INTRODUCTION

November - 2019
VIGAMED PRODUCTS PRIVATE LIMITED

Dedicated to the Cause of Sexual Health & Wellness..

Viswanathan V Naidu 9373111000 [email protected] www.vigamed.in

Sexual Health & Wellness: Currently, there are few companies established and working on futuristic products in this segment.
This is mainly due to stringent international regulatory requirements and lack of vision.
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 CURRENT STATUS OF THE PROJECT:
❑ Incorporated as Private Limited Company with its registered office at 5-B, Shree Avenue Apartment,
Kalpataru Nagar, Ashoka Marg, Nashik - 422 011, Maharashtra, India.
❑ CIN: U24304MH2019PTC321825, Date of Incorporation: 25th February 2019.
❑ On 2nd August 2019, Vigamed has been recognized as Start-up. Certificate No.: DIPP42150
❑ IEC is obtained to facilitate ease of transaction of Services / equipment from overseas. IEC:AAGCV8253M
❑ Board of Directors:
❑ Managing Director: Mrs. Gayatri Viswanathan Naidu [DIN: 08374032],
❑ Director – Technical: Mr. Viswanathan Veeraraghavalu Naidu [DIN: 08374043], Over 30 yrs. of experience in the industry.
❑ Director – Mr. Chaitanya Viswanathan Naidu [DIN: 08374044].
❑ Authorized Capital: Rs. 10.0 Lakhs. Paid-up Capital: Rs. 4.53 Lakhs.
❑ Domains booked: www.vigamed.org, www.vigamed.net, www.vigamedproducts.com; www.vigamed.in;
www.internalcondoms.in, www.vigalubes.com.
❑ I.P. [Intellectual Property], our USP:
▪ Indian Patent Office: Till date, a Total of 19, 6 Male Condom Designs, 9 Female Condom Designs, 1 Female Condom
Mold design & 3 Female Condom Intravaginal Retention Feature Design Patents have been filed.
▪ As on 1st of October 2019, 5 Female Condom designs and 3 Male Condom designs were accepted and certificates
issued by Indian Patent Office.
▪ 3 Female Condom designs filed in 3 foreign countries [USA, South Africa & Brazil] as part of international intellectual
property protection plan.
▪ R&D is being taken up to add more designs in both male condom and female condoms.
▪ Utility Patent is under drafting for innovative Internal Condom/ Female Condom; expected to be ready by end of 2019
and will be filed in Indian Patent Office / WIPO.
▪ Concepts are being thought about on combo packs of Condoms + Lube Sachets + Wipe Sachet. Once it is finalized,
Design or utility patent will be drafted and filed.
▪ TMR with Indian Patent Office: Registration done for logo and word Vigamed under class 10.
❑ Detailed Project Report can be presented during the meet with potential Investors.

Company is formed with an objective to play a significant role in establishing a business house to tap the increasing worldwide demand for
Page 2 of 9 products that cater to SEXUAL HEALTH & WELLNESS.
 We are considering “Single Use” Medical Devices’
- Condoms as CORE product for the project;
- with special emphasis on Female Condoms / Internal Condoms:

Female Condoms: Male Condoms:

• Currently there are only 3 companies, prequalified • There are over 40 companies worldwide
by WHO/UNFPA in the entire world, 1 Malaysian & 2 producing over 20 billion condoms per annum.
Indian companies, producing around 200 million • Demand for Male Condoms Increasing day by
units per annum. day. Public Procurement budgets are also
• It’s non-generic, unique design with product features increasing. New companies coming up and
specific to each of the models and each of the existing companies are undertaking expansion.
manufacturer. • Though there is competition, reasonable
• Involvement of R&D, Clinical Trials, Special margins allow manufacturers to survive.
manufacturing Processes, stringent regulations, less • Contract manufacturing and supplies against
awareness has kept major Male condom International Tenders. Possibilities to supply Govt.
manufacturers away from exploring this product. of India through tenders.
• Less competition, increase in demand with times, • Specialty male condoms – un explored
better margins. potential.
• 20 million pieces per annum initial installed capacity
considered.
• Would take up to 2 years to get UNFPA pre-
qualification status which is required to participate in
the international tenders.
• Supply against tenders and LTAs.
• Potential to tap B2C market with unique value
added variants.

Infrastructure required for manufacture of both Male Condoms & Female Condoms is almost the same.
With the help of change-over gadgets,
the equipment can be set for production of either male or female condoms.
This is the unique feature of our product and project design.
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 LIST OF OTHER POTENTIAL PRODUCT IDENTIFIED FOR MANUFACTURING:
“Sexual Health & Wellness” SEGMENT:

DEVICES: [Single Use] DRUGS:

• Accessories • Erectile dysfunction / long lasting - Solution
▪ Water Based Lubricants – Non-Sterile. • Delay Wipes to address Premature Ejaculation(PE)
▪ Safe Sex Kits • Sterile Water Based Additional Lubricants.
▪ Pleasure Wipes • Pheromones based wipes – to influence sexual
▪ Consumables for sexual activities behavior.
▪ Combo Product Packs
▪ Hospital Consumables/ OTC COSMETICS:
▪ Alcohol Wipes
▪ BZK Wipes • Silicone Based Lubricants.
▪ Wound Wipes • Wipes – Pleasure/Cleansing/other
▪ Sting Relief Pads • Sex Toys / Vibrators
▪ Wipes to address PME. • Mensural Cups
▪ Combo Kits / Co-Packs - Condoms • Other products like Vaginal Cream, Sanitizers,
with Lube sachets. Disinfectants, etc.

To add these product into the basket, additional regulatory requirements have to be met. Investment
required for setting up of these two Mini-Plants (Pharma - Cosmetics & Drugs) would be approximately 2.5
Crores. Team and facilities like Stores, QC, QA, Production, FG Store, Retention Samples room, etc. would
be merged with Condom project; need not be set-up additionally.
Addition of these product can be explored once condom plant gets established.

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 REGULATORY APPROVALS TO BE OBTAINED FOR THIS PROJECT:

1. DCGI: Mfg. License, Device Category: Contraceptives, Device Name: Male / Female Condoms, Risk
Class: Class C. [moderate high risk], Indian Medical Devices Act 2018.

2. WHO, UNAIDS, UNFPA, fhi360 Coalition: Generic Specification, Pre-qualification and Guidelines for
Procurement, 2012.

3. ISO: [International Standards Organization] 13485:2016, ISO 25841:2014, ISO 4047:2014, ISO 9001:2015 &
ISO 14001:2015

4. MDSAP: [Medical Device Single Audit Program] – Australia [TGA], Brazil [ANVISA], Japan [PMDA],
Canada [Health Canada] and USA [FDA]

5. USFDA: 510(k) - Class II (Special Controls), 21 CFR Part 884 OBSTETRICAL AND GYNAECOLOGICAL
DEVICES, 884.5340.

6. Others: cGMP, WHO-GMP & CE Mark.

7. Critical:
• Clinical Trial [Failure Mode Study] on New Design Female Condom – for ISO & UNFPA PQ.
• Contraceptive Efficacy study for USFDA approval. [Currently there is only one FC approved by
USFDA. US market is highly profitable.]

8. Manufacturing Licenses for Cosmetic and Drug Manufacturing divisions from local Drug Authority.

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 FEMALE CONDOM, HIGHLY POTENTIAL PRODUCT:

CURRENTLY AVAILABLE DESIGNS OF FEMALE CONDOMS: VIGAMED DESIGNS OF FEMALE CONDOMS:

There are over 10 unique designs developed, 5

Design Patents granted & 5 are under
examination in India and ready for exploring
producibility.
Cost of production these new designs will be
much lesser than currently available FCs in the
market. User friendliness, cost effectiveness
and producibility were the main criteria
considered while conceptualising our unique
design Female Condoms.

Six male condom designs are also filed for

design registration in India.
Female Health Company, CUPID & HLL are currently together selling
Details of Intellectual Properties processed till
around 70 million pieces per annum against tenders from South Africa
/ Brazil alone. PATH’s Women’s Condom is no more in production. Cost date can be shared during personal meetings
of Production of FC2 condom is higher than Cupid & HLL as it is made with potential investors.
up of Nitrile.

Worth Noting: FEMALE CONDOMS DISTRIBUTED IN SOUTH AFRIA FOR ALONELAST 10 YEARS:
2008-09: 0.28 million, 2009-10: 03.60 million, 2010-11: 05.00 million, 2011-12: 06.26 million, 2012-13: 11.67 million,
2013-14: 13.25 million, 2015-16: 26.96 million, 2016-17: 26.07 million, 2017-18: 21.42 million & 2018-21: 100 million
pieces. There has been increasing demand for this product.

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 KEY INGREDIENT OF THE PROJECT:
1. Expertise & Unique Product Design:
R&D activities already been taken up and design registrations initiated. Prototypes are ready for presentation
along with the features that are different when compared with the already available product. The entire
project is going to be technology driven, with products that has no or less competition.

2. Team:
Our Director-Technical is instrumental in R&D of world’s first 3 latex based female condoms [Panty Condom
Through Dr. Reddy, VA W.O.W & Cupid FC]. VA W.O.W did over 300 Crores business and Cupid FC so far did
over 300 Crores business with over 30% profit margin. He has 30 years of industry experience and hence team
building would be an easy task. His brief resume is available for review upon request.

3. Technology:
The production process machines chosen are of versatile in nature. The equipment set-up can be used for
manufacturing variety of female condoms and male condoms. Similar set-up was successfully implemented &
validated in Medtech & Cupid by our Director – Technical and due to this advantage, investments required
and related risks are minimized. Unique gadgets are being introduced in the dipping lines to produce product
in Poly-Isoprene / PU, new material of construction for condoms with no risk of protein allergy. This again be
redefining the entire female condom segment worldwide.

4. Focus:
VigaMed will focus and establish multi-product centric manufacturing facility to cater products in the Sexual
Health & Wellness segment.
Scientific approach, Innovative products, changes in the recent regulatory requirements, increase consumer
awareness, etc. would be favorable factors for the project and enhances the project viability aspect in
general.
Obtaining regulatory approvals is the key element of the entire project. Vigamed is confident about the
product design and its user-friendliness features, apart from experience in documentation/ QMR experience,
it will be an easy task to clear various non-clinical and clinical tests and obtain the approvals from various
regulatory bodies.

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 RISK & MITIGATION:
1. Risks:
• Female Condoms are new and have less / limited demand.
• Strict regulatory requirements, involvement of Clinical Studies.
• Less product awareness. Less popular due to the cost, Many times more expensive than male condoms.
• Difficult to use and dispose. Not easily available for purchase.
2. Mitigation:
• Though there are around 10 companies working on Female Condoms since decades, only 3 or 4 companies are successful
in commercializing the product. This is due to impractical technologies being explored by those companies. Vigamed Team
has experience in developing producible technologies and the same are validated in more than one company.
• We also possess the expertise to create the necessary documentation and implement systems/ methodologies that meet
/exceed the regulatory requirements of the most stringent certifying bodies / regulatory agencies across the world. In the
other way, due to stringent regulatory requirements, many well-established male condom manufacturers are afraid to
explore female condoms and this provides good leverage for us to explore. The product design is done keeping in view of
the non-clinical and clinical evaluations that each design has to undergo for getting regulatory approvals. The producibility
and scale-ability factors are well considered to compete with the existing products and their pricings.
• Female condoms are being promoted as dual-purpose prevention tool by various international organizations. The
awareness and funding is in increasing trend globally in view of sexual transmission of HIV/AIDS. The total capacity of the
manufacturers are far less than the projected demand.
• Vigamed’s designs are comparatively cheaper to produce and hence it will be priced very competitive.
• VigaMed will explore Natural Latex and other alternative materials including Poly-Isoprene/ PU to address the usage related
concerns. For US market, non-latex option may be the best solution. Viable non-latex option is being actively explored to be
ahead in the segment.
• Vigamed will approach online portals and strengthen e-marketing strategies.
• Product registration in various countries would be taken up to penetrate in maximum number of countries and tap the
potential.
• LTA and exclusivity agreements would be made with potential customers to ensure regular in-flow of orders.
• During the Initial 5 years, proven markets like SA, Brazil and UN will be focused followed by other projects funded by USAID.
• Unique training Materials and tools will be made available for the agencies promoting the increased use of female
condoms. Collaboration will be done with health departments of various governments to participate in promotion of use of
female condoms and empower women.
• Subjecting the product for contraceptive efficacy study and obtain USFDA approval will eliminate every risk and open new
markets where USAID is funding. Currently USAID is the largest funding agency in the world. Most recently USFDA has down-
classified this product to support more manufacturers to enter into this segment. FC2 is the only USFDA approved product as
on today!

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 INVESTMENTS & RETURNS:
1. Investment:
• Approximately Rs. 14 Crores would be required to establish the company. Various probabilities are being explored
to reduce the initial burden on the project.
• Rs. 11 Crores would be infused during the first 18 months and rest during second year.
• The modalities are being worked out to take advantage of the Government schemes for MSMEs & Start-ups. Various
options are being explored to reduce the initial investment, e.g., establish company in a rented place instead of
investing in land/building, look for used & good condition equipment and manufacturing via loan license, etc.
2. Returns:
• Company would effectively start profitable business from 3rd year (an year after getting regulatory approvals and
winning tenders / LTAs).
• From 3rd year onwards, company is expected to do business of around Rs. 15 crores.
• During 4th year, expansion of production capacity to 40 million pieces would be taken up based on the demand
situation.
• Pilot plants that are considered for other Products that would be handy and help the company to meet the routine
expenses for the first 5 years and create foundation for line of innovative product.
3. Target:
• Establish company with good ethics and reputation.
• Make the company debt-free within 5 years of operation, and have minimum of 100 crores cash reserves at the
end of 10th Year.
• Establish the company as an Innovator in the segment. Obtain as many as registrations/ approvals for the project
and product. Continue to keep adding new innovative product in the Sexual Health & Wellness segment so as to
tap the considerable market share and establish as well known brand.
• Establish Presence in minimum 35 countries within a period of 5-7 years.
• Establish manufacturing additional bases in other countries where assured inflow of orders are guaranteed with the
help of local partners/collaborators in each such country.
• Continue R&D activities to ensure sustained business and add value to the company.

NEED OF SITUATION:
➢ Vigamed is looking for potential investors interested in long term returns to participate in the project. Modalities of
the participation can be discussed during the meeting.

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Thanking You.