ACTIVE PHARMA INGREDIENTS (API) [TTCL]
[EIRI/EDPR/4571] J.C.: 2788XL
INTRODUCTION
The Indian pharmaceutical industry has been on an upward trajectory over the past few decades, contributing around 1.72 per cent of the GDP of the nation. The Indian pharma industry is anticipated to reach $ 65 bn by 2024 and $ 130 bn by 2030. This growth is driven by the increasing demand for affordable and high-quality medicines, both domestically and internationally. Currently, India is the 3rd largest producer by volume and 14th largest by value worldwide. Indian pharma exports witnessed a growth of 103 per cent since 2013-14 – from INR 90, 415 Crores in 2013-14 to INR 1,83,422 Crores in 2021-22. About 20% of the global exports in generic drugs are met by India, thereby making India “Pharmacy of the World”.
India’s API Industry
Active Pharmaceutical Ingredient (or API) is a crucial segment of the pharma industry, contributing to around 35 per cent of the market. API is the biologically active component of a drug that causes an intended medical effect. According to World Health Organization, API is any substance or combination of substances used in a finished pharmaceutical product (or FPP) intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to have an immediate impact in restoring, correcting, or modifying physiological functions in human beings.
India is the 3rd largest producer of API accounting for an 8 per cent share of the Global API Industry. 500+ different APIs are manufactured in India, and it contributes 57 per cent of APIs to prequalified list of the WHO. The Indian API market is anticipated to increase at a CAGR of 13.7 per cent during the first four years – about 8 per cent higher than the generic API industry. The Indian API space has become lucrative for several investors and venture capitalists. India’s robust domestic market, advanced chemical industry, skilled workforce, stringent quality and manufacturing standards, and low costs (about 40 per cent less than that in the West) for setting up and operating a modern plant give an added advantage.
The growing antagonism between the West and China has also pushed the global pharma majors to source more from countries other than China. India’s emergence as the alternate source of bulk drugs has been quite remarkable.
Some of the major players operating in the India active pharmaceutical ingredient market include Solara, Aurobindo Pharma Limited, Dr. Reddy's Laboratories, Lupin Limited, Sun Pharmaceutical Industries Limited, Divi’s Laboratories Ltd., Aarti Drugs Ltd., Neuland Labs, Century Pharmaceuticals Ltd., and Proventus Life Sciences Pvt Ltd. among others.
Government of India’s Schemes and Initiatives
To capitalize on its API potential, India is building a holistic and conducive ecosystem. In 2020, the government approved INR 6,940 crore for a production-linked incentive (PLI) scheme for the promotion of domestic manufacturing of Key Starting Materials (KSMs)/Drug Intermediaries (DIs), and APIs. Manufacturing of 35 active pharmaceutical ingredients – representing about 67 per cent of APIs for which India has 90 per cent import dependence – has already started in India under the PLI scheme. The Department of Pharmaceuticals has also given "in-principle" approval to proposals from the states of Himachal Pradesh, Gujarat, and Andhra Pradesh under the "Promotion of Bulk Drug Parks" scheme. This is a crucial initiative to support bulk drug manufacturing in India. The scheme, with a budget of INR 3000 crores, provides financial aid to these three states for the creation of bulk drug parks with the objective of reducing the cost of manufacturing bulk drugs by establishing world-class common infrastructure facilities and increasing the competitiveness of the domestic bulk drug industry. The Government of Assam has also proposed a Pharmaceutical Park in Chaygaon, Kamrup Rural on a land area of 100 acres with an estimated project cost of INR 153.64 crores.
Furthermore, to promote innovation within the industry, various measures have been proposed such as raising the limit for foreign direct investment (up to 100 per cent, FDI has been allowed through automatic route for Greenfield pharmaceuticals projects) and implementing a new strategy for protecting intellectual property rights.
In 2022, India's pharmaceutical business underwent a tremendous transformation, moving from being a volume producer to a valued supplier. Post-COVID-19, the Indian pharma sector has gained momentum as a key player in the global markets. India sets to double its API market in the next 3 years, says Saurabh Mukherjee, Founder and Chief Investment Officer of Marcellus Investment Managers. Cutting-edge research and development in the production of generic APIs would only be possible with the proper regulatory support—through PLI schemes and other incentives—combined with trained, high-skilled individuals. With the ongoing efforts, India is well-positioned to become a global leader in the pharmaceutical industry.
COST ESTIMATION
Plant Capacity 0.8 MT/Day
Land & Building (4000 sq.mt.) Rs. 1.89 Cr
Plant & Machinery Rs. 3.05 Cr
Working Capital for 1 Months Rs. 1.65 Cr
Total Capital Investment Rs. 7.01 Cr
Rate of Return 31%
Break Even Point 59%
CONTENTS
INTRODUCTION
INDIA’S API INDUSTRY
GOVERNMENT OF INDIA’S SCHEMES AND INITIATIVES
ALPHA-LIPOIC ACID
AZITHROMYCIN
KETOPROFEN
PREGABALIN
PROPERTIES AND APPLICATION OF TRITYL CHLORIDE
CHEMISTRY AND MANUFACTURERS OF API
CHEMISTRY
MANUFACTURERS
CARBIDOPA API
DILTIAZEM
PRECAUTIONS
GEMFIBROZIL API
THERAPEUTIC EFFECTS
PRECAUTIONS AND TOXICITIES
DRUG INTERACTIONS
AZITHROMYCIN API
TREATMENT
MECHANISM OF ACTION
SIDE EFFECTS
ACTIVE PHARMA INGREDIENTS
APIS ARE GENERALLY MANUFACTURED THROUGH A VARIETY OF PROCESSES THAT INCLUDE:
MARKET OVERVIEW OF TRITYL CHLORIDE
KEY TAKEAWAYS
API MARKET ANALYSIS
INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) MARKET ANALYSIS
INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) INDUSTRY SEGMENTATION
INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) MARKET GROWTH
ONCOLOGY SEGMENT EXPECTS TO REGISTER A HIGH CAGR
INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) INDUSTRY BULLISH INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) MARKET KEY LEADERS INDIA ACTIVE PHARMACEUTICAL INGREDIENTS (API) MARKET NEWS
CURRENT SITUATION OF API IN INDIA
KEY INTERMEDIATES/ KSMS FROM CHINA HAVING HIGH DEMAND IN INDIA
CHALLENGES FACED BY THE INDIAN API INDUSTRY
STRICTER IMPLEMENTATION OF POLLUTION CONTROL NORMS:
INTERPRETATION OF DPCO, 2013
NO TAX INCENTIVES, HIGHER UTILITIES AND BORROWING COST
LACK OF MEGA BULK DRUG PARKS
ISSUES FACED BY FERMENTATION INDUSTRY
HIGH DEPENDENCE ON A SINGLE SOURCE CAN HAVE A CASCADING EFFECT RECOMMENDATIONS TO REVIVE THE INDIAN API INDUSTRY
RECOMMENDATIONS
IMMEDIATE
LONG TERM
RECOMMENDATIONS – IMMEDIATE
1. FASTER ENVIRONMENT CLEARANCE
2. ENCOURAGE MANUFACTURING BY PROVIDING A FISCAL STIMULUS
FOR APIS AND INTERMEDIATES
FOR FERMENTATION PRODUCTS
3. ACCOMMODATIVE PRICING POLICY UNDER DPCO, 2013
4. FINANCIAL INCENTIVES
RECOMMENDATIONS – LONG TERM
1. DEVELOP LARGE CLUSTERS AND PROVIDE PLUG-AND-PLAY INFRASTRUCTURAL SUPPORT IN DEDICATED ZONES FOR MANUFACTURING APIS
2. INDUSTRY–ACADEMIA INITIATIVES
3. FACILITATE ALTERNATIVE SOURCES OF IMPORT
GLOBAL OVERVIEW OF API
USES AND APPLICATION OF NAPROXEN
PEOPLE USE NAPROXEN FOR THE FOLLOWING CONDITIONS:
DOSAGE AND FORM OF NAPROXEN
MILD TO MODERATE PAIN
OSTEOARTHRITIS, RHEUMATOID ARTHRITIS, ANKYLOSING SPONDYLITIS
ACUTE GOUT ATTACKS
JUVENILE RHEUMATOID ARTHRITIS
HEADACHES
BRIEF DESCRIPTION OF PROCESSES INVOLVED IN API
MANUFACTURING PROCESS OF TTCL [TRITYL CHLORIDE]
RAW MATERIAL REQUIRED/MONTH
MANUFACTURING PROCESS OF AZITHROMYCIN
CHEMICAL REACTION
MATERIAL OR MASS BALANCE
MANUFACTURING PROCESS OF PREGABALIN
STAGE- I
STAGE-II
STAGE-III
PROCESS FLOW DIAGRAM
MATERIAL BALANCE OF PREGABALIN
STAGE-I
STAGE-II
STAGE-III
MANUFACTURING PROCESS OF NAPROXEN
STAGE-I
STAGE-II
STAGE-III
STAGE-IV
STAGE-V
STAGE-VI
STAGE-VII
PROCESS FLOW DIAGRAM
RAW MATERIALS
MANUFACTURING PROCESS OF ALPHA LIPOIC ACID
STAGE-1
STAGE-II
STAGE-III
MANUFACTURING PROCESS OF KETOPROFEN
STEP-I
STEP-II
OTHER PROCESS OF API MANUFACTURE
MANUFACTURING PROCESS OF M-BROMO ANISOLE
REACTION
PROCESS FLOW DIAGRAM OF M-BROMO ANISOLE (BATCH 400 KGS)
MANUFACTURING PROCESS OF ETHYL TRIPHENYL PHOSPHONIUM BROMIDE (BATCH 135 KG)
PROCESS FLOW DIAGRAM (BATCH 135 KG)
MANUFACTURING PROCESS OF CINNAMYLALDEHYDE (BATCH 560 KG)
PROCESS FLOW DIAGRAM
MANUFACTURING PROCESS OF M-PHENOXY BENZYL ALCOHOL (BATCH 175 KG)
PROCESS FLOW DIAGRAM BATCH-175 KG
MANUFACTURING OF BENZYL ALCOHOL BATCH- 187 KGS
PROCESS FLOW DIAGRAM
MATERIAL BALANCE
DISTILLATORY
MANUFACTURING PROCESS OF ALPRAZOLAM
PROCESS FLOW DIAGRAM
MANUFACTURING PROCESS OF METHYLPHENIDATE
PROCESS FLOW DIAGRAM
GOVERNMENT APPROVAL REQUIREMENTS FOR API
EFFLUENT TREATMENT IN API
ENVIRONMENT, HEALTH AND SAFETY (EHS):
THE FOLLOWING TRAININGS SHALL BE THE IMPARTED TO EACH AND EVERY EMPLOYEE:
PRESENT MANUFACTURES OF API (TTCL)
PRINCIPLES OF PLANT LAYOUT
STORAGE LAYOUT:
EQUIPMENT LAYOUT:
SAFETY:
PLANT EXPANSION:
FLOOR SPACE:
UTILITIES SERVICING:
BUILDING:
MATERIAL-HANDLING EQUIPMENT:
RAILROADS AND ROADS:
MAJOR PROVISIONS IN ROAD PLANNING FOR MULTIPURPOSE SERVICE ARE:
PLANT LOCATION FACTORS
PRIMARY FACTORS
1. RAW-MATERIAL SUPPLY:
2. MARKETS:
3. POWER AND FUEL SUPPLY:
4. WATER SUPPLY:
5. CLIMATE:
SPECIFIC FACTORS
6. TRANSPORTATION:
A. AVAILABILITY OF VARIOUS SERVICES AND PROJECTED RATES
7. WASTE DISPOSAL:
8. LABOR:
9. REGULATORY LAWS:
10. TAXES:
11. SITE CHARACTERISTICS:
12. COMMUNITY FACTORS:
13. VULNERABILITY TO WARTIME ATTACK:
14. FLOOD AND FIRE CONTROL:
EXPLANATION OF TERMS USED IN THE PROJECT REPORT
1. DEPRECIATION:
2. FIXED ASSETS:
3. WORKING CAPITAL:
4. BREAK-EVEN POINT:
5. OTHER FIXED EXPENSES:
6. MARGIN MONEY:
7. TOTAL LOAD:
8. LAND AREA/MAN POWER RATIO:
PROJECT IMPLEMENTATION SCHEDULES
INTRODUCTION
PROJECT HANDLING
PROJECT SCHEDULING
PROJECT CONSTRUCTION SCHEDULE
TIME SCHEDULE
ADDRESSES OF RAW MATERIAL SUPPLIERS
ADDRESSES OF PLANT AND MACHINERY SUPPLIERS
APPENDIX – A:
01. PLANT ECONOMICS
02. LAND & BUILDING
03. PLANT AND MACHINERY
04. OTHER FIXED ASSESTS
05. FIXED CAPITAL
06. RAW MATERIAL
07. SALARY AND WAGES
08. UTILITIES AND OVERHEADS
09. TOTAL WORKING CAPITAL
10. TOTAL CAPITAL INVESTMENT
11. COST OF PRODUCTION
12. TURN OVER/ANNUM
13. BREAK EVEN POINT
14. RESOURCES FOR FINANCE
15. INSTALMENT PAYABLE IN 5 YEARS
16. DEPRECIATION CHART FOR 5 YEARS
17. PROFIT ANALYSIS FOR 5 YEARS
18. PROJECTED BALANCE SHEET FOR (5 YEARS)
