С какими вызовами сталкивается крупнейший в мире поставщик непатентованных лекарств


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25.08.2023 10048

Шрея Чакраборти - студентка второго курса Индийского института социального обеспечения и управления бизнесом (IISWBM) в Калькутте, Индия. Ранее она получила степень бакалавра делового администрирования, а теперь - MBA в области финансов. В настоящее время она проходит двухмесячную летнюю стажировку в Московском государственном лингвистическом университете. В рамках соглашения с Союзом журналистов России она прошла практику в Medagro.ru и подготовила цикл статей об особенностях фармацевтического рынка Индии. Сегодня мы представляем вашему вниманию первую из них.

Фармацевтическая промышленность Индии в 2021 году оценивалась примерно в 42 млрд долл., а согласно экономическому обзору 2023 года оборот фармацевтического рынка страны достигал 41 млрд долл. Фармацевтические компании Индии производят около 500 различных активных фармацевтических ингредиентов (АФИ). Более 50% потребностей Африки в непатентованных лекарствах удовлетворяется Индией, а также 40% таких же потребностей США и 25% потребностей во всех фармацевтических препаратах Великобритании. В Индии насчитывается более 3 тыс. фармацевтических компаний, 10,5 тыс. заводов по производству фармацевтических препаратов.

Страна слонов занимает третье место в мире по объему экспорта лекарств в долларовом выражении. Она является крупнейшим в мире поставщиком непатентованных лекарств (более 60 тыс. непатентованных лекарственных средств в 60 терапевтических категориях), на ее долю приходится 20% от общего объема мирового фармацевтического экспорта. Это также крупнейший в мире поставщик вакцин, на долю которого приходится свыше 50% всех вакцин, производимых в мире. Индийская фармацевтическая продукция идет на экспорты в США, Великобританию, Евросоюз, Канаду, Россию и т.д. В 2022-2023 финансовом году выручка Индии от экспорта фармпродукции составила 25,3 млрд долл. Во многом это объясняется доступностью продукции: страна имеет одни из самых низких производственных издержек в мире. 

Выручка на рынке безрецептурных фармацевтических препаратов в 2023 году составит 6 млрд долл. Ожидается, что рынок будет ежегодно расти в среднем на 7,51% в 2023-2027 годы. Крупнейшим сегментом рынка является сегмент витаминов и минералов с объемом рынка в 2 млрд долл. в 2023 году (для сравнения Китай может похвастаться 29,360 млрд долл.) При этом 15,9% от общего объема выручки будет приходиться на онлайн-продажи.

На индийском фармрынке доминируют дженерики, которые составляют почти 70% рынка, в то время как отпускаемые без рецепта лекарства и запатентованные препараты составляют до 21% и 9% соответственно.

Однако в последнее время репутация Индии глобального фармпроизводителя была серьезно подорвана. Всемирная организация здравоохранения (ВОЗ) в прошлом году обнаружила, что сиропы от кашля, выпущенные индийскими производителями, содержат опасные уровни двух известных токсинов - диэтиленгликоля и этиленгликолевой кислоты, что привело к смерти по меньшей мере 300 человек в трех странах, включая Узбекистан (прим. редакции).

В конце декабря в Узбекистане было заведено уголовное дело по факту смерти детей после приема сиропа "Док-1 Макс" и задержаны должностные лица компании-импортера Quramax Medical и Научного центра стандартизации лекарств. Тогда же Агентство по развитию фармацевтической отрасли остановило продажу всех препаратов Marion Biotech, включая "Цинепар кид", "Травамакс" и "Амбронол".

По данным ведомства, лекарства проходили лабораторные испытания в Научном центре стандартизации лекарственных средств, на них были оформлены сертификаты соответствия. Однако в процессе исследований были грубо нарушены требования нормативно-правовой документации, в результате чего некачественные препараты были допущены к реализации. В феврале стало известно, что бывший глава Фармагентства и Центра экспертизы и стандартизации лекарств заключен под стражу. Продажу сиропа "Док-1 Макс" приостановили 22 декабря 2022 года, однако рассылку с призывом не покупать этот препарат Минздрав провел спустя лишь неделю. Возглавлявший тогда министерство здравоохранения Бехзод Мусаев говорил, что информацию о смерти детей после приема сиропа "Док-1 Макс" скрывали от Минздрава.

11 августа Ташкентский городской суд начал рассмотрение этого уголовного дела. На скамье подсудимых 21 человек (16 мужчин и 5 женщин). Им предъявлены обвинения по ряду статей Уголовного кодекса, в том числе уклонение от уплаты налогов, злоупотребление полномочиями, получение и дача взятки, производство, изготовление, приобретение, хранение, перевозка в целях сбыта или сбыт недоброкачественных либо фальсифицированных лекарственных средств или изделий медицинского назначения.

В самой Индии были проведены собрания, встречи и совещания, и принято решение взять под особый контроль соблюдение предприятиями требований Индийской фармакопеи (IP). 

Некоторые проблемы, с которыми сталкивается индийская фармацевтическая промышленность, дефицит квалифицированных специалистов, высокая конкуренция за них, текучесть кадров, зарегулированность отрасли. Так, индийское правительство действительно регулирует цены на лекарства через Национальное управление по ценообразованию на фармацевтические препараты (NPPA). Этот регулирующий орган отвечает за контроль цен на основные лекарственные средства, предотвращение монополистической практики, стимулирование конкуренции, чтобы основные лекарства оставались доступными для граждан. При этом сами производители жалуются на уменьшение прибыли. 

Участники рынка среди проблем отмечают патентные споры, недостаточный объем инвестиций в исследования и разработки для создания новых и инновационных лекарственных средств, усиление конкуренции со стороны других стран. Экологическая устойчивость: баланс между воздействием фармацевтического производства на окружающую среду и утилизацией отходов приобретает все большее значение. 

Чтобы обеспечить большую устойчивость к внешним потрясениям, усилить лекарственную безопасность и увеличить возможности внутреннего производства как жизненно важных массовых лекарств, так и продуктов с высокой добавленной стоимостью, Департамент фармацевтики запустил три программы поддержки. Они призваны стимулировать глобальных и отечественных игроков к увеличению инвестиций и производства в этих категориях продуктов.

Шрея Чакраборти

RESEARCH ON DRUG INDUSTRY IN INDIA

The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021. India is the world's largest provider of generic medicine by volume, with a 20% share of total global pharmaceutical exports. It is also the largest vaccine supplier in the world by volume, accounting for more than 50% of all vaccines manufactured in the world. Indian pharmaceutical products are exported to various regulated markets including the US, UK, European Union and Canada. 

According to Economic Survey 2023 the turnover in the domestic pharmaceutical market was estimated to be $41 billion. India's pharmaceutical exports revenue was $25.3 billion in fiscal year 2022–23. India ranked third globally in terms of dollar value of drugs and medicines exports.  

As of 2023, the Indian pharmaceutical industry is the world's 13th largest by value and third largest in the world by volume. The industry produces over 60,000 generic drugs in different 60 therapeutic categories. India's revenue from pharmaceutical exports was $25.3 billion in the 2022-2023 financial year. In terms of the global market, India currently holds an accountable share and is known as the pharmacy of the world. The country is the largest global supplier of generic medicine.] India produces more than 50% the world's vaccines. 

The Goods and Services Tax (GST) is a historic step taken by the Government of India to boost the GDP and introduce a more effective tax regime. GST is a win-win deal for the whole country. It brings benefits to all stakeholders from industry, government and consumer. It will reduce the cost of goods and services to boost the economy and make products and services globally competitive. By subsuming most central and state taxes into a single tax and allowing set-off of pre-stage taxes for transactions across the value chain, it will reduce the ill effects of cascading and improve the competitiveness and liquidity of businesses. Article 246A stipulates that Parliament and the Legislature of every State have power to make laws with respect to goods and services tax imposed by the Union or by such State. Article 269A of the Constitution stipulates that Goods and Services Tax on supplies in the course of inter-State trade or commerce shall be levied and collected by the Government of India and such tax shall be apportioned between the Union and the States in the manner as may be provided by Parliament by law on the recommendations of the Goods and Services Tax Council GST is a destination-based tax, and it will be levied on the value of goods or services that are consumed within the territory of India. Tax will be collected by the person who is responsible for the final consumption of the goods or services.

The Indian pharmaceutical industry is the 3-largest in the world by volume and valued at $50 bn. The country contributes 3.5% of total drugs and medicines exported globally to over 200 countries. To ensure greater resilience to external shocks, enforce greater drug security and boost the capacity for domestic production for critical bulk drugs and high-value products alike, the Department of Pharmaceuticals has launched 3 supporting schemes to incentivize the global and domestic players to enhance investment and production in these product categories.

The Schemes are envisioned to ensure greater resilience of the Indian pharmaceutical industry to external shocks and contribute significantly to achieving a higher objective of affordable healthcare in the country and globally on a sustained basis.

It is also the world's largest vaccine supplier by volume, accounting for over 50% of all vaccines manufactured in the world. With mega production capabilities at par with industry standards and a large number of skilled domestic workforce, Indian exports meet the standards and requirements of the highly regulated markets of USA, UK, EU and Canada. By 2021, the majority of pharmaceuticals made in India will be low-cost generic drugs comprising the majority of India's pharmaceutical exports. Patented medicines are imported. APIs are imported from China (60% of supplies by volume at US$2.4 billion) and revenue in the OTC Pharmaceuticals market amounts to US$6bn in 2023. The market is expected to grow annually by 7.51% (CAGR 2023-2027).

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Revenue in the OTC pharmaceuticals market amounts to US $6bn in 2023. The market is expected to grow annually by 7.51% (CAGR 2023-2027). The market's largest segment is the segment Vitamins & Minerals with a market volume of US $2bn in 2023. In global comparison most revenue is generated in China (US $29,360 m in 2023). In relation to total population figures, per person revenues of US$4.32 are generated in 2023.In the OTC Pharmaceuticals market, 15.9% of total revenue will be generated through online sales by 2023.

The Indian pharmaceutical market is dominated by generic drugs which constitute nearly 70% of the market, whereas Over the Counter medicines and patented drugs make up to 21% and 9% respectively.

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PHARMACEUTICAL EXPORTS AND ADVANTAGE INDIA

Pharmaceutical export from India stood at US$ 17.27 billion in 2017-18 and is expected to grow by 30% to reach the US $20 billion by the year 2020. Exports of pharmaceutical products together stood at US$ 10.80 billion during April-October 2018. During April-October 2018 top importers of India’s pharmaceutical* products were USA (US$ 3.21 billion), UK (US$ 383.30 million), South Africa (US$ 367.35 million), Russia (US$ 283.33 million) and Nigeria (US$ 255.89 million). 

India is the largest supplier of generic medicines globally (20 to 22% of global export volume). India has one of the lowest manufacturing costs in the world. It is lower than that of the USA and almost half of Europe.

India is well-known for establishing a strong foothold in the global pharmaceutical business. It has expanded considerably in recent years. There are over 60,000 generic brands in 60 therapeutic areas. India’s pharma companies generate about 500 different active pharmaceutical ingredients (APIs). Over 50% of Africa’s need for generic drugs is met by India, as is 40% of generic drug requirements in the US and 25% of all pharmaceuticals in the UK. India has over 3,000 pharmaceutical companies. The pharma sector owns 10,500 production plants for pharmaceuticals and is currently worth $11 billion.

Here, we’ve included a listing of some of the top pharmaceutical firms operating in India that produce excellent drugs and dominate the country’s pharmaceutical industry on the basis of their revenues.

1.Sun Pharmaceutical Industries

Founded:1983 Headquarters: Mumbai Revenue: $5.2 billion (2022)

It was founded by Dilip Sanghvi. The company holds the top position on the list of the largest pharmaceutical companies in India. The company produces and markets active pharmaceutical ingredients and pharmaceutical preparations worldwide. The active pharmaceutical ingredients include baricitinib, brivaracetam, and dapagliflozin, and they cater to a wide range of therapeutic niches.

2.Aurobindo Pharma Limited

Founded:1986 Headquarters: Hyderabad Revenue: US$3.04 billion (2022)

In 1986, it was founded by V. Ramprasad Reddy and K. Nityananda Reddy. The business produces both active medicinal components and generic medications. Six key therapeutic and product areas make up the company’s field of operation: gastroenterology, allergy and immunologyantiretrovirals, cardiovascular products, and medicines for the central nervous system. These goods are sold by the firm in more than 125 nations. Its marketing collaborators include Pfizer and AstraZeneca. In 2022, the corporation generated revenues of $3.04 billion.

3.Reddy’s Laboratories

Founded:1984 Headquarters: Hyderabad Revenue: $2.9 billion (2022).

It began manufacturing active medicinal components in 1984. Dr. Reddy’s laboratories produce and sell a variety of medications both nationally and internationally. Over 190 drugs and 60 active pharmaceutical ingredients (APIs) for the production of pharmaceuticals, test equipment, critical care, and biotechnology are all available from the company. Canagliflozin is one of Dr. Reddy’s well-known products. Naproxen sodium, atorvastatin, ibuprofen, naproxen, and ramipril are a few more. In 2022, the company generated

$2.9 billion in revenue.

4.Cipla

Founded:1935 Headquarters: Mumbai Revenue: US$2.7 billion (2022).

Khwaja Abdul Hamied established it as “The Chemical, Industrial, and Pharmaceutical Laboratories” in 1935. Cipla aims to create medications to treat a variety of illnesses, including arthritis, depression, respiratory problems, and many others. Cipla offers its pharmaceuticals in 86 countries and has 47 manufacturing facilities across the world.

The company’s revenue estimate for 2022 was $2.7 billion.

5.Lupin Limited

Founded:1968 Headquarters: Mumbai Revenue: US$2.1 billion (2022).

In 1968, Desh Bandhu Gupta founded Lupin. It is one of the well-known pharmaceutical producers in India. In 2022, Lupin will have revenues of $2.1 billion. The business produces and sells medications for a variety of conditions, including asthma, diabetes, cardiovascular disease, anti-infectives, and tuberculosis. The USA, India Region Formulations, Europe, Japan, South Africa, Australia, the Philippines, Mexico, Latin America, and other regions are Lupin Limited’s main markets.

6.Cadila Healthcare Limited

Founded: 1952 Headquarters: Ahmedabad Revenue: US$1.9 billion (2022).

It is a pharmaceutical firm with its main office in Ahmedabad, India. It is among the biggest pharmaceutical firms in India and generated $1.9 billion in revenue in 2022. Ramabhai Patel established the organization. Zydus Cadila creates and produces a wide variety of medications, diagnostics, herbal remedies, cosmetics items, and other over-the-counter (OTC) goods.

7.Glenmark Pharmaceuticals

Founded:1977 Headquarters: Mumbai Revenue: US $1.5 billion (2022).

It was founded by Gracias Saldanha and has its roots in Mumbai, India. Glenmark was established with the goal of becoming a major, integrated, research-based global pharmaceutical corporation and has customers in many countries. This pharmaceutical business specializes in drug discovery, which is significant in the therapeutic areas of dermatology, respiratory medicine, and oncology. In 2022, the company generated $1.5 billion in revenue.

8.Alkem Laboratories

Founded: 1959 Headquarters: Mumbai Revenue: US$1.4 billion (2022).

The brand offers high-quality labelled generics, generic pharmaceuticals, medicinal products, and health supplements in India and over 50 countries worldwide. It also supplies in Germany, Australia, South-East Asia, the United States, the United Kingdom, Russia-CIS, and Africa. The company offers medications for various conditions, including disorders of the central nervous system, gastrointestinal illnesses, and, metabolic diseases including diabetes, cancer, etc. In 2022, the company generated $1.4 billion in revenue.

9.Divi Laboratories Limited

Founded:1990 Headquarters: Hyderabad Revenue: US$1.1 billion (2022). Worldwide pharmaceutical firm based in India, Divi’s Laboratories Limited manufactures intermediates and active pharmaceutical components. Murali Devi started Divi Laboratories Limited, which offers products in various countries, including Japan, the USA, Australia, South Africa, and the Philippines. In 2022, the company generated $1.1 billion in revenue.

10.Torrent Pharma

Founded:1959 Headquarters: Ahmedabad Revenue: US$1.1 billion (2022).

Torrent is among the leading pharmaceutical firms in India and was started by Sudhir Mehta. Its headquarters are in Ahmedabad, and as of 2022, it generated US$1.1 billion in revenue. More than 40 countries are served by Torrent Pharmaceuticals, which has more than 2000 registered products worldwide. Cardiovascular (CV), central nervous system (CNS), gastroenterology, diabetology, anti-infective, and pain management therapeutic areas are active for Torrent Pharma.

India is considering a change to its pharmaceutical industry policy after cough syrups made in the country were linked to the deaths of children overseas, according to a document from Prime Minister Narendra Modi's office, which noted that "important things" about the industry had been "overlooked".

A brainstorming session was held in the southern Indian city of Hyderabad "to find a solution to exported cough syrups that killed children," Modi's office said in the document dated May 15 and reviewed by Reuters. The World Health Organization (WHO) found last year that cough syrups made by an Indian drugmaker contained dangerous levels of two known toxins, diethylene glycol and ethylene glycol, leading to the deaths of at least 70 children. 

India has acted against a second Indian company whose cough syrups were linked to the deaths of 19 kids in Uzbekistan, including the arrest of three of its employees. A third Indian drugmaker was found by the WHO to have sold tainted syrups to the Marshall Islands and Micronesia. An Indian representative participated in a meeting of global drug regulators in Indonesia earlier this month to discuss ways to ensure the safety of the pharmaceutical supply chain. According to an advisory sent by Indian regulator CDSCO to all states on April 21 and seen by Reuters, drug officials must ensure that drugs meet the standards of the Indian Pharmacopoeia (IP).

The CDSCO said it was reiterating the need for standards after receiving a public complaint about the standards of drug ingredients in the country. It did not say who filed the complaint.

Some challenges in the Indian pharmaceutical industry's workforce include talent shortages, skill gaps, regulatory complexities, and the need for continuous upskilling due to rapidly evolving technologies and research. Additionally issues related to employee retention, high competition for skilled professionals, and maintaining stringent quality standards are also prevalent. 

The Indian pharmaceutical industry has been known for its significant pool of skilled professionals, including scientists, researchers, pharmacists, and other specialists. However, the availability of specialists can vary based on the specific subfields within the industry and the ongoing demand for certain expertise. For the most accurate and up-to-date information, I recommend checking recent industry reports or news sources.

The Indian government does regulate the prices of drugs through the National Pharmaceutical Pricing Authority (NPPA). This regulatory body is responsible for controlling the prices of essential medicines to ensure affordability and accessibility for the general population. The regulation of drug prices is aimed at preventing monopolistic practices, promoting competition, and ensuring that essential medications remain affordable for the citizens. By regulating drug prices, the Indian government seeks to strike a balance between the interests of pharmaceutical companies and the public's need for affordable healthcare. This helps in making critical medications accessible to a larger section of the population, especially those who might not be able to afford expensive treatments otherwise. The NPPA is responsible for fixing the prices of essential medicines to ensure their affordability and accessibility to the general population. The government can also intervene in exceptional cases to regulate the prices of certain non-essential medicines to prevent excessive pricing and ensure that they remain affordable for the public. 

The Indian pharmaceutical industry faced several challenges, including:

Intellectual Property Issues: The industry has faced issues related to intellectual property rights and patent disputes, which can affect the development and availability of generic drugs.

Regulatory Compliance: Meeting the stringent regulatory requirements of different countries can be challenging and time-consuming, impacting export opportunities.

Quality Control: Ensuring consistent quality across a wide range of products is crucial. Instances of substandard or counterfeit drugs have raised concerns.

Price Control and Pricing Pressure: While price regulation ensures affordability, it can impact profit margins for companies. Balancing quality, innovation, and cost-effectiveness becomes a challenge.

R&D and Innovation: The industry has traditionally been strong in generic manufacturing, but there's a growing need to invest in research and development for new drug discovery and innovation.

Global Competition: The industry faces competition from other countries, especially in the generics market. Competing with low-cost manufacturing nations can be a challenge.

Skilled Workforce: While India has a skilled workforce, attracting and retaining talent, especially in research and development, can be a challenge.

Data Security and Privacy: With increasing digitalization, protecting sensitive patient data and complying with global data privacy regulations is essential.

Environmental Sustainability: Balancing the environmental impact of pharmaceutical manufacturing and waste disposal is gaining importance.

Changing Healthcare Landscape: As healthcare systems evolve, pharmaceutical companies need to adapt to changing reimbursement models and patient preferences

Shreya Chakraborty 

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