India's API in Global Market

Abstract
The Indian pharmaceutical industry is very well established in today’s world and is continuously growing and
expanding to meet the needs of a growing population with a changing disease profile and is grabbing the market
segments. India is the world's 3rd largest provider of generic medicines by volume, with a 20% share of total
global pharmaceutical exports. The Indian pharmaceutical market is the 3rd largest in terms of volume and the
14th largest in terms of value (IBEF, 2021). With its reverse-engineering of generic drugs and active
pharmaceutical ingredients (API), India occupies a significant place in the global market. Active Pharmaceutical
Ingredients (APIs) are the largest segment of the Indian pharma industry. India is the 3rd largest market for
APIs globally. It shares 8% in the Global API Industry & manufactures more than 500 different APIs. It also
contributes 57% of APIs to the prequalified list of the WHO. Raw materials from India are exported to other
countries for the production of affordable finished medicines. This research study attempts to find out the trends
in the export of India’s active pharmaceutical ingredients from 2019 to 2021. It further identifies the challenges
faced by the API industry and proposes recommendations to establish self-sufficiency in APIs. It also compares
the registration and approval processes in different countries for APIs. It also focuses on major therapeutic
categories in API exports, major export destinations, major API exporters and major APIs exported from India.

Introduction
The Indian pharmaceutical industry is
dominated by exports of both formulations
(dosage forms) and bulk drugs (APIs). Of
India's total pharma exports, about 77% are
in the form of formulations, while the
remaining 23% are in the form of bulk
drugs.
Active Pharmaceutical Ingredients
API (Active Pharmaceutical Ingredient): It
is the basic drug with the desired medicinal
pharmaceutical properties, also known as
bulk drug, raw material, or loose drug. It
acts as the basic raw material for
formulations. Formulations are specific
dosage forms of a bulk drug or a
combination of bulk drugs. APIs of good
quality are core to the manufacturing of
effective and safe essential drugs.
India is now emerging as a preferred
supplier of active pharmaceutical ingredients
(APIs) to many global companies. The
Indian API manufacturing segment can be
further divided into two sectors – innovative
or branded and generic or unbranded.
Foreign companies import raw materials
from India into their home countries to
process them into finished products. It is
currently the 3rd largest API player, after
China and Italy. It accounts for 8% of the

1
global API industry and produces over 500
different APIs. It also contributes 57% of
APIs to the prequalified list of the WHO.
According to a Crisil report, bulk drug
exports increased 9% year-on-year in the
first half of FY21. In the 2018-19 fiscal
year, India exported bulk and intermediate
medicines worth $ 3911 million while
import of APIs was $ 730 million.
API manufacturers in India are constantly
making efforts to strengthen their marketing
capacity in the regulated markets by
improving production yields, modifying
production processes, and increasing sales in
international markets. More than 30% of the
APIs manufactured in India are exported to
countries such as the US, UK, Japan, etc. As
an example, generic production of medicines
in Brazil is heavily dependent on APIs
purchased from India. Nearly 80% of the
raw material requirements in the US are
supplied by China and India.
Objectives:
The main objectives of the paper are:
1. To analyze the trends in API exports
of the Indian pharmaceutical trade.
2. To analyze the export market to
explore opportunities for enhancing
India’s API exports.
3. To compare the growth rate of
exports of API for the period of
2017-21
4. To examine the role of exogenous
parameters that continue to affect the
performance of this sector.
5. To understand the regulatory
approval process for pharmaceutical
products exported to different
countries
6. To list out the administrative
requirements of documents for the
export of drug products to different
countries
7. To study the top API exporting
companies, where top API
manufacturers are located, their
capabilities, top export destinations,
top APIs exported from India,
market share, etc.
8. To look at the impact COVID-19 has
had on supply chains and the API
manufacturing industry
Methodology:
This paper was conducted on the basis of
secondary data sources, which included
2
annual reports of the department of
pharmaceuticals, articles, research papers,
pharma magazines, and reports. In addition,
various export-import trade related official
websites and also the official websites of
relevant regulatory agencies were
considered. The study covers a period of two
years from 2019–21. The information was
gathered from the Directorate General of
Commercial Intelligence and Statistics
(DGCIS), an electronic database maintained
by the Ministry of Commerce, Government
of India.
Share of India in Global API Market:
The Indian API industry has been supplying
good quality APIs to top pharmaceutical
companies, both domestically and globally.
There are over 1000 APIs manufacturers in
India. The top ten APIs Exporters account
for 40% share of the total APIs Export worth
USD 4.5 Bn. India manufactures over 1300
APIs and exports to over 100 countries. In
FY 2016, the API market in India held a
share of around 8% in the global API
market. Moreover, the Indian API industry
has gained recognition worldwide due to the
high quality of its APIs. The talent pool in
India is also huge, and if given proper
training, can help in the invention of novel
API molecules. All these factors are bound
to propel the growth of the Indian API
market and increase its share of the global
platform in the coming years.
India Vs China in API industry
According to the Trade Promotion Council
of India (TCPI), India imported around 85%
of its API requirements from China in 2019.
The focus on finished formulations in the
last two decades had resulted in negligence
of in-house manufacture of APIs. This led to
an increased reliance on China.
The impact on the Indian pharma sector is
typically evident during Covid-19. The
Indian Drug regulatory authority had
recently highlighted how 57 APIs of
antibiotics, vitamins and steroids could go
out of stock if there’s a prolonged shutdown
in China, the epicenter of the outbreak. As a
result of the lockdowns, slowed production
of APIs resulted in less availability and
higher costs for the materials required for
generics production. The cost of
paracetamol has gone up from Rs 250-300
kg to 400-450 kg. In addition, the Govt.Of
India had restricted the export of 26 bulk
drugs including antibiotics such as
erythromycin,chloramphenicol,clindamycin,
some antiretroviral drugs, paracetamol,
vitamins, & hormones. This in turn accounts
for almost 10% of India’s total
pharmaceutical exports.
These facts indicate that there is plentiful
scope for the API market to grow, if the
manufacturers are able to produce the
required amount of APIs on their own,
rather than importing it from other countries.
3
China is a dominant force in fermentation
technology resulting in cost-effective
fermentation-based APIs and intermediates.
So to attain a higher profit margin in the
manufacturing of formulations and cheap
supply of the same to the world, India has to
depend largely on China for APIs.
According to an article published in
Pharmabiz, India is dependent on China for
its APIs because importing raw material
from China saves 15-20% of the overall
costs for the Indian drug makers. Given that
China is cheap producer and supplier of API
to the world economy, the formulations
manufactured and exported by China using
its APIs obviously would also be cheap.
China exports bulk drugs (Key APIs) such
as Antibiotics and Hormone intermediates
e.g. penicillin G, levodopa, streptomycin,
meropenem, carbidopa, vancomycin,
gentamicin and progesterone to India. India
continues to rely on imports of key starting
materials, intermediates, and APIs from
China, with the share of dependence
increasing over time. This potentially
exposes us to raw material supply
disruptions and pricing volatility.
India's API Industry Scenario
Top Ten Therapeutic Categories by APIs
Export:
1. Anti -infective
● Share of Anti infective APIs Export
in Total APIs Export is about $ 2,358
million i.e 31.4%.
● The top 10 Anti-infective APIs
Export share in Total Anti infective
APIs Export is about $ 876 million
i.e 37.1%.
● The major anti infective APIs
exported are Oseltamivir,
Cefuroxime , Favipiravir ,Cefixime.
2. Cardiovascular
● Share of Cardiovascular APIs Export
in Total APIs Export is about $ 1,193
million i.e 15.9%
● The top 10 Cardiovascular APIs
Export share in Total Cardiovascular
APIs Export is about $ 819 million
i.e 68.6%.
● The major Cardiovascular APIs
exported are Valsartan ,Atorvastatin ,
Losartan , Rosuvastatin.
3. Central Nervous System
● Share of CNS APIs Export in Total
APIs Export is about $ 1,128 million
i.e 15.0%
● The top 10 CNS APIs Export share
in Total CNS APIs Export is about $
532 million i.e 47.2%.
● The major CNS APIs exported are
Levetiracetam , Gabapentin ,
Pregabalin , Sertraline.
4. Musculoskeletal
● Share of Musculoskeletal APIs
Export in Total APIs Export is about
$ 693 million i.e 9.3%
● The top 10 Musculoskeletal APIs
Export share in Total
Musculoskeletal APIs Export is
about $ 549 million i.e 79.2%.
● The major Musculoskeletal APIs
exported are Naproxen , Ibuprofen ,
Paracetamol & Diclofenac.
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5. Gastrointestinal
● Share of Gastrointestinal APIs
Export in Total APIs Export is about
$ 621 million i.e 8.3%
● The top 10 Gastrointestinal APIs
Export share in Total Gastrointestinal
APIs Export is about $ 469 million
i.e 75.5%
● The major Gastrointestinal APIs
exported are Omeprazole,
Pantroprazole , Esomeprazole &
Lansoprazole.
6. Respiratory
● Share of Respiratory APIs Export in
Total APIs Export is about $ 585
million i.e 7.8%
● The top 10 Respiratory APIs Export
share in Total Respiratory APIs
Export is about $ 462 million i.e
79.1%.
● The major Respiratory APIs
exported are Theophylline,
Dextromethorphan , Montelukast &
Loratadine.
7. Antidiabetic
● Share of Antidiabetic APIs Export in
Total APIs Export is about $ 240
million i.e 3.2%
● The top 10 Antidiabetic APIs Export
share in Total Antidiabetic APIs
Export is about $ 221 million i.e
92.2%.
● The major Antidiabetic APIs
exported are Metformin , Sitagliptin ,
Pioglitazine & Glimepiride.
8. Sensory System
● Share of Sensory System APIs
Export in Total APIs Export is about
$ 161 million i.e 2.1%
● The top 10 Sensory System APIs
Export share in Total Sensory
System APIs Export is about $ 124
million i.e 76.7%.
● The major Sensory System APIs
exported are Fosravuconazole ,
Dorzolamide ,Clobetasol &
Undecylenic
9. Anticancer
● Share of Anticancer APIs Export in
Total APIs Export is about $ 159
million i.e 2.1%
● The top 10 Anticancer APIs Export
share in Total Anticancer APIs
Export is about $ 118 million i.e
74.6%.
● The major Anticancer APIs exported
are Capecitabine , Imatinib ,
Gemcitabine & Finasteride.
10. Genitourinary
● Share of Genitourinary APIs Export
in Total APIs Export is about $ 128
million i.e 1.7%
● The top 10 Genitourinary APIs
Export share in Total Genitourinary
APIs Export is about $ 85 million i.e
66.2%.
● The major Genitourinary APIs
exported are Sildenafil , Tadalafil ,
Solifenacin & Progesterone.
5
Top API Exporters:
1. Divi’s Laboratories, Hyderabad
Divi’s Laboratories was established in the
year 1990 initially as Divis Research Center
(DRC) with Research & Development as
their prime fundamental activity. Their
research is devoted to the development of
cost-effective processes for the manufacture
of generic APIs. Presently, the company is
engaged in manufacture of multiple numbers
of generic APIs and nutraceutical products.
They also undertake custom synthesis of
APIs and intermediates for global innovator
companies. Divis has presently a portfolio of
120 products across diverse therapeutic
areas. The company has established four
manufacturing facilities. It has two
subsidiary units namely Divis Laboratories
(USA) Inc. in the United States of America
and Divi’s Laboratories Europe AG in
Switzerland, where nutraceuticals products
are manufactured. It also carry out research
for the development of cost-effective novel
processes for the future generic APIs. The
company at present manufactures more than
twenty five numbers of generic APIs,
several of which are also exported. The
company has secured multiple numbers of
their processes by patents.
2. Hetero Drugs Limited, Hyderabad
Hetero Drugs Limited (HDL) is one of
India’s leading manufacture of generic APIs
and the considered to be very large global
producer of anti-retroviral drugs. The
business of the company includes generic
APIs, generic and branded generic
formulations, biosimilar products and
custom pharmaceutical services. Hetero has
presently thirty six cGMP compliant
manufacturing facilities strategically located
worldwide. Its products encompass major
therapeutic categories such as AIDS/HIV,
Cardiovascular drugs, Diabetes, Hepatitis,
Hepatology, Immunology, Neurology,
Nephrology, Oncology, Ophthalmology and
Urology. Hetero has a presence in over 126
countries. The company has concentrated in
the development of novel processes for the
manufacture of generic APIs. It has also
invested in novel drug discovery research,
especially in anti HIV drugs, anti-viral
drugs, diabetes and cancer.
3. Dr. Reddy’s Laboratories, Hyderabad
Dr. Reddy’s Laboratories, Hyderabad is an
innovation–driven company which put much
of its investment for the development of new
chemical entities. Dr. Reddy’s Research
Foundation, Hyderabad was established in
1992. They are exploring the development
of new medicines especially in areas of
anti-cancer drugs, anti-diabetes,
cardiovascular drugs and anti infectives. In
mid-1990s and onwards further newer
developments started to take place. Thus far,
no new chemical entity has come out which
has the approval of the regulatory authorities
for use as drugs in human therapy. However,
the company is engaged in the manufacture
6
of a large number of generic APIs. Dr.
Reddy’s Lab has secured their inventions
through a large number of patents.
4. Aurobindo Pharma, Hyderabad
Aurobindo Pharma Limited headquartered in
HITEC City, Hyderabad, India is an Indian
multinational pharmaceuticals
manufacturing company. Aurobindo Pharma
was founded in 1986 by Mr. P. V.
Ramprasad Reddy and Mr. K. Nityananda
Reddy. The company commenced
operations in 1988-89 when they started
manufacturing semi-synthetic penicillins at
their Pondicherry unit. Later, more
manufacturing units were constructed.
Aurobindo Pharma became a public
company in 1992. At present, Aurobindo is
considered to be one of the top API
manufacturing companies in the world.
Aurobindo Pharma is globally known for
production of generic APIs in the category
of beta lactams and non-beta lactams. It also
manufactures other range of APIs which
include anti-retroviral drugs, anti-infectives,
cardiovascular drugs, central nervous system
products, gastroenterological products, and
anti-allergic drugs. Its leadership emanates
from their own advanced API research
house expertise of its research team.
Aurobindo Pharma has its sister concern
Aurobindo (Datong) Bio Pharma Co Ltd,
China which is engaged in the manufacture
of 6-aminopenicillanic acid (6-APA) . The
production of 6-APA is exported to India
and consumed at Aurobindo Pharma.
Aurobindo Pharma also has their
pharmaceutical formulations manufacturing
segments. Aurobindo Pharma is not in the
development of novel APIs. The company
has made several inventions in process
developments of APIs and has taken patents
on multiple of their inventions.
5. Sun Pharmaceutical Industries,
Mumbai
Sun Pharmaceutical Industries Limited (Sun
Pharma), Mumbai is engaged in the
manufacture and sale of a wide range of
pharmaceutical formulations and active
Pharmaceutical ingredients. A wide range of
APIs as well as anticancer drugs, steroids,
peptides, sex hormones, and controlled
substances are also manufactured. Sun
Pharma was established by Mr. Dilip
Sanghvi in 1983.. Presently Sun Pharma has
established over 40 ( API & finished dose)
manufacturing sites located in India, USA,
Brazil, Canada, Egypt, Hungary, Israel,
Bangladesh, Mexico, Romania, Ireland,
Morocco, Nigeria, South Africa and
Malaysia. The product range manufactured
include generic APIs and
drug-intermediates, over-the-counter (OTC)
pharmaceutical products, anti-retroviral
drugs, specialty products of wide range in
dosage forms of tablets, capsules,
injectables, ointments, creams and liquids.
Company’s specialty APIs, include
controlled substances, steroids, peptides and
anti-cancer drugs and products are marketed
across 150 countries worldwide. The
company has a strong focus on R&D and
has employed around 2000 research
scientists, who are working in their multiple
R&D centers. It has developed expertise in
synthesis, management of unit processes and
unit operations required in manufacturing
complex generic APIs. The company also
works on the development of New Chemical
7
Entities (NCEs). Presently, company
manufactures over 200 APIs including
warfarin, carbamazepine and clorazepate. A
large number of patents have been assigned
to the inventions made by Sun Pharma.
Major API Export Destinations:
India's major export destinations for bulk
drugs are the USA , Germany, Braziletv.
USA is the leading destination for India’s
bulk drug exports. The USA accounts for 71
percent of India’s total bulk drug exports to
North America. The major five APIs export
destinations are as follows:
1) United States :
USA ranks first among top major
destinations of APIs Export from India. The
Total export Value of Export to USA is $570
Mn.
Top 3 API exported to United States are
Oseltamivir,Aprepitant & Dextromethophan.
Major 3 Companies exporting to USA are
Divi’s Lab, Macro pharmaceuticals and
Cipla Pvt. Lim.
Regulations: Regulatory Authority of USA
is U.S. Food & Drug Administration. Fees
for Drug Registration is USD 1,71,823.
Normal time taken for registration is 12-18
Months. Registration Requirement [Dossier
format] is CTD. Plant inspection is
mandatory as per regulations. Subsidiary is
required for supplying to Public
procurement agencies. FDA is an agency
within the Department of Health and Human
Services. Website of regulatory Authority is
http://pharmacyboardkenya.org/
2) Brazil :
Brazil ranks second among top major
destinations of APIs Export from india. The
Total export Value of Export to Brazil is $
428 Mn.
Top 3 API exported to Brazil are Losartan ,
Azithromycin and Pantaprazole. Major 3
Companies exporting to Brazil are Ipca lab,
Alembic and Dr. Reddy’s.
Regulation: Regulatory Authority is
ANVISA – Agencia Vigilancia nacional de
Sanitaria (National Health Surveillance
Agency). Fees for Drug Registration is USD
2000. Normal time taken for registration is 3
years. Registration Requirement [Dossier
Format] is Non-CTD. Plant inspection is
mandatory as per regulations. BE need to be
done with Brazil Innovator Product. This
also Barrier in product Registration.
Subsidiary is Required to operate locally.
Website of regulatory Authority :
http://portal.anvisa.gov.br/english
3) Germany:
Germany ranks third among top major
destinations of APIs Export from india. The
total export Value of Germany is $ 302 Mn.
The Top 3 API exported to Germany are
Tacrolimus, Pantaprazole and Ibuprofen.
Major 3 Companies exporting to Germany
are Biocon , Zydus Takeda and Harman
finochem.
Regulation: Regulatory Authority of
Germany is The Federal Institute for Drugs
8
and Medical Devices ( BfArM) /European
Medicines Agency (EMA). Fees for Drug
Registration is 15,600 € for Generic
Application in National Procedure. Normal
time taken for registration is 12-18 months.
Registration Requirement [Dossier Format]
is e-CTD. Plant inspection is mandatory as
per regulations. Subsidiary is Required to
operate Locally.
Website: https://www.bfarm.de/
http://www.ema.europa.eu/
4) Turkey :
Turkey ranks Forth among top major
destinations of APIs Export from India. The
total export value of Turkey is $ 272 Mn.
The top 3 API exported to Turkey are
favipiravir, Thiocolchicoside and
Pantoprazole. Major 3 Companies exporting
to Turkey are Hetero Pharmaceuticals,
optrix lab and Tagoor lab.
Regulations: Regulatory Authority js
Turkish Medicines and Medical Devices
Authority (TMMDA). Fees for Drug
Registration is TRY 45,788 (produced
abroad), TRY 22,894 (produced in Turkey).
Normal time taken for registration is 6-7
Months. Registration Requirement [Dossier
Format] is. CTD. Plant inspection is not
mandatory as per regulations. Local agent is
not required for Registration. Website of
regulatory Authority : www.saglik.gov.tr
5) Bangladesh :
Bangladesh ranks fifth among top major
destinations of APIs Export from India. The
total export value of Bangladesh is $242
Mn.
The top 3 APIs exported to Bangladesh are
cefuroxime , Omeprazole and Esmoprazole.
Major 3 Companies exporting to Bangladesh
are Nectar lifescience, Covalent lab and
Vasudha pharma.
Regulations:
Regulatory Authority is The Directorate
General of Drug Administration (DGDA).
Fees for Drug Registration is BDT 1500.
Normal time taken for registration is 12
Months. Registration Requirement [Dossier
Format] is CTD. Plant inspection is not
mandatory. Local agent is required for
registration. Website of regulatory
Authority: https://www.dgda.portal.gov.bd/
Top APIs Exporting from India (By
Value)
1)Ibuprofen: Ibuprofen is an analgesic. It
was ranked 1st among top APIs exported
from India in 2019 & jumped upto rank 3 in
2020. Netherland is the top export
destination for ibuprofen from India. The
rate of ibuprofen in Netherland is 15/kg.
Major 3 APIs export destinations are
Netherland, Iran, UK; which account for
22% of total ibuprofen exports from India.
9
Major 2 companies exporting ibuprofen are
IOL, Solara, accounting for 91% of total
exports.
India has an export volume of 8133MT in
2019 & 7386MT in 2020. Export value is
$141Mn in 2019 & $124Mn in 2020.
2)Atorvastatin : It is an anti hyperlipidemic
drug . It was ranked second among top APIs
exported from India in 2019-2020. USA is
the top export destination for atorvastatin
from India. The rate of atorvastatin in USA
is 350/kg.
Major 3 API export destinations are USA,
Iran, Netherland; account for 40% of total
exports from India.
Major 3 companies exporting atorvastatin
are Dr.Reddy's , Simiax, Teva; accounting
for 52% total exports. India has an export
volume of 398MT in 2019 & 508MT in
2020. Export value of $124Mn in 2019 &
$130Mn in 2020.
3) Cefuroxime: It is an anti-bacterial. It
ranked 3rd among top APIs exported from
India in year 2019 & jumped to rank 5th in
year 2020. UK is the top export destination
for cefuroxime from India. The rate of
cefuroxime is 147/kg in UK. Major 3 API
exports destinations are UK Bangladesh &
Vietnam , which account for 64% of total
exports from India. Company who exports
cefuroxime are Nectar, Covalent,
Aurobindo, accounting for 79% of total
exports. Export volume is 817 MT in 2019
& 720MT in 2020. Export value is $119Mn
in 2019 & $113Mn in 2020.
4)Paracetamol: Paracetamol is an analgesic
and antipyretic drug. It was ranked 8th
among top APIs exported from India in
2019 and jumped upto 4th rank in 2020.
Ireland is the top export destination for
paracetamol from India. Rate of Paracetamol
in Ireland is 5/kg.
Major three APIs export destinations are
Ireland, Nigeria & Spain which accounts for
44% of total paracetamol exports from
India.
Major three companies exporting
Paracetamol are granules, Farmson & Shri
Krishna ,accounting for 76% of total
exports. India has an export volume of
17,203 MT in 2019 & 22,598MT in 2020.
Export value is $87Mn in 2019 & $117 in
2020.
5) Metformin: It is an anti-diabetic drug. It
ranked 5th among all APIs exported from
India in 2019 and jumped to rank 7th in
2020. Germany is the top export destination
for metformin from India. The rate of
metformin is 4/kg in Germany.
Major 3 API exports destinations are
Germany, Turkey & Iran , which account for
26% of total exports from India.
Major companies who export metformin are
USV Wanbury & Aarti , accounting for 48%
of total exports. Export volume of 23,613
MT in 2019 & 24,275 MT in 2020. Export
value of $102Mn in 2019 & $103Mn in
2020.
6) Levetiracetam: It is a neuroprotectant
drug. It was ranked 10th among top API
exported from India in 2019 and jumped up
to 6th in 2020. Belgium is the top export
destination for levetiracetam from India. The
rate of levetiracetam in Belgium is 98/kg.
The major three market destinations are
10
Belgium, USA, and Turkey, which account
for 37% of total levetiracetam exports from
India.
The major three companies exporting
Levetiracetam are Divis, Hetero, and
Aurobindo, accounting for 73% of total
exports.
India has an export volume of 982 MT in
2019 and 1320 MT in 2020. While the value
of exports is expected to be $85 million in
2019 and $106 million in 2020.
7) Rosuvastatin: It is an anti-
hyperlipidemic drug. It ranked 7th among
top APIs exported from India in 2019 and
jumped upto 9th rank in 2020. Switzerland
is the top export destination for Rosuvastatin
from India. Rate of rosuvastatin in
Switzerland is 1649/kg .
The major 3 APIs export destinations are
Switzerland, South Korea & Brazil , which
account for 30% of total exports from India.
Major three companies who exports those
rosuvastatin are MSN , Biocon & Centrient,
accounting for 69% of total exports. . India's
export volume in 2019 is 81 MT & 100MT
in 2020. Export value is $92Mn in 2019 &
$96Mn in 2020.
Top 5 API's exported from India ($ 10Mn
+) with highest growth during Covid-19 (
By Value)
Conclusion
Our estimates show that there has been an
increase in the growth rate of exports of
intermediates and bulk drugs. In the above
article, we can see that India exported APIs
worth $ 3420 million in the year 2020 while
import of APIs was $ 730 million. It shows
that export of APIs is more than import. We
also saw the drug approval process by
various regulatory authorities for marketing
authorization of the drug. We observed the
major APIs exporters such as Divi’s
Laboratories, Hetero Drugs Limited, Sun
pharma, etc, major therapeutic categories
exported in terms of APIs, major export
destinations and major APIs exported during
the last two years from India. We also
observed how the growth rate of some drugs
increased tremendously during Covid-19.
We also observed that achieving
self-reliance on APIs is very important. The
COVID-19 situation provides India an
opportunity to become a preferred alternate
hub for manufacturing APIs and
intermediates. The article concludes that this
is the right time for India to remove its
dependency on China and other countries for
bulk drugs and start producing its own API
in the country itself. The government of
India plans to incentivise bulk drug
manufacturers to encourage the "Make in
India" programme and reduce dependence
on imports of Active Pharmaceutical
Ingredients (API). The availability of bulk
drugs domestically would no doubt assist the
Indian economy in attaining health security,
particularly during an emergency, as it
would not have to depend on foreign
countries for its domestic requirements. If
China decides to halt the supply of
11
intermediate products and other raw 8. India’s Road to Independence in
materials to India, it will have a significant Manufacturing Active Pharmaceutical
Ingredients: Focus on Essential Medicines
impact on the Indian pharmaceutical
https://www.mdpi.com/2227-7099/9/2/71/ht
industry, likely bringing it to a halt. m
9. Department of Pharmaceuticals, GOI
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https://rbidocs.rbi.org.in/rdocs/Bulletin/PD
3. Reviving India’s API industry
Fs/03AR_15072021B75D322EF39B4B3A83
https://www.pwc.in/assets/pdfs/industries/ph
C9B918B459A759.PDF
armaceuticals-and-life-sciences/reviving-ind
12. Swot Analysis Of Indian Pharmaceutical
ias-api-industry.pdf
Industry Kapil Kumar*; Dr. M. K.
4. IBEF Presentation
Kulshreshtha**
https://www.ibef.org/download/Pharmaceuti
http://indianresearchjournals.com/pdf/IJMF
cals-November-2021.pdf
SMR/2013/May/4.pdf
5. Arjun Gupta, Rohit Bansal Indian
13. Indian API Market Outlook 2022
Pharmaceutical Industry: A Diagnostic
ASSOCHAM India
Overview
14. India: Towards a Global Pharma Hub
https://www.researchgate.net/publication/31
15. WEBBERRY - Presentation "India: Towards
8225062_INDIAN_PHARMACEUTICAL_I
a Global Pharma Hub"
NDUSTRY_A_DIAGNOSTIC_OVERVIEW
http://webberry.info/index.php/latest-news/1
6. Narendra Vyas*, Ankur Joshi, Sapna
42-presentation-india-towards-a-global-pha
Malviya, Anil Kharia Reduced Pharma
rma-hub
Supply Chain in COVID-19: Measures to
16. Sunil Kumar Informative Videos on
Reduce India’s Reliance for Active
Pharmaceutical Industry
Pharmaceutical Ingredients on China and
https://www.linkedin.com/pulse/informative-
other Countries
videos-pharmaceutical-industry-sunil-kumar
https://www.researchgate.net/publication/34
/?trackingId=Vac7muCnRj6xLlLSc68b2A%
7943555_Reduced_Pharma_Supply_Chain_
3D%3D
in_COVID-19_Measures_to_Reduce_India
17. Revisiting Novel Active Pharmaceutical
%27s_Reliance_for_Active_Pharmaceutical
Ingredients from India-Achievements and
_Ingredients_on_China_and_other_Countri
Future Challenges by Prasanta Kumar
es
Ghosh
7. Webinar: Trends in global API
https://ris.org.in/sites/default/files/Publicati
manufacturing and strategic success in
on/NOVEL%20ACTIVE%20PHARMACEU
regulatory affairs.
TICAL%20INGREDIENTS%20FROM%20I
https://clarivate.com/cortellis/wp-content/up
NDIA_PK%20Ghosh-2%20August%202021
loads/sites/4/2021/05/IDMA-Webinar_Maste
.pdf
rDeck.pdf

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18. https://tradestat.commerce.gov.in/eidb/defau
lt.asp
19. https://www.indiafilings.com/learn/hsn-code
-gst-rate-pharmaceuticals-medicines/
20. https://pharmexcil.com/
21. http://www.eximguru.com/
22. https://www.ibef.org/
23. https://commerce.gov.in/
24. https://pharmaceuticals.gov.in/
25. https://en.m.wikipedia.org/wiki/Pharmaceuti
cal_industry_in_India

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