed the need for a national health insurance policy to bring every citizen under the health cover. “In health insurance, we have lots to learn from micro-health insurance instruments developed by NGOs, self help groups and small private entities. The Rashtriya Swastha Bima Yojna is working fine in some states, but is limited to BPL families. I plan to rope in all economic groups and make the health ministry some kind of regulatory body for oversight on the existing micro-health insurance programmes”, the minister said. In the coming weeks, Dr Vardhan has planned a series of meetings with bureaucrats within his ministry to work on his agenda. “Expect good, clean hospitals and zero corruption”, Dr Vardhan says. A senior health ministry official said that the previous government had also worked out plans for national wide preventive health programmes. “It’s all planned. What we did not have was sufficient funds to roll out the programmes. No money was sanctioned for several programme for the last one year. If funds are made available, the implementation can begin now”, he pointed out, adding that the programmes could be tweaked keeping in mind the ideas the new minister might have. Dr Vardhan has been a founding leader and the national convenor of the doctors’ cell of BJP.
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On May 16th, when the general election results indicated a landslide victory for Narendra Modi led BJP, Sensex, the bellwether index of Bombay Stock Exchange, rose to a record high. But, not all shares gained. The share prices of all major public listed pharmaceutical companies, considered to be the most defensive of all stocks, fell. The reason why pharma stocks did not follow the market sentiment – which cheered Modi’s ascent towards Prime ministership – was simple. The stock market rally was caused by the dollar denominated investments made by the foreign institutional investors (FIIs), and the surge of dollar had resulted in rupee appreciation against dollar. As Reserve Bank of India (RBI) data indicates, conversion rate of one US dollar on May 16, 2014 was Rs 58.86, lowest since June 19, 2013, when the rate was Rs 58.75 a dollar. Read Also: Can Modi Revive SEZs?Read Also: Will Modi Dismantle Coal India?More than anyone else pharmaceutical industry, which earns approximately $12 billion as sales revenues from the US market, had reasons to worry. Appreciation of rupee against dollar meant less revenue in rupee terms. “It can affect 2–3 per cent of their sales revenues and 5–6 per cent of their profits”, says Ranjit Kapadia, Vice President-Institutional Research at HDFC Securities. In the days that followed, pharma stocks showed slight improvement, so did the exchange value of rupee against dollar. The euphoria that is associated with the electoral success of BJP is creating problems for not just the pharmaceutical industry. Modi himself will find his government fending against the rupee appreciation if the continued flow of short term dollar denominated investments into the stock market pushes down the value of dollar further. It can affect the export competitiveness, and earnings of a host of industries both in the manufacturing as well as services sectors. It is not the industry alone that will suffer. Apex banker Reserve Bank of India (RBI) will have a tough time managing the value of rupee vis-a-vis dollar as the more dollars it buy to maintain the value of rupee, the more rupees it will be pumping into the system, thereby pushing up domestic inflation, the biggest worry of the common citizen. Modi’s ascent and resultant dollar inflow has already started showing its impact in the RBI’s foreign currency purchase pattern too. According to the latest data available, the RBI’s foreign exchange reserves started swelling because of such market interventions well before election results came in. Ever since the talks of a Modi wave started, the dollar inflow and RBI’s dollar purchase had been on the rise. As on May 9, the foreign exchange reserves with RBI was $313.83 billion, highest ever since it started decreasing from $314.34 billion on November 11, 2011, RBI data indicates. The reserve, a week before, on May 2, 2014 was $311.86 billion. With reports suggesting that the Sensex could rise to 30,000 points from the current 24,298 points (as on 21 May, 2014) by the year end, it’s going to be an anxious wait for the exporters, the consumers, RBI and the Modi government to see what the dollar movement has in store for each of them in the coming months.joe@businessworld.in, joecmathew@gmail.com,twitter@joecmathew
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Multinational drug companies may not have grown in the country like some of the domestic drug companies like Cipla, Lupin or Sun Pharma have managed to do, but the top selling drugs in India still belong to the MNCs.GlaxoSmithKline's Augmentin, an antibiotic used to treat bacterial infections is the largest selling drug in the country with sales of Rs 294.2 crore for the 12 months ended May 2013, data from IMS Health says.The second and third largest selling drugs in the country are Pfizer's Corex and Abbott's Phensedyl — both cough and cold preparations — with sales of Rs 286.2 crore and Rs 282.6 crore respectively. The fourth largest selling drug also belongs to a multinational company — Novartis India's Voveran (RS 263 crore) which is used as an analgesic to treat pain and inflammatory disorders. Novo Nordisk's insulin brand Human Mixtard is the fifth largest selling drug with sales of Rs 261.1 crore for the same period. The next two spots are occupied by drugs produced by two domestic companies — Aristo Pharmaceuticals' Monocef which is used to cure typhoid and Bangalore-based Ayurveda company Himalaya's Liv-52, which claims to protect the liver against various hepato-toxins. Liv-52 is also the fastest growing among the top ten brands for the 12-month period, with 29.9 percent in terms of value growth. IMS Health tracks the sales of pharmaceutical drugs in the country sold through the stockists and distributors.For the period MAT (Moving Annual Total) May 2013, IMS Health reports the pharmaceutical market has grown to Rs 74,117 crore, with a growth of 10 per cent, over the same period last year.Abbott, which acquired Piramal Healthcare's formulation business, is the largest drug company operating in India with sales of Rs 5,172 crore and a market share of 7 per Abbott is well ahead of Cipla, with sales of Rs 3,623 crore (market share of 4.9 per cent) and Sun Pharma with sales of Rs 3,277 crore (market share of 4.4 per cent). Glaxosmithkline and Ranbaxy (4.1 per cent each) share the next two slots in terms of market share and sales. Daiichi Sankyo owned Ranbaxy Laboratories was the largest drug company in terms of sales and market share for many years till its sell-off in 2008. email: pb(dot)jayakumar(at)abp(dot)inemail: pbjayan(at)gmail(dot)comtwitter: (at)pbjayakumar
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