PREVENTION
OF FOOD
ADULTERATION
PROGRAMME
Adulteration of food and drugs can cause
serious damage to human life. This antisocial
menace is sought to be countered by making the
legal provisions more stringent and deterrent
even entailing life imprisonment for
adulterations causing grevious hurt and danger
to human life. This malpractice is also being
tackled through effective health education
measures. The drug de-addicition centres are
being strengthened to provide treatment
facilities f or the drug abuse problem and drug
dependence disorders.
5.2. Prevention of Food Adulteration
Programme
5 . 2 . 1 . The Prevention of Food Adulteration
Act, 1954: Food is a basic need of life. It is,
therefore, imperative to ensure that whatever
we consume is pure and wholesome. With this
objective, the Prevention of Food
Adulteration Act, was enacted in 1 954. The
aims envisaged under this Act are:
(i) To ensure pure and wholesome
food to the Consumers;
(ii) To protect the Consumers from
fraud and deception; and
(iii) To encourage fair trade practices.
5.2.2. The Act, which came into effect from
1 s t June, 195 5, has been amended thrice in 1
964, 1 976 and 1 986 f o r plugging the loop-
holes and for making the punishments more
stringent and empowering the Consumer and
Voluntary Organisations to take samples.
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5.3. Constitutional Status & Enforcement of
the Act
5 . 3 . 1 . The subject of Prevention of Food
Adulteration is in the concurrent list of the
Constitution. However, in general, the en-
forcement of the Act is done by the
State/Union Territory Governments. The
Central Government primarily plays an ad-
visory role in its implementation besides
carrying out various statutory functions/ du-
ties assigned to it under the various provisions
of the Act.
5.4. Main Functions of the Central
Government
5 . 4 . 1 . The Central Committee for Food
Standards (A Statutory Committee constituted
by the Central Govt. under the Act) is responsible
for considering amendments to various provi-
sions of the Act, Rules and Standards. The
Central Government conducts examination for
the Chemists for their appointment as Public
Analyst under the Act. It approves the State
Prevention of Food Adulteration Rules under the
Act and is also Required to examine and approve
the labels for/infant food. The Central Govern-
ment evaluate and monitor the working of the
PFA Act in-the States/Union Territories by col-
lecting analytical data from Food Laboratories for
Standardisation purpose. It also arranges training
programmes for various functionaries under the
PFA .Act and creates consumer awareness
through workshops/seminars etc. The Central
Government ensures the quality of food imported
into the country under the PFA Act and also deals
with matters relating to International agencies,
namely, CODEX/FAO/WHO.
5.5. Central Food Laboratories
5 . 5 . 1 . Four Central Food Laboratories have
been established/specified under the Act, which
work as Appellate Laboratories for the
purpose of samples lifted by Food Inspectors of
States/Union Territories and local bodies. The
two laboratories viz. (i) Food Research and
Standardisation Laboratory, Ghaziabad ;and
(ii) Central Food Laboratory, Calcutta, are
under the administrative control of the
Directorate General of Health Services and the
other two, viz. (iii) Central Food Laboratory,
Pune and (iv) Central Food Laboratory,
Mysore are under the administrative control
of Government of Maharashtra and Council
of Scientific and Industrial Research,
Government of India respectively.
5.6. State Food Laboratories
5.6 .1. There are 81 Food Laboratories under
the administrative control of State/Union
Territory Governments and Local Bodies.
5.7. Activities Being Undertaken by the
Central Government
5 . 7 . 1 . In addition to framing rules and
standards of various Food Products, monitor-
ing other activities of the States/Union
Territories, the Central Government have been
carrying out following activities also regularly.
5.7.2. Training Programme: The PFA Division
has been arranging a number of training
courses for senior officers of the
States/Analysts/Food Inspectors with the
objective of ensuring uniform implementa-
tion of the Act. A total of 53 Training
Courses have been arranged so far by the PFA
Division in collaboration with various institu-
tions/organisations, for Food (Health)
Authorities, Local (Health) Authorities, Food
Inspectors, Chemists/Analysts and Consumer
Organisations, on various aspects of the PFA
Programme.
5.7.3. Examination for Chemists: ^ e x -
aminations have been conducted so far for
chemists working in the States/Union Ter-
ritories and other Food Testing Laboratories
and uptil now 237 chemists have been
declared to be qualified for appointment as
114
a Public Analyst by the Board appointed and
notified f o r the purpose by the Central
Government.
5.7.4. Consumer Involvement & Health
Education: Every effort is made to involved the
consumers in the Prevention of Food
Adulteration Programme, since more Legisla-
tion is not enough to curb the menace of food
adulteration. 5 representatives from consum-
ers have been associated in the working of
Central Committee for Food Standards and
similarly on its Sub-Committees.
5.7.4.(i). Training programmes have
been started for consumer organisations/con
sumer activists in our Central Food Laborato
ries with the assistance of State Govern
ments.
5.7.4.(ii). The PFA Division of the Cen
tral Government has published following fold
ers for the guidance of consumers:
(a) PFA & Consumer Awareness Tips to
Consumer (Hindi & English);
(b) Tips to Food Safety & Sound Diet (Hindi
& English);
(c) Guide on Safe Food to Travellers
(English);
(d) Help Fight Food Adulteration;
(e) You can prevent Lathyrism (Hindi &
English);
(f) Food Laws in India - A Profile (Hindi &
English);
(g) Tips to Food Safety & Nutritional Diet
(Hindi & English); and
(h) Simple test for common adulterants in
foods;
5.7.4.(iii). A kit has been developed for
the Simple Test of Common Adulterants in
Food by housewife/common man.
5.7.4.(iv). A documentary film high
lighting the evils of adulteration has also been
prepared.
5.8.1. Ministry of Health & Family Welfare has
launched a Centrally Sponsored Scheme for
providing funds to the State Governments for
purchase of equipments for strengthening their
Food Laboratories, during the 8th Five Year
Plan. The amount of financial assistance is one
time grant. Under this Scheme, an amount of Rs.
201 lakh has already been given to 23 States/Union
Territories during 1 9 9 0 - 9 1 , 1 9 9 1 - 9 2 , 1 9 9 2 -9 3
& 1993-94. During the year 1 994-95 Central
assistance, in the form of sophisticated
laboratory equipments, amounting to about
Rs.50 lakh is proposed to be provided to the State
Food Testing Laboratory of the States of Bihar,
Goa, Gujarat, Haryana, Himachal Pradesh,
Jammu & Kashmir, Karnataka, Kerala, Mad-
hya Pradesh, Meghalaya, Nagaland and Tamil
Nadu respectively.
5.9. Medical Stores Organisation
5.9.1. The Medical Stores Organisation (MSO)
with seven Depots at Bombay, Calcutta,
Guwahati, Hyderabad, Karnal, Madras and
New Delhi is responsible for the procurement
and supply of quality medical stores including
equipment to various hospitals and dispensaries
all over the country at the most economical rates.
There are about 1,800 regular indentors who
draw their requirements from these Depots. The
Organisation has three Chemicals Laboratories
attached to the Medical Stores Depots at Bombay,
Madras and Calcutta for conducting the quality
control tests.
5.9.1.(i). The Medical Stores Organisation
procures various drugs and other items for
implementation of the National Health Pro-
grammes. It receives supplies from international
agencies like UNICEF, CIDA, WHO, USAID etc.
and distributes them to various parts of the
country. It arranges relief supplies to the victims
of natural and national calamities. During
natural calamities like drought, cyclones,
floodsr, earthquakes etc. in various parts of
India, the Medical Stores Depots play an
important role in supplying life saving drugs on
emergent basis under Civil Defence Programme.
The organisation also arranges gift supplies to
foreign countries at the instance of the
Ministry of External Affairs on behalf of the
Govt. of India.
115
5.9.2. In view of the increased activities and
important role being played by Medical Stores
Organisation, the Ministry have initiated
several steps for improvement in its functioning
by way of providing in-house testing facilities
in Govt. Medical Stores Depots at Delhi &
Guwahati during 1 9 9 4 - 95 in phases. Measures
to provide adequate cold storage facilities in
various Medical Stores Depots are being taken
besides providing racks, tressles for storage of
valuable medicines and equipment.
5.9.3. The cost of stores purchased during 1994-
95 upto 11 / 9 4 is Rs.75 crore as compared to
R s. 10 0. 42 crore during 1 9 93 - 9 4 upto March,
1994.
5.10. Central Drug Standard Control
Organisation
5 . 1 0 . 1 . The main functions of Central Drugs
Standard Control Organisation are: (i) Control
the quality of drugs imported into the country;
(ii) Co-ordinate the activities of States/ Union
Territories Drug Control Author!- ties and to
advise them on unifrom administration of Drugs
and Cosmetics Act; (iii) Approve new drugs
proposed to be imported into or manufactured
in the country; (iv) Lay down regulatory
measures and standard of drugs; and (v) To act as
Central Licence Approving Authority in respect
of whole human blood, blood product, large
volume parenterals (Intravenous Fluids), Sera
and Vaccine.
5.1 0. 2. Quality Control over Imported Drugs:
The statutory control on imported drugs is
exercised by various ports and airports of f ice s
of Central Drug Standard Control Organisation
located at Bombay, Nhavashava, Calcutta,
Madras, New Delhi and Cochin.
5 . 1 0 . 3 . During the period from April to Sep-
tember, 1 9 9 4 the value of imported drugs, drug
intermediates, finished formulations, chemical
solvents, etc. was Rs. 645.76 Crores approximately
and export during this period was upto Rs.
1286.57 crore.
5 .10.4 . Co-ordination and Liaison with the
States: Four Zonal Offices located at Bombay,
Calcutta, Madras, Ghaziabad and Sub-Zonal
Offices at Lucknow and Patna co-ordinate with
the State Drug-Control Authorities under their
jurisdiction for uniform standard, of inspection
and enforcement of the Drugs Rules.
5.10.5. The Zonal Officers inspected either
jointly with State Drug Control Authorities or
independently as many as 1 88 manufacturing
units, 1 5 7 blood banks and 18 approved
laboratories. Two more Sub-Zonal Offices are
likely to start.
5.10.6. The State Drug Control Authorities
were informed of the deficiencies observed
during these inspections.
5.10.7. Approval of New Drugs: Voluminous
literature in relation to Pharmaceutical
information, Pharmacology, Pharmacody-
namics, Pharmacokinetic studies, acute and
long-term toxicity studies in different species
of animals, special toxicity studies including
reproductive studies, mutagenecity and car-
cinogenecity, clinical trial reports on new
drugs for safety, efficacy of a new drug
molecule, are examined before considering
grant of permission for clinical trials of new
drugs in India. The clinical trial reports con-
ducted in India are examined including the bio-
availability studies to establish bio-
equivalence of different brands of a new drug
before granting marketing approval. The ap-
proval of new drug includes examination of
package insert, promotional literature, the
label claims etc. and also testing of bulk drugs
at Central Drugs Laboratory, Calcutta.
5 .1 0.8. Permissions to import 9 new orugs
under Rule 1 2 2 - A and 12 new drug formu-
lations under Rule 1 2 2 - B and 1 2 2 - C were
granted during the period April to Septem-
ber, 1 9 9 4 for manufacture in the country.
During this period 37 new applications were
received for grant of approval under the
above mentioned rules.
5.10.9. Central Drugs Laboratory, Calcutta:
The main functions of this Laboratory is to
test samples of imported drugs and to act as
appellate laboratory under Drugs and Cos-
metics Act and act as Government Analyst for
21 States/Union Territories and as well as for
samples drawn by the Central Drug Inspectors.
It also supplies reference standard of various
drugs to drug manufactures.
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5.1 0 . 1 0 . A number of 746 samples were
tested and 104-samples were found as not of
standard quality during the period April to
September, 1 9 9 4 . ' Out of this, 66 tested"
samples related to National Survey on Quality of
Essential Drugs Programmes. 10 samples found
to be as not of standard quality related to
NSQED.
5 . 1 0 . 1 1 . During this period, two training
programmes on
(1) Instrumental method of analysis of
drugs; and
(2) Pharmacological and toxicological
method of testing of drugs were
conducted in which a total of 8
participants were trained.
5 . 1 1 . Central Indian Pharmacopoeia
Laboratory, Ghaziabad
5 . 1 1 . 1 . It is the statutory appellate Labora-
tory for testing of Condoms as well as
functions as Government Analyst for 8
States/Union Territories in addition to testing
of samples on behalf of Central Government
Departments. The experimental work relating
to standards of drugs included in the Indian
Pharmacopoeia is also carried out in this
laboratory. During the period April to
September, 1 9 9 4 , a total of 631 number of
samples were tested, out of which 99 were
found as not of standard quality.
5 .12 . Biological Laboratory and Animal
House, Madras
5 . 1 2 . 1 . This Laboratory tests the drug sam-
ples received from Drug Inspectors of Central
Drugs Standard Control Organisation, South
Zone, and Medical Store Depot, Madras.
5 . 1 2 . 2 . The total number of 4 1 5 samples
were tested out of which 50 number of samples
were found as not of standard quality during
the period from April to September, 1 9 9 4 .
5.1 3. Drugs Consultative Committee
5 . 1 3 . 1 . It is a statutory body under Drugs
and Cosmetics Act to advise for uniform
implementation of Drugs and Cosmetics Act
throughout the country. The 29th Meeting of
DGC.was -held in January 19 9 4 ' in.which
important matters relating to qualilty control,
manufacture and distribution of drugs including
Diagnostic Kits and reagents were discussed.
5.13.2. Weeding out of Irrational Combination:
In the meeting of expert committee held in July
1994 on weeding out of irrational/ harmful/
sub-therapeutic drugs, the following
formulations were reviewed for rationality:
(i) Analgin combination;
(ii) Fixed dose combination of Oxy-
phenbutazone with other drugs;
and
(iii) Fixed dose combination of Dextro-
propoxyphene with other drugs.
5.13.3. The Committee asked the manufacturers
to conduct further clinical trials and submit the
reports.
5.14. Central Licence Approving Authority
(CLAA)
5 . 1 4 . 1 . The Drugs Controller (India) has been
entrusted with the task of examining the
application for grant and renewal of licenses in
respect of Blood Banks, Sera and Vaccine and
large volume parenterals under the Drugs and
Cosmetics Act in the country. During the period
April to September, 1994, 50 number of licences
were issued/renewed with respect to above
category of drugs.
5.14.2. Drugs Technical Advisory Board: Drugs
Technical Advisory Board (DTAB) is a statutory
body constituted under the Drugs and Cosmetics
Act to advise the Central and State Governments
on technical matters arising out of the
administration of this Act. The Board normally
meets once in a year. The following three
amendments to the Drugs and Cosmetics Rules
approved earlier have been finalised and
published during this period:
(i) Inclusion of Black Iron Oxide in the list
of Natural Colours in Rule 127 and
amendment in Form 18, 20-B, 26, 26-
C, etc. and
117
(ii) Amendment of Rule 85(3) to provide right
of "appeal to Government against the order
of suspension/cancellation of licenses by
licensing authority.
5 . 1 4 . 3 . The following notifications of draft
Rules were published for eliciting comments
from the public during this period:
(i) Amendment of Rule 54-A to include
cosmetics along with drugs and amendment
of Rule 97 to in-„ elude ointments,
antiseptics cream;
(ii) Amendment of Rule 71 to include
Graduate in Veterinary Science as
competent person to manufacture
veterinary drugs;
(iii) Amendment to Schedule C and C-1 to
include diagnostic reagents;
(iv) Amendment of Rule 58-A for disposal
of confiscated drugs to hospitals or
dispensaries maintained by
Government or Charitable Institutions
and amendment of Form 1 3 , 34 and
Rule 46 regarding seals on packages
sent for test;
(v) Amendment of Rule 96 regarding sale
of drugs;
(vi) Amendment of Rule 139-A and 85-E
regarding inspection before the grant
or renewal of licences; and
(vii) Amendment of Schedule R regarding
standards of condoms and other
mechanical contraceptives;
5.15. Indian Pharmacopoeia Committee:
5 . 1 5 . 1 . During the period April to September
1994, three amendments were issued to Indian
Pharmacopoeia (III Edition) and 4 9 1 number of
monographs were finalised for printing in
addition to 1 0 0 number of draft monographs
made ready for computerisation.
5 .1 5.2. A meeting of the sub-committee on hard
gelatin monographs was held during September,
1 9 9 4 for finalisation of monographs on hard
gelatin capsules. Besides
this, 5000 copies of Indian Pharmacopoeia
(III Edition) were got reprinted.
5.16. Setting up of a National Drug
Authority
5 . 1 6 . 1 . Consequent upon the announcement
of New Drug Policy, 1994, in September, 1994,
Draft Bill has been prepared for bringing out an
enactment for establishing a National Drug
Authority to ensure quality control and rational
use of drugs in the country.
5.17. Drugs De-addiction Programme
5 . 1 7 . 1 . Ministry of Health and Family
Welfare is responsible for providing treat-
ment facilities including preventive health
and after care service in the field of drug
addiction.
5.1 7. 2. For effe ctive coordination and
functioning amongst various Minis
tries/Departments, the Cabinet
Sub-Committee on Drug Abuse Control
has set up a Coordination Committee of
Secretaries. A High Level Committee con
sisting inter-alia of some Members of
Parliament has also been set up to take
comprehensive review of the arrange
ments for dealing with various aspects of
drug problem.
5 .17 .3 . The Drug De-addiction Programme
had commenced in 1987-88 by establishing a
30 bedded Drug-De-addiction Centre at
A.1.1.M.S., New Delhi. Thereafter four more
Centres were established in Central Insti-
118
tutes/Hospitals viz. PGI, Chandigarh; JIP-
MER, Pondicherry; Lady Hardinge Medical
College & Hospital, New Delhi and Dr. R.M.L.
Hospital, New Delhi.
5 . 1 7 . 4 . In addition, Regional level Centres
with the assistance of UNDCP have also been
developed at KEM Hospital, Bombay and
Institute of Post-Graduate Medical
Education and Research (IPG-MER),
Calcutta.
5 . 1 7 . 5 . The above Centres besides pro-
viding treatment services also provide
training to medical/para-medical personnel,
prepare health education material and
render community outreach services.
5 .1 7 . 6 . The scope of the scheme has been
enlarged since 1992-93 to provide
assistance to State Governments to set up
their own Centres and train medical per-
sonnel. So far 31 Centres in various States
have been provided assistance in the form of
equipment; construction of building
training of doctors, etc.
5.17 .7. It is estimated that about 800
doctors have been trained since the initiation
of the scheme in 1 9 9 2 - 9 3 .
5.17.8. The new initiatives include devel-
opment of a National Master Plan; a
Training Master Plan; and conduct of a f e w
Epidemiological Studies/Surveys in priority
areas.