The 45th Anniversary of Institute for State Control of Drugs and ...

The 45th Anniversary of Institute for State
Control of Drugs and Pharmaceutical
Researches »Petre Ionescu Stoian«
Olimpia Sanda, Maria Gabriela man, Iulia NitescuSuli
The foundation, on the 6 th of April 1956 of this Institute was considered
as an important step towards the insurance of medicine control
and the settlement of the basis for pharmaceutical researches.
Founded in 1929 under the name of Pharmaceutical Institute, it
was recognized as Chimico-Pharmaceutical Institute, depending upon
the Health Ministry, by the sanitary law from 1930. Until 1944, the
Institute had administrative and organizing duties, regarding the
functioning of the pharmaceutical sector: the evidence of the sanitary
control stamp applied on the items containing drugs, insulin distribution,
verifying the administration of the drugstores in hospitals.
In 1946, by Law no. 785 of Health Ministry, the Institute is given
attributions regarding: statistical studies, quality control of the specialities
and pharmaceuticals produced in laboratories.
At that time, the Institute had a laboratory for chemical analysis
and a galenic nucleus.
On January the 1 st 1949 Health Ministry decided to reorganize the
Institute, as a consequence of the nationalization of medicine industry
on the 11 th of June 1948.
In June 1952, the Laboratory for Antibiotics was integrated in the
Institute for Pharmaceutical Researches, resulting into Antibiotics
Section, a good opportunity for a third center.
During 1949-1954, the Institute was ruled with competence and
dedication by prof. C.N. Ionescu and dr. pharm. I. Polovrageanu.
In 1954, according to HCM no. 4454, the medicine industry
passes from the Health Ministry to the one of Oil and Chemistry.
Thus, The Institute of Pharmaceutical Research was divided and
reorganized into two units:
• ICCF (The institute of Chemico-Pharmaceutical Research),
within the Ministry of Oil and Chemistry, with duties of researches
in the industrial technology of medicine

Acta - Congressus Historiae Pharmaciae 2001
• ICMCF (Institute for Medicine Control and Pharmaceutical Researches),
within the Health Ministry, with duties of research in
the domain of methodology control and of checking the medicines
used in therapies, and also of supporting the pharmaceutical
network..
By the Order of Health Ministry no. 390 from April 1956, the Institute
of Medicine Control and Pharmaceutical Researches, the
Chemiotherapy Section Of Dr. Cantacuzino Institute, The Center of
Medicinal Herbs and the Laboratory of Medicine Control are unified,
thus resulting a single unit named “ Institute of Pharmaceutical Researches
and Medicine Control”.
By the order the order of Health Ministry from September 30 th ,
1960, its name is changed into the institute for State Control of
Medicine and Pharmaceutical Researches (ICSMCF).
Based upon this order, the Institute was given the duties of the
Pharmacopoeia Committee, Medicine Committee and the Scientific
Council ruled by the director of ICSMCF was founded.
In 1961, the leadership of Health and Social Regulations Ministry
has decided that the editing of the 8 th release of the Romanian Pharmacopoeia
and of its Supplements is the duty of the Institute. Text
gathering and final editing of monographies were done by a commission
of specialists lead by prof. Dr. Petre Ionescu-Stoian.
The Romanian Pharmacopoeia (8 th release) was born in 1965 and
it was followed by three supplements.
The rapid progress of the pharmaceutical sciences imposed the release
of the 9 th edition of the Romanian Pharmacopoeia, that was
born on the 1 st of January 1977, with two supplements in 1981 and
1984.
The need of a new edition of the Pharmacopoeia was imposed by
the global and national progress in the field of medicines, some
modifications to the existent monographies and creation of some
others for the new products being necessary.
The release in 1993 of the 10 th edition of the Romanian Pharmacopea
meant an increase in exigency regarding Romanian medicine
quality control and the conformity with the last editions of the international
Pharmacopoeia.
Since January, the 13 th 1996, Romania represented by ICSMCF
has an observer statue for the European Pharmacopoeia.

Olimpia Sanda, Maria Gabriela man, Iulia NitescuSuli
Fonded in 1949, the Medical Scientific Committee of Health Ministry
had the duty of leading and coordinating the medical scientific
activities at the national level.
This one functioned through committees, problem institutes
among which is the Medicine Committee, with the responsibility of
approving new medicines, made in the country or imported.
By the order of Health Ministry no. 1040 from 30 th of September
1960 the institute undertook the duties of Medicine Committee.
According to Law no 3 from 1978 that stipulates that authorization
and recording of new medicines is done by the Health Ministry
with the agreement of the Medicine Committee on the basis of a scientific
research methodology of the proposals of new medicines. By
Order no. 387 from 15 th of September 1979, ICSMCF received the
duty of ensuring the Secretary of Medicine Committee.
Since 1973, the Institute had played the role of coordinating the
pharmacovigilence network, founded in our country in that year, activity
exercised through the Medicine Committee. Thus, it collaborates
with OMS regarding the adverse reactions of medicines.
Since 1963, the Institute has worked in a new center, built on the
criteria of functionality characteristic to its profile and duties; in
1979, in the vicinity of this center, a modern construction was built,
destined to the laboratory of research and biologic control.
The regulation of organizing and functioning of ICSMCF was approved
by the order of Health Ministry no. 323 from March, 21 st ,
1963.
Among the attributions of the institute comprised in this regulation,
are:
• Complex control of the medicines made in the country and of
the imported ones.
• Editing Pharmacopoeia and its supplements, on the basis of
laboratory researches
• Preparing the substances and reference patterns.
• Validation of quality norms for the indigene products.
• Establishing the methodology for medicine quality control by
physico-chemical, pharmacological, microbiological and phytobiological
studies
• Yearly release of a medicine nomenclature
• Observation of the global movements appeared in medicine
production

Acta - Congressus Historiae Pharmaciae 2001
The organizatoric structure of I.C.S.M.C.F in 1973 was:
• The Laboratory of research and physico-chemical control, with
a nuclear unit (since 1974) of the 4 th category for checking radioactive
products with therapeutic use
• Laboratory of research for Pharmacopoeia and Patterns
• Laboratory of research and biologic and microbiologic control
with the quarters in Cernica and Nucet-Adunati
• Laboratory of technique and pharmaceutical organization, having
also as a duty to study the history of pharmacy.
• Laboratory of research and control of vegetal products located
in Domnesti
• The group for pharmacological experiments upon new medicines.
Even since 1961, it was decided that the institute to beneficiate
from a representative in the medicine factories in Bucharest and since
1973 this activity has been included in the order no. 588 of the State
Inspectorate for product quality control, of the Health Ministry and
Ministry of Chemical Industry regarding the manufacturing, control
and storage of medicine, checking how the fabrication rules are observed.
As a consequence of the adherence of our country in 1980 at the
Convince for mutual recognition of pharmaceutical inspections (PIC)
the Institute was designated as a competent authority for making the
inspections regarding observation of rules of good fabrication practice
and control.
The United Nations Office for Industrial Development (ONUDI)
had solicited the colaboration of the Institute for technical assistance
in some poor countries and starting with 1980 the specialists from
I.C.S.M.C.F have contributed to a good development of the courses
for ONUDI scholarships regarding the specialization in the field of
medicinal herbs.
By HGR no 15 from January, the 10 th 1991, and Order of Health
Ministry no 176 from March, the 1 st , 1992, regarding the functioning
of pharmaceutical commercial societies, the institute undertook the
territorial laboratories in Bacau, Brasov, Bucuresti, Cluj-Napoca,
Constanta, Craiova, Deva, Galati, Iasi, Oradea, Pitesti, Ploiesti, Satu
Mare, Suceava, Timisoara, Targu Mures.

Olimpia Sanda, Maria Gabriela man, Iulia NitescuSuli
Since April 1956, for 20 years, the institute was lead by prof. Dr.
Petre Ionescu-Stoian. The activity of scientific research was coordinated
by the deputies Emil Puscaru, Emil Cionga, Corneliu Baloescu.
From 1976 until February 1990 the manager of the institute was
prof. Dr. Corneliu Baloescu. Scientific Deputy Managers were dr.
pharmacist dr. eng chem. Rotislav Vasiliev, researchers Maria Medianu
and Georgeta Calin.
From March 1990 until August 1993 the manager of the Institute
was prof. Dr. Dumitru Dobrescu and deputy managers were Georgeta
Calin, Maria Medianu, Simona Raicu, Rodica Badescu.
Since 1993, the manager has been prof dr. farm. Crina-Maria Popa
and deputy Rodica Badescu.
Having in mind the outstanding contribution of Prof. Acad. Petre
Ionescu-Stoian, by the order 55 fron January, the 10 th 1996 the name
of the Institute becomes Institute for State Control of Drugs and
Pharmaceutical Researches “Petre-Ionescu-Stoian”.
The settlement, starting with the 1 st of January 1999 of National
Medicines Agency, by reorganizing the ICSMCF-“PIS”, would lead
to continuing traditions of the drug quality control in Romania, at the
high level of international standards.