Establishment of Formulations Manufacturing Facility
Establishment of Formulations Manufacturing Facility
Establishment of Formulations Manufacturing Facility
Manufacturing Facility
Pharmaceuticals
Government of Gujarat
Contents
Project Concept 3
Market Potential 6
Growth Drivers 9
Gujarat – Competitive Advantage 10
Project Information 11
- Location/ Size
- Manufacturing Process
- Key Players
Project Financials 16
Approvals & Incentives 17
Key Department Contacts 19
Page 2
Project Concept
Page 3
Project Concept
The facility will be in alignment with international guidelines such as the WHO
good manufacturing practise (GMP) standards
Tablet Facility The facility will have hygiene zones such as 'O' Area for products exposed to
environment; 'E' Area for products in close containers. Entry from 'E' to 'O'
area will be restricted by separate gowning procedure
The facility will undertake encapsulation using hard gelatin and soft gelatin
Capsule
Facility Hard gelatin will comprise pellet filling, tablet filling and a combination of
powder/pellet and powder/ tablet filling
The facility will undertake packaging in the form of blister (aluminium – PVC /
PVDC), strips (aluminium - aluminium foil), cold forming (aluminium –
aluminium), pouch packaging (triple laminated foil) and vials / bottle packaging
Packaging
All primary packaging will be in 'O' Area while secondary packaging will be in E
Facility
area
Each machine will be in a closed cubicle with connection to dust extraction
system
The proposed facility would have a Quality Control department which can
Quality perform visual, dimensional, mechanical and analytical testing
Control
Facility Testing would be performed in laboratories with ISO 9001-2008 procedures,
meeting the requirements of ISO, USFDA / MHRA / WHO-cGMP
Page 4
Project Concept
US FDA MHRA
Region with plants TGA approved PICS approved
approved approved
Ahmedabad 11 9 7 4
Bharuch 2 3 2 2
Bhuj 1
Godhara 2 2 2 2
Mehsana 1 1
Nadiad 1
Surendranagar 1 1 2
Vadodara 1 1
Valsad 1 1
Grand Total 18 16 14 12
For production and quality assurance, the proposed facility will adopt guidelines of good
manufacturing practice (GMP)
Recently, Central Drugs Standard Control Organization (CDSCO) is sending staff to drug
manufacturing hubs to get them trained in GMP
Page 5
Market Potential
Globally, India, as a producer, is among the India ranks as the 4th largest generic
top six pharmaceutical producers producer in the world
Source: Make in India, IBEF, Department of Pharmaceuticals, “Indian generic exports to decline 1012 in next 5 years,”
Mint, 17 May 2016
Page 6
Market Potential
State manufactures and exports generic drugs, intricate vaccines, r-DNA products, cytotoxic
drugs external preparations, sex hormone drugs, small and large volume parenteral, APIs, hi-
tech cardiac stents, bio-pharma products among others
30000 390
29000
8
28000 679
27,029 26,881
27000 2,338
26000
25000
Allopathic Ayurvedic
Technical Non-Technical Field Staff
Homeopathic Cosmetics
Page 7
Market Potential
Government initiatives such as “Pharma Vision 2020” will provide boost to the pharmaceutical
industry.
Pharma Vision 2020 aims to make India a global leader in end-to-end drug manufacturing. The
government will provide support in the form of infrastructure, R&D and venture fund for research in
the public and private domain.
Source: Make in India; Market and Markets; Department of Pharmaceuticals; “Global pharma sales reach above 1
trillion,” Thomson Reuters
Page 8
Growth Drivers
Global factors
Increased global demand for formulations: Increased demand for generics due to
public healthcare reforms in US and Latin countries. The ~USD80b Latin American
market is expected to touch USD100 b by 2020
Demand supply gap in US and Latin America leading to increased export to these
countries. Since 2011-12, export of formulation to Latin America increased two fold to
USD680m in 2014-15
Source: Department of Pharmaceuticals, Make in India, “A billion dollar destination for Indian pharma exports,” Financial
Express; Brand India pharma
Page 9
Gujarat - Competitive
Advantage
Gujarat Drug Manufacturing Industry Overview
Ahmedabad cluster
Formulations, APIs, Bharuch – Ankleshwar
Biologicals, CRO cluster
API, Formulations, Vaccines
Vadodara cluster
Formulations, Vapi – Valsad cluster:
Biogenerics Formulations, API, Device
and Diagnostics
Advantages in Gujarat
Gujarat is the one of the power surplus states in the country as a result this helps
bring in huge amount of investment from the industries
Flourishing economy
Gujarat contributes 7.2% of the Nation’s GDP and shows leadership in many areas of
manufacturing and infrastructure sectors. Gujarat’s SDP (State Domestic Product) at
current price registered a growth of 11% during the year 2014-15.
Page 10
Project Information
1. Vadodara
1
2
Proximity to ports 3
Accessibility to API
India imports 70-80% of clusters
API requirement from Proximity to Bharuch –
China Alkeshwar and Vapi – Valsad
Large component of final
product exported
Key Players
Page 11
Project Information
Rail Road
Gujarat has a total railway length of 5,257 Gujarat has a wide road network of around
km (8.25% of India) 77,030 km. Of these, 95% roads are
Mumbai-Ahmedabad bullet train project surfaced, all-weather roads.
In 2015-16 budget, the state government
planned with investment of USD 16.58b
further plans to invest USD 8.3m in a four-lane
Ahmedabad metro rail project construction to
road joining Vadodara- Ankleshwar, USD 2.7m
begin in 2015-2016 with USD 101.3m budget in construction of expressways and USD
Govt of Gujarat further plans to invest USD 81.4m in resurfacing roads
1.65m in regional rail projects
Air Port
The state has 18 domestic airports (the The state has one of the strongest port
highest in any state) and one international infrastructures in India, with 42 ports(21% of
airport. India’s ports are in Gujarat), including one
During 2014-15, the Ahmedabad airport major port at Kandla and 41 minor ports, along
handled 59,313 thousand tonnes of freight. a 1,600 km coastline.
Freight traffic at Vadodara and Rajkot It is the first state in India to take up port
measured 966 tonnes and 79 tonnes privatisation. Gujarat Maritime Board, has
respectively during April-September, 2015. developed port privatisation models such as
private/joint sector ports, private/captive jetties
Utility
Water Power
Page 12
Project Information
Manufacturing process–Small molecule
The tablet may be coated Finished product packed The packaged product is
and capsule may be in two steps – inner stored in warehouses.
polished. packaging comprising
aluminium foil or PVC,
external packaging
comprising wrapper and
package insert.
Page 13