Introduction RM, KSM, Intermediate & API?? Steps involved in manufacturing & their terminologies Legal Requirement Green field project Land size required Various department Product List & Market Equipment Designing, procurement, Installation, Qualification & manufacturing

4.  Currently, China is the global leader in the
production and export of APIs, which is around 20
percent of the world’s API production.
As per KPMG Report:
Country
API market Growth
In year 2020 In year 2024
China Rs 982 billion Rs 1,234 billion
India Rs 798 billion Rs 1,109 billion

5. Why China is global leader for API Production:
 The cost of production in China is 20-30% lower than in India.
 This is what the breakup looks like: Raw material cost in India is
25-30 percent higher than in China.
 Electricity is 20 percent more expensive in India than in China.
 Labour costs in India are 1.8X lower than in China, but China's
labour productivity is 1.5X higher than India's.

6. Why China is global leader for API Production:
 Other costs which include financing, logistics, production and
set-up costs are 30 percent higher in India than in China.
 This is a result of China’s cost efficiency, large scale
manufacturing capacities, technical capabilities and supportive
government policies.

7. Why China is global leader for API Production:
Parameter India China
Registering Property (time in days) 58 9
Registering Property (number of
procedures)
9 4
Getting electricity (days) 53 32
Getting electricity (number of procedures) 4 2
Dealing with construction permits (days) 106 111
Starting a business (days) 18 9
Starting a business (procedures) 10 4

8. RM, KSM, Intermediate & API???:
 RM: Raw Material like:
 Solvents (liquids): MDC, Et. Ac, Acetone, EDC, DMF, THF, Toluene etc.
 Reagents (Liquids or solid): H2SO4, HCl, HNO3, DMSO4, Sodium
Thiochloride etc.
 Solid RM: Carbon, Pt Catalyst etc.
 KSM: Key Starting Material
 Main material
 It has similar chemical structure with of API having difference in
functional group attached.
 High Price of KSM implies High price of API
 Mostly KSM are being procured from China

10. RM, KSM, Intermediate & API???:
 API: Active Pharmaceutical Ingredient.
 Biologically active chemical compound in solid, liquid form
 Manufacturing involves various reaction in different stages
 E.g. Paracetamol 500 mg dose tablet means:
 Each tablet contains 500mg of paracetamol which is
active part & other ingredients are maize starch,
potassium sorbate, purified talc, stearic acid, povidone, and
soluble starch which all are biological inactive.

11. Steps involved in Manufacturing???:
 Stage-1: Intermediate-1 Manufacturing
RM1
RM2
KSM
Cooking as per recipe
Byproducts (liq. Or
Solid)
Intermediate-1

12. Steps involved in Manufacturing???:
 Stage-2: Intermediate-2 Manufacturing
RM1
RM2
Intermediate-1
Cooking as per recipe
Byproducts (liq. Or
Solid)
Intermediate-2

13. Steps involved in Manufacturing???:
 Stage-3 / 4 / 5: Intermediate-3 / 4 / API Manufacturing Done.
 In this way intermediates are categories as
 N-1 intermediate
 N-2 intermediate
 N-3 intermediates

14. Legal Requirements???:
 For starting API manufacturing unit, you need to compile with
the specifications of Drug and Cosmetic Act & Rules.
 Specific requirements of premises, plant and materials for
manufacture of active pharmaceutical ingredients (bulk drugs) is
covered under Part 1F of Schedule M and WHO good
manufacturing practice specifications i.e. site has to be certified
by WHO at least for local market.
 Export business needs country FDA approvals

15. Legal Requirements???:
 Licenses and NOC Required:
 Constitution of Firm or Company Registration
 Bulk Drug Manufacturing License
 Wholesale Drug license
 Goods and Service Tax Registration
 Factory Act Registration if applicable
 Fire NOC
 NOC from pollution board and various other things.