Indian regulators are privately pressuring major drug firms to better police how they sell popular codeine-based cough syrups to tackle smuggling and addiction, a move that is reducing supplies of a medicine doctors say is an effective treatment.India's Cipla stopped making the product last year owing to regulatory demands, and US-based Abbott Laboratories and Pfizer have had to reduce batch sizes by up to half, cutting how much medicine their factories can produce.But they are pushing back against other demands, a Reuters review of correspondence between companies and regulators showed, including selling one batch to only one buyer and printing labels that specify where the drug would be sold.Regulators want to make it easier for law enforcement agencies to track cough syrup abuse in the country and bottles smuggled to neighbouring Bangladesh, where it was banned in the 1980s but is still sought by addicts.Retailers worried about liability from potential abuse by people addicted to the opiate codeine are in some cases refusing to stock the cough syrup, said J.S. Shinde, president of pharmaceutical lobby group All India Organization of Chemists and Druggists. Sales of the drug in India fell 4 percent to 121 million bottles in the year through August, and 15 percent in the year before, according to IMS Health, a healthcare statistics provider.For drug regulators, the challenge is to strike a balance."Any non-therapeutic usage is a concern, but you have to weigh the risks versus benefits," said an official at the federal drugs controller in New Delhi.Rising CostsAccording to an industry executive, the likes of Pfizer and Abbott, who control most of the $103 million market for the drug, face a "significant" increase in costs as plants run well below capacity because of changes demanded of them.And the regulatory regime could get tougher.According to minutes of a July meeting of state and federal drug regulators, there was a recommendation to ban the sale of the syrup altogether because of "rampant misuse and its illegal exports to neighbouring countries.""A large number of regulators were in favour of strict control," said Akun Sabharwal, drugs controller for southern Telangana state, who attended the meeting.The federal drugs official, who spoke on condition of anonymity, said an outright ban would not be easy to impose, given the medicine's importance. Abbott estimates roughly 60 million people suffer from regular dry cough in India.Pfizer's India unit said in a statement the company takes all steps to maintain the highest standards of regulatory compliance, including supply-chain audits.Abbott India said they believed existing Indian drug laws were adequate to control the abuse and the company had taken steps to support enforcement agencies.Ruined LivesLast year, the International Narcotics Control Board (INCB) billed the abuse of medicines containing narcotics and their smuggling from India among the "greatest drug-related challenges" facing South Asia.About 83,000 bottles of codeine-based cough syrups were seized in India in the six months through March. In meetings with companies, Indian regulators called the "menace of abuse" a "growing concern".Abuse is particularly common in Bangladesh. At a treatment centre in the capital Dhaka, tales abound of ruined careers and family struggles.A 40-year-old former banker at the Bangladesh Rehabilitation and Assistance Center for Addicts said his addiction was so bad he felt he loved cough syrup more than his four-year-old son."I felt I must recover from this menace," he said, requesting anonymity because of the shame associated with addiction.The regulatory crackdown in recent years appears to have curtailed smuggling. About 750,000 bottles were seized in Bangladesh in 2014, 24 percent lower than 2013, the INCB said.Still, a fifth of Bangladesh's estimated 4 million drug users are addicted to such syrups, said Sayedur Rahman, a professor at the Bangabandhu Sheikh Mujib Medical University.Inside Bangladesh, the cost of a bottle has more than tripled, indicating scarcity. Still, drug officials say the problem is underreported and more should be done.Increasing PressureThe latest crackdown on companies dates back to at least February 2014, the review shows.Indian narcotics officials told companies to take several measures, including reducing batch sizes and printing where it would be sold on the label.They also asked them to sell drugs from one batch to one stockist only, a measure the executive said was impractical.That summer, regulators temporarily held back Cipla's allocation of codeine, manufactured solely in government factories, after the company failed to inform the government about steps it had taken to comply with the directive.Cipla said it never received the request for information.A Cipla spokeswoman said the company stopped making the drug last year after "considering the business environment ... and the fact that this product was regulated by multiple agencies."At another meeting in October, government officials again pressured pharmaceutical companies to comply with their demands.In August this year, regulators sent a letter asking for updates on further steps they had taken, an industry executive said.(Reuters)
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A strict enforcement of IPR may create panic among the generic industries and consumer action groups, says CH UnnikrishnanThe final draft of India’s first national intellectual property rights (IPR) policy, which is expected to be made public by the end of the year after Cabinet clearance, emphasises on stricter enforcement of IP (patent, copyrights and trademark etc) law in the country and has recommended that IPR must form an integral part of the overall development policy of the country going forward. The policy document, which was submitted by the IP Think Tank to the ministry of commerce and industry for Cabinet approval, was leaked out on a blog -- Don’t Trade Our Lives Away-- on Tuesday (13 October). "The strength of the substantive laws will be reinforced by equally strong administrative, enforcement mechanisms and improved judicial infrastructure," says the final draft of the national IPR policy of which a copy of the leaked version is available with BW Businessworld. A strict enforcement of IPR that might result in instant grant of court injunctions to rights holders and perhaps more restricted use of flexibilities allowed by TRIPS (Trade Related Aspects of Intellectual Property Rights) in the country, may create panic among the generic industries and consumer action groups.The final draft prepared by Justice Prabha Srideven-headed IP Think Tank, however, emphasises that attempts by vested interests to label India’s generic goods, especially drugs and pharmaceuticals, as counterfeits need to be resisted. It also strongly recommends continuation of India’s stand against TRIPS plus provisions demanded by developed countries especially the US and its trade bodies. "The National IP Policy envisages Intellectual Property (IP) as an integral part of the overall development policy of India and adopts the motto 'Creative India, Innovative India' and it will guide and enable all creators and inventors to realise their potential for generating, protecting and utilising intellectual property which would contribute to wealth creation, employment opportunities and business development,” states the policy draft in its executive summary. It also emphasised the point that the country’s IPR Policy will protect concerns such as public health, food security and environment, and encourage generation and diffusion of knowledge by laying a roadmap for holistic, effective and balanced development of the Indian IP system. “India has a strong legislative framework balancing its developmental priorities and international obligations. This balance will be maintained in all international negotiations and TRIPS plus provisions will be avoided. International, regional and South-South cooperation will be promoted," says the final draft of the national IPR policy. However, the bloggers who first made the leaked policy for public eyes, expressed concerns on the policy’s strong stress on the enforcement of IPR. “The adoption of this policy would present a serious threat to the affordability of health products. Overzealous use of enforcement measures, including injunctions, could undermine key TRIPS flexibilities and have a chilling effect on generic competition,” the blog stated its post on Tuesday. “In fact, it does not address the growing number of ex-parte injunctions against APIs (Active Pharmaceutical Ingredient) and formulation producers from the Delhi High Court in violation of Supreme Court guidelines,” it said. But, the draft document states that national policy will ensure that IP rights are not abused and that implementation and enforcement of IP rights do not adversely affect India's developmental objectives. Rather, the policy will catalyse the full potential of intellectual property for India's economic growth and socio-cultural development while promoting public interest, it added. India's Department of Industrial Policies and Promotion (DIPP), which is responsible for formulation and implementation of intellectual property legislation under the ministry of commerce and industries had last week offered that the country will unveil its national IPR policy in two months. "India in the next two months will be coming out with a completely new and one of the finest IPR policies in the world," said DIPP secretary, while talking at an Indo-German Business Roundtable in New Delhi on July 6. The first draft of the policy, which was circulated for comments from public and various stakeholders in December 2014, had invoked mixed responses and reactions in the industry.
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The company has about 6,000 people in the field force in India and operates full-fledged marketing and distribution arms in the US, Australia and other countries
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Haider Ali KhanRashtriya Swasth Bhima Yojana (RSBY) will be restructured to make its coverage wider, intensive, flexible and IT driven. The restructured scheme coordinated by the Union Health Ministry will bring together the disjointed schemes coordinated by different agencies under one umbrella. The new scheme is likely to be operational shortly.Giving details of the proposed restructured RSBY at the 9th Health Insurance Summit organized by Confederation of Indian Industry (CII) in the capital today, Bhanu Pratap Sharma, secretary, health, ministry of health and family welfare, said, “The new scheme would have more benefits and beneficiaries. MOUs would be entered with the state governments. Those States which want to extend the services to people above poverty line (APL) and provide secondary and tertiary benefits could do so as a top up of the scheme.”An important feature of the new scheme is the strong IT platform which would be created for facilitating the operations of the scheme. A large database is being created that would detail facilities at every hospitals, disease profile and other details and would help immensely every stakeholder, he added. He also informed that the restructured RSBY would cover around 8 to 10 crore BPL families and there will be enhancement of cash limits for treatment. Improved quality, universal coverage, affordability would be the hall mark of the new scheme, which will also lay stress on preventive medical care. The scheme envisages free medical check-ups once in every three years for the age group vulnerable to cardiac diseases and diabetes.The Health Secretary stressed that the private-public partnership (PPP) model would be used for creating strong infrastructure in the health landscape. He assured that legislation should be passed in the near future for augmenting the supply of quality personnel, such as doctors, para-medical staff. There is also a proposal to speed up the process of accredition of hospitals.G Srinivasan, CMD, New India Assurance Co, stressed the need for insurance companies coming out with simple products to gain acceptance of the customers as India has become a disease and accident capital of the world.Dr Naresh Trehan, chairman, CII National Council on Healthcare, said, “We have a lot of reservoir of knowledge technology and human capital in the private sector. This along with predetermined realistic costs can be used to our advantage to plug the gaps that may exist today in healthcare delivery.”
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Did you ever imagine that the Healthcare industry would follow the travel, banking and insurance model of ubiquity? Well, let's just say necessity drove innovation. The $250 billion dollars spends on sales and marketing by the pharmaceuticals industry is now breaking down for the want of more effective channels to engage with the doctors. The key metric here is the time spent per doctor per medical rep and on demand engagement. The approach is shifting from pure marketing to relationship building leveraging the power of multi channel technology.Let us take a deeper dive into the digital transformation story of the pharmaceuticals industry. And let's start with China, where it happened closest to India - the opportunity for millennium growth as well as the rules of the Big game in the form of compliance.Much as the industry loosely qualifies digital transformation as a simplistic provision of technology platforms and services for enterprise communication and convergence, each country presents its own unique challenges. China, for example, has grown 22% CAGR from 2003 to 2013. Of this, the pharmaceuticals market in China is estimated at $100 billion approx., with a double digital growth over the last 7-8 years. However, the returns from new product launches haven't grown proportionately. Global MNCs face challenges at two levels:" Access / coverage - Sales force covers only 17-18% of the 2 million doctor population and are looking at various ways to cover rest of the huge uncovered doctor base" Governments crackdown on doctors and pharma on compliance and ethical marketing has reduced access and raised questions around quality of access. Pricing is under pressure.Short-term digital alternatives such as tele-reps, broad market representatives, digital promotions, are only incremental and not sustainable. There are emerging intermediaries, doctors' behavior is unpredictable, and B2B channels have specific requirements of longevity, stickiness and finally, scalability. Layer this with the complexity of healthcare spending and regulations for each city in China and investments for thousands of primary and secondary care hospitals in the offing. The outcome is an overwhelming deluge of behavioural trends from each disease vertical in each hospital in every city that needs to be examined for developing the right protocols for better patient outcomes being the overriding goal. And this is just the picture in one country.Here is an illustration of a paradigm shift from the traditional feet on the ground sales rep model to an enterprise wide multi channel deployment for on- demand information service to doctors. What this requires is a long -term view of doctors relationships and capability of managing tailor made approved scientific content. Three core steps -" Deliver enterprise-level multi-channel doctor engagement platforms , tele-detailing centres , channel usage analytics and multiple format content to set up access beyond their present markets" Set up amplification of reps with support channels for Big city - big hospitals reps where access is an issue due to compliance." Apply IP platforms like APTILON and Field central, Medical expertise, Analytics and business know how to set up algorithms and provide content to effectively engage betterLet's also look at the blurring boundaries between traditional research and development and commercial functions. The stakeholders of the healthcare industry have come to terms with usage of treatment and cost data for deriving better health outcomes. Sophisticated analytics offer decision -making tools to doctors and others in the care giving chain to reduce costs across the value chain.Can horizontal IT companies deliver this capability? Is the game still in scale or in know-how and service? You can draw your own conclusions.The author, Manish Gupta, is CEO, Indegene - a global healthcare solutions company
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As many as 850,000 small chemist shops in India will shut for a day next week to protest against a burgeoning online pharmacy industry that is attracting big money backers. Healthcare provider Apollo Hospitals Enterprise Ltd plans to start online drug sales in India, while Zigy, and Sequoia Capital-backed 1mg already have e-pharmacies to tap a retail market IMS Health says is worth about $13 billion. Varun Gupta, head of medical affairs at 1mg said the company gets up to 60 million hits a month on its website and its mobile app has been downloaded 3.5 million times since 2012. Indian law does not regulate e-pharmacies. The one-day nationwide strike on October 14, called by the All India Organization of Chemists and Druggists (AIOCD) comes as a government panel started working on regulations for the sector. Drug retailers say e-pharmacies challenge their businesses and would allow medicines that could be abused to be sold without verification. They also say the online pharmacies make it easier to use one prescription to purchase medicines numerous times. "Our children are savvy to social media. If they put one prescription online, they will take a picture and send it to other companies to get medicines," AIOCD President J.S. Shinde said. The group will also organise a street protest in the capital New Delhi. An indefinite strike will be considered if the government does not stop online sales, Shinde said. Medical shops in hospitals and 24-hour pharmacies will not be shut. A drug regulator in the state of Maharashtra who is aware of the deliberations on the issue called AIOCD's decision "premature" and said draft guidelines were several months away. Regulators began checks after online retailer Snapdeal was found selling prescription medicines online without prescriptions in May. Snapdeal was forced to delist some products and sellers. But drug sales, even at traditional shops in India, are weakly regulated. Pharmacists often sell medicines without verifying prescriptions. E-pharmacies said they were not violating drug laws and customers needed to upload prescriptions before buying regulated drugs. "We expect new regulations to give clarity for online players to exist," said Hemant Bhardwaj, chief executive at Zigy. Apollo's Joint Managing Director Sangita Reddy told Reuters they will start online drug sales once the new regulations are finalised. Consumers are attracted by the convenience. "A huge database of medicines makes it a one-stop shop," said Thongsuanmung Vualnam, a New Delhi health consultant who recently started shopping for drugs online.(Reuters)
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Energy company ACME has organised a Free Medical Health Check-up Camp at Bhikapali, Mahasamund, Chhattisgarh in association with Dr Revendra Dev Singh, Dev Arogya Hospital, Baghbara, who have established themselves as the leaders with a social cause in the region.At the health camp, tests were conducted for Blood Group, Blood Pressure and general health check-up including weight and respective consultation provided for the same.The camp benefitted 150 persons from various sections of the society. Manoj Kumar Upadhyay, Founder & Chairman, ACME said, "Through such activities, we wish to drive the point that corporate citizens have a very important role to play in ensuring wellness of immediate neighbourhood. As a firm believer and proponent of green technologies in the country as they work towards creating healthier environment, we intend to bring awareness about good health and endeavour to participate in activities that help bringing healthier environment closer to the society."ACME, an ideal corporate citizen, has been a frontrunner in green technologies in the country, has undertaken various campaigns related to health and wellness for its immediate neighbourhood and help the stakeholders lead a healthier life.(BW Online Bureau)
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India has seen spectacular growth in the last two decades. The term 'India Shining' brings to mind the rapid commercialisation the country has experienced, malls cropping up like mushrooms. Brand 'India' has become a reliable export and everyone wants a piece of the pie. However this development has had no effect on certain sections of the populace. Flagrant human rights abuses are still rampant, whether in the form of discrimination against women and children, or abuse and neglect of the disabled and mentally ill. For in a country that is growing rapidly, trying hard to match the development of the West, these issues are still largely ignored and not open for discussion.The Mental Health Act of 1987 is outdated and failed in providing an in depth understanding of how to treat people suffering from mental illness. There are no reinforcement or accountability measures to review the performance of government or private run institutions. The dismal treatment of patients in these homes is not hidden, just ignored. Human Rights Watch mentioned the pathetic conditions of patients in New Delhi's Asha Kiran, a government run residential facility for people with intellectual disabilities. Almost 900 people housed in a 350-bed facility. There were several reports of physical and sexual abuse. The report did enforce the government into agreeing to cooperate and improve conditions but unfortunately the realities on ground have changed very little.Sweta RawatIn most cases, superstition and lack of awareness and education have made people turn to faith, an example is the Hanumanthpuram temple in Tamil Nadu. Individuals are brought by family or simply abandoned there, the belief being that a glimpse of the statue of Lord Shiva will 'fix' the person. Countless other temples and dargahs across the country offer similar 'solutions'.'Possession' by evil spirits is another explanation given for certain behaviors. It is not just people suffering from mental illness that are affected by ignorance, but even the people working with them such as psychiatrists and social workers face the skepticism of the public.How can we change the way we think about mental health?In recent times a famous Bollywood celebrity spoke about depression and mental illness. In a country where celebrities command so much respect and attention, this was a great way to start talking about the issues. Because to affect change we need to first accept there is a problem. Education and transparency are also essential steps we need to take to ensure people are aware of mental illness and what resources are and can be available to ensure the individual can lead a normal, enriching life in the community.The WHO (World Health Organization) MIND Project states that mental health services need to be integrated into primary healthcare, universally available to all people. If mental health can be a part of universal healthcare, it will go a long way to reduce the stigma and improve social integration for the concerned individual and his or her family. Also providing treatment at the primary level and informal community care, can prevent people from being admitted into psychiatric institutions. Today there is one psychiatrist for every 400,000 people, a startling statistic that highlights the glaring gaps in the provision of care.There has to be a multi-organizational effort to jumpstart the positive initiatives. Public-private partnerships can improve access and outreachof services and hopefully with the right focus, mental health can change from being a topic of taboo to one of education and understanding.The author, Sweta Rawat, is chairperson, The Hans Foundation
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