By Aarti Kelkar-Khambete | IndiaSpend As the current dengue epidemic in Delhi and other urban areas of India such as Mumbai, Pune and Bangalore indicates, a once-obscure disease of poor neighbourhoods has become a great leveller, affecting and scaring both rich and poor and laying bare the infirmities of public healthcare. The Comptroller & Auditor General (CAG), the central government’s auditor, has ordered an audit of Delhi’s handling of the epidemic as it prepares to analyse the preparedness in other states hit by dengue.Health experts contend that very little has been learnt despite annual dengue epidemics striking with almost clockwork precision. The world’s fastest-spreading tropical disease struck Bollywood actress Kareena Kapoor Khan earlier this year, one of the high-profile patients of the mosquito-borne virus that resides in the Aedes aegypti mosquito. The mosquito has invaded Mumbai’s toniest areas, Malabar Hills and Juhu. Many public figures, such as actors Juhi Chawla, Anil Kapoor and Jeetendra, were issued notices after mosquito breeding sites were found in their homes and gardens. Dengue is not new to India, but there has been a sharp rise in dengue cases over the past two decades, with a 50% increase over 2014, the rich being hit as hard as the poor and rural areas increasingly being affected. Striking rich and poor, dengue ravages India more than any other country “Now you can find dengue-causing mosquitoes even in posh buildings, but people there do not allow (municipal corporation) workers to come and spray inside,” said Shantabai (she uses only one name), a domestic worker in Pune. Poor research, late prevention, flawed implementation, a shortage of specialists and limited community involvement hinders India’s dengue-control programme. Recognising the gravity of the situation, the World Health Organisation included dengue in its list of important vector-borne diseases that need to be controlled on a priority basis in 2014. (1) Of an estimated 96 million cases globally every year, 70% occur in Asia, with India alone contributing about a third, 34%, of all cases. (1) India had 33 million apparent dengue cases and 100 million asymptomatic infections every year, more than any other country, reported a recent Oxford University study. (2) A comparison of year-wise data related to dengue and malaria in India shows that malarial deaths have been decreasing while the number of deaths due to dengue has gone the other way with a small dip in deaths in 2013. (8) State-wise dengue reporting shows that cases have doubled this year over last. The most affected states (with dengue cases above 1,500), according to National Vector Borne Disease Control Programme (NVBDCP), include Delhi (the highest number of dengue cases recorded), followed by Karnataka, Kerala, Tamil Nadu, Andhra Pradesh, Gujarat, Maharashtra, Punjab and Arunachal Pradesh. Although studies have shown a high occurrence of dengue in the Indian subcontinent, only a fraction of clinically apparent cases is diagnosed and reported; the true burden of the disease remains uncertain. (3) Very few studies have attempted to measure the extent of transmission through the population. (4) What’s changed over the past two decades Both urban and rural areas exposed: Dengue has spread from urban areas to rural. (5) The disease has recently spread to hilly regions, such as the Nilgiris and Cardamom Hills, and larger and more frequent outbreaks have been reported Higher and middle-income groups in urban areas affected: Recent examples from cities such as Pune show that the infection trend has changed and is now expanding into higher- and middle-income groups. (6) Not just hot and humid climates impacted: Once limited to tropical areas, dengue outbreaks have also been reported from areas with sub-tropical and desert conditions, as two recent studies reported. (1) Rapid unplanned development and urbanisation are triggers: Although unseasonal rains have been found to trigger the epidemic, other reasons include rapid, unplanned development and urbanisation, increase in construction sites, where the Aedes mosquito breeds, inefficient garbage management and the use of plastic bags and containers. Some call it a “runaway epidemic“. (1) Ignorance worsens the situation: Storage of water because of irregular supply has also found to help the Aedes mosquito breed. (7) In cities, residents of high-rise buildings and posh apartments prevent health workers from visiting their flats for preventive fogging, triggering an increase in mosquitoes. (6) New strains of the dengue virus: The situation has worsened this year. Although four dengue serotypes were found to be circulating together in Delhi, scientists suspect a new strain may have emerged. This year has seen a predominance of the more dangerous type 2 and type 4 serotypes. A tottering healthcare system: As the worst-hit city this year, Delhi’s health services have been strained. The virus has been difficult to control: In addition to the rapid spread of mosquitoes, the virus is believed to have mutated, becoming more resistant to medical treatment. Genetic changes in the virus have possibly helped it become hardier and more infectious. These factors have presented new challenges in the control of the virus and the vector, the Aedes aegypti (1) Are vaccines the answer? Science is finding that vaccines are not practical due to the complicated nature of the epidemic. (1) Blocking the channel of transmission by improved prevention measures against the Aedes mosquito and better community awareness measures is a more sensible option. (1) India could learn from other countries, such as Singapore, Thailand and Indonesia that have successfully kept dengue at bay.
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C H UnnikrishnanCipla, one of India's top generic drug makers, and the country's largest vaccine exporter Serum Institute of India has signed a marketing and distribution partnership for South African market. With this, Cipla's South African subsidiary Cipla Medpro will partner with the vaccine maker for not only enable affordable and accessible vaccines for South Africans, but will also facilitate a reliable supply stream to the South African Government. “This agreement will enable Cipla Medpro to become a significant player in the market," said Paul Miller, chief executive officer of Cipla Medpro. With a presence in 140 countries and 1.3 billion doses manufactured and sold, SII is an ideal ally for Cipla Medpro and this partnership will be instrumental in addressing the national vaccine shortage, he added. Serum Institute currently manufactures a variety of vaccine classes including vaccines for Polio, Diphtheria, Tetanus, BCG (Tuberculosis), Hepatitis B, Measles, Mumps and Rubella. South Africa will be participating in the majority of these vaccine programmes. According to Michel Baijot, head of vaccines at Cipla, this partnership reflects again the complementarities of our two like-minded companies in bringing high quality, affordable vaccines to more countries. The partnership agreement also stipulates that Cipla Medpro will become the holder of all Medical Control Council (MCC) regulatory approvals such as product registrations and marketing authorisations. Cipla Medpro has exclusivity and first right of refusal of the SII pipeline within South Africa. On the agreement, Serunm Institutue chief executive Adar Poonawalla, said; “Serum Institute is looking to extend the strong partnership that it has with Cipla in Europe and India by working with Cipla Medpro in South Africa.”
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By Haider Ali Khan The Union Cabinet has cleared proposals to set up three new All India Institutes of Medical Sciences (AllMS) at Nagpur in Maharashtra, Manglagiri in Andhra Pradesh and Kalyani in West Bengal under the Pradhan Mantri Swasthya Suraksha Yojna (PMSSY) at a cost of Rs 4,949 crore. “The new AIIMS will be established as institutes of national importance for providing quality medical education, nursing education and also to provide tertiary healthcare facilities to the people of these locations. The proposed institution shall have a hospital with capacity of 960 beds. In addition, there shall be a teaching block, administrative block, AYUSH block, auditorium, nursing college, night shelter, hostel and residential facilities,” Power Minister Piyush Goyal said. Of the total expenditure of Rs 4,949 crore, the cost of the new AIIMS at Manglagiri would be to the tune of Rs 1,618 crore, at Nagpur Rs 1,577 crore and at Kalyani Rs 1,754 crore. Setting up of these AIIMS will address regional imbalances in availability of affordable and reliable tertiary health care services in these regions. It will augment the facilities of quality medical education and would also address the shortfall of health care professionals in these regions. The large populations of Andhra Pradesh, Maharashtra and West Bengal along with adjoining States and region will be beneficiary of this project. Six new AIIMS under the PMSSY have been made functional so far and also construction of AIIMS at Rae Barely is under progress. However, there has been no announcement about the proposed AIIMS in Jammu and Kashmir about which Omar Abdullah showed his displeasure in a tweet.
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US companies and trade bodies have been brutally critical of India’s comparatively tight intellectual property right law and the judiciary rulings, points out C H Unnikrishnan Delhi High Court’s Wednesday (7 October) order asking Indian generic drug maker Glenmark Pharmaceuticals to stop manufacturing and sales of anti-diabetes drug sitagliptin is a classic testimony of India’s balanced judiciary on intellectual property rights (IPR) and yet another case in hand for India to defend its strong stand against the contentious “anti-IPR nation” campaign promoted by some of its foreign counterparts including US. The IPR infringement case, filed by US drug multinational Merck Sharp and Dohme Corporation or Merck and Co., against Glenmark after the latter launched generic versions of this anti-diabetic drug, was pending with the court since 2013. In the interim, a division bench of the court had also issued a similar order restraining Glenmark from selling its generic versions. C H UnnikrishnanSitagliptin, a comparatively new drug molecule to treat type-2 diabetes invented and patented by Merck, has been granted patent protection in India since 2007. Merck’s local subsidiary MSD Pharmaceuticals has been selling two formulation brands--Januvia and Janumet-- of this drug in the local market. While the brand Januvia is a formulation of sitagliptin alone, Janumet is a combination of sitagliptin and another age-old anti-diabetes drug metformin. Glenmark had launched similar versions using a salt of sitagliptin—sitagliptin phosphate monohydrate and metformin in India with a price tag that is slightly lower than MSD Pharma’s Rs 43 a tablet. Although the Indian company argued that its drug is different from the original molecule, the court has now ruled that Glenmark’s generic version is infringing Merck’s main patent on sitagliptin as it covers all its derivatives and salts too. The court has also observed that the Merck’s drug, which was launched in India at a much lower price as compared to it prices abroad, also doesn't have an issue on accessibility to Indian patients. This ruling, in a way, also supports India’s IPR law that doesn’t allow patent protection for derivatives and any other forms of a previously known molecule, which doesn’t qualify for a patent in India due to various reasons including the 1995 prior art criteria among others. The court’s order has also stressed the point that that Merck’s patent application faced no opposition in India despite multiple options such as pre-grant and post grant oppositions allowed by Indian patent law. India’s comparatively tight intellectual property right law and the judiciary rulings have been subject to brutal criticism by several economically developed countries, especially from the US companies and trade bodies, for reasons such as not recognising incremental innovations, multiple options for oppositions and for allegedly favouring local industry. There have been also severe pressure on India by the US administration through trade and diplomatic routes to ‘comply’ with international practices, which by and large recognises incremental claims for market exclusivity for products including essential drugs. The court ruling in this case to restrain the local company by a decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in sitagliptin phosphate monohydrate or any other salt of sitagliptin in any form, alone or in combination with one or more other drugs thereby infringing the suit patent no. 209816 of Merck, thereby clearly shows India by no chance suffer a patent bias and government of India should now display this case ostentatiously to its foreign counterparts who have been attacking the country’s IPR law with baseless charges.
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In a blow to Indian drug firm Glenmark Pharmaceuticals, the Delhi High Court restrained it from making, selling, advertising, distributing or exporting its anti-diabetes drugs Zita and Zita-Met on the ground that it violated the patent of US pharma major Merck Sharp and Dohme (MSD).Justice A.K. Pathak, while permanently injuncting Glenmark from making and selling the two drugs, also said there was no public interest in the matter as there were other chemical compounds, other than the one invented by MSD, which were used in anti-diabetes drugs."Arguments of the defendant (Glenmark) about public interest does not have much force in the facts and circumstances of the present case," the court said."Sitagliptin (invented by MSD) is not the only DPP-IV inhibitor (oral anti-diabetes drug) for treatment of type II diabetes in the market and there are several other DPP-IV inhibitors, including the one manufactured and marketed by the defendant, that is, Teneligliptin," it said.The court also said that merely because Glenmark was selling its drugs at a rate lower than that of MSD cannot be a ground for not stopping it from making them."The invention of plaintiffs (MSD), that is, Sitagliptin improves the efficient management of the condition of a patient suffering from type II diabetes by inhibiting the DPP-IV enzyme."Merely because defendant (Glenmark), who is manufacturing generic version, is selling a tablet at a lower price than that of plaintiffs cannot be made ground to decline injunction against the defendant, who has been found to have been infringing the invention of the plaintiffs, is as much as, a competitor of the plaintiffs," the court said.While MSD's anti-diabetes drug Januvia costs Rs 43 a pill, which is roughly 1/5th of its price in the US, according to market sources, Glenmark's version costs around 30 per cent less.Reacting to the verdict an MSD spokesperson said the company was pleased that the High Court "has found Glenmark to have infringed the patents of our Sitagliptin products Januvia and Janumet and have restrained Glenmark by decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in SPM or any other salt of Sitagliptin in any form, alone or in combination with one or more drugs."Referring to various documents and testimony of experts, the court also concluded that Glenmark by using Sitagliptin phosphate monohydrate salt in Zita and Zita-Met, "clearly infringed" the patent of MSD.The court, however, did not say anything about the sale of existing stock.In its 133-page judgment, the court said that on perusing the product inserts of Glenmark's two drugs, it found that they were a "replica" of product inserts of MSD's products "with minor and insignificant variations"."...it emerges from the comparison of the product inserts of the plaintiffs' (MSD) product and that of defendant (Glenmark) that they are same and contain same compound, that is, Sitagliptin phosphate monohydrate, inasmuch as, the drug is DPP-IV inhibitor and used for treatment of type II diabetes," it said.It also said that "use of Sitaglpitin salt in Zita and Zita-Met, by itself, amounts to infringement of patent" as per the Indian Patents Act, 1970.It also observed that MSD's Sitagliptin phosphate monohydrate "exhibits potent DPP-IV inhibitory properties and is particularly useful for prevention of type-2 diabetes"."Defendant is restrained by a decree of permanent injunction from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in Sitagliptin phosphate monohydrate or any other salt of Sitagliptin in any form, alone or in combination with one or more other drugs thereby infringing patent of the plaintiffs."...Plaintiffs shall, however, be entitled to actual costs of the proceedings," the court said.MSD in its plea had sought permanent injunction against Glenmark alleging that the Indian pharma company had violated its IPR over its anti-diabetes medicines, Januvia and Janumet, by coming out with their own drugs containing the same salts.The US firm had said it had invented 'Sitagliptin' salt used in its anti-diabetes drugs and has patent over molecule.Glenmark, on the other hand, had contended that it has used 'Sitagliptin Phosphate' in its anti-diabetes drugs, Zita and Zita-Met, and US firm has no patent right over this salt.Glenmark had said that Sitagliptin Phosphate has been a distinct product from Sitagliptin and due to this, MSD had obtained separate patent for Sitagliptin Phosphate in the US.MSD first applied for a separate patent for Sitagliptin Phosphate in India and later abandoned it, Glenmark had said.(PTI)
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There is a huge shortage of doctors and nurses across the globe. As per WHO estimates, the shortfall stands at around 7 million, says Mark Britnell, chairman and partner, Global Health Practice, at KPMG. In his book "In Search of the Perfect Health System", he analyses 25 countries' healthcare systems, including India's, starting from the demographic burden of aging populations to making healthcare affordable and universal without bankrupting the state. Britnell talked about these issues in an interview to BW Businessworld's Paramita Chatterjee. Excerpts: How would you define a perfect health system and what is India's status?There is nothing called a perfect healthcare system and it definitely does not reside in one country. However, having said that, there are fantastic examples of health and healthcare around the world which can offer inspiration and learning for countries across the world. Take for instance, the US. It has excellent R&D, while the UK is known for its universal healthcare and values. As far as India is concerned, there are some great hospitals here. Further, it has an advantage in terms of application of smart IT systems. This is a combination which in turn works out as a great advantage. Going forward, how can India contribute to the world in terms of its health system?Currently, there is a mammoth shortfall of doctors and nurses across the world. In fact, if you take the WHO figure, the shortfall stands at around 7 million. India certainly can take advantage of this and try to fill in the gap thereby becoming the world's cradle for training doctors and nurses. In fact, it can partner with flagship medical institutions across the world and start training here. In my view, whichever country makes this move will stand to gain going forward. In India, one of the biggest challenges is to make healthcare affordable to the masses. What are your views on it and how can that be achieved? First of all, let me clarify that it cannot be done overnight. However, having said that, in the current situation where resources are anyways scarce, the government and the hospitals should come forward and work together instead of operating in silos. There should be a synergy in the way they operate. In that way, they will be able to make healthcare not only affordable but reachable too even in remote areas. A host of day care centres have come up in recent times which are also attracting significant investor interest. Alongside, there are the multi-specialty hospitals. How do you think the two will co-exist?Well, day care centres are extremely popular in the West, In fact, I would say as much 70 per cent of all the planned procedures today can be done in day care centres. However, this is not to say multi-speciality healthcare chains will cease to exist. Currently, the opportunity in the Indian healthcare system is such that it is prompting a lot of foreign investors to enter the country. I personally know a lot of them from countries likes Japan, Australia, Malaysia, Singapore and the UK.
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15 million people in India are blind, which is 50 per cent of world's blind populationBy Peyush BansalFor most of us, it is impossible to imagine life without sight.But do we give enough importance to taking care of our eyes that enable us to enjoy the colours of life?One look at the statistics and it is quite apparent that eye care is at the bottom of the priority list in peoples' minds when it should be one of paramount importance. Consequently, we are confronted with concerning statistic of India housing 40% of the worlds' blind population.According to a World Health Organisation (WHO) study, globally about 285 million people have visual impairment, including 39 million individuals who are blind and an additional 246 million who have poor vision. The causes of moderate and severe vision impairment worldwide are uncorrected near-sightedness, farsightedness and astigmatism. While the global statistics are alarming,India's numbers are shocking with nearly half of all Indiansin dire need of vision correction.The root cause for the increase in the numbers of patients with blindness in India is the insufficient mechanism for primary eye care. With eye care featuring in the lowest rung for personal healthcare, the problem is exacerbated by a general lack of awareness and poor access to eye care professionals. While government initiatives like National Programme for Control of Blindness (NPCB)is a step in the right direction, much still remains to be donein the country towards achieving a better eye care system. To add to the challenge, there are only about 12,000 ophthalmologists in India for its 1 billion-plus population, resulting in a ratio of 1 ophthalmologist for every 90,000 people. While in The United States of America, there is 1 ophthalmologist for every 15,800 people, which is recognized as an adequate ratio.There is an urgent need to bridge this void as poor vision can not only impact the personal life of an individual but can also have a telling effect on his or her productivity. According to WHO estimates, globally, poor vision results in an economic productivity loss of $275 billion, with China accounting for the biggest chunk of that at $65 billion. According to another study done among Indian workers, good eye care and vision correction led to an over 30% increase in their incomes and a 25% increase in productivity.All thedata and findingspoint towards the impending need of bringing focus on eyewear and encouraging people to get their eyes checked at regular intervals, the absence of which has immediate and long-term consequences such as loss of educational and employment opportunities, loss of economic gain for individuals, families and societies, and an impaired quality of life in general.While India is waking up to the need for eye care with the government making policy initiatives at both the state and centre levels, a lot still needs to be done. The entry of several service providers and active participation from NGOs through various initiatives has also slightly assisted in raising the awareness of eye care in India. One such initiative is Vision 2020 that was launched bythe World Health Organisation together with more than 20 international non-governmental organisations that aim to provide technical support and advocacy to prevention of blindness activities worldwide by the year 2020.Another initiative that has seen some success is the Global Action Plan (GAP) which is a commitment endorsed by all WHO Member States to improve eye health for everyone ('Universal Eye Health') by 2018. GAP is now the most important strategic document in eye health. This initiative represents a significant step forward towards achieving 'universal access' to eye health. Approximately 25 VISION 2020 workshops take place every year at local and internationallevels, tackling specific national or regional priorities for the GAP. These workshops help to align GAP's objectives in tandem with the specific region.The relevance of eye care cannot be undermined. It has a direct impact on our lives and our happiness. Consequently, there is an urgent need to raise awareness on regular eye check-ups and the necessity of wearing prescribed spectacles on a regular basis. If detected at an early stage, appropriate solutions can be prescribed which will go a long way in reducing the levels of visual impairment in the country. We look forward to support from the government in terms of enabling policies, establishing minimum standards and investing in technologies which will all come together to ensure that more and more Indians will enjoy a full life that is not marred by visual impairment.The author is founder and CEO of Lenskart
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Glencore has told investors it is on track to cut debt and has shown new data about its secretive trading unit in a fresh attempt to dispel market worries over its finances which have knocked 70 percent off its share price this year. Its stock gained as much as 6 percent on Thursday after credit analysts from Barclays said a meeting they had organised with members of Glencore's management on Wednesday, including the co-head of corporate finance Carlos Perezagua and the head of strategy Paul Smith, managed to address many concerns of investors and bondholders. But it then tumbled back into negative territory, extending the week's losses after suffering a 30 percent plunge on Monday. At 1238 GMT it traded down 3.76 percent on the day. "It was an encouraging meeting (on Wednesday) as we believe it helped to clear up many misconceptions and confusion we believe is currently in the market around commodity trading," credit analysts from Barclays said in a note on Thursday. A source close to Glencore confirmed that the meeting had mainly focused on the balance sheet and debt reduction plan. The market jitters over Glencore reflect concerns over the Swiss-based trader and miner's ability to service its heavy debts, accumulated after an asset buying spree, following the collapse in global commodity prices over the past year. "The market is telling us that Glencore is in financial distress. Our credit colleagues believe this is premature and do not have those concerns - they do not think Glencore is at risk of imminent default," the Barclays note said, adding it believed the company could retain its investment grade credit rating. Glencore has already pledged to cut its net debt to $20 billion from $30 billion, by selling assets, reducing capital expenditure, suspending dividend payments and raising $2.5 billion of new equity capital with the share sale completed earlier this month. On Wednesday, Glencore said it was on track to sell a stake in its agricultural business by early next year, according to Barclays. It also hopes to complete a so-called streaming deal by the end of this year. This entails selling by-products such as silver or gold from copper production at a fixed price before it is mined. The deals could generate around $2 billion, according to market estimates. "MISCONCEPTIONS" The pledge to reduce the debt has failed to fully address market fears and some analysts have said more measures might be needed if copper and coal prices remain low for longer. Analysts from bank Investec said this week they saw a scenario under which Glencore would direct all its earnings toward debt repayment. Last week, Goldman Sachs said that because Glencore's trading relied heavily on short-term credit, its financing costs would soar if it were to lose its investment grade rating. Barclays said Glencore's managers had stressed the firm had no financial covenants, no material adverse change clauses and no high yield rating triggers in its credit facilities. "One of the misconceptions is that Glencore needs its investment grade credit rating for the marketing business. The higher cost of trading does impact trading competitiveness but most of the traders pass this through to customers. At the moment this appears to be minimal given the low interest rate environment," Barclays said. Most analysts say that even though they understand Glencore's mining division, their models are of no use to calculate forward earnings of the trading division as Glencore discloses very little, like private rivals such as Vitol. On Wednesday, Glencore unveiled some fresh data, according to Barclays, including the way it funds trading. The company said that it had up to $50 billion of short-term credit lines, known as letters of credits, from over 70 banks to support its trading operations, of which only 30 percent or $17 billion were currently utilised. Those credit lines are used to support Glencore's huge commodities inventories which the company says can be sold any moment and therefore should be seen as cash, not debt. Glencore also disclosed that oil inventories - one of the most liquid asset - amounted to $12 billion out of the total of $17 billion in inventories.(Reuters)
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