Food Adul Act

8/8/2019 Food Adul Act

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PREVENTIONOF FOODADULTERATION

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 foradulterations 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 for 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 fa ir trade practices.

5.2.2. The Act, which came into effect from

1st June, 1955, has been amended thrice in 1

964, 1 976 and 1 986 for plugging the loop-

holes and for making the punishments more

stringent and empowering the Consumer and

Voluntary Organisations to take samples.

5.3. Constitutional Status & Enforcement ofthe Act

5.3.1. The subject of Prevention of Food

Adulteration is in the concurrent list of theConstitution. 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 provisionsof the Act .

5.4. Main Functions of the Central

Government

5.4.1. The Central Committee for FoodStandards (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 forStandardisation 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.

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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 underthe 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 Divisionhas 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

a Public An alys t by the Board appointed andnotified for the purpose by the CentralGovernment.

5.7.4. Consumer Involvement & HealthEducation: 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 foodadulteration. 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 havebeen 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 folders 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 infoods;

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.

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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 1990-91, 199 1-92 , 1992-93& 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 onemergent 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.

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 1994-95 in phases. Measures

to provide adequate cold storage facilities in

various Medical Stores Depots are being takenbesides 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

Rs.100.42 crore during 1993-94 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) Controlthe 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.

5.10.2. Quality Control over Imported Drugs:

The statutory control on imported drugs is

exercised by various ports and airports offices

of Central Drug Standard Control Organisation

located at Bombay, Nhavashava, Calcutta,

Madras, New Delhi and Cochin.

5.10.3. 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

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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 approvedlaboratories. 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 includingreproductive 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 drugsat Central Drugs Laboratory, Calcutta.

5.10.8. Permissions to import 9 new orugs

under Rule 1 2 2 -A and 12 new drug formu-

lations under Rule 122-B and 122-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 totest 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.

5.10 . 10 . 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 ofdrugs; 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, 1994, a total of 631 number of

samples were tested, out of which 99 were

found as not of standard quality.

5 .1 2. 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 ofsamples

were found as not of standard quality during

the period from April to September, 1994.

5.13. 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

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throughout the country. The 29th Meeting of

DGC.was -held in January 1994' 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 manufacturersto conduct further clinical trials and submit the

reports.

5.14. Central Licence Approving Authority

(CLAA)

5. 14. 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 licenceswere 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

(ii) Amendment of Rule 85(3) to provide right

of "appeal to Government against the order

of suspension/cancellation of licenses by

licensing authority.

5.14.3. The following notifications of draft

Rules were published for eliciting comments

from the public during this period:

(i) Amendment of Rule 54-A to includecosmetics 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 13, 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 grantor 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 49 1 number of

monographs were finalised for printing in

addition to 100 number of draft monographsmade ready for computerisation.

5.15.2. A meeting of the sub-committee on hard

gelatin monographs was held during September,

1 99 4 for finalisation of monographs on hard

gelatin capsules. Besides

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this, 5000 copies of Indian Pharmacopoeia(III Edition) were got reprinted.

5.16 . Setting up of a National DrugAuthority

5 . 1 6 . 1 . Consequent upon the announcement

of New Drug Policy, 1994, in September, 1994,

Draft Bill has been prepared for bringing out anenactment 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 FamilyWelfare is responsible for providing treat-

ment facilities including preventive health

and after care service in the field of drug

addiction.

5.17.2. For effective coordination andfunctioning amongst various Minis

tries/Departments, the CabinetSub-Committee on Drug Abuse Control

has set up a Coordination Committee of

Secretaries. A High Level Committee consisting 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 ofdrug problem.

5.17.3. The Drug De-addiction Programme

had commenced in 1987-88 by establishing a30 bedded Drug-De-addiction Centre at

A.1.1.M.S., New Delhi. Thereafter four more

Centres were established in Central Insti-

tutes/Hospitals viz. PGI, Chandigarh; JIP-MER, Pondicherry; Lady Hardinge MedicalCollege & Hospital, New Delhi and Dr. R.M.L.

Hospital, New Delhi.

5.17.4. In addition, Regional level Centreswith the assistance of UNDCP have also been

developed at KEM Hospital, Bombay and

Institute of Post-Graduate MedicalEducation and Research (IPG-MER),

Calcutta.

5.17.5. The above Centres besides pro-viding treatment services also provide

training to med ica l/pa ra-m edical personnel,

prepare health education material and

render community outreach services.

5.17.6. The scope of the scheme has been

enlarged since 1992-93 to provide

assistance to State Governments to set uptheir own Centres and train medical per-

sonnel. So far 31 Centres in various Stateshave been provided assistance in the form ofequipment; construction of buildingtraining of doctors, etc.

5.17.7. It is estimated that about 800doctors have been trained since the initiation

of the scheme in 19 92 -9 3.

5.17.8. The new initiatives include devel-

opment of a National Master Plan; aTraining Master Plan; and cond uct of a fe w

Epidemiological Studies/Surveys in priority

areas.

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Food Adul Act