Pharmaceutical Industry

pharmaceutical industry

Public and private organizations involved in the discovery, development, and manufacture of drugs and medications. Historically, medicines were prepared by physicians and later by apothecaries. Today, drug development relies on the collaboration and effort of highly trained scientists at universities and private companies. The modern era of drug discovery and development originated in the 19th century when scientists learned how to isolate and purify medicinal compounds and developed large-scale manufacturing techniques. As understanding of biology and chemistry improved in the 20th century, the occurrence and severity of such diseases as typhoid fever, poliomyelitis, and syphilis were greatly reduced. While many drugs, such as quinine and morphine, are extracted from plant substances, others are discovered and synthesized by techniques including combinatorial chemistry and recombinant DNA technology. The pharmaceutical industry has greatly aided medical progress, and many new drugs have been discovered and produced in industrial laboratories. Identifying new drug targets, attaining regulatory approval, and refining drug discovery processes are among the challenges that the pharmaceutical industry faces in the continual advancement of control and elimination of disease.

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Pharmaceutical Industry 

the branch of the chemical industry that manufactures drugs. The industry comprises enterprises that produce synthetic and plant-derived (phytochemical) preparations, antibiotics, vitamins, blood substitutes and hormone preparations derived from animal organs, and drugs in various dosages (including injection solutions in ampuls, tablets, lozenges, capsules, pills, and suppositories), as well as ointments, emulsions, aerosols, and plasters.

The pharmaceutical industry has several unique characteristics. The industry’s range and volume of production are determined by morbidity. Exceptionally high demands are made of the quality of production—for chemical purity and for sterility of preparations intended for subcutaneous, intramuscular, and intravenous injections. As a result of the continuous introduction of new, more effective, and less toxic drugs, the list of products manufactured by the pharmaceutical industry undergoes a rapid turnover.

In the USSR, the production of a new drug is carried out under authorization by the Ministry of Public Health of the USSR after the drug’s therapeutic or preventive efficacy has been established. The ministry is also the state agency responsible for drug quality control.

Drugs have been produced since the earliest times. Industrial enterprises for the manufacture of drugs appeared in the late 19th century. Their development became especially rapid in the early 20th century, after the discovery of synthetic drugs. The manufacture of pharmaceuticals developed most rapidly in Germany, Great Britain, and Switzerland; before World War II, Germany dominated the world market in many types of pharmaceuticals. In the 1970’s the production of synthetic pharmaceuticals and antibiotics rose sharply in the USA and Great Britain.

The development of the pharmaceutical industry stems from advances in chemistry. The distinguishing feature of the present stage of development is the expansion of research both in duplicating valuable pharmaceutical compounds obtained from natural products and in creating new compounds with high and specific therapeutic action not found innature. The amount of work on the creation of new, extremely potent drugs by means of enzymatic synthesis (antibiotics, vitamin B₁₂) has also increased appreciably.

In prerevolutionary Russia there was no domestic pharmaceutical industry. The small, semicottage enterprises and pharmaceutical warehouses belonged to foreign companies; they were located primarily in the major cities (Moscow, St. Petersburg, Kiev) and in general only packaged imported drugs.

A dynamic pharmaceutical industry has been established in the USSR. The reconstruction of existing enterprises was begun in the early years of Soviet power. The S. Ordzhonikidze All-Union Scientific Research Institute of Pharmaceutical Chemistry was founded in 1920, followed by several similar institutes. During the period of the prewar five-year plans (1929–40), pharmaceutical plants were constructed in Kharkov, Kiev, Khabarovsk, and other cities. For the production of antimalarial and other medicines the pharmaceutical plant Akrikhin, the largest in the USSR, was built near Moscow. Other enterprises were established in Byelorussia, Georgia, Azerbaijan, Armenia, and other Union republics. Between 1920 and 1940 industrial production was organized for almost all important drugs known at that time, including sulfanilamides, hypnotics, and analgesics.

During the Great Patriotic War of 1941–45, pharmaceutical plants were built in cities in the Urals and Western Siberia (Irbit, Tiumen’, Anzhero-Sudzhensk, Kemerovo, Novosibirsk). The production of amphetamine, rubrocol, Salsoline, and Salsolidine was begun, and the range of sulfanilamide drugs was expanded. In 1947 the All-Union Scientific Research Institute of Antibiotics was established, and industrial production of penicillin, streptomycin, and gramicidin was begun. By 1948 the full prewar range of drugs had been returned to production.

Subsequently, the Scientific Research Institute of Antibiotics and Medically Useful Enzymes was established in Leningrad, and the Scientific Research Institute for the Discovery of New Antibiotics was established in Moscow. The growth of a scientific research base fostered the significant expansion of the range and volume of antibiotics manufactured.

Between 1946 and 1950 production was organized for synthetic hormones, insulin, Naganin, synthetic papaverine, caffeine, and other substances—a total of more than 50 items. The volume of production of the pharmaceutical industry in 1950 was 5 times greater than in 1940, and in 1955 it was 3.1 times greater than in 1950. The production of more than 65 new drugs, including PAS, Phthivazid, Levomycetin, Pregnin (ethisterone), Tiphen (thiphenamil hydrochloride), and methadone hydrochloride, was initiated between 1951 and 1955. Between the second half of the 1950’s and the mid-1960’s many new drugs were introduced. Between 1960 and 1965 production was organized for vitamins A, B,₁ B₂, B₆, B₁₂, B₁₅, PP, and folic acid. The output of the pharmaceutical industry in 1965 was 2.8 times greater than in 1958. During the eighth five year plan (1966–70) industry output increased by a factor of 1.8, and more than 200 new drugs went into production. During the ninth five year plan (1971–75) the volume of production increased by a factor of 1.7, and 180 new drugs were introduced into production. New research establishments included the All-Union Scientific Research Institute for the Production of Blood Substitutes and Hormones and an institute for the biological testing of chemical compounds.

There was no pharmaceutical industry in the European socialist countries before World War II, other than small semicottage enterprises in Hungary and Czechoslovakia that manufactured alkaloids and packaged imported drugs. The widely known pharmaceutical enterprises in Germany were situated mainly in the western part of the country; in the territory of what is now the German Democratic Republic pharmaceuticals were produced in insignificant quantities. Today the production of modern pharmaceuticals has been established in all the European socialist countries. The Soviet Union has rendered major assistance to these countries in planning, constructing, equipping, and starting up new pharmaceutical enterprises.

The production of pharmaceuticals in the capitalist countries is steadily increasing. Medicines are manufactured in almost all capitalist countries, but the major portion of production is shared by seven countries—the USA, Japan, the Federal Republic of Germany, Great Britain, France, Italy, and Switzerland.

The output of pharmaceuticals is also growing in the developing countries, for example, India, Egypt, and Iraq. The USSR provides these countries with scientific, technological, and economic assistance and in particular has assisted with the organization and establishment of production programs.

REFERENCES

Gusenkov, P. V., and A. G. Natradze. “Meditsinskaia promyshlennost’.” In Sorok let sovetskogo zdravookhraneniia. Moscow, 1957.
Natradze, A. G. “Khimiko-farmatsevticheskaia promyshlennost’ za 40 let.” Meditsinskaia promyshlennost’, 1957, no. 10.
Natradze, A. G. Ocherk razvitiia khimiko-farmatsevticheskoi promyshlennosti SSSR. Moscow, 1967.
Mel’nichenko, A. K. “Resheniia XXV c”ezda KPSS pretvorim v zhizn’.” Khimiko-farmatsevticheskii zhurnal, 1976, no. 3.

A. G. NATRADZE