Investment Opportunities in APIs-KSMs-Drug Intermediates Bulk Drug Industries.

 

Investment Opportunities in APIs-KSMs-Drug Intermediates Bulk Drug Industries. Cabinet Approves Promotion of Domestic Manufacturing of Critical Key Starting Materials-Drug Intermediates and Active Pharmaceutical Ingredients in the Country.

Key Starting Materials (KSMs)/Drug Intermediates

KSMs from the essential medicines list for strategic reasons posed by the COVID-19.

Role of Government towards (KSMs)/Drug Intermediates

The Union Cabinet chaired by the Prime Minister, Shri Narendra Modi has approved the following schemes:

The scheme on Promotion of Bulk Drug Parks for financing Common Infrastructure Facilities in 3 Bulk Drug Parks with financial implication of Rs. 3,000 crore for next five years.

Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical KSMs/Drug Intermediates and APIs in the country with financial implications of Rs6, 940 crore for next eight years.

Details:

Promotion of Bulk Drug Parks

·         Decision is to develop 3 mega Bulk Drug parks in India in partnership with States.

·         Government of India will give Grants-in-Aid to States with a maximum limit of Rs. 1000 Crore per Bulk Drug Park.

Read our Book Here: Handbook on Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products

·         Parks will have common facilities such as solvent recovery plant, distillation plant, power & steam units, common effluent treatment plant etc.

·         A sum of Rs. 3,000 crore has been approved for this scheme for next 5 years.

·         Related Projects: - Pharmaceutical, Drugs, Fine Chemicals, Bulk Drug Intermediates,

Production Linked Incentive Scheme

·         Financial incentive will be given to eligible manufacturers of identified 53 critical bulk drugs on their incremental sales over the base year (2019-20) for a period of 6 years.

·         Out of 53 identified bulk drugs, 26 are fermentation based bulk drugs and 27 are chemical synthesis based bulk drugs.

·         Rate of incentive will be 20 % (of incremental sales value) for fermentation based bulk drugs and 10% for chemical synthesis based bulk drugs.

·         A sum of Rs. 6,940 crore has been approved for next 8 years.

Impact:

Promotion of Bulk Drug Parks:

The scheme is expected to reduce manufacturing cost of bulk drugs in the country and dependency on other countries for bulk drugs.

Production Linked Incentive Scheme:

·         The scheme intends to boost domestic manufacturing of critical KSMs/Drug Intermediates and APIs by attracting large investments in the sector to ensure their sustainable domestic supply and thereby reduce India's import dependence on other countries for critical KSMs/Drug Intermediates and APIs.

·         It will lead to expected incremental sales of Rs. 46,400 crore and significant additional employment generation over 8 years.

Implementation:

Promotion of Bulk Drug Parks

The scheme will be implemented by State Implementing Agencies (SIA) to be set up by the respective State Governments and the target is to set up 3 mega Bulk Drug Parks.

Production Linked Incentive Scheme

The scheme will be implemented through a Project Management Agency (PMA) to be nominated by the Department of Pharmaceuticals. The Scheme will be applicable only for manufacturing of 53 identified critical bulk drugs (KSMs/Drug Intermediates and APIs).

Related Books: - Pharmaceutical, Drugs, Proteins Technology Handbooks

Benefits:

·         Common infrastructure facilities would be created with the financial assistance under the sub-scheme in 03 Bulk Drug Parks.

·         It is expected to reduce manufacturing cost and dependency on other countries of Bulk Drug in the country.

Related videos: - Manufacturing Business Ideas in Pharmaceutical Industry

Manufacturing of Pharmaceutical Bulk Drugs and Medicine

Pharmaceutical Pellets and Granules

 

Pharmaceutical Manufacturing Unit

Indian Pharma Industry: An Investment Opportunity

Manufacturing Business Ideas in Pharmaceutical Industry

 

List of Critical KSMs/Drug Intermediates and APIs

Fermentation Based 04 KSMs/Drug Intermediates and Corresponding APIs

1.       Penicillin G/6-Amino Penicillinc Acid (6-APA)

2.       Cephalosporin C/7-Amino Cephalosporanic Acid (7-ACA)

3.       Erythromycin Thiocyanate/TIOC

4.       Potassium Clavulanate 

 

Fermentation Based 10 Niche KSMs/Drug Intermediates and Corresponding APIs

1.       Cyclins (Tetracycline, Oxycycline, Doxyxcline)

2.       Aminoglycosides (Gentamycin)

3.       Aminoglycosides (Neomycin)

4.       Aminoglycosides (Streptomycin)

5.       Steroids (Betamethasone)

6.       Steroids (Dexamethasone)

7.       Steroids (Prednisolone)

8.       Anti TB (Rifampicin)

9.       Vitamins and Nutraceuticals (Vitamin B6)

10.     Vitamins and Nutraceuticals (Vitamin B1)

 

Chemical Synthesis Based 04 KSMs/Drug Intermediates and Corresponding APIs (with backward integration)

1.       Dicyandiamide (DCDA)

2.       Para-aminophenol

3.       2-Methyl -5 Nitro- Imidazole (2-MNI) including Imidazoles.

4.       1, 1 Cyclohexane Diacetic Acid (CDA)

 

Other Chemical Synthesis Based 23 KSMs/Drug Intermediates and Corresponding APIs (with backward integration)

1)       Levofloxacin

2)       Sulfadiazine

3)       Ciprofloxacin

4)       Ofloxacin

5)       Norfloxacin

6)       Artesunate

7)       Telmisartan

8)       Losartan

9)       Valsartan

10)     Olmesartan

11)     Atorvastatin

12)     Acyclovir

13)     Lopinavir

14)     Ritonavir

15)     Oxcarbazepine

16)     Carbamazepine

17)     Levodopa

18)     Carbidopa

19)     Levetiracetam

20)     Aspirin

21)     Diclofenac Sodium

22)     Tinidazole

23)     Ornidazole

Market

The Indian pharmaceutical industry is the 3rd largest in the world by volume. However, despite this achievement, India is significantly dependent on the import of basic raw materials, viz., Bulk Drugs that are used to produce medicines. In some specific bulk drugs the import dependence is 80 to 100%.

The government has plans to put in place a production-linked incentive (PLI) scheme to boost domestic manufacturing of critical key starting materials (KSMs) or drug intermediates, used to make bulk drugs, as well as APIs. That PLI could cost $911.5 million over the next eight years.

India imports 53 APIs and KSMs from China. According to the Trade Promotion Council of India (TCPI), India imports 70% of its API requirements from China, mostly antibiotics and vitamins. In 2018-19, Indian pharma companies imported bulk drugs and intermediates worth $2.4 billion from China.

The Indian pharmaceutical market should grow from nearly $34.3 billion in 2020 to more than $45 billion by 2025 million.

Quantum of Incentive

The fermentation based eligible, incentive for first four years (2022-2023 to 2025-2026) would be 20%, for fifth year (2026-27) incentive would be 15% and the sixth year (2027-2028) incentive would be 5%; on incremental sale of KSMs/Drug Intermediates/APIs.

For chemically synthesis eligible products, incentive for five years (2021-2022 to 2025-2026) would be 10% on incremental sales of KSMs/Drug Intermediates/APIs.

Related Videos: - https://bit.ly/2XVNXsY

For More Details, Click Here: - https://bit.ly/2ACReEn

Tags:-

#Levofloxacin #Sulfadiazine #Ciprofloxacin #Ofloxacin #Norfloxacin #Artesunate #Telmisartan #Losartan  #Valsartan #Olmesartan #Atorvastatin #Acyclovir #Lopinavir #Ritonavir #Oxcarbazepine #Carbamazepine #Levodopa #Carbidopa #Levetiracetam #Aspirin #Diclofenac Sodium #Tinidazole #Ornidazole #businessopportunity #projectreport #DetailedProjectReport #businessconsultant #businessfeasibilityreport #BusinessPlan #startyourbusiness #investmentopportunity #growyourbusiness  #startups #business #covidbusiness #covid19 #covidsmallbusiness #APIBusiness #ActivePharmaceuticalIngredient

 

ABOUT NPCS

 

NIIR PROJECT CONSULTANCY SERVICES (NPCS) is a reliable name in the industrial world for offering integrated technical consultancy services. NPCS is manned by engineers, planners, specialists, financial experts, economic analysts and design specialists with extensive experience in the related industries.

Our various services are: Detailed Project Report,  Business Plan for Manufacturing Plant, Start-up Ideas, Business Ideas for Entrepreneurs, Start up Business Opportunities, entrepreneurship projects, Successful Business Plan, Industry Trends, Market Research, Manufacturing Process, Machinery, Raw Materials, project report, Cost and Revenue, Pre-feasibility study for Profitable Manufacturing Business, Project Identification, Project Feasibility and Market Study, Identification of Profitable Industrial Project Opportunities, Business Opportunities, Investment Opportunities for Most Profitable Business in India, Manufacturing Business Ideas, Preparation of Project Profile, Pre-Investment and Pre-Feasibility Study, Market Research Study, Preparation of Techno-Economic Feasibility Report, Identification and Section of Plant, Process, Equipment, General Guidance, Startup Help, Technical and Commercial Counseling for setting up new industrial project and Most Profitable Small Scale Business.

NPCS also publishes varies process technology, technical, reference, self employment and startup books, directory, business and industry database, bankable detailed project report, market research report on various industries, small scale industry and profit making business. Besides being used by manufacturers, industrialists and entrepreneurs, our publications are also used by professionals including project engineers, information services bureau, consultants and project consultancy firms as one of the input in their research.

Our Detailed Project report aims at providing all the critical data required by any entrepreneur vying to venture into Project. While expanding a current business or while venturing into new business, entrepreneurs are often faced with the dilemma of zeroing in on a suitable product/line.

 


And before diversifying/venturing into any product, wish to study the following aspects of the identified product:


• Good Present/Future Demand
• Export-Import Market Potential
• Raw Material & Manpower Availability
• Project Costs and Payback Period


We at NPCS, through our reliable expertise in the project consultancy and market research field, Provides exhaustive information about the project, which satisfies all the above mentioned requirements and has high growth potential in the markets. And through our report we aim to help you make sound and informed business decision.

 

The report contains all the data which will help an entrepreneur find answers to questions like:

• Why I should invest in this project?
• What will drive the growth of the product?
• What are the costs involved?
• What will be the market potential?


The report first focuses on enhancing the basic knowledge of the entrepreneur about the main product, by elucidating details like product definition, its uses and applications, industry segmentation as well as an overall overview of the industry sector in India. The report then helps an entrepreneur identify the target customer group of its product. It further helps in making sound investment decision by listing and then elaborating on factors that will contribute to the growth of product consumption in India and also talks about the foreign trade of the product along with the list of top importing and top exporting countries. Report includes graphical representation and forecasts of key data discussed in the above mentioned segment. It further explicates the growth potential of the product.

The report includes other market data like key players in the Industry segment along with their contact information and recent developments. It includes crucial information like raw material requirements, list of machinery and manufacturing process for the plant. Core project financials like plant capacity, costs involved in setting up of project, working capital requirements, projected revenue and profit are further listed in the report.


Reasons for buying the report:

• This report helps you to identify a profitable project for investing or diversifying into by throwing light to crucial areas like industry size, demand of the product and reasons for investing in the product.

• This report provides vital information on the product like its definition, characteristics and segmentation.

• This report helps you market and place the product correctly by identifying the target customer group of the product.

• This report helps you understand the viability of the project by disclosing details like raw materials required, manufacturing process, project costs and snapshot of other project financials.

• The report provides forecasts of key parameters which helps to anticipate the industry performance and make sound business decision.

 

Our Approach:


• Our research reports broadly cover Indian markets, present analysis, outlook and forecast.

• The market forecasts are developed on the basis of secondary research and are cross-validated through interactions with the industry players. 

• We use reliable sources of information and databases.  And information from such sources is processed by us and included in the report.

 

Our Market Survey cum Detailed Techno Economic Feasibility Report Contains following information:

 

 

Ø  Introduction

·         Project Introduction

·         Project Objective and Strategy

·         Concise History of the Product

·         Properties

·         BIS (Bureau of Indian Standards) Provision & Specification

·         Uses & Applications

 

Ø  Market Study and Assessment

·         Current Indian Market Scenario

·         Present Market Demand and Supply

·         Estimated Future Market Demand and Forecast

·         Statistics of Import & Export

·         Names & Addresses of Existing Units (Present Players)

·         Market Opportunity

 

Ø  Raw Material

·         List of Raw Materials

·         Properties of Raw Materials

·         Prescribed Quality of Raw Materials

·         List of Suppliers and Manufacturers

 

Ø  Personnel (Manpower) Requirements

·         Requirement of Staff & Labor (Skilled and Unskilled) Managerial, Technical, Office Staff and Marketing Personnel

 

Ø  Plant and Machinery

·         List of Plant & Machinery

·         Miscellaneous Items

·         Appliances & Equipments

·         Laboratory Equipments & Accessories

·         Electrification

·         Electric Load & Water

·         Maintenance Cost

·         Sources of Plant & Machinery (Suppliers and Manufacturers)

 

Ø  Manufacturing Process and Formulations

·         Detailed Process of Manufacture with Formulation

·         Packaging Required

·         Process Flow Sheet Diagram

 

Ø  Infrastructure and Utilities

·         Project Location

·         Requirement of Land Area

·         Rates of the Land

·         Built Up Area

·         Construction Schedule

·         Plant Layout and Requirement of Utilities

 

Project at a Glance

Along with financial details as under:

 

  •     Assumptions for Profitability workings

  •    Plant Economics

  •    Production Schedule

  •    Land & Building

            Factory Land & Building

            Site Development Expenses

  •    Plant & Machinery

             Indigenous Machineries

            Other Machineries (Miscellaneous, Laboratory etc.)

  •    Other Fixed Assets

            Furniture & Fixtures

            Pre-operative and Preliminary Expenses

            Technical Knowhow

            Provision of Contingencies

  •   Working Capital Requirement Per Month

             Raw Material

            Packing Material

            Lab & ETP Chemical Cost

           Consumable Store

  •   Overheads Required Per Month And Per Annum

         Utilities & Overheads (Power, Water and Fuel Expenses etc.)

             Royalty and Other Charges

            Selling and Distribution Expenses

  •    Salary and Wages

  •    Turnover Per Annum

  •   Share Capital

            Equity Capital

            Preference Share Capital

 

  •    Annexure 1:: Cost of Project and Means of Finance

  •    Annexure 2::  Profitability and Net Cash Accruals

                Revenue/Income/Realisation

                Expenses/Cost of Products/Services/Items

                Gross Profit

                Financial Charges     

                Total Cost of Sales

                Net Profit After Taxes

                Net Cash Accruals

  •   Annexure 3 :: Assessment of Working Capital requirements

                Current Assets

                Gross Working. Capital

                Current Liabilities

                Net Working Capital

                Working Note for Calculation of Work-in-process

  •    Annexure 4 :: Sources and Disposition of Funds

  •    Annexure 5 :: Projected Balance Sheets

                ROI (Average of Fixed Assets)

                RONW (Average of Share Capital)

                ROI (Average of Total Assets)

  •    Annexure 6 :: Profitability ratios

                D.S.C.R

                Earnings Per Share (EPS)

               

             Debt Equity Ratio

        Annexure 7   :: Break-Even Analysis

                Variable Cost & Expenses

                Semi-Var./Semi-Fixed Exp.

                Profit Volume Ratio (PVR)

                Fixed Expenses / Cost 

                B.E.P

  •   Annexure 8 to 11:: Sensitivity Analysis-Price/Volume

            Resultant N.P.B.T

            Resultant D.S.C.R

   Resultant PV Ratio

   Resultant DER

  Resultant ROI

          Resultant BEP

  •    Annexure 12 :: Shareholding Pattern and Stake Status

        Equity Capital

        Preference Share Capital

  •   Annexure 13 :: Quantitative Details-Output/Sales/Stocks

        Determined Capacity P.A of Products/Services

        Achievable Efficiency/Yield % of Products/Services/Items 

        Net Usable Load/Capacity of Products/Services/Items   

       Expected Sales/ Revenue/ Income of Products/ Services/ Items   

  •    Annexure 14 :: Product wise domestic Sales Realisation

  •    Annexure 15 :: Total Raw Material Cost

  •    Annexure 16 :: Raw Material Cost per unit

  •    Annexure 17 :: Total Lab & ETP Chemical Cost

  •    Annexure 18  :: Consumables, Store etc.,

  •    Annexure 19  :: Packing Material Cost

  •    Annexure 20  :: Packing Material Cost Per Unit

  •    Annexure 21 :: Employees Expenses

  •    Annexure 22 :: Fuel Expenses

  •    Annexure 23 :: Power/Electricity Expenses

  •    Annexure 24 :: Royalty & Other Charges

  •    Annexure 25 :: Repairs & Maintenance Exp.

  •    Annexure 26 :: Other Mfg. Expenses

  •    Annexure 27 :: Administration Expenses

  •    Annexure 28 :: Selling Expenses

  •    Annexure 29 :: Depreciation Charges – as per Books (Total)

  •   Annexure 30   :: Depreciation Charges – as per Books (P & M)

  •   Annexure 31   :: Depreciation Charges - As per IT Act WDV (Total)

  •   Annexure 32   :: Depreciation Charges - As per IT Act WDV (P & M)

  •   Annexure 33   :: Interest and Repayment - Term Loans

  •   Annexure 34   :: Tax on Profits

  •   Annexure 35   ::Projected Pay-Back Period And IRR