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The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021.
India India, officially the Republic of India ( Hindi: ), is a country in South Asia. It is the seventh-largest country by area, the second-most populous country, and the most populous democracy in the world. Bounded by the Indian Ocean on the ...
is the world's largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports. It is also the largest
vaccine A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified.
supplier in the world by volume, accounting for more than 50% of all vaccines manufactured in the world. With industry standards compliant mega production capabilities and large number of skilled domestic workforce, Indian exports meet the standards and requirements of highly regulated markets of USA, UK, European Union and Canada. According to the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, domestic pharmaceutical market turnover reached Rs 129,015 crore (US$18.12 billion) in 2018, growing 9.4 per cent year-on-year and exports revenue was US$17.28 billion in FY18 and US$19.14 billion in FY19. As of 2021, most of pharmaceuticals made in India are low cost generic drug which comprise most of pharmaceutical export of India. Patented medicines are imported. APIs are imported from China (60% supplies by volume worth US$2.4 billion) and Germany (US$1.6 billion) as well as from US, Italy and Singapore. To foster an Atmanirbhar Bharat by enhancing the R&D, Make in India product development and high-value production capabilities, import substitution and domestic manufacture of
active pharmaceutical ingredient An active ingredient is any ingredient that provides biologically active or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans or animals. The ...
(API) the government has introduced a US$2 billion incentive program which will run from 2021–22 to 2027–28. In 2019 the Department of Pharmaceuticals announced that as part of the Make in India initiative, drugs for local use and exports must have 75% and 10% local APIs respectively and a bill of material must be produced for verification. During 2018–2021, India ranked third globally in terms of dollar value of drugs and medicines exports. Major pharmaceutical hubs in India are (clockwise from northwest):
Vadodara Vadodara (), also known as Baroda, is the second largest city in the Indian state of Gujarat. It serves as the administrative headquarters of the Vadodara district and is situated on the banks of the Vishwamitri River, from the state capital ...
,
Ahmedabad Ahmedabad ( ; Gujarati: Amdavad ) is the most populous city in the Indian state of Gujarat. It is the administrative headquarters of the Ahmedabad district and the seat of the Gujarat High Court. Ahmedabad's population of 5,570,585 (p ...
,
Ankleshwar Ankleshwar (sometimes written Ankaleshwar) is a city and a municipality in Bharuch district in the state of Gujarat, India. The city is located 14 kilometres from Bharuch. Ankleshwar Industrial Association (AIA) is the largest organisation of t ...
,
Vapi Vapi (IAST: vāpī,), is a city and municipality in Valsad district in the state of Gujarat, India.It is situated near the banks of the Daman Ganga River, around 28 km south of the district headquarters in the city of Valsad, and it is ...
, Baddi,
Sikkim Sikkim (; ) is a state in Northeastern India. It borders the Tibet Autonomous Region of China in the north and northeast, Bhutan in the east, Province No. 1 of Nepal in the west and West Bengal in the south. Sikkim is also close to the Silig ...
,
Kolkata Kolkata (, or , ; also known as Calcutta , the official name until 2001) is the capital of the Indian state of West Bengal, on the eastern bank of the Hooghly River west of the border with Bangladesh. It is the primary business, comm ...
,
Visakhapatnam , image_alt = , image_caption = From top, left to right: Visakhapatnam aerial view, Vizag seaport, Simhachalam Temple, Aerial view of Rushikonda Beach, Beach road, Novotel Visakhapatnam, INS Kursura submarine museu ...
,
Hyderabad Hyderabad ( ; , ) is the capital and largest city of the Indian state of Telangana and the ''de jure'' capital of Andhra Pradesh. It occupies on the Deccan Plateau along the banks of the Musi River, in the northern part of Southern India. ...
,
Bangalore Bangalore (), officially Bengaluru (), is the capital and largest city of the Indian state of Karnataka. It has a population of more than and a metropolitan population of around , making it the third most populous city and fifth most ...
,
Chennai Chennai (, ), formerly known as Madras ( the official name until 1996), is the capital city of Tamil Nadu, the southernmost Indian state. The largest city of the state in area and population, Chennai is located on the Coromandel Coast of t ...
,
Margao Margao or Madgaon is the commercial capital of the Indian state of Goa. It stands on banks of the Sal river and is the administrative headquarters of Salcete sub-district and South Goa district. It is Goa's second largest city by population af ...
,
Navi Mumbai Navi Mumbai (), is a planned city situated on the west coast of the Indian subcontinent, located in the Konkan division of Maharashtra state, on the mainland of India. Navi Mumbai is part of the Mumbai Metropolitan Region (MMR). The city is ...
,
Mumbai Mumbai (, ; also known as Bombay — the official name until 1995) is the capital city of the Indian state of Maharashtra and the '' de facto'' financial centre of India. According to the United Nations, as of 2018, Mumbai is the secon ...
,
Pune Pune (; ; also known as Poona, ( the official name from 1818 until 1978) is one of the most important industrial and educational hubs of India, with an estimated population of 7.4 million As of 2021, Pune Metropolitan Region is the largest i ...
and
Aurangabad Aurangabad ( is a city in the Indian state of Maharashtra. It is the administrative headquarters of Aurangabad district and is the largest city in the Marathwada region. Located on a hilly upland terrain in the Deccan Traps, Aurangabad is the ...
.


Overview


Summary

, over 20,000 registered drug-manufacturers in India sold $9 billion worth of
formulations Formulation is a term used in various senses in various applications, both the material and the abstract or formal. Its fundamental meaning is the putting together of components in appropriate relationships or structures, according to a formul ...
and bulk drugs. 85% of these formulations were sold in India while over 60% of the bulk drugs were exported, mostly to the United States and to Russia. Most of the players in the market are small-to-medium enterprises; 250 of the largest companies control 70% of the Indian market. Thanks to the 1970 Patent Act, multinationals represent only 35% of the market, down from 70% thirty years ago. Most pharma companies operating in India, even the multinationals, employ Indians almost exclusively from the lowest ranks to high-level management. Homegrown pharmaceuticals, like many other businesses in India, are often a mix of public and private enterprise. In terms of the global market, India currently holds an accountable share and is known as the pharmacy of the world and as the biggest
generic Generic or generics may refer to: In business * Generic term, a common name used for a range or class of similar things not protected by trademark * Generic brand, a brand for a product that does not have an associated brand or trademark, other ...
supplier. India produces more than 50% the world's vaccines and is the third largest pharmaceutical producer by volume. It supplies 40% of the US's demand for generic drugs. India gained its foothold on the global scene with its innovatively-engineered generic drugs and active pharmaceutical ingredients (API), The country accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$70–80 billion US generics market. Growth in other fields notwithstanding, generics are still a large part of the picture. India is the largest provider of generic drugs globally. The Indian pharmaceutical-sector industry supplies over 50 per cent of global demand for various vaccines, 40 per cent of generic demand in the US and 25 per cent of all medicine in the UK. India is the largest contributor in UNESC with over 50-60% share.


Industry sector development


Government intervention

The Indian government established the Department of Biotechnology in 1986 under the Ministry of Science and Technology. Since then, there have been a number of dispensations offered by both the central government and various states to encourage the growth of the industry. India's science minister launched a program that provides tax incentives and grants for biotech start-ups and firms seeking to expand and establishes the Biotechnology Parks Society of India to support ten biotech parks by 2010. Previously limited to rodents, animal testing was expanded to include large animals as part of the minister's initiative. States have started to vie with one another for biotech business, and they are offering such goodies as exemption from VAT and other fees, financial assistance with patents and subsidies on everything ranging from investment to land to utilities. The Government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970. The government has addressed the problem of educated but unqualified candidates in its Draft National Biotech Development Strategy. This plan included a proposal to create a National Task Force that will work with the biotech industry to revise the curriculum for undergraduate and graduate study in life sciences and biotechnology. The government's strategy also stated intentions to increase the number of PhD Fellowships awarded by the Department of Biotechnology to 200 per year. These human resources will be further leveraged with a "Bio-Edu-Grid" that will knit together the resources of the academic and scientific industrial communities, much as they are in the US. The biotechnology sector faces some major challenges in its quest for growth. Chief among them is a lack of funding, particularly for firms that are just starting out. The most likely sources of funds are government grants and venture capital, which is a relatively young industry in India. Government grants are difficult to secure, and due to the expensive and uncertain nature of biotech research, venture capitalists are reluctant to invest in firms that have not yet developed a commercially viable product.


Incentives for R&D, product development and high-value production

Government of India has launched a Production Linked Incentive (PLI) Scheme for Pharmaceuticals with provision for disbursal of US$2 billion or iNR 15,000 crore government incentives, which will run from 2020–21 to 2028–29, to reduce import dependence, benefit domestic manufacturers, boost product diversification and innovation for development of complex and high-tech products especially in
in vitro ''In vitro'' (meaning in glass, or ''in the glass'') studies are performed with microorganisms, cells, or biological molecules outside their normal biological context. Colloquially called " test-tube experiments", these studies in biology ...
diagnostic devices and emerging technologies especially in cell based or gene therapy, employment generation and production of wide range of lower cost affordable medicines for consumers with the aim to achieve incremental sales of US$4 billion or INR 294,000 crore and incremental exports of US$2.7 billion or INR 196,000 crore between 2022–23 to 2027–28.Cabinet approves Production Linked Incentive Scheme for Pharmaceuticals
Press Information Bureau of India, 24 Feb 2021.


Manufacture of API supplies in India

To eliminate the dependence on China after the 2017 China–India border standoff to foster an Atmanirbhar Bharat, in July 2021 India's
Council of Scientific and Industrial Research The Council of Scientific and Industrial Research (IAST: ''vaigyanik tathā audyogik anusandhāna pariṣada''), abbreviated as CSIR, was established by the Government of India in September 1942 as an autonomous body that has emerged as the ...
(CSIR) initiated a Make in India program in collaboration with the
coal Coal is a combustible black or brownish-black sedimentary rock, formed as rock strata called coal seams. Coal is mostly carbon with variable amounts of other elements, chiefly hydrogen, sulfur, oxygen, and nitrogen. Coal is formed when dead ...
and
petroleum Petroleum, also known as crude oil, or simply oil, is a naturally occurring yellowish-black liquid mixture of mainly hydrocarbons, and is found in geological formations. The name ''petroleum'' covers both naturally occurring unprocessed crude ...
industries of India to end-to-end manufacture 56 prioritised
active pharmaceutical ingredient An active ingredient is any ingredient that provides biologically active or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans or animals. The ...
(API) for the
essential medicines Essential medicines, as defined by the World Health Organization (WHO), are the medicines that "satisfy the priority health care needs of the population". These are the medications to which people should have access at all times in sufficient a ...
. In 2016–17, China was the largest supplier of API to India with 66% share by volume of API raw material supplies to India worth US$2.4 billion or INR 18,000 crore, followed by US$1.6 billion API imported from Germany, the US, Italy and Singapore are other major suppliers to India.CSIR working on making 56 bulk drugs in India as Modi govt wants to cut imports from China
The Print, 3 July 2021.


Foreign investment

Per India's Consolidated FDI Policy, 2020 (the “FDI Policy”), foreign direct investment (“FDI”) in the pharmaceutical sector in greenfield (new) projects is permitted up to 100% without the approval of the Department of Pharmaceuticals (the “DoP”). In brownfield (existing) projects, FDI exceeding 74% requires the investor to seek prior approval from the DoP in compliance with the prescribed conditions under the FDI Policy. Separately, FDI up to 100% is permitted for the manufacturing of medical devices for both greenfield and brownfield projects without the approval of the DoP. An FDI approval from the DoP can be obtained within a period of ten to twelve weeks from the date of the application, depending on the completeness of the documentation submitted by the investor in support of the application, failing which, this timeline could vary.


Relation between pharma and biotech

India's
biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...
industry clocked a 17% growth with revenues of Rs. 137 billion ($1.8 billion) in the 2009-10 financial year over the previous fiscal. Bio-pharma was the biggest contributor generating 60 percent of the industry's growth at Rs. 8,829 crore, followed by bio-services at Rs. 2,639 crore and bio-agri at Rs. 1,936 crore. Indian companies carved a niche in both the Indian and world markets with their expertise in reverse-engineering new processes for manufacturing drugs at low costs which became the advantage for industry. Unlike in other countries, the difference between biotechnology and pharmaceuticals remains fairly defined in India, with biotech a much smaller part of the economy. India accounted for 2% of the $41 billion global biotech market and in 2003 was ranked 3rd in the Asia-Pacific region and 13th in the world in number of biotech. In 2004–5, the Indian biotech industry saw its revenues grow 37% to $1.1 billion. The Indian biotech market is dominated by biopharmaceuticals; 76% of 2004–5 revenues came from biopharmaceuticals, which saw 30% growth last year. Of the revenues from biopharmaceuticals, vaccines led the way, comprising 47% of sales. Biologics and large-molecule drugs tend to be more expensive than small-molecule drugs, and India hopes to sweep the market in bio-generics and contract manufacturing as drugs go off patent and Indian companies upgrade their manufacturing capabilities. Most companies in the biotech sector are extremely small, with only two firms breaking 100 million dollars in revenues. At last count there were 265 firms registered in India, over 92% of which were incorporated in the last five years. The newness of the companies explains the industry's high consolidation in both physical and financial terms. Almost 30% of all biotech are in or around Bangalore, and the top ten companies capture 47% of the market. The top five companies were homegrown; Indian firms account for 72% of the bio-pharma sector and 52% of the industry as a whole. ,46The Association of Biotechnology-Led Enterprises (ABLE) is aiming to grow the industry to $5 billion in revenues generated by 1 million employees by 2009, and data from the Confederation of Indian Industry (CII) seem to suggest that it is possible.


Comparison with the United States

The Indian biotech sector parallels that of the US in many ways. Both are filled with small start-ups while the majority of the market is controlled by a few powerful companies. Both are dependent upon government grants and venture capitalists for funding because neither will be commercially viable for years. Pharmaceutical companies in both countries see growth potential in biotechnology and have either invested in existing start-ups or ventured into the field themselves.


Research and product development


Product development

Indian companies are also starting to adapt their product development processes to the new environment. For years, firms have made their ways into the global market by researching generic competitors to patented drugs and following up with litigation to challenge the patent. This approach remains untouched by the new patent regime and looks to increase in the future. However, those that can afford it have set their sights on an even higher goal: new molecule discovery. Although the initial investment is huge, companies are lured by the promise of hefty profit margins and thus a legitimate competitor in the global industry. Local firms have slowly been investing more money into their R&D programs or have formed alliances to tap into these opportunities.


Patents

In 1970,
Indira Gandhi Indira Priyadarshini Gandhi (; ''née'' Nehru; 19 November 1917 – 31 October 1984) was an Indian politician and a central figure of the Indian National Congress. She was elected as third prime minister of India in 1966 and was al ...
enacted legislation which barred medical products from being patented in the country. In 1994, 162 countries including India signed the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which stipulated that patents had to be given to all inventions including medicines. India and other developing countries were provided an extra ten years to comply fully with the conditions mandated by TRIPS. India succeeded in including a crucial clause to the agreement in the form of the right to grant
compulsory license A compulsory license provides that the owner of a patent or copyright licenses the use of their rights against payment either set by law or determined through some form of adjudication or arbitration. In essence, under a compulsory license, an i ...
s (CLs) to others to manufacture drugs in cases where the government felt that the patent holder was not serving the public health interest. This right was used in 2012, when Natco was granted a CL to produce Nexavar, a cancer drug. In 2005, a provision was added to the new legislation as section 3(d) which stipulated that a medicine could not be patented if it did not result in "the enhancement of the known efficacy of that substance". A significant change in intellectual property protection in India was 1 January 2005 enactment of an amendment to India's
patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...
law that reinstated product patents for the first time since 1972. The legislation took effect on the deadline set by the WTO's Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which mandated patent protection on both products and processes for a period of 20 years. Under this new law, India will be forced to recognise not only new patents but also any patents filed after 1 January 1995. In December 2005, the TRIPS pact was amended to incorporate specific safeguards to ensure that the public health concerns of affordability and accessibility for a large section of people in developing countries was not compromised. These amendments came into force only in January 2017, however, after two-thirds of the member countries ratified them. In the domestic market, this new patent legislation has resulted in fairly clear segmentation. The multinationals narrowed their focus onto high-end patents who make up only 12% of the market, taking advantage of their newly bestowed patent protection. Meanwhile, Indian firms have chosen to take their existing product portfolios and target semi-urban and rural populations.


Types of companies

The Indian pharmaceutical industry has 5 important segments; contract research and manufacturing services (CRAMS), active pharmaceutical ingredients (APIs),
formulations Formulation is a term used in various senses in various applications, both the material and the abstract or formal. Its fundamental meaning is the putting together of components in appropriate relationships or structures, according to a formul ...
,
biologics A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...
and
biosimilar A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved ...
s, and
vaccine A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified.
s. Various types of companies are within these segments.


Formulations

India is considered globally as a high-quality generic medicines manufacturer. Most of India's largest pharmaceutical companies manufacture and export generic medicines, and are among the largest generic medicine companies globally. These companies include
Sun Pharma Sun Pharmaceutical Industries Limited ( d/b/a Sun Pharma) is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) in more ...
, which is India's largest and the world's fourth largest specialty generics pharmaceutical company. Cipla, another large Indian pharmaceutical company, is noted for its pioneering role in manufacturing and exporting low-cost generic HIV/AIDS drugs to developing countries. As of 2021,
Lupin ''Lupinus'', commonly known as lupin, lupine, or regionally bluebonnet etc., is a genus of plants in the legume family Fabaceae. The genus includes over 199 species, with centers of diversity in North and South America. Smaller centers occur ...
is the third largest pharmaceutical company in the
United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territo ...
by prescriptions.


Active pharmaceutical ingredients (APIs)

As of 2021, India's APIs market is worth $11.8 billion and is forecasted to grow at a compound annual growth rate of 12.24% until 2027. Several Indian companies manufacture APIs. One of India's largest pharmaceutical companies, Divi's Laboratories, is the world's largest manufacturer of more than 10 generic APIs. Laurus Labs supplies APIs to 9 out of the 10 largest generic pharmaceutical companies, and is a leading producer of APIs for
antiretroviral The management of HIV/AIDS normally includes the use of multiple antiretroviral drugs as a strategy to control HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life-cycle. The use of multip ...
,
cardiovascular The blood circulatory system is a system of organs that includes the heart, blood vessels, and blood which is circulated throughout the entire body of a human or other vertebrate. It includes the cardiovascular system, or vascular system, tha ...
and
oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''� ...
drugs. Piramal Pharma, a company that is part of the
Piramal Group The Piramal Group is an Indian multinational conglomerate that has presence across various sectors such as healthcare, life sciences, drug discovery, financial services, alternative investment and real estate. History In the early 1980s, Aja ...
, develops and manufactures
peptide Peptides (, ) are short chains of amino acids linked by peptide bonds. Long chains of amino acids are called proteins. Chains of fewer than twenty amino acids are called oligopeptides, and include dipeptides, tripeptides, and tetrapeptides. A ...
APIs.


Contract research and manufacturing services (CRAMS)

India has a rapidly growing CRAMS sector. Several Indian companies offer CRAMS services, which also includes contract development and manufacturing (CDMO) services. Most of India's CRAMS companies and contract manufacturing organizations (CMO) operate in the
small molecule Within the fields of molecular biology and pharmacology, a small molecule or micromolecule is a low molecular weight (≤ 1000 daltons) organic compound that may regulate a biological process, with a size on the order of 1 nm. Many drugs are ...
s segment. Laurus labs offers biologics and fermentation CDMO services. Divi's Laboratories's CDMO client's include 6 of the top 10 largest multinational pharmaceutical companies. Syngene, a subsidiary of Biocon, offers CRAMS small molecules APIs and
biologics A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...
. Piramal Pharma, through its investment in Yapan Bio offers CDMO services for biologics which include vaccines, gene therapies, and
monoclonal antibodies A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies ...
. Suven Pharmaceuticals offers services across the entire CDMO value chain with both intermediates & API related CDMO services. The company is also among the top five CDMO companies in India who supply high quality intermediaries to innovator companies.


Biologics and biosimilars

As of 2021, India controls only 8% of the world's
biopharmaceutical A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...
market. India's domestic biosimilars market is projected to be valued at US$35 billion by 2030. Biocon is India's largest and fully-integrated biopharmaceutical company. In 2021, Biocon Biologics, a subsidiary of Biocon, received USFDA approval for Semglee, which is the first interchangeable biosimilar
insulin glargine Insulin glargine, sold under the brand name Lantus among others, is a long-acting modified form of medical insulin, used in the management of type I and type II diabetes. It is typically the recommended long acting insulin in the United Kin ...
. Another subsidiary of Biocon, Biocon Sdn Bhd, built Asia's largest integrated insulin manufacturing and R&D facility in Malaysia, with a $300 million investment. Sun Pharma has stated that it intends to look at opportunities in third wave of bio-pharmaceuticals that are going off patent in 2026–27. Intas Pharmaceuticals is a large company in the global biosimilar
monoclonal antibodies A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies ...
market.


Vaccines

As of 2021, India is the world's largest manufacturing region for vaccines. In 2021, the
World Health Organization (WHO) The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of ...
stated that India has more than a 40% of the global market share in vaccines.
Serum Institute of India Serum Institute of India (SII) is an Indian biotechnology and biopharmaceuticals company, based in Pune. It is the world's largest manufacturer of vaccines. It was founded by Cyrus Poonawalla in 1966 and is a part of Cyrus Poonawalla Group. ...
(SII) is the world's largest vaccine manufacturer by volume. SII manufactured Covishield, the Oxford-AstraZeneca COVID-19 vaccine, which is the most administered COVID-19 vaccine in India. SII and MassBiologics, part of the
University of Massachusetts Chan Medical School The University of Massachusetts Chan Medical School is a public medical school in Worcester, Massachusetts. It is part of the University of Massachusetts system. It is home to three schools: the T.H. Chan School of Medicine, the Morningside Gr ...
, developed Rabishield, a first of its kind rabies human monoclonal antibody.
Bharat Biotech Bharat Biotech International Limited (BBIL) is an Indian multinational biotechnology company headquartered in the city of Hyderabad, India engaged in the drug discovery, drug development, manufacture of vaccines, bio-therapeutics, pharmaceuti ...
, in collobartion with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), developed
Covaxin Covaxin (codenamed as BBV152) is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology. As of October 2021, 110.6 milli ...
, India's first
COVID-19 vaccine A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an es ...
. Bharat Biotech is also one of the first companies to develop vaccines for the
Zika Zika fever, also known as Zika virus disease or simply Zika, is an infectious disease caused by the Zika virus. Most cases have no symptoms, but when present they are usually mild and can resemble dengue fever. Symptoms may include fever, red ...
and
Chikungunya Chikungunya is an infection caused by the ''Chikungunya virus'' (CHIKV). Symptoms include fever and joint pains. These typically occur two to twelve days after exposure. Other symptoms may include headache, muscle pain, joint swelling, and a ras ...
viruses. Zydus Lifesciences developed the world's first human DNA COVID-19 vaccine and India's second indigenous COVID-19 Vaccine.


Largest companies


By market capitalization

Top 12 public pharmaceutical companies in India by market capitalization as of December 2022. Top 6 private pharmaceutical companies in India by reported valuation in 2022.


By sales and marketing operations within India

Multinational Pharmaceutical Companies ranked as per active presence of sales, marketing and business in India are as follows: # Pfizer #
GlaxoSmithKline GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the tent ...
# Sanofi Aventis # Merck #
Johnson and Johnson Johnson & Johnson (J&J) is an American multinational corporation founded in 1886 that develops medical devices, pharmaceuticals, and consumer packaged goods. Its common stock is a component of the Dow Jones Industrial Average and the company i ...
#
Amgen Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. One of the world's largest independent biotechnology companies, Amgen was established in T ...
#
Novartis Novartis AG is a Swiss-American multinational pharmaceutical corporation based in Basel, Switzerland and Cambridge, Massachusetts, United States (global research).name="novartis.com">https://www.novartis.com/research-development/research-loc ...
#
Roche F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX S ...
#
Bristol-Myers Squibb The Bristol Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the ''Fortune'' 500 list of the lar ...
#
Eli Lilly and Company Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Colonel ...
# Abbott # Takeda Pharmaceutical Company #
Boehringer Ingelheim C.H. Boehringer Sohn AG & Co. is the parent company of the Boehringer Ingelheim group, which was founded in 1885 by Albert Boehringer in Ingelheim am Rhein, Germany. As of 2018, Boehringer Ingelheim is one of the world's largest pharmaceutical ...
#
Astellas is a Japanese multinational pharmaceutical company, formed on 1 April 2005 from the merger of and . On February 5, 2020, the company announced management changes effective from April 1, 2020. Astellas is a member of the Mitsubishi UFJ Finan ...


Exports

Exports of pharmaceuticals products from India increased from US$6.23 billion in 2006–07 to US$8.7 billion in 2008-09 a combined annual growth rate of 21.25%.It's ‘India Calling’ for global pharmaceutical companies, says a PricewaterhouseCoopers report
India exported $11.7 billion worth of pharmaceuticals in 2014. Pharmaceutical export from India stood at US$17.27 billion in 2017–18, and is expected to grow by 30 per cent to reach US$20 billion by 2020.And India Share in This 40% The 10 countries below imported 56.5% of that total:


Criticism


Patents

It has been pointed out that the pharma industry is not scrutinised enough when it comes to withdrawing patent challenges. For example, in the case of the patent application filed by
Gilead Sciences Gilead Sciences, Inc. () is an American biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and C ...
for the Hepatitis C medicine
sofosbuvir Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. It is taken by mouth. Common side effects include fatigue, headache, nausea, and trouble sleeping. Side effects are generally more common in ...
in 2014, Natco initially filed challenges to this application in Delhi. However, a month after signing a voluntary licensing agreement with Gilead, Natco withdrew the patent challenge. It has been argued that
Mylan Mylan N.V. was a global generic and specialty pharmaceuticals company. In November 2020, Mylan merged with Upjohn, Pfizer's off-patent medicine division, to form Viatris. Previously, the company was domiciled in the Netherlands, with principal ...
(an influential pharmaceutical company which was Natco's client) exerted pressure on the latter and 'brokered' a deal, though the term 'brokered' has been refuted by Mylan. Many activists argue that such agreements in effect deny patients in some countries the right to affordable drugs. It has also been pointed out that without the patent, voluntary licensing would imply charging rent on property not even owned by the company. The
Competition Commission of India The Competition Commission of India (CCI) is the chief national competition regulator in India. It is a statutory body within the Ministry of Corporate Affairs and is responsible for enforcing the Competition Act, 2002 to promote competition ...
ought to carefully look at every withdrawal of patent challenges, as well as such private agreements, since these impact both public health and the competitive environment of the market.


Quality

Between 2015 and 2017, there were 31 FDA warning letters to Indian pharmaceutical companies citing serious Data Integrity issues, including data deletion, manipulation or fabrication of test results. According to Outsourcing Pharma in 2012, 75% of counterfeit drugs supplied world over had some origins in India, followed by 7% from Egypt and 6% from China. The Central Drug Standards Control Organisation (CDSCO), the drug regulatory authority of India conducted a nationwide survey in 2009 and announced that of "24,000 samples
hat A hat is a head covering which is worn for various reasons, including protection against weather conditions, ceremonial reasons such as university graduation, religious reasons, safety, or as a fashion accessory. Hats which incorporate mecha ...
were collected from all over India and tested. It was found that only 11 samples or 0.046% were spurious." In 2017 a similar survey found 3.16% of the medicines sampled were substandard and 0.0245% were fake. Those more commonly prescribed are probably more often faked.


See also

*
Ayurveda Ayurveda () is an alternative medicine system with historical roots in the Indian subcontinent. The theory and practice of Ayurveda is pseudoscientific. Ayurveda is heavily practiced in India and Nepal, where around 80% of the population repo ...
*
Healthcare in India India has a multi-payer universal health care model that is paid for by a combination of public and private health insurance funds along with the element of almost entirely tax-funded public hospitals. The public hospital system is essential ...
* Medical tourism in India * Opium and Alkaloid Works *
Contract Research Organization In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide ...
*
Genome Valley Genome Valley is an Indian high-technology business district spread across /(3.1 sq mi) in Hyderabad, India. It is located across the suburbs, Turakapally, Shamirpet, Medchal, Uppal, Patancheru, Jeedimetla, Gachibowli and Keesara. The Genom ...


References

{{DEFAULTSORT:Pharmaceutical industry in India Healthcare in India Pharmacy in India Industries in India