PROJECT REPORT

On
“INDIAN PHARMACEUTICAL INDUSTRY”

FOR
THE PARTIAL FULFILLMENT OF THE AWARD OF THE DEGREE OF
“MASTER OF BUSINESS ADMINSTRATION”
GANGA GLOBAL INSTITUTE OF MANAGEMENT & STUDIES
AFFILIATED TO—
ARYABHATTA KNOWLEDGE UNIVERSITY PATNA

BATCH: 2020-2022

SUBMITTED BY: SUBMITTED TO:

Name of the student Name of the faculty supervisor
PRASHANT GAURAV MS. SABAHAT ANJUM
20317336097 Asst. Prof GGIMS
 SUPERVISOR CERTIFICATE

This is to certify that PRASHANT GAURAV a student of Master of Business

Administration, Batch –MBA-20-22, has successfully completed her project under my
supervision. GANGA GLOBAL INSTITUTE OF MANAGEMENT & STUDIES

During this period, She worked on the project titled

“INDIAN PHARMACEUTICAL INDUSTRY in partial fulfillment for the award
of the degree of Master of Business Administration of ARYABHATTA
KNOWLEDGE UNIVERSITY PATNA….

To the best of my knowledge the project work done by the candidate has not been
submitted to any university for award of any degree. Her performance and conduct
has been good.

(Signature)
Name of the faculty supervisor
MS..SABAHAT ANJUM
Assistant. Professor
GGIMS BEGUSARAI

Date: 10th August 2023

 CERTIFICATE OF ORIGINIALITY

I, Mr.PRASHANT GAURAV Roll No. 203173336097 20-22

GANGA GLOBAL INSTITUTE OF MANAGEMENT & STUDIES
as undergone Project report on established a pharma company
RIVANTA MEDICARE [LUCKNOW] 09BQSPG6043G1ZK on a project title
“ INDIAN PHARMACEUTICAL INDUSTRY” , hereby declare that this project
is my original piece of work.

Signature of the student:

Student Name: PRASHANT GAURAV
Date : 10th August 2023
 ACKNOWLEDGEMENT

I want to show my sincere gratitude to all those who made this study possible. First of
all I am thankful to the helpful staff and the faculty of GANGA GLOBAL
INSTITUTE OF MANAGEMENT & STUDIES. Second I would like to extend my
sincere thanks to my Industry Guide, NAVEEN MISHRA for his/her untiring
cooperation. One of the most important tasks in every good study is its critical
evaluation and feedback which was performed by my faculty guide Asst. Prof
MS. SABAHAT ANJUM.
I am very thankful to my Faculty as well as Industry guide for investing his precious
time to discuss and criticize this study in depth, and explained the meaning of
different concepts and how to think when it comes to problem discussions and
theoretical discussions. My sincere thanks go to my Institute and family, who
supported and encouraged me.

Name of the Student : PRASHAN GAURAV

Course ; MBA 20-22
 Declaration

I am PRASHANT GAURAV this project report is my original work and have not
been submitted in any form as a part of any other project. Information derived from
the published and unpublished work of other has been acknowledgement in the list
references in given in the bibliography.

PRASHANT GAURAV
MBA 2020-22
 CONTENTS

1. EXCUTIVE SUMMARY
2.EXPORT
3. INVESTMENTS AND RECENT DEVELOPMENTS
4. GOVERNMENT INITIATIVES
5. Ayushman Bharat Digital Mission (ABDM)
6.RIVANTA MEDICARE [A LEADING
PHARMACEUTICAL COMPANY]
7. Promotion of Medical Devices Parks
8.MARKET POTENTIAL & MARKETING
ISSUES
9.MANUFACTURING PROCESS
10. Scheme for Promotion of Bulk Drug
Parks
11.PCD PHARMA MARKET..
12.
 INTRODUCTION

The Indian pharmaceutical industry ranks third globally in

pharmaceutical production by volume and is known for its generic
medicines and low-cost vaccines.
The sector contributed to around 1.32% of the Gross Value Added
(at 2011-12 constant prices) of the Indian Economy in 2020-21.
The total annual turnover of Pharmaceuticals in the fiscal year 2021-22
was Rs. 3,44,125 crore (USD 42.34 Bn).
Major segments of Indian Pharmaceutical Industry include generic
drugs, OTC medicines, bulk drugs, vaccines, contract research &
manufacturing, biosimilars and biologics.
India is a global leader in the supply of DPT, BCG, and Measles
vaccines. India is one of the biggest suppliers of low-cost vaccines in the
world.
India accounts for 60 percent of global vaccine production, contributing
40 to 70 percent of the WHO demand for Diphtheria, Tetanus and
Pertussis (DPT) and Bacillus Calmette–Guérin (BCG) vaccines, and 90
percent of the WHO demand for the measles vaccine.
There are 500 API manufacturers contributing about 8% in the global
API Industry.
India is the largest supplier of generic medicines.
It manufactures about 60,000 different generic brands across 60
therapeutic categories and accounts for 20% of the global supply of
generics. Access to affordable HIV treatment from India is one of the
greatest success stories in medicine.
Because of the low price and high quality, Indian medicines are
preferred worldwide, making it “pharmacy of the world”.
The sector has been growing at a healthy rate. The trend in annual
turnover in the sector over the last five years may be seen in the Table-
 Financial year Turnover in crore Growth rate

2017-18 2,26,423 3.03

2018-19 2,58,534 14.18
2019-20 2,89,998 12.17
2020-21 3,28,054 13.12
2021-22 3,44,125 4.89

India plays an important role in the global pharmaceuticals and

vaccine industry. It is the largest provider of generic medicines
globally. The country has a share of 20% in the global supply
volume and contributes to around 60% of the global vaccines.
India ranks third in the world in terms of volume and is the
fourteenth largest in terms of value.

Key segments of the Indian pharmaceutical industry are OTC

medicines, Generics, APIs, Vaccines, Biosimilars, and Custom
Research Manufacturing (CRM).

India is the world leader in supplying vaccines like DPT, BCG,

and Measles. It also has the highest number of US FDA-approved
plants outside of USA.

The key USP of the Indian Pharmaceutical Industry is affordable

price and high quality and because of this, India is also
sometimes called the “Pharmacy of the World”.

The total annual turnover of the industry was US$ 41.68 billion in
2021-22. One of the major achievements of the Indian Pharma
Industry is access to affordable HIV drugs.

Additionally, India is one of the largest suppliers of low-cost

vaccines to the world.
India majorly exports drug formulations & biologicals, and these
products contribute to about 75% of the total pharmaceuticals
exports out of India.
EXPORT TREND

India’s share of pharmaceuticals and drugs in the global market is

5.92%.

Formulations and Biologics constituted the major portion of India’s

exports with a share of 73.31% followed by drug intermediates and bulk
drugs. During April-February 2023, the exports of drugs and
pharmaceuticals stood at US$ 22.9 billion.

During 2021-22, the country exported pharma products worth US$ 24.62
billion, while in 2020-21, the exports grew at 18% YoY to US$ 24.4
billion.

This robust performance was achieved despite the global supply chain
disruptions, lockdowns, and subdued manufacturing.

In February 2023, India exported US$ 2.05 billion worth of drugs and
pharmaceuticals, a 4.72% increase from US$ 1.96 billion in February
2022. USA, UK, South Africa, Russia, and Nigeria are India’s top five
export destinations. India played a key role during the Covid-19
pandemic and demonstrated its ability to be a consistent and reliable
pharma supplier to the world even during time of crisis.

India has the highest number of United States Food and Drug
Administration (USFDA) compliant companies with plants outside of
USA. About eight out of 20 global generic companies are from India and
over 55% of the exports from the country are to the highly regulated
markets. As the country is the biggest vaccine exporter, about 65-70% of
the World Health Organization (WHO) vaccine requirements are
sourced from India. From April 2022-September 2022, exports of Drugs
& Pharmaceuticals stood at US$ 12.72 billion and exports of Medicinal
and Pharmaceutical products stood at US$ 4,066.86 million.
EXPORT DESTINATIONS
India exports pharmaceutical products to North America, Africa, the EU,
ASEAN, Latin America & Caribbean (LAC), Middle East, Asia, CIS,
and other European regions. Nearly two-thirds of India’s exports goes to
NAFTA, Europe, and Africa.

The top five export destinations for Indian Pharma Industry in 2021-22
were the US, UK, South Africa, Russia, and Nigeria.

The US, UK, and Russia are among the largest importers from India at a
share of 29%, 3%, and 2.4%, respectively during 2021-22.

India’s exports of pharma products to these countries in FY22 were:

USA with US$ 7.10 billion, the UK with US$ 704.5 million, South
Africa with US$ 612.3 million, Russia with US$ 597.8 million, and
Nigeria with US$ 588.6 million.

India’s pharma exports to USA in value grew at a CAGR of 6.9% over

last three years. Additionally, for UK and Russia, it grew at a CAGR of
3.8%, and 7.2%, respectively over the same period.

As of August 2021, the number of USFDA approved facilities stood at

741. Additionally, the number of ANDAs won by the Indian firms till
December 2020 stood at 4,346. USFDA inspections were not conducted
during the last couple of years due to the Covid pandemic, however, the
inspections have started happening now and are expected to further
increase Indian exports to USA.

GOVERNMENT INITIATIVES

The Government of India has set up several schemes to further

strengthen the pharmaceutical industry. The Strengthening of
Pharmaceutical Industry (SPI) scheme focuses on bolstering the existing
infrastructure facility, with a total financial outlay of Rs. 500 crore

(US$ 64.5 million).

Production Linked Incentive (PLI) schemes for pharmaceuticals, critical

key starting materials (KSMs), medical devices, bulk drug parks, etc. are
introduced to encourage manufacturers.

Through the PLI scheme, the Government of India hopes to increase

investment and production in the Indian pharmaceutical sector. The
scheme is expected to generate incremental sales of Rs. 2,94,000 crore
(US$ 37.09 billion) in six years, starting from 2022-23 to 2027-28.
For the promotion of the Indian pharmaceutical industry, the
Pharmaceutical Promotion and Development Scheme (PPDS) was
introduced in 2017 with financial support for conducting seminars,
conferences, exhibitions and delegations.

Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)

was implemented to facilitate small and medium sized enterprises
(SMEs) to attain WHO-GMP norms. This will enable them to compete
at a global scale.

The Pradhan Mantri Bhartiya Janaushadhi Pariyojana’ (PMBJP), was

originally launched in 2008 as “Jan Aushadhi Scheme”. This scheme
aims to make quality affordable generic medicines available to all.
GOVERNING BODY
Pharmaceutical Export Promotion Council of India (Pharmexcil)
Pharmexcil is a promotion body set up by the Government of
India to promote the Indian pharmaceutical industry.

The roles of the council are to advise the government, organize

seminars and meetings on export-related issues, organize
business meetings in India and abroad and also organize trade
delegations.

The council also assists its members in getting Market Access

Incentive (MAI) claims from the Government of India.

Department of Pharmaceuticals
The Department of Pharmaceuticals was formed in 2008 to focus
on the development of the pharmaceutical sector in the country.

The key functions of the department are to ensure availability of

drugs at reasonable prices, proper functioning of Central Pharma
Undertakings, support projects and revival of schemes, ensure
proper management, develop human resources and
infrastructure, formulate schemes & projects and formulate an
annual plan, budget and monitoring of budget expenditure.
 Executive Summary

Indian pharmaceutical industry

India is the largest provider of generic drugs globally and is known

for its affordable vaccines and generic medications.

The Indian Pharmaceutical industry is currently ranked third in

pharmaceutical production by volume after evolving over time into
a thriving industry growing at a CAGR of 9.43% since the past
nine years.

Generic drugs, over-the-counter medications, bulk drugs,

vaccines, contract research & manufacturing, biosimilars, and
biologics are some of the major segments of the Indian pharma
industry.
 India has the most number of pharmaceutical manufacturing
facilities that are in compliance with the US Food and Drug
Administration (USFDA) and has 500 API producers that make for
around 8% of the worldwide API market.

Indian pharmaceutical sector supplies over 50% of global demand

for various vaccines, 40% of generic demand in the US and 25%
of all medicine in the UK.

The domestic pharmaceutical industry includes a network of

3,000 drug companies and ~10,500 manufacturing units.

India enjoys an important position in the global pharmaceuticals

sector.

The country also has a large pool of scientists and engineers with
a potential to steer the industry ahead to greater heights.
Presently, over 80% of the antiretroviral drugs used globally to
combat AIDS (Acquired Immune Deficiency Syndrome) are
supplied by Indian pharmaceutical firms. India is rightfully known
as the "pharmacy of the world" due to the low cost and high
quality of its medicines.
Indian pharmaceutical industry is known for its generic medicines
and low-cost vaccines globally. Transformed over the years as a
vibrant sector, presently Indian Pharma ranks third in
pharmaceutical production by volume. The Pharmaceutical
industry in India is the third largest in the world in terms of volume
and 14th largest in terms of value. The Pharma sector currently
contributes to around 1.72% of the country’s GDP.

According to a recent EY FICCI report, as there has been a

growing consensus over providing new innovative therapies to
patients, Indian pharmaceutical market is estimated to touch US$
130 billion in value by the end of 2030. Meanwhile, the global
market size of pharmaceutical products is estimated to cross over
the US$ 1 trillion mark in 2023.
Market size of India pharmaceuticals industry is expected to reach
US$ 65 billion by 2024, and ~US$ 130 billion by 2030. According
to the government data, the Indian pharmaceutical industry is
worth approximately US$ 50 billion with over US$ 25 billion of the
value coming from exports. About 20% of the global exports in
generic drugs are met by India.

India is among the top 12 destinations for biotechnology

worldwide and 3rd largest destination for biotechnology in Asia
Pacific. In 2022, India’s Biotechnology industry has crossed US$
80.12 billion, growing 14% from the previous year.

The Indian pharmaceutical industry has seen a massive

expansion over the last few years and is expected to reach about
13% of the size of the global pharma market while enhancing its
quality, affordability, and innovation.

The biosimilars market in India is estimated to grow at a

compounded annual growth rate (CAGR) of 22% to become US$
12 billion by 2025. This would represent almost 20% of the total
pharmaceutical market in India.

India is the 3rd largest producer of API accounting for an 8%

share of the Global API Industry. About 500+ different APIs are
manufactured in India, and it contributes 57% of APIs to
prequalified list of the WHO.
The current market size of the medical devices sector in India is
estimated to be US$ 11 billion and its share in the global medical
device market is estimated to be 1.5%.

Indian pharma companies have a substantial share in the

prescription market in the US and EU. The largest number of
FDA-approved plants outside the US is in India.

According to the Indian Economic Survey 2021, the domestic

market is expected to grow 3x in the next decade. India’s
domestic pharmaceutical market stood at US$ 42 billion in 2021
and is likely to reach US$ 65 billion by 2024 and further expand to
reach US$ 120-130 billion by 2030. India's biotechnology industry
comprises biopharmaceuticals, bio-services, bio-agriculture, bio-
industry, and bioinformatics. The Indian biotechnology industry
was valued at US$ 70.2 billion in 2020 and is expected to reach
US$ 150 billion by 2025. India’s medical devices market stood at
US$ 10.36 billion in FY20. The market is expected to increase at
a CAGR of 37% from 2020 to 2025 to reach US$ 50 billion. As of
August 2021, CARE Ratings expect India's pharmaceutical
business to develop at an annual rate of ~11% over the next two
years to reach more than US$ 60 billion in value.

In the global pharmaceuticals sector, India is a significant and

rising player. India is the world's largest supplier of generic
medications, accounting for 20% of the worldwide supply by
volume and supplying about 60% of the global vaccination
demand. The Indian pharmaceutical sector is worth US$ 42 billion
worldwide. In August 2021, the Indian pharmaceutical market
increased at 17.7% annually, up from 13.7% in July 2020.
According to India Ratings & Research, the Indian pharmaceutical
market revenue is expected to be over 12% Y-o-Y in FY22.

EXPORTS
Pharmaceutical is one of the top ten attractive sectors for foreign
investment in India. The pharmaceutical exports from India reach
more than 200 nations around the world, including highly
regulated markets of the USA, West Europe, Japan, and
Australia. India supplied around 45 tonnes and 400 million tablets
of hydroxychloroquine to around 114 countries globally.

India’s drugs and pharmaceuticals exports stood at Rs. 2,08,231

crore (US$ 25.3 billion) for FY23, as per the data by Pharmexcil.

Exports of Drugs & Pharmaceuticals was estimated to be at US$

2.48 billion in March, 2023 and shared 6.47% of the total exports
of the month.

India is the 12th largest exporter of medical goods in the world.

Indian drugs are exported to more than 200 countries in the world,
with US being the key market.

Generic drugs account for 20% of the global export in terms of

volume, making the country the largest provider of generic
medicines globally.

Indian drug & pharmaceutical exports stood at US$ 24.60 billion

in FY22 and US$ 24.44 billion in FY21.

Indian drug & pharmaceutical exports stood at US$ 2.19 billion in

September 2022.

INVESTMENTS AND RECENT DEVELOPMENTS

The Indian Pharmaceuticals industry plays a prominent role in the

global pharmaceuticals industry.
 India ranks third worldwide for production by volume and 14th by
value.

In this regard the sector has seen a lot of investments and

developments in the recent past.

 Up to 100%, FDI has been allowed through automatic route for

Greenfield pharmaceuticals projects.
 For Brownfield pharmaceuticals projects, FDI allowed is up to
74% through automatic route and beyond that through
government approval.
 The cumulative FDI equity inflow in the Drugs and
Pharmaceuticals industry is US$ 21.22 billion during the period
April 2000-December 2022.
 This constitutes almost 3% of the total FDI inflow received across
sectors.
 Emcure Pharmaceuticals Limited (EPL) becomes the first ever
company to launch Orofer FCM 750, a new extension of its
parenteral iron brand containing Ferric carboxymaltose (FCM).
 The dose is suitable for the majority of Indian patients with iron
deficiency and iron deficiency anemia.
 Japanese companies have been invited to invest in the Indian
Pharmaceutical and Medical Device Industry.
 The cooperation between Pharmaceutical Traders Association
and Japan Federation of Medical Devices Associations of the two
countries can contribute to stabilize the global supply-chain
especially of APIs and Medical Devices.
 Sun Pharmaceutical Industries Limited announced the successful
completion of its acquisition of Concert Pharmaceuticals, Inc.
 on March 6, 2023, a late-stage clinical biopharmaceutical
company that is developing deuruxolitinib, a novel, deuterated,
 oral JAK1/2 inhibitor, for the potential treatment of adult patients
with moderate to severe alopecia areata.
 Glenmark Pharmaceuticals Ltd. (Glenmark), an innovation-driven,
global pharmaceutical company, is the first to launch a unique I.V.
 injection formulation, Akynzeo I.V., in India for the prevention of
chemotherapy-induced nausea and vomiting (CINV), under an
exclusive licensing agreement with Helsinn, a Swiss biopharma
group company.
 Entod Pharmaceuticals has recently launched its new ocular
aesthetic range focused on improving eye comfort and enhancing
the aesthetics of the eyes.
 BDR Pharmaceutical has launched the first generic apalutamide
(brand name Apatide) in India to treat both metastatic castration
sensitive prostate cancer as well as non-metastatic castration
resistant prostate cancer. The product will be available across
India.
 Anglo French Drugs & Industries Limited (AFDIL), a 99-year-old
organization in the pharmaceutical sector, announced that it has
entered into the fertility space with the launch of the LYBER
range.
 Eli Lilly introduces Ramiven in India, for certain high-risk early
breast cancer patients in November 2022.
 ICPA Health Products Ltd (ICPA), a leading pharma company in
the oral healthcare segment, has launched its latest product –
Heximetro at the annual conference of the Indian Society of
Periodontology (ISP) in November 2022.
 The FDI inflows in the Indian drugs and pharmaceuticals sector
reached US$ 19.90 billion between April 2000-June 2022.
 The Indian drugs and pharmaceuticals sector received cumulative
FDIs worth US$ 19.41 billion between April 2000-March 2022.
 The foreign direct investment (FDI) inflows in the Indian drugs and
pharmaceuticals sector reached US$ 1,414 million between in FY
2021-22.
 The Indian pharmaceutical industry generated a trade surplus of
US$ 15.81 billion in FY22.
 Medical Device industry is expected to reach US$ 50 billion by
2030 growing at a CAGR of 15%.
 In November 2022, Sun Pharma and SPARC entered into a
license agreement for commercialization of phenobarbital for
injection in the US.
 Glenmark becomes the First Company in India to launch
Teneligliptin + Dapagliflozin Fixed Dose Combination in October
2022.
 In October 2022, Lupin signed an agreement to acquire two
inhalation brands from Sunovion Pharmaceuticals Inc.
 Dr. Reddy's Laboratories announced the launch of Lenalidomide
Capsules in the U.S. with two of six strengths eligible for first-to-
market, 180-day exclusivity in September 2022.
 In June 2022, Cipla partnered with Drugs for Neglected Diseases
initiative (DNDi) to announce the launch of a 4-in-1 antiretroviral
treatment for children living with HIV in South Africa.
 Glenmark becomes the first pharmaceutical company to launch
Indacaterol + Mometasone fixed-Dose combination drug for
Asthma in India.
 In May 2022, Sun Pharmaceutical Industries Limited through one
of its wholly owned subsidiaries plans to launch Bempedoic Acid
under the brand name Brillo, in India for reducing low-density
lipoprotein (LDL) cholesterol.
 In May 2022, Dr. Reddy’s Laboratories enters into exclusive
partnership with HK inno.N Corporation to commercialise novel
molecule Tegoprazan in India & select emerging markets.
 In April 2022, Dr Reddy's Laboratories Ltd. inked a pact with
MediCane Health to announce the launch of medical cannabis
products in Germany.
 The Union Cabinet has given its nod for the amendment of
existing Foreign Direct Investment (FDI) policy in the
pharmaceutical sector in order to allow FDI up to 100% under the
automatic route for manufacturing of medical devices subject to
certain conditions.
 In March 2022, Themis Medicare Ltd. (Themis), announced the
approval of its antiviral drug VIRALEX by the Drug Controller
General of India (DCGI).
 The National Digital Health Blueprint has the potential to generate
nearly US$ 200 billion in added economic value for India's
healthcare industry over the next 10 years.
 In October 2021, AstraZeneca India launched a Clinical Data and
Insights (CDI) division to further strengthen its global presence
and manage data-related aspects of its clinical trials.
 In September 2021, the Indian government contributed US$ 4
billion to the pharmaceutical and medical industries.
 In August 2021, Uniza Group, an Ahmedabad-based
pharmaceutical firm, signed an agreement with Lysulin Inc. (an
US-based firm) to introduce Lysulin, a nutritional product for
Indian consumers.
 In May 2021, Indian Immunologicals Ltd. (IIL) and Bharat
Immunologicals and Biologicals Corporation (BIBCOL) inked
technology transfer pacts with Bharat Biotech to develop the
vaccine locally to boost India's vaccination drive. The two PSUs
plan to start production of vaccines by September 2021.
 GOVERNMENT INITIATIVES
Some of the initiatives taken by the Government to promote the
pharmaceutical sector in India are as follows:
 As per the Union Budget 2023-24:
o A mission to eliminate sickle cell anemia by 2047 will be
launched. It would involve raising awareness, conducting a
comprehensive screening of seven crore individuals in the
impacted tribal regions between the ages of 0 and 40, and
providing counselling through coordinated efforts.
o For innovation in the pharmaceutical sector, through centres of
excellence, a new initiative to encourage pharmaceutical research
and innovation will be implemented.
o The government persuades business to spend money on R&D in
a few chosen priority fields. At the grassroots level, government
has also announced on building 157 nursing colleges in co-
location with government medical colleges.
o The Union Cabinet, on April 26, 2023, approved the National
Medical Devices Policy, 2023.
o The National Medical Devices Policy, 2023 is expected to
facilitate an orderly growth of the medical device sector to meet
the public health objectives of access, affordability, quality and
innovation.
 Ayushman Bharat Digital Mission (ABDM):

o Under the ABDM, citizens will be able to create their ABHA

(Ayushman Bharat Health Account) numbers, to which their digital
health records can be linked. This will enable creation of
longitudinal health records for individuals across various
healthcare providers and improve clinical decision making by
healthcare providers.
o The pilot of ABDM is completed in the six Union Territories of
Ladakh, Chandigarh, Dadra & Nagar Haveli and Daman & Diu,
Puducherry, Andaman and Nicobar Islands and Lakshadweep
with successful demonstration of technology platform developed
by the NHA.
o During the pilot, digital sandbox was created in which more than
774 partner solutions are undergoing integration.
o As on February 21, 2022, 173,369,087 Ayushman Bharat Health
Accounts have been created and 10,114 doctors and 17,319
health facilities have been registered in ABDM.
 Scheme for Development of Pharma industry – Umbrella
Scheme:
o The Department of Pharmaceuticals has prepared an Umbrella
Scheme namely ‘Scheme for Development of Pharma industry’.
Which comprises of the following sub schemes:
o Assistance to Bulk Drug Industry for Common Facilitation Centres
o Assistance to Medical Device Industry for Common Facilitation
Centres
o Assistance to Pharmaceutical Industry (CDP-PS)
o Pharmaceutical Promotion and Development Scheme (PPDS)
o Pharmaceutical Technology Upgradation Assistance Scheme
(PTUAS)
 As per the Union Budget 2022-23:
o Rs. 3,201 crore (US$ 419.2 million) has been set aside for
research and Rs. 83,000 crore (US$ 10.86 billion) has been
allocated for the Ministry of Health and Family Welfare.
o Rs. 37,000 crore (US$ 4.83 billion) has been allocated to the
'National Health Mission’.
o Rs. 10,000 crore (US$ 1.28 billion) has been allocated to Pradhan
Mantri Swasthya Suraksha Yojana.
o The Ministry of AYUSH has been allocated Rs. 3,050 crore (US$
399.4 million), up from Rs. 2,970 crore (US$ 389 million).
 In March 2022, under the Strengthening of Pharmaceutical
Industry (SPI) Scheme, a total financial outlay of Rs. 500 crore
(US$ 665.5 million) for the period FY22 to FY26 were announced.
 India could restart deliveries of COVID-19 shots to global vaccine-
sharing platform COVAX in November-December 2021 for the
first time since April 2021. The World Health Organization (WHO),
which co-leads COVAX, has been pushing India to resume
supplies for the programme, particularly after it sent ~4 million
doses to neighbours and allies in October 2021.
 In November 2021, PM Mr. Narendra Modi inaugurated the first
Global Innovation Summit of the pharmaceuticals sector. The
summit will have 12 sessions and over 40 national and
international speakers deliberating on a range of subjects
including regulatory environment, funding for innovation, industry-
academia collaboration and innovation infrastructure.
 In August 2021, Union Health Minister, Mr. Mansukh Mandaviya
announced that an additional number of pharmaceutical
 companies in India are expected to commence manufacturing of
anti-coronavirus vaccines by October-November 2021. This move
is expected to further boost the vaccination drive across the
country.
 In June 2021, Finance Minister Ms. Nirmala Sitharaman
announced an additional outlay of Rs. 197,000 crore (US$
26,578.3 million) that will be utilised over five years for the
pharmaceutical PLI scheme in 13 key sectors such as active
pharmaceutical ingredients, drug intermediaries and key starting
materials.
 To achieve self-reliance and minimise import dependency in the
country's essential bulk drugs, the Department of
Pharmaceuticals initiated a PLI scheme to promote domestic
manufacturing by setting up greenfield plants with minimum
domestic value addition in four separate ‘Target Segments’ with a
cumulative outlay of Rs. 6,940 crore (US$ 951.27 million) from
FY21 to FY30.
 In May 2021, under Atmanirbhar Bharat 3.0, Mission COVID
Suraksha was announced by the Government of India to
accelerate development and production of indigenous COVID
vaccines. To augment the capacity of indigenous production of
Covaxin under the mission, the Department of Biotechnology,
Government of India, provided financial support in the form of a
grant to vaccine manufacturing facilities for enhanced production
capacities, which is expected to reach >10 crore doses per month
by September 2021

The pharmaceutical industry in India is a significant part of the

nation's foreign trade and offers lucrative potential for investors.
Millions of people around the world receive affordable and
inexpensive generic medications from India, which also runs a
sizable number of plants that adhere to Good Manufacturing
Practices (GMP) standards set by the World Health Organization
(WHO) and the United States Food and Drug Administration
(USFDA).

Among nations that produce pharmaceuticals, India has long

held the top spot. Medicine spending in India is projected to grow
9-12% over the next five years, leading India to become one of
the top 10 countries in terms of medicine spending.

Going forward, better growth in domestic sales would also

depend on the ability of companies to align their product portfolio
towards chronic therapies for diseases such as such as
cardiovascular, anti-diabetes, anti-depressants and anti-cancers,
which are on the rise.

The Indian Government has taken many steps to reduce costs

and bring down healthcare expenses.

The National Health Protection Scheme, which aims to offer

universal healthcare, the ageing population, the rise in chronic
diseases, and other government programmes, including the
opening of pharmacies that offer inexpensive generic
medications, should all contribute to boost the Indian
pharmaceutical industry.

Speedy introduction of generic drugs into the market has

remained in focus and is expected to benefit the Indian
pharmaceutical companies. In addition, the thrust on rural health
programmes, lifesaving drugs and preventive vaccines also
augurs well for the pharmaceutical companies.
RIVANTA MEDICARE

Rivanta Medicare is an ISO 9001: 2015 and GMP certified organization,

complying with the norms of WHO, GMP and M schedule.
Its reach is Pan India, having corporate office in Lucknow.
Its Head Office is situated in kursi road Lucknow. Having
manufacturing capacity of in tablets, capsules, liquid bottles, ointments
and dry syrups etc.
Rivanta Medicare product portfolio is enriched with products having
approval from Drug Controller General of India (DCGI).
Also Deals In Pharma Franchise - Rivanta Medicare clearly defines the
excellence and precision through its pharmaceutical product Range.
The Company is dedicated to delivering effective and high-quality
products to patients for better treatment. Being the top Pharma Franchise
Company in all over india.
we are an ideal choice for business in the Pharmaceutical sector.
We are also work globally with our medicines for domestic animals, pets
and cattles.These days the trend is for taking care of pets, domestics and
cattles.
Manufacture medicines that are good for your pet in all possible ways.
These are 100% generic medicines which do not have any side effects
rather they will work effectively and efficiently. These medicines wont
change the supply of products of your pets. If cows are for milk, not
even milk supply will get affected. In the case of hens, egg quality won’t
get disturbed. In the case of meat animals, there is no change in the
quality of meat.
Today everyone wants to join the pharma industry because of its
evergreen and developing nature. The industry will continuously work
on new technologies and techniques for prosecution of medicines.
VISION

Rivanta Medicare is edicated to meeting the requirements of each and

every patient, and as a result, the company is actively engaged in the
research and development of an efficient, high-quality, and cost-
effective range of General range products for the purpose of operating a
prosperous Pharma marketing business in India. We are bridging the gap
between the unmet needs of patients and advanced scientific solutions
made by understanding the need of the pharma Market and the need of
patients in the modern world significantly with the assistance of our
insight and a handful of experience in the General sector.

The project proposes to establish a small scale unit to manufacture

Pharmaceutical Formulations (Tablets, Capsules, etc.). The
pharmaceutical industry can be divided into the bulk drug and
formulations segments.
Bulk drugs are the active pharmaceutical ingredients (APIs) with
medicinal properties, which are used to manufacture formulations..

Bulk Drugs

The Indian pharmaceutical industry manufactures about 400 bulk drugs

belonging to various therapeutic segments. Formulations still account for
a large share of the overall pharmaceutical production (in value terms),

Formulations

Formulations are the end-products of the medicine manufacturing

process, and can take the form of tablets, capsules, injectable or syrups,
and can be administered directly to patients. Tablets are solid forms of
the drug which include antibiotics, painkillers and vitamins.
Their weight ranges from 25 to 500 mg. Capsules are solid formulations
with the powder drug enclosed in a gelatin shell. The shell which
disintegrates after swallowing, serves to mask the taste of the active
drug. Capsules are mostly antibiotics.

Product and its application

Tablets may be defined as solid pharmaceutical dosage forms

containing drug substances with or without suitable diluents and
prepared either by compression or molding methods.
The British Pharmacopoeia States that tablet are solid preparation each
containing a single dose of one or more active ingredients is obtained by
compressing uniform volume of particles.
They have been in widespread use since the latter part of the 19th
century and their popularity continues.
In the modern days also the tablet are undoubtedly the most popular
mode of presentation of solid dosages form intended for oral
administration.

TABLETS

Tablets remain popular as a dosage form because of the advantages

afforded both to the manufacturer viz simplicity and economy of
preparation, stability, and convenience in packaging, shipping, and
dispensing and the patient viz. accuracy of dosage, compactness,
portability, blandness of taste, and ease of administration.
The tablets vary greatly is shape, size and weight which depends upon
the amount of medicaments and the mode of administration.
Most commonly, the tablets are disk shaped with convex surface.
Although tablets are more frequently discoid in shape, they also may be
round, oval, oblong, cylindrical, or triangular.
They may differ greatly in size and weight depending on the amount of
drug substance present and the intended method of administration.
Tablets are divided into two general classes, whether they are made by
compression – compressed tablets or molding- molded tablets or tablet
triturates (TT).
Compressed tablets are usually prepared by large-scale production
methods while molded tablets generally involve small-scale operation
Capsules are solid dosage forms in which the drug substance is enclosed
in either a hard or soft, soluble container or shell of a suitable form of
gelatin. According to British Pharmacopoeia, the capsules are defined as
solid preparation with hard soft shells, of various size, shapes and
capacities, containing a single dosage of active ingredient.

The capsules are intended for oral administration. The encapsulation of

medicinal agents remains a popular method for administering drugs.
In prescription practices the use of hard gelatin capsules permits a
choice in prescribing a single drug or combination of a drug at the exact
dosage level considered best for the individual’s patients.
This flexibility is an advantage over tablets. Some patient finds it easier
to swallow capsules than tablets and prefer this form of dosages. The
preference of promoted pharmaceutical companies to market the product
in 3 capsules form even though the product has already been produced in
tablets forms.
The capsules form of dosage offers the following advantages:-
 Capsules are tasteless, odorless and can be easily administered.
 They are elegant and attractive in appearance.
 The drugs having unpleasant order and taste are enclosed in tasteless
shell.
 Can be filled quickly and congenitally, physician can the dosage and
combination suiting to individuals patient.
 Capsules are to easy handled and carry.
 The capsules forms are dosage is readability economically The
project envisages the manufacture of drug formulations mainly
paracetamol, anta-acid and iron-folic acid in tablet form, vitamin B
complex in capsule form and ORS in powder form. Other need based
drug formulation could also be manufactured in tablet or Capsule dosage
form.
DESIRED QUALIFICATION FOR PROMOTER

The promoter should be having formal qualifications in the field of

pharmacy (B.Pharm. or M. Pharm). Further he / she should have
experience of working in a unit manufacturing such pharmaceutical
formulations and recognition as Approved pharmacist from Drug
Control Authority.

INDUSTRY OUTLOOK / TREND

The Indian Pharmaceutical industry is highly fragmented with about

24,000 players (around 330 in the organised sector).
The top ten companies make up for more than a third of the market. The
Indian pharma industry accounts for about 1.4% of the world’s pharma
industry in value terms and 10% in volume terms.
The Indian pharmaceuticals market is the third largest in terms of
volume and thirteenth largest in terms of value, as per a report by Equity
Master.

India is the largest provider of generic drugs globally with the Indian
generics accounting for 20 per cent of global exports in terms of volume.
Of late, consolidation has become an important characteristic of the
Indian pharmaceutical market as the industry is highly fragmented.

MARKET POTENTIAL AND MARKETING ISSUES,

IF ANY The Indian Pharmaceutical industry is highly fragmented with

about 24,000 players (around 330 in the organised sector).
The top ten companies make up for more than a third of the market.

The Indian pharma industry accounts for about 1.4% of the world’s
pharma industry in value terms and 10% in volume terms.
Besides the domestic market, Indian pharma companies also have a
large chunk of their revenues coming from exports.
While some are focusing on the generics market in the US, Europe and
semi-regulated markets, others are focusing on custom manufacturing
for innovator companies.
The Indian pharmaceuticals market is the third largest in terms of
volume and thirteenth largest in terms of value, as per a report by Equity
Master.
India is the largest provider of generic drugs globally with the Indian
generics accounting for 20 per cent of global exports in terms of volume.

Of late, consolidation has become an important characteristic of the

Indian pharmaceutical market as the industry is highly fragmented.
 The increased cost competitiveness of Indian producers (for various
products) ,established quality of products, and approval of
manufacturing facilities by international regulatory authorities (like the
United States Food and Drugs Administration, or USFDA, and the
United Kingdom Medicines Control Agency, or UKMCA) have resulted
in export orders coming from both developed and developing markets.

India enjoys an important position in the global pharmaceuticals sector.

The country also has a large pool of scientists and engineers who have
the 5 potential to steer the industry ahead to an even higher level.
Presently over 80 per cent of the antiretroviral drugs used globally to
combat AIDS (Acquired Immuno Deficiency Syndrome) are supplied
by Indian pharmaceutical firms.
The Indian pharma industry, which is expected to grow over 15 per cent
per annum between 2015 and 2020, will outperform the global pharma
industry, which is set to grow at an annual rate of 5 per cent between the
same periods.
The market is expected to grow to US$ 55 billion by 2020, thereby
emerging as the sixth largest pharmaceutical market globally by absolute
size, as stated by Mr. Arun Singh, Indian Ambassador to the US.
Branded generics dominate the pharmaceuticals market, constituting
nearly 80 per cent of the market share (in terms of revenues).
India has also maintained its lead over China in pharmaceutical exports
with a year-on-year growth of 11.44 per cent to US$ 12.91 billion in FY
2015-16, according to data from the Ministry of Commerce and
Industry.
Imports of pharmaceutical products rose marginally by 0.80 per cent
year-on-year to US$ 1,641.15 million.
Overall drug approvals given by the US Food and Drug Administration
(USFDA) to Indian companies have nearly doubled to 201 in FY 2015-
16 from 109 in FY 2014-15.
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.
India is primarily a retail-based branded generic market with 80%
dispensed through pharmaceutical outlets.
As in most emerging economies, acute therapies dominate and account
for close to 70% of the market.
Acute Therapies – target short duration diseases – cough & cold, fever,
pain – such as anti-infective, analgesics, pain-killers.

Chronic therapies – target lifestyle diseases and/or recurring in nature –

such as diabetes, cardiovascular, ophthalmology, and products used to
treat central nervous system ailments, are growing faster than acute
therapy.

India's biotechnology industry comprising bio-pharmaceuticals, bio-

services, bio-agriculture, bio-industry and bioinformatics is expected
grow at an average growth rate of around 30 per cent a year and reach
US$ 100 billion by 2025. Biopharma, comprising vaccines, therapeutics
and diagnostics, is the largest sub-sector contributing nearly 62 per cent
of the total revenues at Rs 12,600 crore (US$ 1.88 billion).

RAW MATERIAL REQUIREMENTS

The unit would require Paracetamol, Folic Acid, Aluminum Hydroxide,

and such other active ingredients. In addition to basic drug or a
combination of drugs commonly known as therapeutic ingredient or
active ingredient, the tablet consists of a number of inert ingredients
which are called excipients or additives.
These additives are added to give the qualities of a good tablet. These
additives are formulated in the form of powder or granules before they
are made in tablet form.
In case of capsules also the active ingredient are invariably formulated
with the addition of excipients or additives. However, their use is move
predominant in the production of tablets.
These additives are classified in accordance with the function they play
in the preparation of tablets or in imparting certain characterizes of the
tablets.

Some of them are as follows

  Diluents : lactose, sodium chloride, starch, powdered sucrose,
mannitol, calcium carbonate
 Binders : starch, acacia, tragacanth, gelatin, glucose, lactose, sucrose,
methyl cellulose etc

 Granulating agents : maze starch and potato starch

 Lubricants: magnesium stearate, calcium stearate, stearic acid and talc.

The project would also require packaging materials and consumables.
These include empty hard gelatin capsules, boxes, bottles, caps, etc. 7
All of the above are easily available in India.

MANUFACTURING PROCESS

The Drugs and Pharmaceutical Industry in general is highly regulated in

India. Regulatory authorities at the Central level and the State level
monitor the same.
At the Central level, the Central Drugs Standard Control Organisation
(CDSCO), Ministry of Health & Family Welfare, Government of India
is the apex organisation.
At the state level the Food and Drugs Control Authority (FDCA) is the
regulatory authority.
Drugs & Cosmetics Act and Schedule M These authority monitor and
control the production of Drugs and Pharmaceutical products under the
provisions of the Drugs and Cosmetics (amendment) Act, 2005 & 2008
and guidelines (July 2015).
The revised Schedule M under this Act is the main basis which specifies
the detailed norms for location; building premises plant lay out,
building, plant & machinery, manufacture, sterilization, packaging,
quality control and such other key components.

Good Manufacturing Practices (GMP)

The Drugs and Pharmaceutical Industry in general is highly regulated in
India. Regulatory authorities at the Central level and the State level
monitor the same.
The revised Schedule M under this Act is the main basis which specifies
the Further the pharma units in general and such sterile products
manufacturing units in particular would also have to comply with
following:
 Good Manufacturing Practices ( GMP),
 Current Good Manufacturing Practices(cGMP) and
 WHO-GMP 8 Good manufacturing practice (GMP) is a system for
ensuring that products are consistently produced and controlled
according to quality standards.
It is designed to minimize the risks involved in any pharmaceutical
production that cannot be eliminated through testing the final product.

WHO-GMP certification is essentially for the plant set up,

manufacturing facilities and related aspects.
However Certificate of Pharmaceutical Products (CoPP) is also required
for each of the products to exporting the same.
This is given only after six months (stability period) of getting -
WHO-GMP Certificate.
Current GMP (cGMP) is essentially an updation of the systems and
facilities as per the requirement of regulated pharma market at the
international level The above are in the form of guidelines and not part
of any Act (except basic GMP).
However they are essential to follow and implement to fulfill the
requirement of the industry and the international market.
Further highly systematic documentation and record keeping is a must
as per the requirement of concerned authorities.
It is to be noted that the Department of Health and Family Welfare
proposes to introduce the Drug and Cosmetics (Amendment) Bill, 2015.
This is in process.
As and when this is passed and put into effect by way of an Act, all the
Drugs and Pharmaceutical units (existing and new) would have to follow
the norms under the amended act.
Technology Different technologies and processes are used at various
stages for the Manufacture of tablets and capsules are depending on the
type of drug formulation. Similarly, different types of packaging
techniques are employed keeping in view the type of drug formulation
and target market.

The key steps of manufacturing for tablets and capsules are

given below Manufacturing process for tablets Compression molding is
the most widely used technology for the manufacture of tablets.
The project also envisages the use of compression molding technique.
The manufacture of compressed tablets involves the following four
process operations.
 Formulation & Granulation
 Compression  Coating ( if required – optional)
 Packaging Manufacturing process for Capsules The most commonly
used dosages in capsules form hard gelatin capsules.
In the manufacturer of hard gelatin capsules following process
operations are used:
 Mixing / blending and granulation
 Capsules filling
 Capsules packing 8 MANPOWER REQUIREMENTS
Indian pharma industry has seen an extraordinary growth and has
reached from Zero to 13 percent of the global market, a report by
Asian Lite has stated.
As per the report, this impressive growth is an outcome of a
series of sound legislation and economic environment, timely
actions, and to a greater extent, the motive of welfare of the
masses.

The Indian pharmaceutical industry has seen a massive

expansion over the last few years and is expected to reach about
13 percent of the size of the global pharma market while
enhancing its quality, affordability, and innovation.
Performing as per its tag as the 'pharmacy of the world', India has
been a global generic medicine supplier for over 200 countries
from both developed and emerging markets.

As per the report, the country has attained recent traction for
being the largest producer of vaccines in the world, contributing
60 per cent to the world's supply of vaccines.
As per the report by McKinsey, a large presence of local players
producing branded generics, along with lower price levels, has
provided the Indian pharmaceutical industry with a unique
opportunity.
The kind of growth the pharma industry has seen in India, from a
non-existent to a global pharmacy, is undoubtedly extraordinary.
This impressive growth is an outcome of a series of sound
legislation and economic environment, timely actions, and to a
greater extent, the motive of welfare to the masses, Asian Lite
reported.
It all began with the introduction of the Patents Act of 1970,
leading to process patents instead of product patents.
This implied that patenting was focused on manufacturing and not
product patents.
It enabled Indian pharma companies in three main ways.

First,
manufacturers engaged in manufacturing drugs without paying
patent holders exorbitant royalties.
Second,
it allowed India to reduce dependence on drug imports and
development of self-reliant Indian pharmaceutical industry.

Third,
the pharma industry boomed in India by developing affordable
versions of patented drugs and gradually moved to the global
market as a generic drug supplier, Asian Lite reported.
However, after the WTO's establishment, India signed the Trade-
Related Aspects of Intellectual Property Rights (TRIPS)
agreement and changed its patent norms.
India then made a few amendments to its patent laws as the
agreement required patents for pharmaceutical products and
processes inventions.
Despite the paradigm shift, India by that time experienced stellar
progress in its pharma supply.
When Covid hit the world in 2020, Indian pharma found an
unprecedented window of opportunity.

Combining expansion in the R-D ecosystem with favourable

policies, India became a major vaccine supplier to the world,
ensuring self-reliance in vaccine provisioning.
India administered free vaccine doses to its citizens, reaching one
billion marks.
Besides acquiring its role as an important international player,
India provided COVID-19-related medical assistance to over 150
countries, Asian Lite reported.

Sticking to its motto of Vasudhaiva Kutumbhakam, India started a

Vaccine Maitri Programme in January 2021, supplying 72.3
million doses of COVID vaccine to more than 94 countries by the
end of 2021.
Many countries also preferred the Indian vaccine due to its low-
cost vaccine development and ability to make large-scale export
consignments, besides the effectiveness of vaccines.
This was of special significance for low-income countries that
could not compete with richer nations for vaccine procurement
during the crisis.

According to an expert, Indian pharma has learned to respond to

the crisis by producing large-scale drugs quickly at short notice
compared to any other country.

It is important to note that the boom for Indian pharma is not

sporadic. It continues to experience sustained and robust growth
in the post-pandemic period as well. By the end of 2022, Indian
pharma has turned from volume to value creator.
As per an expert, with a heightened sense of collaboration
between the industry and the government, the industry's focus
has shifted to other diseases, the advancement of cell therapies,
and policies for IP and government procurements.
Cumulative FDI in the pharma sector was over USD 20 billion in
September 2022.
India is the largest vaccine supplier, with the Serum Institute of
India producing 1.5 billion vaccines a year for polio, diphtheria,
measles, mumps, and rubella to be used by the immunisation
programmes across 170 countries, Asian Lite reported.

Recently, the government of India extended support to pharma

companies using the Production Linked Incentive (PLI) scheme to
ensure self-reliance through enhanced domestic manufacturing
capacity for high-value products.

The PLI schemes are for bulk drugs and pharmaceutical

manufacturing, together accounting for an outlay of around USD
2.7 billion.
Another important aspect of the pharma landscape in India is the
stress on the welfare of the masses using its legislative
provisions.
Recently, the Indian Patent Office rejected the request for an
extension of a patent by Johnson and Johnson for a TB drug on
multiple grounds. This rejection is important in two respects.
First, Indian manufacturers can produce a generic version of this
anti-TB drug since the patent period has expired. Second, it
allows the availability of a cheaper version of the drug, thus,
strengthening India's muscle power in combat against TB.

India's public interest-oriented stance on drug patents has been at

crossroads with the big pharmaceutical companies of the West,
especially the US.
These companies seek to do away with various aspects of the
Indian Patent Act, of the 1970s which they find a hurdle in
establishing their monopoly and rent-seeking behaviour.
While the US pharma companies are against the Form 27 of IPA,
1970 which requires details on patent working in India, experts9
believe that information on the working of a patent is essential to
enquire if the act is successful in promoting innovation as public
health.
In its practice, India has refused to grant secondary and ever-
greening patents on slight modifications of the extant drugs, or
new uses of existing medicines, and combinations of existing
substances, much to the annoyance of big pharmas.
Big pharma has often projected their monopoly interests as the
acceptable international IP norms and continues to pressurise the
US government to act against India
.As per Brook Baker.
Professor at the North-eastern University, Indian patent laws
focus on balancing producer as well as consumer interests.
He has often called out the big pharmaceutical companies of the
US for lobbying against India with their "disinformation
campaigns" blaming India for discriminating against the US
companies.
Contrary to the propaganda, according to Prof. Baker, India's
patent policies are in tandem with both domestic legislation and
international norms laid by TRIPS, Asian Lite reported.

Interestingly, the pharma industry in India is operating in a self-

sustained model setup, ensuring that demand for drugs meets its
supply. To put into perspective, India is keen on the promotion of
the production of generic drugs.
Now to ensure this supply meets the demand for generic drugs,
the Indian government started PM Bhartiya Janaushadhi
Pariyojana (PMBJP), in which Janaudhadi kendras (shops) sell
generic drugs at affordable prices to the masses. By the end of
2022, more than 8,500 kendras were functional nationwide.
Apart from reducing the out-of-pocket expenditure of the people,
these kendras or medicine stores help create awareness about
generic medicines, thus expanding the market for generic drug
manufacturers and providing employment to entrepreneurs
engaging in the establishment of kendras, Asian Lite reported.

With the current valuation of USD 50 billion, the congenial

government policies and the robust R-D expansion in the pharma
sector are expected to lead to the path of resilient growth not just
in volume but in value as well.
The commitment of both the government and the pharma sector
to ensure the abundant availability of quality medicines at
reasonable prices provides India with an opportunity to play a
leading role in the global market with a special concern for the
welfare of the masses.

Scheme for Promotion of Bulk Drug Parks

The scheme to promote setting up of bulk drug parks in the country was
approved by the Government on 20th March, 2020. The Scheme
envisages creation of world class common infrastructure facilities to
bulk drug units located in the parks.
The easy access to such facilities to bulk drug units located in the parks
would bring down their manufacturing cost and increase
competitiveness of the domestic bulk drug industry.
 The scheme would help minimize country’s dependence on imports by
providing fillip to indigenous manufacturing and facilitate Indian bulk
drug industry becoming global leaders.

• Under the scheme, financial assistance would be provided for the

creation of Common Infrastructure Facilities (CIF) like
1. Central Effluent Treatment Plant(s) (CETP)
(ii) Solid waste management
(iii) Storm water drains network
(iv) Common Solvent Storage System, Solvent recovery
and distillation plant (v) Common Warehouse
(vi) Dedicated power sub-station and distribution system
with the necessary transformers at factory gate
(vii) Raw, Potable and Demineralized Water
(viii) Steam generation and distribution system
(ix) Common cooling system and distribution network
(x) Common logistics
(xi) Advanced laboratory testing Centre, suitable for even
complex testing/ research needs of APIs, including
microbiology laboratory and stability chambers
(xii) Emergency Response Centre
(xiii) Safety/ Hazardous operations audits centre and
(xiv) Centre of Excellence etc. in any upcoming Bulk
Drug Park promoted by State Government/State
Corporation
. • The total financial outlay of the scheme is Rs. 3000
crore. The tenure of the scheme is from FY 2020-2021 to
FY 2024-2025.
Financial assistance to a selected Bulk Drug Park would
be 70% of the project cost of common infrastructure
facilities.
 In case of North Eastern States and Hilly States
(Himachal Pradesh, Uttarakhand, Union Territory of
Jammu & Kashmir and Union Territory of Ladakh)
financial assistance would be 90% of the project cost.
Maximum assistance under the scheme for one Bulk Drug
Park would be limited to Rs. 1000 crore.

• Gujarat, Himachal Pradesh and Andhra Pradesh were

selected under the scheme for providing grant-in-aid for
creation of common infrastructure facilities in their
proposed Bulk Drug Parks. The salient features of the CIF
project of Andhra Pradesh are:

• Total Project Cost-Rs. 1635.98 crore

• Area: 2000.46 acres • Major Common Infrastructure
facilities being developed under the scheme include
Roads, drainage, Boundary, green area, water supply,
Waste Water Conveyance Network System –HTDIS and
LTDIS (CETP) and treatment system, marine outfall,
Power Supply, Steam Co-generation plant including
distribution, Common Solvent recovery system, Solid
Waste Management, Common Solvent Recovery system,
Warehousing and common logistics, Analytical Testing
labs, Centre of Excellence, etc.

The salient features of the CIF project of gujarat are: 37

Annual Report - 2022-23
• Total Project Cost – Rs.2507.02 crore
• Area: 2015.02 acres
• Major Common Infrastructure facilities being developed
under the scheme include Steam Generation and supply,
Common Effluent Treatment Plant (CETP), Centre of
Excellence, Solvent recovery facility, Treatment, Storage
& Disposal Facilities (TSDF), Raw water supply and
Effluent collection pipeline, Infrastructure of Roads and
internal drains, common Infrastructure of Marine
Discharge and Power infrastructure. The salient features of
the CIF project of Himachal Pradesh are:
• Total Project Cost – Rs.1923 crore
• Area: 1405.41 acres
• Major Common Infrastructure facilities being developed
under the scheme include Common Effluent Treatment
Plant with ZLD 5 MLD, Solid Waste Management, Storm
water drains network, Common Solvent storage system,
Solvent recovery and distillation plant, Common
Warehouse, Dedicated Power sub-station, Steam
generation and distribution system, raw, potable and
demineralized water, emergency response centre, safety /
hazardous operations audit centre, Internal road network,
Advanced Laboratory testing centre, Centre of Excellence
etc.
 Promotion of Medical Devices Parks

The Department has approved financial assistance of ₹ 25

crore to the project of Andhra Pradesh Medtech Zone Ltd.
(AMTZ), Andhra Pradesh under the sub-scheme
“Assistance to Medical Device Industry for Common
Facility Centre”
. The financial assistance is being given for development
of Common Facility Centre for superconducting magnetic
coils testing & research facility. The Department has
released of ₹ 22.49 crore to AMTZ.
This scheme aimed at providing financial assistance to
States/UTs for creation of Common Facility Centre in the
medical devices parks being developed by them.
The scheme has now been revised to “Promotion of
Medical Devices Parks”. The objective of the Promotion
of Medical Devices Parks scheme is to provide easy
access to standard testing and laboratory facilities through
the creation of world-class Common Infrastructure
Facilities at medical device parks.
This would help reduce the cost of production and
increase competitiveness and improve availability and
affordability of medical devices thereby creating a robust
ecosystem for domestic manufacturing of medical devices.

The guidelines of the scheme were issued on 27th July

2020. The scheme provides grant-in-aid to medical device
parks with a maximum limit of ₹ 100 Crore per park or
70% of the project cost of common infrastructure
facilities, whichever is less.
The Government approved financial assistance for
common infrastructure facilities for four medical device
parks i.e. Himachal Pradesh, Tamil Nadu, Madhya
Pradesh and Uttar Pradesh. The expected date of
completion of the Parks is June, 2024.
As per scheme guidelines, first tranche of grant-in-aid of
Rs. 30 crore each has been released to the four States.

Strengthening of Pharmaceutical Industry [SPI]

 Department of Pharmaceuticals, Ministry of Chemicals
and Fertilizers has released the guidelines for the scheme
“Strengthening of Pharmaceutical Industry” (SPI), with a
total financial outlay of Rs. 500 Cr for the period from FY
2021-22 to FY 2025-26 on 11.3.2022. The scheme will
address the rising demand for support to the existing
Pharma clusters and MSMEs across the country to
improve their productivity, 38 Annual Report - 2022-23
quality and sustainability.
The objectives of the scheme “Strengthening of
Pharmaceutical Industry” (SPI) are to strengthen the
existing infrastructure facilities in order to make India a
global leader in the Pharma Sector.

This Scheme is a Central Sector Scheme and comprises

the following sub-schemes:
• Assistance to Pharmaceutical Industry for Common
Facilities (API-CF)
• Pharmaceutical Technology Upgradation Assistance
Scheme (PTUAS)
• Pharmaceutical & Medical Devices Promotion and
Development Scheme (PMPDS)
i. Assistance to Pharmaceutical Industry for
Common Facilities (API-CF) is provided to
strengthen the existing pharmaceutical clusters’
capacity for creating common facilities. This
will not only improve the quality but also
promote competitiveness and sustainable
growth of the units in the clusters.
ii. ii. Pharmaceutical Technology Upgradation
Assistance Scheme (PTUAS) aims to facilitate
 Micro, Small and Medium Pharma Enterprises
(MSMEs) of proven track record to meet
national and international regulatory standards
(WHO-GMP or Schedule-M).
iii. Under the scheme, interest subvention or
capital subsidy on loans of such enterprises are
provided, which further facilitates the growth
in volumes as well as in quality of these units;
and
iv. Pharmaceutical & Medical Devices
Promotion and Development Scheme
(PMPDS) to facilitate growth and development
of Pharmaceutical and Medical Devices
Sectors through study/survey reports,
awareness programs, creation of database, and
promotion of industry. The above three sub-
schemes are already approved in the
Department of Pharmaceuticals as part of
scheme for ‘Development of Pharmaceutical
Industries’ (DPI). Now, the DoP has combined
the above schemes into a single scheme namely
‘Strengthening of Pharmaceutical Industry
(SPI)’ with modification in the scheme
guidelines, after stakeholder consultations for
effective intervention. SIDBI has been
appointed as the Project Management
Consultant (PMC) for the SPI scheme. It is
expected that the units supported under this
scheme will act as Demonstration Firms for the
pharma clusters and MSMEs Pharma
Industries, encouraging them to improve
 quality and undertake technological
upgradation of the units. In the earlier scheme
known as Cluster Development Programme for
Pharma Sector (CDP-PS) which is now
renamed as Assistance to Pharmaceutical
Industry for Common Facilities (API-CF), one
project of Chennai Pharma Industrial
Infrastructure Upgradation Company (CPIIUC)
viz., setting up Common Effluent Treatment
Plant (CETP) at Alathur, Tamil Nadu has been
completed. The total cost of the project was Rs.
11.02 crore (revised from Rs.10.59 crore due to
GST implementation). Further, two more
project proposals were given final approval on
31.3.2021 viz.:
v. i. Proposal of Inducare Pharmaceuticals and
Research Foundation (IPRF) for creation of
Common Facility Centre at Pune, Maharashtra
at approved project cost of Rs. 31.44 crore.
Three instalments have been released to the
SPV of project (IPRF).
vi. Proposal of Kala Amb Infrastructure
Development Company (KIDC) to set up a
Common Effluent Treatment Plant (CETP) at
Industrial area Kala Amb Tehsil Nahan,
District Sirmaur, Himachal Pradesh with
project cost of Rs. 7.20 crore. Three
instalments has been released to the SPV of
project (IPRF)
PCD PHARMA
You must have come across different kinds of
medicine and wondered where they come from or
where they are manufactured. We will look at how
the distribution and marketing of these medicines
are done and who is involved. It will be particularly
helpful if you are planning to start a medicine
business specially PCD Pharma.

There are many types of Pharma industries involved

in the marketing and distribution of pharmaceuticals.
One of these is the PCD Pharma. Here we will look at
what is PCD Pharma and its scope.

PCD PHARMA

PCD in full stands for Propaganda Cum Distribution.

It is a terminology often used in pharmaceutical
marketing. Propaganda Cum Distribution highlights
the right to market and distribute in
the Pharmaceutical industry.

A PCD Pharma franchise company provides all the

products to all its branch franchise partners. This is
in addition to other benefits that come along with
association with the parent Pharma Franchise.
A Pharma Franchise provides the advantage of a
monopoly of the product to its partners as well as
promotional support.
The parent company provides an exclusive range of
its medicines to the partners who then sell in the
market. The partner company is given the benefit of
keeping the profit margins from its sales. A partner
franchise is also given the right to use the trademark
and brand name of the company itself.

A PCD Pharma works much the same way as Pharma

Franchise, with the main difference being the size of
the business. A Pharma Franchise involves dealing
with larger units, and it requires significant
investments, large market targets, and covers a
large area in its operations.
On the other hand, a PCD Pharma works on small
units requires less investment and covers a
relatively small area.

WHY START A PCD PHARMA BUSINESS

✓ Less investment

You don’t need a massive amount of money to start,

unlike other businesses. You can invest a limited
amount of money in starting a PCD Pharma company.
The product range and business compatibility are all
up to the Pharma Franchise Company.

✓ Low Risk
Since you need a small amount of money to invest at
the start, the rate is minimal, with the potential of
much higher profits. You will, therefore, need not
worry about making potential losses as compared to
high investment and risk businesses.

✓ No Targets

With a PCD Pharma, you will have no pressure of

meeting set targets from the Parent company. You
will sell the product depending on the demand in the
market, not according to the company’s guidelines
and objectives.

✓ High Growth Rate

The PCD Pharma business space in increasing

rapidly. The pharmaceutical industry is changing and
requires more PCD pharma companies. Therefore you
are sure of continued growth once you venture into
the business.

✓ Be your Own Boss

Owning a PCD Pharma gives you the freedom to

manage the business as your own. You make all the
decisions, such as the location of the company and
the amount of money to invest in the future. You can
also make decisions regarding strategies you feel
can improve your business
THE SCOPE OF PCD PHARMA

The pharmaceutical industry is one of the biggest in

the world. With the ever-increasing population, you
can be sure of a steady demand for pharmaceutical
products. The increasing population and increasing
literacy globally provides a large market for
pharmaceutical products.

With the changing lifestyle of people and the

increase in the level of income for most people in the
world translates to more people being able to
purchase a wide range of pharmaceutical goods.
People are becoming aware of healthy lifestyles,
therefore, providing an ever-present market for these
products. The present and future populations will
need excellent health facilities that cover both
medicines and overall healthcare.

With this ever-increasing demand for pharmaceutical

products, PCD Pharma Companies are sure to get
increased growth presently and in the future.
Therefore the PCD Pharma business will become one
of the top business opportunities.
CONCLUSION

If you are planning to start a medicine business, I

hope the above information will surely help you make
the right decision. With the correct information on
what is a PCD pharma and its scope, you can take
the right steps on growing your business in the ever-
increasing pharmaceutical industry.
The PCD Pharma business has proper scope, and it is
an excellent business opportunity that guarantees
your growth and increased revenue.
 Bibliography

Books

INDIAN PHARMA
MODERN PHARMACEUTICAL INDUSTRY
Intellectual property right in pharma industry
Caring for life …the cipla story

Links Visited

www.rivantamedicare.com
www.researchgate.net
www.udyamimitra.in
www.pharmahub.com
-www.ibef.org
-www.investindia.com