Did You Know?

   India’s pharmaceutical industry is expected to expand at a compound annual growth rate (CAGR) of 22.4% in 2015–20 to reach $ 55 billion.

   According to WHO, non-communicable diseases such as cancer, diabetes, and cardiovascular diseases have been collectively responsible for 70 per cent of all deaths worldwide.

   Vildagliptin, a class of medication called dipeptidyl peptidase IV (DPP4) inhibitors, has about 25% share of the Indian gliptins market of Rs. 3,600 crore.

   Over 68 per cent of cancer patients, over nearly two-thirds of cancer patients, are dying in India.

   The market size for chronic Hepatitis B in India is estimated at Rs 140-crore.

   According to USFDA’s definitions, OAI (official action indicated) means “objectionable conditions were found and regulatory administrative sanctions by FDA are indicated” during inspections.

   According to Pharmexcil, India imported Rs. 17,400 crore worth of APIs from China in FY 2019.

   Raw materials from China are used in making antibiotics, paracetamol, and diabetes and cardiovascular drugs, among others.

   About 90% of the needs of antibiotic makers in India is fulfilled by China.

   According to India’s drug regulatory body, the country has 1,500 plants that manufacture APIs.

   The Ahmedabad-based company Torrent Pharmaceuticals is the only domestic pharma company that has invested nearly $1 billion in local acquisition over the last three years.

   Wockhardt employs more than 7,000 people and has a presence in the US, Britain, Ireland, Switzerland, France, Mexico, Russia and other countries. It has manufacturing and research facilities in India, the US and Britain, and a plant in Ireland.

   As per an August 2019 research report by ICICI Securities, Cipla currently has a 5% share of the domestic formulations business.

   Spending on medicines in India is projected to grow 9-12% over the next five years, putting it in the top 10, according to the Indian Brand Equity Foundation’s October 2019 report on the country’s pharmaceutical sector.

   Indian pharma companies total sales from the US market is estimated to be Rs 55 thousand crore.

   Currently, more than 60,000 patients are participating in cell-based and gene therapy clinical trials globally.

   Low and middle income countries contribute to 80% of the global diabetes burden.

   Despite insulin’s universal availability for the last 97 years, it is yet to be universally accessible.

   While the Indian pharm industry reached a size of $40 billion last fiscal, its exports stood at $19.2 billion. US market accounts for a third of India’s pharma exports.

   The import of chemicals, intermediates and active pharmaceutical ingredients from China is now standing at around $2.5 billion a year.

   KRAS is a gene that suppresses the proliferation of cells. A mutated KRAS gene leads to cell proliferation causing cancer. KRAS mutations occur in 1 in 7 of all human metastatic cancers.

   India’s medical device imports jumped 24% to Rs 38,837 crore in FY19, according to the latest export import data.

   The US is the largest exporter of medical devices to India, constituting one-fifth of the pie, followed by Germany, China, Singapore and the Netherlands.

   In 2018, 21.5 lakh TB cases in India were notified to the Revised National Tuberculosis Control Programme (RNTCP), a 16 per cent increase over 2017 and the highest so far.

   Statistics show that approximately 20-30% of leukaemia and lymphoma patients with remission after CD19 CAR T therapy experience relapse after a few years.

   In chimeric antigen receptor (CAR) T-cell therapy, patients’ T-cells from the bloodstream are genetically engineered to identify and attack a specific cancer protein after reintroduction into the blood.

   Multinational drug company Mylan has invested more than one billion dollars in India to upkeep and expand the capacities during the last six or seven years.

   Chronic lung diseases are a group of diseases that target airways and other lung structures.

   Bavarian Nordic’s Jynneos is said to be the first vaccine approved to prevent monkeypox worldwide. It is the only non-replicating vaccine to receive FDA approval for smallpox.

   The US Strategic National Stockpile (SNS) is the country’s largest supply of pharmaceuticals and medical supplies for public health emergencies.

   The prevalence of retinal diseases is expected to rise globally over the next ten years as a result of ageing populations and the diabetes epidemic

   Nearly 1 million children are infected by the Cholera bacteria (vibrio cholerae) every year worldwide, with Sub-Sahara and South Asian countries reporting the most number of cases. Mortality due to the infection is between 21,000 and 143,000 each year.

   New HIV/ AIDS infections have declined in India by more than 80 per cent from peak of epidemic in 1995 and deaths from the disease have come down by 71 per cent since its peak in 2005.

   India has a special licence, the UN-backed Medicines Patent Pool, to manufacture anti AIDS medicine TenofovirAlafenamide (TAF) for 112 developing countries.

   Multinational drug company Mylan currently has 21 facilities and 15,000 employees working in India.

   Diabetes is a global pandemic that affects nearly half a billion people and four out of five diabetic patients live in low and middle income countries.

   Ranitidine is a commonly prescribed medicine for countering acidity and is on the WHO’s Model List of Essential Medicines. In India, a host of companies sell over 180 versions of the drug, and the estimated market size for the brand in India is Rs 688.6 crore.

   Chikungunya virus was first identified in 1952 in Tanzania and led to sporadic outbreaks across Africa and Asia. It started to spread in 2004, with more than 3.4 million cases occurring in 43 countries since the re-emergence.

   TB is considered as the deadliest infectious disease worldwide. Drug-resistant TB (DR-TB) contributes the most to the emerging global antimicrobial resistance (AMR).

   Non-TB mycobacterial (NTM) infections are known to be less prevalent than TB. However, existing treatments are suboptimal and require the development of new therapies.

   Group A Streptococcus bacteria (Strep A) can cause a range of conditions, from sore throats and outbreaks of scarlet fever in the UK, to infections leading to rheumatic heart disease in populations such as the Australian Aboriginal population.

   Wilson disease is a monogenetic mutation which impairs the body’s ability to transport and excrete copper. If left untreated, the disease causes can cause fibrosis and cirrhosis, as well as a range of neurological and psychiatric symptoms, which can prove fatal.

   Approximately one billion packs of medicines cross the UK-EU border each year, including around 45 million each month from the UK to the EU.

   Developing treatments to treat drug-resistant bacterial infections is key to achieve universal health coverage.

   The number of companies engaged in antimicrobial drug discovery is continuously decreasing due to scientific and commercial challenges

   Currently no FDA approved therapeutic is available for NASH (Nonalcoholic steatohepatitis) and liver fibrosis patients.

   India’s biotechnology sector, growing at 20%, was at $11.6 billion in 2017, with the biopharma sector accounting for 65% of total revenue.

   Excessive loss of blood after childbirth is considered to be the primary cause of maternal mortality worldwide, with approximately 60,000 deaths recorded each year.

   The addressable medicine market for e-pharmacies in the country stands currently at USD 9.3 billion and is estimated to grow at a CAGR of 18.1 per cent.

   At present 35 per cent of domestic pharmaceutical market relates to chronic medications and the remaining 65 per cent to acute medicines

   In the latest update of its catalogue of diseases and injuries around the world, WHO defines burnout as “a syndrome conceptualised as resulting from chronic workplace stress that has not been successfully managed.”

   According to the US Trade Representative office’s annual report on intellectual property protection and review of notorious markets for privacy and counterfeiting, studies have suggested that up to 20% of all drugs sold in the Indian market are counterfeit.

   Surveys in India in recent years have pegged the proportion of substandard drugs at about 3% of the total drugs sold, while about 0.28% were found to be spurious.

   According to a report released by the WHO in 2017, about 10.5% of medicines sold in low and middle-income countries, including India, are substandard and falsified.

   The growing burden of diabetes has created a Rs 15,000 crore market in India for drugs to treat the disease, one that is growing in double digits.

   With 72 million Indian adults suffering from diabetes, drug companies have a range of patients to target.

   Generics account for 90% of the US drug market – up from 33% three decades ago.

   Group A Streptococcus bacteria (Strep A) is considered one of the top ten causes of infectious disease-related deaths globally. It is estimated that the bacteria is responsible for more than half a million deaths annually.

   There are more than 30 million Americans living with diabetes, and approximately 7.4 million of them must take insulin every day to live.

   Humira (adalimumab) is claimed to be one of the world’s best-selling drugs, recording sales revenues of $4.9bn globally in Q4 2018.

   Fixed-dose combinations (FDCs) comprise around 50% of the over Rs 1.3-lakh-crore domestic retail market.

   Generic drugs are used to fill nine of every 10 prescriptions in the US. Nearly 90% of medicines that American patients take are non-branded generics.

   The US healthcare system has benefitted to the tune of $2 trillion in savings from generic drugs in the last decade. Of that, $293 billion came in 2018 alone.

   FDA’s total pre-approval and surveillance inspections in China rose from 19 in 2007 to 153 in 2018 and in India from 66 in 2007 to 252 in 2018.

   The anti-diabetes drug market in India, estimated to be Rs 12,000 crore, is growing at 16%.

   Among the top drug companies in India, 47% provide tools for clinical decision support (for physicians) and 33% for virtual caregiving (for patients), according to a report by consultancy firm EY.

   Genomics primarily involves the examination of an individual’s set of genes and their interactions through comprehensive analysis.

   India is home to the largest number of stillbirths. (Stillbirth is a condition where an infant dies in the womb, having survived at least the first 28 weeks of pregnancy. A neonatal death is one that occurs in the first 28 days of birth).

   Preventive healthcare is predicted to become a $100 billion market by 2022. In which the Asian market, especially India, is expected to witness a boost in demand for genetic testing.

   Indians are now increasingly becoming aware and conscious of health and wellness. Currently, India is home to 90 million health conscious individuals.

   In the span of a decade beginning in 2007, India’s biotechnology industry has grown exponentially in size from about $2 billion to over $11 billion in terms of revenue. By 2025, it is targeted to touch $100 billion.

   More than half the Indian population is below the age of 25. On a global scale, the median age in India (26.5 years) is much below that of China (35.9 years) and the US (37.1 years).

   India’s biotechnology R&D expenditure is quite low at 0.67 per cent of GDP, compared to that of Japan and the US (around 3 per cent), and also of China (around 2 percent).

   Nonalcoholic steatohepatitis (NASH) is one of the leading causes for liver transplantation, and is a serious, chronic liver disease estimated to impact over 16 million people in the US alone.

   Estimates show that more than 70% of the Rs 1 lakh crore local pharma market is dominated by branded generics, whereas patented medicines constitute around 9%.

   Currently, essential medicines constitute over 60% of out-of-pocket expenditure on medicines in India.

   According to the USFDA, a class II recall is initiated in a situation, “in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.

   Torrent Pharmaceuticals is recalling 2,29,896 bottles of tablets used for treatment of high blood pressure from the US and Puerto Rico, on account of deviations from the current goods manufacturing norms.

   Multinational pharmaceutical companies sell most of the patented drugs in India.

   WHO defines “rare disease” as often debilitating lifelong disease or disorder condition with a prevalence of 1 or less, per 1,000 population. Some common rare diseases are Haemophilia, Pompe disease, Thalassemia, Sickle-cell Anaemia and Gaucher’s disease.

   The government-funded, the Human Microbiome Project (HMP) will map trillions upon trillions of microbes – bacteria, fungi, viruses, archaea – that are found in Indians.

   According to a study by the National Institute of Biomedical Genomics, modern mainland Indians have descended from four ancestral populations – Indo-European, Dravidian, Tibeto-Burman and Austro-Asiatic.

   According to a 2014 Union government survey, nearly 99% of Telangana’s population eat meat, while only a quarter of those in Rajasthan do so.

   One estimate by researchers at Israel’s Weizmann Institute of Science and the Hospital for Sick Children in Toronto, Canada, pegs the total number of bacteria in a human body at 40 trillion, compared with 37 trillion human cells.

   Gut bacteria, especially those found in the large intestine or colon, help in breaking down undigested nutrients, producing vitamins and controlling disease-causing bacteria.

   Antibiotic use is one of the causes, along with staying in a healthcare facility, of Clostridium difficile (C diff) infections, whose symptoms include diarrhoea, nausea, fever and dehydration which could be life-threatening.

   Africa, Europe and CIS are the most important markets after the US market for Indian pharma exports.

   Indian drug firms are increasingly looking to set up manufacturing facilities in China. Some of these include Hetero Labs, Aurobindo Pharma, Emcure and Lupin among others.

   Mylan is the world’s second-largest manufacturer of generic drugs.

   India is the world’s largest exporter of generic drugs, making almost 40 percent of all new generics the FDA approved in 2018.

   Globally, India accounts for 20 percent of generic-drug exports. About 700 Indian factories are licensed for exporting to the U.S.

   Since 2015, an index of Indian pharma company stocks has declined 25 percent on the Bombay Stock Exchange.

   India’s share of FDA warning letters from the agency’s Office of Manufacturing Quality began to decline in 2016 as companies in China received more. Last year, out of 53 warning letters issued worldwide, 10 went to drug factories in India and 16 in China.

   Lipitor, or atorvastatin calcium, is the most-studied statin and has a well-established efficacy and safety profile. Since its approval in the U.S. more than 20 years ago, Lipitor has been prescribed to millions of patients and studied in more than 400 clinical trials.

   Of the approximately 36.9 million people living with HIV at the end of 2017, 940,000 died due to HIV-related causes. Furthermore, 1.8 million people were newly infected with the virus that year.

   Pandemics are becoming a growing concern globally, partially due to increasing numbers of drug-resistant pathogens.

   Antimicrobial resistance is listed among the World Health Organization’s top ten threats to global health in 2019.

   Recent research suggests that India is estimated to have had 72 million cases of diabetes in 2017 and the figure is expected to almost double to 134 million by 2025.

   The estimate of the global biosimilar market is $9.5-13 billion by 2022, despite the fact that over $90 billion worth of biotech-based medicines are expected to go off-patent in the next few years.

   India is leading the global biosimilar pipeline, with the largest number of products launched in the country and emerging economies.

   As many as 2,783 samples or 3.36 per cent of the total 82,599 samples tested by drug controllers of various states and Union Territories in 2017-18 were declared substandard.

   Fixing of ceiling prices of 856 essential medicines by National Pharmaceutical Pricing Authority (NPPA) has resulted in a saving of Rs 11,462 crore as on November 30, 2018.

   Uttar Pradesh is a major centre having 30 per cent of manufacturing and exports of pharmaceuticals in the country.

   India’s online pharmacy sector saw investments of about $180 million in 2018, the highest in the last three years, according to startup data tracking platform Tracxn.

   Separately, the three largest e-pharmacy players – 1mg, Netmeds and PharmEasy – have raised $20-46 million in 2018, according to business signals platform Paper.vc.

   According to WHO, India houses the second highest number of people suffering from anxiety disorders, around 3.8 crore.

   Statistics for depression are even more alarming – at 5.6 crore people, India rates the highest in the world

   Depression is the leading cause of death by a non-communicable disease among Indians aged 15-39 years, stated the Indian Council of Medical Research. (India has the highest number of teenage suicide rates globally).

   Approximately 150 million people in India need care for their mental health condition. About 70-92% of these cases failed to receive treatment, according to National Mental Health Survey 2018.

   One of every 10 people in India has a mental illness, according to a survey by Bengaluru’s National Institute of Mental Health & Neuro Sciences (NIMHANS).

   Depression and anxiety disorders cost the global economy $1 trillion each year in lost productivity.

   India has approximately 898 clinical psychologists, 850 psychiatric social workers, 1,500 psychiatric nurses.

   As compared to 90 per cent of children in China who go through newborn screening, the number is just 2 per cent in India.

   Inborn Errors of Metabolism (IEM) is a rare genetic (inherited) disorder in which the body cannot properly turn food into energy. The disorder is usually caused by defects in specific proteins (enzymes) that help break down (metabolize) parts of food.

   42.5% of employees in the private sector in India suffer from anxiety, depression and stress triggered by difficult or inhumane working conditions (Assocham Survey, 2015).

   Globally, depression is the leading cause of poor health and disability. It is estimated that more than 300 million people are now living with depression, a spike of more than 18% between 2005 and 2015 (WHO, 2017).

   The direct and indirect annual costs of major depression to the US economy were estimated to be $210.5 billion, with 50% being attributable to workplace costs (Greenberg et al, 2015).

   India’s biotech industry currently has a 2% share of the global market and is the third-largest in the Asia-Pacific region.

   A recent report by World Health Organization estimates that 20% of all drugs sold in India are fake.

   India, the largest producer of generic drugs in the world, is reported to be the source of 35% of all counterfeit drugs sold worldwide.

   Rabies kills an estimated 20,000 people in India every year, according to the government’s National Rabies Control Programme.

   38 million Indians, or 3% of the population, suffer from anxiety disorders, post-traumatic stress disorder (PTSD) and obsessive-compulsive disorder (OCD).

   Zydus Cadila has more than 220 approvals and so far filed over 330 abbreviated new drug applications (ANDAs).

   Nearly 40% of generic drugs consumed in the US come from India. But in the last three years quality issues in Indian manufacturing plants have hit exports to the US.

   Aurobindo Pharma has now become the second-largest generics player in the US in terms of share of prescriptions, ahead of Indian rival Lupin and even global giant Mylan.

   Sun Pharma’s India business revenues stood at Rs 8,029 crore in 2017-18, a growth of 4 per cent over 2016-17.

   Overall, the Indian pharmaceutical market has witnessed a CAGR growth of 11.2% in last five years.

   Dermatology is showing the fastest sales growth of 17.5% with a CAGR of five years in the domestic pharma retail market.

   The world’s biggest pharmaceutical companies appear to be evading an estimated $3.8 billion in tax per year across 16 countries, stated an Oxfam report.

   An analysis of legal costs of 67 companies from the BSE 100 index shows that six pharma companies together constituted a quarter of the total of Rs 3,597 crore incurred by these companies on legal expenses.

   Oxytocin, a hormone drug used to induce labour in pregnant women and prevent post-partum bleeding, is considered a lifesaving drug and is included in the National List of Essential Medicines as well as the WHO Model List of Essential Medicines.

   About four women die every hour in India from complications developed during childbirth, with heavy blood loss from haemorrhaging being a major factor.

   An estimated one in 10 medical products circulating in low- and middle-income countries is either substandard or falsified, according to research released by WHO in November 2017.

   A nationwide survey conducted in 2014-16 showed that around 3% medicines marketed in India were substandard, while around 0.023% were either spurious or counterfeit.

   An estimated 46% of adults with Type 2 diabetes worldwide are undiagnosed, risking serious health complications and higher health costs, according to WHO.

   Breakthrough therapy designation is given when preliminary clinical evidence has been provided to show that a treatment effect may represent substantial improvement over available therapies for the treatment of a serious condition.

   Hypertension is one of the most common lifestyle diseases in India, with one in three adults with high blood pressure.

   India dominates the world’s generic drugs market, exporting $17.3 billion of drugs in the 2017/18 (April-March) year, including to the US and the EU.

   Only 1% of Indian drug exports went to China in the 2017/18 (April-March) year, the world’s second-largest market for pharmaceuticals.

   The UK-based multinational Mallinckrodt has world’s most diverse line of bulk medicinal controlled substances including fentanyl, methadone, hydrocodone, hydromorphone, oxycodone, morphine and codeine-based drugs.

   Mallinckrodt is also the only generic manufacturer that has its own controlled substance active pharmaceutical ingredient (API) manufacturing capability.

   About 4.3 million people are diagnosed with cancer annually in China, according to a report of the state-run China Central Television.

   Indian drugs, specially cancer curing medicines, are in big demand in China as they are far cheaper than their western counterparts.

   As per USFDA, a class II recall is initiated in a “situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

   A class III recall is initiated in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

   Currently, Government of India directly controls prices of over 850 essential medicines by capping their prices. Around 17% of the more than Rs 1 lakh crore domestic pharmaceutical market is under direct government price control. By volume, the government regulates 24% of all medicines sold.

   56 million Indians, that is, 4.5% of the Indian population suffer from depression, according to WHO.

   India has witnessed the highest increase in consumption of antibiotics over 15 years and is the biggest consumer of a specific class of newer antibiotics taken as a last resort.

   By 2020, global access to medications will be higher than ever, with patients receiving an estimated 4.5 trillion doses, an increase of 24% from 2015.

   With 65% of drug shortages caused by manufacturing and quality issues, implementing emerging technology and modernizing pharmaceutical manufacturing can assure drug supply and improve patient safety.

   Opioid-based drugs are one of the most commonly prescribed medicines for pain relief across the world. The main ingredient of the drug is opium, a narcotic substance derived from poppy seeds.

   The total market size of opioid-based painkillers is estimated at $24 billion, with Fentanyl and Oxycontin being some of the commonly prescribed drugs. Of late, prescription of Opioid-based drugs has seen a drastic fall in US.

   With nearly 45,000 recorded deaths in the US in 2016 due to drug overdose, the role of pharma companies in encouraging the use of such drugs is being probed by authorities.

   According to the India Brand Equity Foundation, India’s pharmaceutical industry is expected to grow to USD 100 billion by 2025.

   India’s consumer healthcare business is estimated to expand to $280 billion from about $100 billion currently. In India, traditional drug makers appear to be entering the space after building their generic drugs business.

   India’s medical devices market was valued at nearly Rs. 34,000 crore last year, according to the 2016-17 annual report of the Department of Pharmaceuticals.

   On the other hand, the Association of Indian Medical Device Industry (AiMeD) claims the size of the market was much higher at around Rs 65,000 crore, with government hospital tenders estimated to contribute over Rs 15,000 crore.

   Waste management market in India is expected to reach USD 13.62 billion by 2025. Major waste sections such as municipal solid waste management market, e-waste market and bio-medical waste are expected to grow at CAGR of 7.14 per cent, 10.03 per cent and 8.14 per cent respectively.

   India recently banned imports of active pharmaceutical ingredients (APIs) from six manufacturing plants in China after site inspections in October-November unveiled serious quality lapses.

   India imports medicines like biologics, cancer medicines, drug intermediates for APIs and patented medicines from places including the US, European Union (EU) and China.

   The audits of Indian drug making sites would rise significantly after the USFDA and eight European member states entered a pact in October 2017 that would allow the US to rely on data from inspections by EU regulators.

   About 67,000 doctors graduate in India annually, but there are only 27,000 primary health centres and only 3,500 vacancies, according to the Indian Medical Association.

   India is estimated to have one doctor for every 1,668 patients, and had a shortfall of 3,027 doctors at primary health centres as of March 31, 2017.

   Private sector plays an important role in India’s healthcare system, where more than 70% people are seeking care at private facilities.

   India had an estimated 1.3 lakh multi-drug resistant tuberculosis patients in 2015, according to the government’s TB India annual status report of 2017.

   India generates estimated 13 tonnes of menstrual waste annually in the form of 12.3 billion disposed sanitary pads.

   Psoriasis is a non-contagious disorder that speeds the growth cycle of skin cells and results in thick scaly areas of skin. The most common form, affecting about 80 to 90 percent of people living with psoriasis, is called plaque.

   Of roughly $7 billion market for anti-psoriasis compounds in the US, the interleukin-based treatments account for about 30% or $2.5 billion.

   One of the significant progresses in anti-psoriasis market is the much-awaited development of Risankizumab, being developed jointly by AbbVie and Boehringer Ingelheim.

   Bayer’s pharmaceuticals business continued to be one of the fastest growing among top pharmaceutical multinational companies in the Asia Pacific region with sales of Euro (€) 5 billion in 2017.

   Bedaquiline, sold under the brand name Serturu by Janseen (a subsidiary of Johnson & Johnson), and Delamanid, sold by Japanese drug maker Otsuka, are two of the new TB drugs approved by the US Food and Drug Administration and European Medicine Agency after 40 years.

   India imports medicines like biologics, cancer medicines, drug intermediates for APIs and patented medicines from places including the US, European Union (EU) and China.

   Lupin, one of the top five pharma companies India, has forayed into over-the-counter (OTC) segment in the country with plans to touch Rs 300 crore turnover in the vertical over the next five years.

   India’s vaccine maker Bharat Biotech’s Rotavac is considered the developing world’s first rotavirus vaccine.

   Valued at $147 billion per year, bottled water is the fastest-growing beverage market in the world.

   Zydus Cadila, a global pharmaceutical firm, employs over 21,000 people worldwide.

   Over the last few years, companies like Lupin, Aurobindo and Mankind have made significant investments in the US. Lupin, for instance, carried out a $750-million acquisition of Gavis Pharma, the biggest overseas acquisition by any Indian company.

   As per the USFDA, a class II recall is initiated in a situation, “in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.

   There are over 28 manufacturing sites registered in India from the US. Most of them manufacture critical formulations or critical new therapies which are not available in other countries.

   By 2021, it is estimated that branded generics will account for one-fifth of the $1.5 trillion a year spent on medicines worldwide. That’s $300 billion – or almost $100 billion more than at present.

   As many as 44 drug-manufacturing facilities in India, which makes 40 percent of the generic drugs taken by Americans, are banned from sending products to the U.S.

   The Indian consumer healthcare business is pegged at around USD 2.7 billion (over Rs 18,800 crore) and is expected to touch USD 6 billion mark (over Rs 40,000 crore) by around 2026.

   The push to curb the branding of generic formulations was a risky one for India’s local drug industry, which last year derived about 80 percent of its $30 billion revenue from so-called branded generics.

   Generic drugs stamped with brand names command a 96 percent premium over equivalent generics sold at state-run pharmacies.

   Sun Pharmaceutical Industries Ltd, country’s largest drugmaker gets 26 percent of its global revenue from branded generics in India.

   India’s public health spending is among the lowest in the world.

   Despite legal worries, opioid or medicinal-controlled substances remain an attractive therapeutic segment with less competition and higher profit margins.

   Gujarat based SMT is the largest developer, manufacturer and market leader of minimally invasive coronary stents (drug-eluting & bare metal), renal stents, PTCA balloon catheters and other cardio vascular accessories in India.

   For India’s leading drug makers, the US is one of the biggest markets, accounting for at least 40% of their revenue.

   About 60 lakh people in India have Hepatitis C. The potentially fatal Hepatitis C virus harms the liver.

   Data from the Ministry for Chemicals and Fertilisers states that India gets 70 per cent of its raw material for drugs from China.

   In India, 7,900 or nearly 2% of a total of 4.76 lakh stents implanted in patients in 2015 were bioresorbable stents.

   India’s OTC drug market, currently pegged at around $4 billion, is growing rapidly with many pharma companies launching products in categories such as mother-and-child care, weight management, dietary supplements and cardiac care.

   Mumbai-based Glenmark Pharmaceuticals has 16 manufacturing facilities across four continents and employs nearly 13,000 people globally.

   Indianapolis-based Eli Lilly & Co is among the world’s biggest makers of diabetes medicines.

   According to the International Diabetes Federation, in recent years India has been home to about 69 million diabetics, while China has about 110 million diabetes patients.

   Over the last five years, virtually all the growth in the volume of medicines sold globally has been in the largest developing markets, while the developed world stagnated.

   The WHO estimates that every year there are roughly 1.3 to 4 million cases of Cholera globally and cause of nearly 21 000 to 143 000 deaths.

   India is on the WHO’s current list of 30 high TB burden countries, and in 2015 recorded the highest TB-related deaths – around 60,000 – among children under 15 years of age.

   India also has a high burden of malaria, recording upwards of 10.90 lakh cases every year since 2014. As of June this year, India has already recorded 3.52 lakh cases.

   In 2016, India recorded the highest number of cases of dengue (1.29 lakh) and chikungunya fever (64,057) in the last seven years.

   India supplies 60% of the world’s vaccines for vaccine-preventable diseases and contributes to 60-80% of the United Nation’s annual vaccine purchases.

   ‘Shanchol’, developed by Shantha Biotechnics in collaboration with International Vaccine Institute (IVI), is the world’s first low-cost oral cholera vaccine.

   Delhi based Mankind Pharma, one of India’s top pharmaceutical companies and maker of leading brands like Manforce condoms, PregaNews & Unwanted 72, operates in 22 countries with a workforce of more than 14,000 employees.

   India expects to bring down the proportion of its substandard drugs to 2% over the next three years to match global standards.

   The annual number of new HIV infections in Asia and the Pacific has declined 13 per cent over the last six years, from 310,000 in 2010 to 270,000 in 2016.

   India, China and Pakistan are among the 10 countries that accounted for more than 95 per cent of all new HIV infections in the Asia and the Pacific region in 2016. (Others are Indonesia, Vietnam, Myanmar, Papua New Guinea, the Philippines, Thailand and Malaysia).

   Today India supplies 90% of the anti-retroviral drugs (ARVs) across the world.

   Biosimilar market size globally was $3.30 billion in 2016, and is projected to reach $10 billion by 2023.

   Estimates suggest nearly 75,000 Indian women die of breast cancer every year.

   In the EU, the number of cases of TB is relatively low but according to WHO, the region has one of the highest rates of drug-resistant TB in the world.

   Because of drug resistance, TB is evolving to become an untreatable disease for a growing number of people.

   Every year in England, about 2,300 people are diagnosed with glioblastoma, one of the most common and aggressive forms of brain tumours, less than 5% of which survive for five years or more.

   Less than half of all people with multidrug-resistant TB are cured successfully.

   WHO has initiated an ‘End TB Strategy’ that plans to decrease TB deaths by 95% and reduce new cases by 90% between 2015 and 2035.

   Cardiovascular diseases, diabetes, respiratory illnesses and breast cancer are responsible for nearly one-fifth of deaths in Pakistan annually within people aged 30-70.

   Big Pharma is a term used to describe the world’s top 20 pharmaceutical companies [Pfizer, Novartis, Roche, Merck & Co Inc, Sanofi, Gilead Sciences, Johnson and Johnson, GSK, AstraZeneca, AbbVie, Amgen, Allergan, Teva, Novo Nordisk, Eli Lilly, Bayer, Bristol-Myers Squibb, Takeda, Boehringer Ingelheim, and Astellas Pharma] (2016 Ranking).

   In India, deaths due to cancer are projected to go up by 20% to over 8.8 lakh in the next four years, according to the Indian Council of Medicinal Research.

   Due to disparities in the quality of cancer care globally, less developed regions have a higher cancer mortality rate of 66%, compared to 48% in more developed regions.

   India’s pharmaceutical industry is the third largest exchange earner (USD 10 billion in 2013-14) in the goods category, after apparels and cereals.

   India has over 850,000 private pharmacies or chemists nationwide.

   With leading brands such as Gelusil and Mucaine, Pfizer Limited has been a trusted provider for strong and effective solutions in the Antacid space for over 30 years.

   Pfizer ranks 12th in the Indian market with a sales revenue of roughly Rs 2,800 crore, according to data from AIOCD.

   As per the US FDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.

   The global branded inhaler market is estimated to be over $700 million in sales and projected to touch $3.4 billion by 2024, according to estimates by market research firm Report Buyer.

   The respiratory segment globally is dominated by Metered Dose Inhalers, with companies like Novartis and GSK cornering a large chunk of this market. The dry powder inhaler segment, a relatively newer product, is expected to grow at 16%.

   Last year, the pharmaceuticals sector witnessed 51 deals with aggregate disclosed deal value of $4.6 billion, according to an EY report titled Transactions 2017.

   Atopic dermatitis (AD), the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin.

   Diarrheal diseases were collectively responsible for 13 lakh deaths across all age groups around the world, according to the 2015 Global Burden of Disease report.

   Shigella, a bacteria that causes dysentery, reportedly resulted in 1.64 lakh deaths in total, mostly concentrated in African and South Asian regions, including India.

   Compassionate grounds refers to the use of a drug outside of a clinical trial of an investigational medical product (that is one that has not been approved by drug controller or competent authority) and under this protocol, a medical practitioner can prescribe such medicine to the needy patients.

   In 2016, a total of 17,54,957 cases of Drug Sensitive TB was reported in India.

   According to the WHO Global TB reports, the estimated proportion of multi-drug-resistant tuberculosis (MDRTB) cases in India is not increasing.

   Rabies, usually transmitted through dog bites, reports a near 100% fatality rate, and claims an estimated 59,000 lives every year.

   Every year, about 30,000 people are dying because of the mosquito-borne virus yellow fever that can cause a life-threatening infection with jaundice, systemic bleeding, shock, and organ failure.

   Ahmedabad-based Intas Pharmaceuticals is among the India’s top 10 pharma companies with Rs 6,600 crore ($1billion) revenue in FY16, and has 2.8% share of the domestic market. The company garners 60% revenue from over 70 global markets.

   India has the highest burden of worm infections in the world, with the WHO estimating 22 crore Indian children aged between 1 and 14 years at risk.

   In August 2016, the Drug Controller General of India had issued a circular to the pharmaceutical industry stipulating the deadline of January 1, 2018 for upgrading the skillsets of its employees.

   Antimicrobial resistance occurs when microorganisms such as bacteria, fungi, viruses and parasites change when exposed to drugs such as antibiotics.

   A recent survey published by the government showed that about 3% of the medicines sold in the India are substandard.

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