Dr Anasua Bagchi

Head – Technical services

HLFPPT – A trust promoted by HLL Life care

From God’s own country - “Kerala“, India

A promise of “Affordable” and “Powerful” Solution for ‘Empowering women’ ….

The land of Abundant Natural Rubber

A Govt. of India Enterprise

India's leading provider of contraceptives, and women's healthcare products.

A Mini-Ratna Public Sector Enterprise with seven manufacturing units, and vast array of innovative products and services.

HLL Lifecare Ltd.

Reproductive and Child Health

(RCH)

Family Planning

HIV/ AIDS

Maternal and Child

Health

Child Survival Social

Marketing

Capacity Building

Social Franchising

Program Management

MISSION :

“Offer Innovative, Affordable and Sustainable Reproductive Health

Solutions”

HLFPPT A Not-for-Profit Trust promoted by

HLL Lifecare Ltd. Operational in 22 states in India,

with more than 1400 team members

Extensive network in India

India at a Glance

Population (Census 2011)– 1210 Million

Male – 623 Million

Female – 586 Million

HIV Prevalence Rate (As per DLHS III) – 0.36%

Male – 0.43

Female – 0.29

Contraceptive Prevalence Rate (As per DLHS III) – 59.3%

Maternal Mortality Ratio (SRS 2010) – 212

Infant Mortality Rate (SRS 2010)– 47

Total Fertility Rate (SRS 2010) – 2.5

Situational Analysis (India)

1.1 35.8

5.7

11

0.6 0.6

13.2

0.2

15.9

9.2

0.4

Share of ever used specific method used by married women aged 15-49 yrs (NFHS 3)

Male Sterlisation

Female Sterlisation

IUD

Pills

ECP

Injectables

Condom

Female Condom

Rhythm

Withdrawal

Other

Our Journey with FC in India…

2005: Indian ‘FDA’ approval for marketing FC

2007: Launch of HLL’s own brand of FC – “Velvet” & “Confidom”

2008: Assembly, Testing & Packaging of FC in own facility

45 years of expertise in Manufacturing & Marketing of Condoms

Exclusive FC Unit

•Cochin, Kerala, India •Quality Testing, Assembly & Packing •Present Capacity: 25 MPcs /Annum

HLFPPT

Advocacy with GOI

TSG for condom programing GOI

>0.3ml FC Users in 13 states

>3.5million pcs Off take of FC

Product Journey…

FC2 - (Nitrile condom with PU ring)

The only female-initiated HIV/AIDS prevention product approved by the USFDA and cleared by

WHO for purchase by UN agencies

HLL FC (Latex condom with Copolymer ring)

FC1 (Polyurethane condom with

PU ring)

The GAP

Development of alternate Female Condom which is

Affordable, Safe, Easy to Use, Pleasurable & environment

friendly

HLL – FC aimed at Protection & Pleasure Safety,

Efficacy, Convenience

&

“Affordability” Made from specially formulated Natural Rubber latex

Material of choice for Barrier Method Affordability assured from abundant availability of locally

available Raw material No plastic frames/adhesives used for retention ring

Moulding Operations

• Former cleaning •Former drying

•First latex dip •First Intermediate drying

•Second latex dip • Second Intermediate drying

•Third Intermediate drying •Hot air drying

• Leaching & Swelling • Stripping

•Integral beading •with no adhesive •no coagulant dipping evolved •no plastic frames are used in the outer ring •Flexible coverage to external genitals

Condom Washing

Spin Drying

Vulcanizing Tumbler

Electronic testing machine

Sachet Packing machine

• ISO13485

• CE mark

• GMP

International Quality Certifications for HLL F C

WHO prequalification Status: • Product Master File & Site Master File submitted for review • Functionality study and Prequalification process will be completed by August 2014

Specification HLL FC

Material NR latex

Retention

Device

Inner Ring – Co-

polymer

Length (mm) 170±10

Thickness

(mm)

0.07 to 0.11

Width (mm) 79±3

Top ring

thickness

(mm)

2.9-3.6

Lubricant Silicone oil

New designs and variants….

Design Features •V shaped outer frame with moulded triangular polyethylene (90 mm of latex film folded over it). •Shaft portion similar to conventional male •Cylindrical shaft portion then gets into a constriction of 45mm width •Culminates at a closed end accommodating a sponge of 60mm dia with a thickness of 10-12 mm.

VA w.o.w (Reddy FC). •HLL will be manufacturing and marketing “ VA w.o.w.” .

International Quality Certifications for VA W.O.W

ISO13485

CE mark

DC approval

WHO prequalification Status

The product has already completed the functionality study successfully in the trials conducted in SA and China in 2012

PQ and Facility Audit will be completed by first half of 2014

Component Spec

Sheath Latex Outer Ring/ V frame Polyethylene Retaining device PU foam Lubricant Silicone Sachet Polyester/ Poly

Ethylene

Dimension Spec

Length NLT 90 mm Width 75+/-2 mm Thickness Min 60 microns Outer

Ring(thickness)

/ V-frame

Horizontal & vertical length- 80+/-2 mm

Outer ring (Dia) NA

Material specification details

Dimensional details:

Properties Spec Burst Volume 20 dm3 (min.) Burst Pressure 0.75KPa (min.)

Inflation Properties:

India Brazil Australia Nepal Bahamas

Product availability – HLL FC

• NACO, India

• Ministry Of Health, Myanmar

• Registration process with Rwanda and Mauritius in progress

• Market studies are on to understand the global demand

Main buyers for HLL FC

Promoting the product Globally through its global distribution channel spread across 50

countries Targeting – Private sector market initially

Latex Based HLL FC Promotion Strategy In India

Free Supplies Target Group – Eligible

Couple

Positioning - An additional option in the basket of contraceptive choice

Social Marketing Target Group –High Risk

Group and Vulnerable Women

Positioning - Empowerment, Protection against STI/HIV

Commercial Target Group

Independent free spirited women

Positioning - Enabling choices for ease of life, Urban Elite

An empowerment tool for women

An additional, alternate option to Male condom

A Tool for protection and safety against STIs, HIV infection

Address inconsistent Male Condom usage and Reinforce Risk perception

with regular partner

Promoting Female Condom as…

Advocacy Strategy … Advocacy at multiple levels- Policy, implementing, community level

Capacity Building of Service Providers and Grass root NGOs/CBOs for creating enabling environment

Focused Demand Generation Activity-- Involving Male partners, platforms for maximum IPC

Generating Evidence through Studies, assessments, Program evaluation, analysis of data

Social Marketing to sustain demand generation

Our Commitment Provide men and women

the best & affordable

reproductive health

solutions

…

Feedback

Questions….