public testing laboratory for food and drugs 03102016 · following sites are proposed for setting...

Public Testing Laboratoryfor Food and DrugsPharmaceuticalsGovernment of Gujarat

Contents

Project Concept 3

Market Potential 5

Growth Drivers 6

Gujarat – Competitive Advantage 7

Project Information 8

- Location/ Size

- Infrastructure Availability/ Connectivity

- Key Players

- Manpower Requirement

Project Financials 11

Approvals & Incentives 12

Key Department Contacts 13

Project Concept

Testing Laboratory for Food and Drugs

Food testing laboratory:

A laboratory that performs tests on food products, ingredients, in process samples, foodpackaging materials for additives, chemical analytes and microorganisms andassociated environmental aspects

Drug testing laboratory:

A laboratory that performs tests on the chemical and microbiological quality of APIs(active pharmaceutical ingredients), raw materials and finished products in compliancewith good laboratory practices

Services to be provided by the proposed Laboratory

Drug testing:

Microbial Test� Antibiotic assays� Microbial limit tests� Preservative efficacy test� Bacterial, Yeast and Mould

counts� Bacterial Endotoxins Test

Chemical Test� Dissolution� Content uniformity� Assay (including vitamins)

Instrumental Analysis� Related substance� Organic volatile impurities

/residual solvent� IR for finished product and

raw material� UV absorption� Disintegration testing

Food testing:

Additives and Contaminants� Food additives� Pesticide residues analysis� Drug and antibiotic residues� Mycotoxin analysis� Food adulterant

General Parameters� Moisture� Fat� Protein� Carbohydrate� Calories/Energy� Sugar� Acid Insoluble Ash� Water Soluble /Insoluble Ash� Alkalinity of Ash

*The list is not exhaustive

Tests for Oils and Fats� Iodine value� Peroxide value� Saponification value� Flash point� RM value� Melting point� Unsaponifiable matter� Acid value� Bellier test

The proposed laboratory is expected provide testing services for the following parameters:

Project Concept

Other Service Offerings

AccreditationsThe laboratory will be accredited by:

� FDCA- Food and Drug Control Administration Gujarat State� GPCB - Gujarat Pollution Control Board Schedule II Environmental Auditor� ISO 9001-2008� NABL - National Accreditation Board for Testing and Calibration Laboratories

The proposed laboratory will also support high end technologies such as nuclear magneticresonance (NMR), powder X-ray diffraction, mass spectrometry for drug testing.

� NMR analysis can provide detailed information about molecular structures and can help toconfirm and establish the identity of pharmaceutical substances and impurities

� Mass Spectrometry is widely used in accurate and precise measurement of elemental andmolecular components of drugs

Markets that will be catered to by the laboratoryA part from the normal pharmaceutical industry and processed food industry, the laboratory willcater to the following:

� Contract manufacturers� Wholesalers� Hospitals� Anyone in general public who wants to get his food and drug samples analysed

� The Food and Drug testing laboratory will not only support regulatory authorities in mandatorycertification of food products and drugs used locally in India but also assist the food and drugindustry in the following:

� Nutritional (food) and drug labelling

� Trace analysis

� Shelf life studies

Market Potential

Indian Drug Industry

Source: India Brand Equity Foundation. Sector Report. January 2016; Make in India website

2,04,000

3,74,000

0

1,00,000

2,00,000

3,00,000

4,00,000

2015 2020

Indian Drug Industry(INR crore)

The Indian drug manufacturing industry isconcentrated by generic drugmanufacturers and contract research andmanufacturing service providers (CRAMS)

� Generics accounted for 70% of marketshare in terms of revenues in 2015

� As of December 2013, India had 3411Drug Master Files (DMFs) with USFDA(highest filing by a country globally)

� There are >1000 players in the CRAMSsegment estimated to contribute INR54,400 crore in 2015, up from INR25,800 crore in 2012

Source: Indian Brand Equity Foundation, April 2016

Indian Food Industry

� Food is the biggest expense for an urban and rural Indian household and constitutes 38.5% and48.6% of the total consumption expenditure of urban and rural households, respectively

� Major industries constituting the food processing sector are grain milling, sugar, edible oils,beverages, fruits & vegetables processing and dairy products

It is expected that the industry willemploy 9 m people by 2024

In FY2015, food processingindustry constituted 14% to India’sGDP through manufacturingFood

processingsector

Source: Make in India website

INR

cro

re

258

482

0100200300400500600

2015 2020 E

Size of food processing industry (USD b)

US

D b

Growth Drivers

Insufficient number oflaboratories in India

Example - processed food market: in 2014, there were only72 state laboratories and 68 private NABL accreditedlaboratories for 640 districts

Common Drivers

Initiatives of Government of IndiaHealth Ministry is collaborating with states for setting up or for revamping laboratories

� In October 2015, the Indian government planned an investment of INR 1,750 crore to revamp thedrug regulatory apparatus in order to ensure that there is at least one functional drug testing lab inevery state

� As part of the MoU, the state or Union Territory will provide their share of the total expenditure forsetting up a new laboratory/ or strengthening an existing facility from their own resources

The government is taking steps to make testing of food samples easy� Private laboratories that have received NABL (National Accreditation Board for Testing and

Calibration Laboratories) accreditation would automatically be considered as notified by FSSAI(Food Safety and Standards Authority of India)

Driver for Drug Laboratories

� India is among top six drug producers in world and willcontinue to grow at a CAGR of 13% till 2020

� Ranks third world wide by production volume and 14thby value

� Accounts for ~10% of world’s production by volume and1.5% by value

� Accounts for 20% of global exports in generics, makingit the largest provider of generic medicines globally

Drug testing to be driven by:

� Growing market, both withinIndia and globally

� Increasing scrutiny by variousregulatory bodies for ensuringquality of drugs

Driver for Food Laboratories

The Indian food processing industry is primarily export oriented (INR 31,600 crore in 2014-15). Asthe exports keep on growing, the quality control measures will keep on becoming strict and willrequire more stringent testing of the food products.

Growth in the drug and food industry testing is expected to be drivenby increasing market size, Government initiatives and an insufficient

number of laboratories

Source: Indianexpress

Source: Make in India website, Department of Pharmaceuticals

Gujarat - CompetitiveAdvantageExisting Gujarat FDCA* Laboratories

Only manufacturer ofdoxorubicin HCL liposomeinjection in the world atpresent

Other Advantages

Bhuj

Rajkot

Vadodara

Surplus Power

� Gujarat is the one of the power surplusstates in the country as a result this helpsbring in huge amount of investment fromthe industries

Flourishing Economy

� Gujarat contributes 7.2% of the NationGDP and shows leadership in many areasof manufacturing and infrastructure sectors

� Gujarat’s SDP (State Domestic Product) atcurrent price registered a growth of 11%during the year 2014-15

Only manufacturer of vitaminC and dapsone in India

Home to ~40% of CROs inthe country

40% of CRAMS companiesin India

33% of India’s drug sectorturnover; 28% of India’s drugexport

Siddhapur

Food testing laboratories

Food and drug testing laboratories

In addition to the 4 FDCA laboratories,Gujarat also has ~13 private laboratories

for food and drug testing in Gujarat

Gujarat is an Established Manufacturing Base for Drugs

Availability of skilled resources: more than 120 colleges# in GujaratAround ~6,000 qualified students pass annually

*Food & Drugs Control Administration^The private laboratories are either for testing of drugs or food or combination of both

#These colleges provide education in chemistry, microbiology and pharmacy

Source: Vibrant Gujarat, manufacturing: sector profile (2015)

Source: Pharmabiz

Source: IBEF

Government labs are NABLaccredited in Gujarat

Project Information

Area 20,000 sq meter

Built-up area 10,000 sq meter

Total project cost INR 63.8 crore

Locations Suggested

Key Highlights for Proposed Facility

Following sites are proposed for setting up the proposed lab:� Surat� Ahmedabad

Vapi/Valsad cluster

Ahmedabad

Surat

Bharuch and Ankleshwar cluster

Vadodara cluster

Pharma Clusters in GujaratOptions for site locations

Source: Vibrant Gujarat, manufacturing: sector profile (2015)

Utility

� Gujarat has a state-wide “water supply grid”spread across 1,20,769 km that aims to serve75% of Gujarat’s population.

� In the state budget for 2015-16, USD83m wasallocated for bulk water supply schemes andUSD574m was allocated for improving theinfrastructure of existing water supply systems

Project Information

Logistics & Connectivity

� Gujarat has 24-hour 3-phase uninterruptedpower supply throughout the state, withinstalled power capacity of 29,293MW(10.38% of India’s overall powercapacitys)

� The state has surplus power to the tune of2000 MW

Water Power

� Gujarat has a total railway length of 5,257 km(8.25% of India)

� Mumbai-Ahmedabad bullet train projectplanned with investment of USD16.58b

� Ahmedabad metro rail project construction tobegin in 2015-2016 with USD101.3m budget

� Govt of Gujarat further plans to investUSD1.65m in regional rail projects

� Gujarat has a wide road network of around77,030 km. Of these, 95% roads aresurfaced, all-weather roads.

� In 2015-16 budget, the state governmentfurther plans to invest USD8.3m in a four-lane road joining Vadodara-Ankleshwar,USD2.7m in construction ofexpressways and USD81.4m in resurfacingroads

� The state has 18 domestic airports (the highestin any state) and one international airport.

� During 2014-15, the Ahmedabad airporthandled 59,313 thousand tonnes of freight.Freight traffic at Vadodara and Rajkotmeasured 966 tonnes and 79 tonnesrespectively during April-September, 2015.

Air

RoadRail

Port

� The state has one of the strongest portinfrastructures in India, with 42 ports(21% ofIndia’s ports are in Gujarat), including onemajor port at Kandla and 41 non-majorports, along a 1,600 km coastline.

� It is the first state in India to take up portprivatisation. Gujarat Maritime Board, hasdeveloped port privatisation models such asprivate/joint sector ports, private/captivejetties

Gujarat has an extensive outlay of robust physical, social and industrial infrastructure,which makes it an excellent investment destination.

Source: Vibrant Gujarat Summit, 2015 and Gujarat The Growth Engine of India – IBEF, Nov 2015

Project Information

Leading Players in Gujarat^

^The list is not exhaustive

Public testing laboratory can collaborate with leading pharmaceutical manufacturers in the state

State Food Testing Lab,Bhuj

State Food Testing Lab,Rajkot

State Food & DrugsTesting Lab and ChoksiLaboratories Ltd,Vadodara

State Food & Drugs Testing Lab,Siddhapur

Food testing laboratoriesFood and drug testing laboratories

Drug testing laboratories

Shree DhanvantaryPharmaceuticals Analysis andResearch Centre, Kim (dist. Surat)

Estimated Manpower Requirement for Testing Laboratory for Foodand Drugs

AccountantLab Technician (food analystand chemist–equal split

between food and drug lab)

Support

3130

Accuprec Research Labs Pvt. Ltd. Changodar

Surat Corporation

Corporation owned laboratories

Ahmedabad CorporationVaibhav Laboratory

Vadodara Corporation

Project Financials

Assumptions:� Benchmark project : Food and drug testing lab By Gujarat FDCA at Siddhapur, Gujarat (INR 80 crore facility set

up in 2014) and Report of the working group on drugs & food regulation for the 12th five year plan

Cost of Setting-up Testing Laboratory for Food and Drugs

Project components & specifications Cost (INR crore)

Site development (site levelling, internal roads, sewage lines, water supply,drainage, landscaping, street lighting)(Area: 20,000 sq meter,Average rate: INR 1,200 per sq meter)

2.4

Building and construction(Built-up area: 10,000 sq meter,Average rate: INR 25,000 per sq meter)

25.0

Machinery and equipment 24.1

Miscellaneous fixed assets(Furniture and fixtures) 6.6

Sub-total 58.0

Contingency (@10%) 5.8

Total Project Cost* 63.8

Approvals

� Regulatory approval from the following:

� Food and Drug Control Administration Gujarat State (FDCA)

� National Accreditation Board for Testing and Calibration Laboratories (NABL)

� Food Safety and Standards Authority of India (FSSAI)

� Bureau of Indian Standards (BIS)

� Ministry of Environment & Forests (MoEF), India

� Infrastructure related: Approval/NOC required from civic bodies like Gujarat Water Supply andSewerage Board, Gujarat Electricity Board, etc.

� Environment-related clearances:

� Approval from Gujarat Pollution Control Board (GPCB)

� Approval from Ministry of Environment and Forests, Government of India

� Rapid Environment Impact Assessment (REIA) studies

Clearances Required*

*List of clearances required is not exhaustive

Incentives by Government of Gujarat

Operative Period From 01/01/2015 to 31/12/2019

Eligibility of institutions Industries Association, Chamber of Commerce and Industries or SPVof Industries

Assistance available Assistance will be considered up-to 60% of project cost or Rs. 25Crores per project whichever less

Assistance for Industrial Infrastructure

National Accreditation Board for Testing and Calibration Laboratories (NABL)

http://www.nabl-india.org/

Agricultural and Processed Food Products Export Development Authority (APEDA)

http://apeda.gov.in/apedawebsite/

https://gujhealth.gujarat.gov.in/food-and-drug-control-administration.htm

Food and Drugs Control Administration

http://www.fssai.gov.in/

Food Safety and Standards Authority of India (FSSAI)

Note: This project profile is based on preliminary study to facilitate prospective entrepreneurs to assess aprima facie scope. It is, however, advisable to get a detailed feasibility study prepared before taking a finalinvestment decision.

Food & Drug Control Administration,GandhinagarOld Sachivalya, Block No.8, 1st Floor,Dr. Jivraj Mehta Bhavan,Gandhi Nagar-382010Phone: 079-23253400, 9825049232,26851817(R)Fax:079-23252417

public testing laboratory for food and drugs 03102016 · following sites are proposed for setting...

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