Our History

  1. Home
  2. chevron_right
  3. ABOUT US
  4. chevron_right
  5. Our History

2005  |  2007  |  2010  |  2013  |  2014  |  2015

1993

Cyclofem® becomes available in 2 countries

Cyclofem® is first made available in April in Indonesia, then in Mexico. It further went on to be made available in Thailand, Hong Kong, and throughout Latin America.

cyclofem

1995

First dedicated emergency contraceptive product

As a follow-up to an agreement between the WHO and Gideon Richter (Hungary), Concept starts work to introduce the first dedicated emergency contraceptive product, Postinor-2®, into low- and middle-income country markets.

1997

Upjohn licenses Cyclofem® from Concept

Upjohn licenses Cyclofem® from Concept Foundation, and continues to undertake the trials necessary for USFDA, under the name Lunelle®.

2006

Funding for development of what eventually becomes Medabon®

Concept Foundation receives funding from a large anonymous donor and DFID, under a license agreement with WHO to develop a combination product with misoprostol and mifepristone, using WHO data.

Due diligence to find a manufacturing partner willing to develop the product and take it through to country registrations and access is started.

main

September 2006

WHO Prequalification of Medicines programme launches EOI for RH

Launch of WHO Prequalification (WHO PQ) Programme Expression Of Interest (EOI) invitation for Essential Reproductive Health (RH) Medicines.

October 2006

Bonn Consensus

The Reproductive Health Supplies Coalition (RHSC) accepts WHO Prequalification as the primary quality assurance measure for the procurement of RH products, as they become available.

2007

Manufacturer found for medical abortion combined product

An agreement is reached between Concept Foundation and Sun Pharmaceutical Industries Ltd., India, to develop a new dedicated product for medical abortion and make it available in low- and middle-income countries.

March 2007

Cyclofem® added to WHO Model List of Essential Medicines

The WHO adds medroxyprogesterone acetate (25mg) + estradiol cypionate (5mg) to its Model List of Essential Medicines.

2009

WHO PQ of RH products: need for technical assistance

Of 42 dossiers submitted to WHO PQ for RH products up to this point, 25 (60%) are rejected or cancelled due to the product not meeting required quality assurance standards, inadequate/incomplete documentation or inappropriate bioequivalence study.

2009

Accessing Quality Assurance Supplies Initiative (AQAS) programme is launched (RHSC-funded)

In follow-up to the 2007 study, this programme was designed to identify manufacturers of generic hormonal contraceptives that are potentially capable and willing to obtain WHO prequalification for one or more of their RH products in their portfolio. Concept Foundation provided technical assistance to 12 manufacturers of generic RH products.

Gap analyses were conducted for each company to identify actions, resources and time required to meet WHO PQ requirements.

AQAS programme was the predecessor to the QuRHM programme

2009

Medabon® country registrations

Medabon® is registered in Cambodia.

2010

Meeting in Kampala

  • Concept Foundation holds plenary on why quality matters, to increase awareness. Presentation of AQAS findings.
  • DFID invites Concept Foundation to develop a concept proposal.
  • Small working group is put together to develop a strategy paper, including Concept Foundation, UNFPA, WHO PQP, and the Global Fund.

2010

Medabon® country registrations

Medabon® is registered in Zambia.

Concept Foundation embarks on major introductory strategy across numerous low- and middle-income countries. The results of these efforts and further country registrations can be viewed on our Access to Safe Medical Abortion programme page.

September 2011

First WHO prequalification of a generic oral contraceptive

Prequalification of Ethinylestradiol (0.03mg) + Levonorgestrel (0.15mg), pack of 21 oral contraceptive tablets manufactured by Famy Care Ltd, India.

December 2011

WHO prequalification of generic Ethinylestradiol + Levonorgestrel

Prequalification of Ethinylestradiol (0.03mg) + Levonorgestrel (0.15mg), pack of 21 active +7 placebo oral contraceptive tablets manufactured by Cipla Ltd, India.

April 2012

Meeting on Hormonal Contraceptives and other Essential Medicines at UNFPA headquarters in New York

This meeting was a follow-up to an interagency consultation with procurers held by RHSC in Washington DC in May 2010, and focused on the harmonization and alignment of quality assurance policies and practices amongst international procurers.

This was part of the planned activities of the QuRHM programme, and was hosted by UNFPA with the support of Concept Foundation.

July 2012

London Summit on Family Planning and FP2020

The London Summit on Family Planning was held in July 2012. More than 20 governments made commitments to address the policy, financing, delivery and socio-cultural barriers to women accessing contraceptive information, services and supplies. Donors pledged an additional US$2.6 billion.

The goal of reaching an additional 120 million women and girls in low- and middle-income countries by family planning services by 2020 was set and FP2020 was born.

Meetings were held that eventually lead to the formation of the Generics Manufacturers Caucus for Reproductive Health (GEMs/RH), with 4 founding members receiving help from PR firm GMMB, funded by BMGF.

October 2012

Bill and Melinda Gates Foundation (BMGF) provide additional funding to the QuRHM programme to focus on DMPA

Approximately one year into the QuRHM programme, BMGF provided further funding within the QuRHM programme framework to build on the ongoing work to increase the availability of quality assured intra-muscular injectable contraceptive DMPA.

This increased effort was part of BMGF’s strategy to address the severe shortcoming of DMPA in high need countries.

February 2013

Generic Manufacturers Caucus for Reproductive Health (GEMs/RH) formed

GEMs/RH comprises seven select generic manufacturers in Asia, Africa and Europe, and functions as a caucus within the RHSC.

The caucus collaborates with RHSC members to increase the availability of quality, affordable and safe reproductive health products and medicines to women, girls, and families in need.

June 2013

First API and emergency contraceptive FPP are WHO prequalified under QuRHM programme

Ethinyl estradiol, manufactured by Qinhuangdao Zizhu Pharmaceutical Co Ltd in China (QZP), is prequalified by the WHO PQP under its API prequalification procedure. This is the first API prequalified for reproductive health medicines, with the technical support of Concept Foundation.

First generic emergency contraceptive product (Levonorgestrel 0.75mg) manufactured by Famycare Ltd in India is prequalified by WHO PQP.

August 2013

Combined oral contraceptive is WHO prequalified

Desogestrel + ethinylestradiol formulation, manufactured by Famycare India, is prequalified by WHO PQP.

September 2013

Second API for reproductive health is WHO prequalified

Levonorgestrel API, manufactured by Qinhuangdao Zizhu Pharmaceutical Co Ltd in China (QZP) is prequalified by WHO PQP.

October 2013

A record 9 products are prequalified by WHO PQP in a single day

9 products are prequalified by WHO PQP in a single day, of which 4 are generic reproductive health products. This demonstrates that the WHO-PQP programme for reproductive health products is achieving results, with RHSC’s QuRHM programme, managed by Concept Foundation, playing a major role by providing technical support to manufacturers and raising awareness among international donors and procurers.

These 4 generic RH products include:

  • Ethinylestradiol (0.03mg) + Levonorgestrel (0.15mg), in a blister pack of 28 tablets (21 active + 7 placebo), oral contraceptives manufactured by Famy Care Ltd, India.
  • Levonorgestrel (1.5mg) emergency contraceptive, manufactured by Famy Care Ltd, India.
  • Noresthisterone (0.35mg) oral contraceptives, manufactured by Lupin Ltd, India.
  • Desogestrel (0.15mg) + Ethinylestradiol (0.03mg) oral contraceptives, manufactured by Lupin Ltd, India.

2014

QuRHM Programme DFID funding ends, however work continues for key products with ongoing support from BMGF.

The DFID funding for the QuRHM programme formally ended in March 2014. By this time, significant results had been achieved; a further four generic APIs and 16 generic FPPs had been WHO prequalified.

Concept recognised that the majority of the successes focused on oral contraceptives and misoprostol and that activities would need to continue to increase the number of WHO prequalified DMPA, oxytocin and magnesium sulphate.

BMGF has continued to fund Concept Foundation to work with manufacturers of generic DMPA to achieve WHO PQ as well as support on regulatory activities in parallel.

The BMGF funds are also being used to conduct a DMPA forecasting exercise and research in 10 target countries on advocacy for emerging quality assured generic products in country markets.

March 2014

WHO prequalification of Ethinylestradiol + Levonorgestrel

Prequalification of Ethinylestradiol (0.03mg) + Levonorgestrel (0.15mg), pack of 21 active +7 ferrous fumarate oral contraceptive tablets produced by Famy Care Ltd, India.

April 2014

Two RH medicines are prequalified in the same month

Levonorgestrel (0.75mg), emergency contraceptive manufactured by Cipla Ltd, India, is prequalified by WHO PQP.

Misoprostol (0.2mg), maternal health medicine manufactured by Cipla Ltd, India, is prequalified by WHO PQP.

October 2014

BMGF expands scope of funding

BMGF continues to support and fund Concept Foundation’s efforts with DMPA, and expands the scope of activities to include access to markets, reassessment of demand forecasts, and country-level research.

October 2014

UNCoLSC funding for maternal health

The United Nations Commission of Life Saving Commodities (UNCoLSC) funded Concept Foundation to continue its work towards WHO PQ of selected maternal health products; misoprostol, oxytocin and magnesium sulphate as well as work with procurers at the country level to discuss and improve procurement modalities of these commodities.

April 2015

The first generic oxytocin product is prequalified by WHO

Oxytocin, as a solution for infusion manufactured by JSC GRINDEKS, Latvia, is prequalified by WHO PQP. This is the first oxytocin product to be prequalified by WHO, and is an important medicine for maternal health used notably in the prevention and treatment of postpartum haemorrhage.

July 2015

Another emergency contraception product is prequalified by the WHO

The WHO PQP prequalifies the emergency contraceptive, Levonorgestrel, as manufactured by Cipla Ltd in 1.5mg tablets. Cipla Ltd is located in Goa, India, and is one of the founding members of the RHSC Generic Manufacturers for Reproductive Health (GEM/RH) Caucus. This is the fourth Cipla reproductive health product to be prequalified with technical support from Concept Foundation.

December 2015

 WHO adds to the list of prequalified emergency contraceptives and APIs

The list of prequalified emergency contraception products expands to a total of 6 with the addition of Levonorgestrel 1.5mg tablets manufactured by Lupin Ltd. in India, thereby increasing the choice for procurers seeking to get quality emergency contraceptives into lower- and middle-income countries (LMICs).

Piramal Healthcare UK Ltd also has their 1% Misoprostol in HPMC product prequalified by the WHO, having been assisted by Concept Foundation in ensuring availability of appropriate documentation for the prequalification process.

Menu