WHO Pre- Qualification and Entry into Global RH Market

Krishna Jadhav

“A Fresh, New Approach to the world of Women’s Reproductive Health Care”

Company Profile

A dedicated contraceptive manufacturer.

Over the past decade Famy Care has gained international recognition in more than 70 countries across the globe

We have 3 state-of-the-art dedicated contraceptive manufacturing facilities located in India.

Proven R & D and Manufacturing capabilities for hormonal products

Our facilities are US-FDA, WHO-GENEVA, ANVISA, EU-GMP, WHO-GMP, ISO & CE certified

Milestones

India’s first dedicated contraceptive manufacturer

Export of IUDs Export of OCPs

Established relationship with major NGOs and funding agencies

Equipped with state-of-the-art R&D center

Tie up with Mylan Inc. Entered Europe market

WHO-Geneva approval and USFDA for 1 Plant

US-FDA for 2nd Plant & ANVISA approval

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WHO Pre-Qualification- Why FCL aspired for it?

• FCL’s commitment to supply affordable quality products and FCL wanted the buyers to feel confident about shifting from innovator products to generic products. • FCL’s desire to partner with UNFPA and other partners in RH community to increase access to quality contraceptives for millions of women in developing world. • FCL being a dedicated company for contraceptives it was natural for FCL to get the stamp of prequalified supplier • To meet the objective of WHO Pre Qualified program to provide product with quality, safety and efficacy

WHO Pre-Qualification – Where do we stand?

Famy Care products are pre-qualified for the following categories –

Combined Oral Contraceptives Emergency Contraceptives

Expression of Interest Product dossier

SMF

Compliance

Additional information and data

Corrective actions

Compliance

Assessment Inspections

Steps in prequalification

Prequalification Monitoring

Overview: Approval Process – PQ Program

Facility inspection-Our experience .

Famy Care Limited has two WHO approved manufacturing sites at present: • Inspection duration-approximate 4 days

• Experienced inspectors provide guidance to companies on how to meet the

WHO expectation for GMP

• WHO technical people are always approachable for any technical discussion and opinion

• The learning from WHO inspection helped us to improve the quality and GMP status of our facility.

• WHO inspectors response time - very fast and it is always a two-way process.

WHO Pre Qualification and Registration across the countries - Challenges • Except for 2-3 countries most of the countries are not in line with WHO and UNFPA objectives of priority registration for RH products. • Major challenges are delay in getting national registrations.

• Dossier filings in smaller countries with inadequate regulatory infrastructure.

• High cost of registration and annual retention fees

WHO Pre Qualification and Procurement

• Most of the procuring agencies, ministries and donors are having different technical criteria, which hopefully is now being harmonized. • Delay in national registration are delaying procuring opportunities from new suppliers • Unlike ARVs, Anti Malarial or TB products RH commodities are not considered as Life saving products and the receiver decides whether they want to allocate budgets or not for procuring contraceptives. Thus the Supplier has no avenue to understand and forecast the country’s requirements.

MANUFACTURER EXPECTATION FROM PREQUALIFICATION PROGRAMME

Once the company has invested resources in getting their product prequalified, we expect that this should get translated in business

opportunities.

Thank You