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United Nations Population Fund
Issue 5 January 1995
LOCAL PRODUCTION OF CONTRACEPTIVES
I. BACKGROUND
T
he main objective of UNFPAs assistance to local manufacturing is to ensure a stable
supply of safe, effective and modern contraceptive methods in the project countries by
improving product quality, worker safety and good manufacturing practices (GMPs).
Approximately $50 million have been provided by UNFPA in support of local production in
China, India and Vietnam during 1980-1994. The main considerations, which guided the
decision to support local production in these countries, were:
a relatively high prevalence of contraceptive use.
a strong support for family planning programmes from the government.
the existence of local contraceptive manufacturing capabilities or in the case of
Vietnam, an abundant supply of latex raw material.
UNFPA has provided support primarily for the production of condoms, IUDs and
steroids. Steroid projects included oral contraceptives and injectable product forms. Other
projects supported include the manufacturing of Nonoxyl-9 and vaginal tablets, as well as the
establishment of a regulatory mechanism and quality control programme in India and operations
training in China.
As illustrated in
figure 1
, condom manufacturing and steroids (including oral
contraceptives and injectables) have received the most funding.
The components of UNFPA assistance in production of contraceptives included:
production, packaging and testing equipment, including spare parts;
design concepts for modern production facilities;
supply of raw materials;
training in: contraceptive technology, testing of products and good management
practices (GMPs); and
technical assistance, as needed. 2
Local Production of Contraceptives
FIGURE 1
The programme for Appropriate Technology in Health (PATH), an NGO based in Seattle,
USA was designated as the executing agency for the UNFPA supported local production
projects in China and Vietnam. The projects in India were executed by the Government with
some external technical inputs.
II.
EVALUATION
T
he objective of this evaluation was to assess the effectiveness of UNFPAs support for
the local production of contraceptives and to recommend a future course of action in regard to
local manufacture of contraceptives. Three missions to China, India and Vietnam were
undertaken during 1993-1994 to conduct case studies. These missions included inspection of
the manufacturing premises, discussions with the management and with the client agencies
supplied from these factories and discussions with the executing agency. In addition, site visits
were made to other local pharmaceutical and device manufacturing facilities, government
testing laboratories, district contraceptive training centres, village, township and national service
centres, Ministry of Health, other relevant government ministries and departments, government
warehouses, and social marketing programmes. Additional information was obtained from
survey questionnaires, project documents, user surveys, user interviews, reports from related
missions.
Project Funding
Condom
38%
Steroids
35%
IUD
19%
Other
8%
Condom
Steroids
IUD
Other 3
Local Production of Contraceptives
III.
MAJOR FINDINGS
O
verall, the projects have achieved substantial progress in many areas. These include:
Improving the supply and diversity of contraceptive products available in China, India
and Vietnam by producing contraceptives locally;
Improving the quality and safety of IUDs produced in China through the introduction
of Copper T;
Improving the quality, and acceptability of condoms produced in China;
Establishment of the first condom manufacturing plant in Vietnam;
Introduction of IUD production in India; and
Establishment of a national standard for the production and testing of IUDs in India.
The projects in China were implemented during a period when UNFPA was the only
source of external support for local manufacturing of contraceptives. Reduction of the
manufacturing and distribution of unsafe and ineffective products in China could not have been
achieved without these projects. The condom project in Vietnam has had a similar effect on
stabilising the supply of condoms in that country.
The human and financial resources required establishing good manufacturing practices
(GMPs) in these factories were seriously underestimated. The changes that are necessary in
the work place for establishing controlled manufacturing environment for production of high-
quality contraceptives, have proven to be greater obstacles to overcome than the actual
installation and operation of equipment. Areas of weaknesses remain in quality management
and process control at all the facilities evaluated in this study.
Technical support and training efforts were too thinly spread, making it difficult to
achieve a critical mass of skills and resources required for sustainability. GMP training sessions
were in most cases not effectively followed up. In China, the government policy of
decentralising production sites contributed to the dilution of efforts.
Overestimation of demand in China and the Governments unwillingness to purchase the
agreed upon quantities from the project factories have resulted in idle and under utilised
capacity that has further aggravated the threat to sustainability.
All three-study countries have entered into period of rapid economic growth and
development that has radically changed the assumptions upon which the projects were
originally conceived. Government imposed pricing has not kept pace with the inflationary
pressure of rapidly expanding economies. The facilities in China and Vietnam are trying to
survive in competitive markets and are facing serious sustainability threats.
The following section provides a summary of the country case studies. 4
Local Production of Contraceptives
IV.
C
OUNTRY
L
EVEL
F
INDINGS
C
hina has always met its contraceptive needs principally through local production,
which began as early as 1955. It is the largest recipient of UNFPA funding for local production
of contraceptives, with an approximate investment of $28 million during the 1980-1994 period.
UNFPAs inputs supported the production of a wide range of contraceptive methods: IUDs
(220C and 380A), condoms, steroidal products (oral pills, injectable and steroid synthesis) and
spermicides (vaginal suppositories, tablets and production of nonoxynol-9). Most, if not all,
contraceptives produced locally are purchased by the Government and distributed through the
national family planning programme.
IUDs:
IUDs account for about 40% of the contraceptive prevalence in the country. UNFPAs
assistance was intended primarily to make available modern copper T IUDs as a substitute for
the stainless steel ring and a range of other Chinese IUDs which were considered, in
comparison, less effective and safe. Two CuT 220C manufacturing plants were established in
Tianjin and Wuxi. The production goal of each plant was 3 million IUDs per year, although the
actual production capacity was higher. Together the two facilities supplied 5.8 and 4.5 million
IUDs to the national family planning programme in 1992 and 1993 respectively. The factory in
Tianjin is now moving to a new location with modernised facilities. In the most recent
programme cycle beginning in 1991, UNFPA assistance was provided for setting up two CuT
380A facilities in Shanghai and Siping. The Shanghai facility will start production by early 1995.
The facility in Siping started operation in 1993 with a production capacity of 3 million IUDs per
year. In 1993 it produced .8 million and was expected to produce .4 million in 1994. The drop
in production was tied to demand, which is still rather limited due to the newness of the device in
the country. The price of the product and lack of promotion are probably contributing factors.
As in the case with other contraceptives, increased production would require larger orders from
the Government.
The planned substitution of Chinese IUDs with modern copper Ts has not materialised at
the expected rate. Although the Government has banned production of the steel rings, a large
variety of Chinese IUDs are still in production, use and further development.
Condoms:
UNFPA assistance was provided to five condom production facilities. In addition,
condom testing and latex research was also supported to improve the quality of the products.
The objectives of these facilities were to produce approximately 900 million condoms a year.
The combined yearly sales of the facilities were approximately 500 million condoms in 1993 and
1994. As a percentage of method mix, condom usage has remained low (3.7% in 1990 and
2.1% in 1992).
CHINA 5
Local Production of Contraceptives
Steroidal Products:
In order to provide a wider choice of contraceptives, almost 33% of UNFPAs funding
was invested in support of local production of steroidal products, including one injectable, two
oral pills and two steroid synthesis facilities. These facilities remain largely idle and under-
utilised since the demand for pills and injectables have not increased as projected. In fact, as a
percentage of method mi