Chapter– 5

Prevention of Food
Adulteration Programme

5.1.1. Adulteration of food and drugs can causes serious damage to human life. This anti-
social menace is sought to be countered by making the legal provisions more stringent
and deterrent even entailing life imporisonment for adulterations causing grevious hurt
and danger to human life. This malapractice is also being tackled through effective health
education measures. The drug de-addiction centres are being strengthened to provide
treatment facilities for the drug abuse problem and drug dependence disorders.

5.1.2. One of the recent important amendments made in the PFA Rules in that all
common salt shall be compulsorily iodised so as to meet the iodine requirement of our
population. A notification to this effect issued on 27.11.97 will come into effect from
27.5.98, and will go a long way to combat Iodine Deficiency Disorders.

5.1.3. Food safety through food Quality Control Programme is of paramount importance
in achieving the goal of 'Health For All by 2000 A.D.' It can be achieved through the
combined effort and co-operation of food industry, the Government Organisations/ Non-
Government Organisations. The legislative measures adopted for food safety are
provided under the Prevention of Food Adulteration (P.F.A.) Act a piece of central
legislation promulgated in 1954 – which repealed all earlier Acts of the State
Governments. The Act which came into effect from 1st June, 1955 has been amended
thrice – in 1964, 1976 and 1986 – for plugging the loopholes, making punishments more
stringent and empowering the Consumer and Voluntary Organisations to play a more
effective role in its implementation.

5.2. Role of Central Government

5.2.1. To review the provisions of PFA Act, Rules & Standards in consultation with the
Central Committee for Food Standards, a statutory Advisory Committee under the Act
and its 9 technical Sub-Committees.

5.2.2. To conduct examination for the Chemists for their appointment as Public Analyst
under the Act.

5.2.3. To organise training programmes for various functionaries (viz, Senior Level
Officers, Chemists, Food Inspectors and Consumers Organisations) under the Act.

5.2.4. To approve the State PFA Rules.

5.2.5. To examine and approve the labels of infant foods.

5.2.6. To evaluate and monitor progress of implementation of the Act in the States/UTs
by collecting periodical reports and through spot visits.

5.2.7. To liaise with National & International Food Quality Control Organisations i.e.
B.I.S. (associated with certification of processed food articles), Directorate of Marketing
& Inspection operating the Agmark Scheme, Ministry of Food Processing. Industries
implementing Fruits Products Order (FPO), Codex Alimentarius Commission and World
Trade Organisation.

5.2.8. To ensure quality of food imported into India, under the provisions of the Act.

5.2.9. To create consumer awareness.

5.2.10. To augment the Food Testing Labs.

5.3. Central Food Laboratories.

5.3.1. Four Central Food Laboratories have been established under the Act, which work
as appellate laboratories, for the purpose of analysis of appeal samples of food articles
lifted by the Food Inspectors of States/UTs and local Bodies. Two of the Laboratories,
viz., Food Research & Standardisation Laboratory, Ghaziabad and Central Food
Laboratory, Calcutta are under the administrative control of the Directorate General of
Health Services while the two, Central Food Laboratory at Pune and Mysore are under
the administrative control of the Government of Maharashtra and Council of Scientific
and Industrial Research, Government of India, Respectively.

5.4. State Food Laboratories

5.4.1. There are 78 Food Laboratories under the administrative control of State/UT
Governments and Local Bodies.

5.4.1. (a) Achievements during the year:

(i) 8 training programmes have been arranged for Senior Level Officers/Public
Analysts/Food Inspectors as well as recognised Consumer Organisations so as
to acquaint them with the latest developments of the programme of Food
Safety and Quality Control.

(ii) An amount of Rs. 1.16 crore has been released by the Central Government to
the States/UTs during 1996-97 and Rs. 0.80 crore during 1997-98 for purchase
of equipment by the State Food Laboratories.

5.4.2. A survey has been carried out on the quality of plastic containers used in food
packaging with financial support from WHO.
5.4.3. 5 final notifications amending the PFA Rules 1955 have been published during
1996-97 and 8 final notifications have been published during 1997-98.

5.4.4. 16 draft notifications inviting public comments relating to amendments to the PFA
Rules, 1955 have been published during 1996-97, and 12 draft notifications have been
published during 1997-98.

(i) A meeting of the National Codex Committee was convened on 28.1.97 to

formulate the views of the Government of India on various aspects of
standardisation of food articles at International level handled by Codex
Alimentarius Commission – A Joint body of FAO/WHO. A number of shadow
committee meetings were held during the year 1996-97 and views of India
formulated and despatched to Codex Secretariat. India sent delegations to a
number of Codex meetings viz. fish and fishery products, food labelling, milk
and milk products, cocoa products, chocolate, nutrition and food for special
dietary, food hygiene, fats and oils, general principles, import and export,
method of sampling pesticide residues and Codex Alimentarius Commission.

(ii) A meeting of the Central Committee for Food Standards, a statutory committee
under the PFA Act, 1954, was convened in November, 1997.

(iii) One of the recent important amendments made in the PFA Rules, 1955 is that
all common salt shall be compulsorily iodised so as to meet the iodine
requirements of our population. A notification to this effect has been issued on
27.11.1997 which will go a long way to combat Iodine Deficiency Disorders.

5.4.4. (a) WHO Assisted Activities:

(i) The Government of India organised WHO assisted training programmes for
Analyst/Chemists working in the food labs. of the States/UTs in the field of
sophisticated analysis for presence of heavy metal, aflatoxin, pesticide
residues, microbiological analysis and food packaging materials. A training
programme was organised for recognised Consumer Organisations so as to
acquaint them with the latest developments of Programmes of food Safety and
Quality Control. Training programmes for the Chemists in detection of
adulterant in milk have been arranged. A survey on the quality of plastic
containers in use for food packaging was carried out in the Central Food
Laboratories, at Calcutta and Pune. A study on quality control of meat and
meat products is being caried out at the Defence Food Research Laboratory,
Mysore. A survey to find out the extent of heavy metal and aflatoxin
contamination in food articles was carried out at the Central Food laboratories,
at Pune, Calcutta, and Mysore and the Indian Toxicology Research Centre,
Lucknow.
 (ii) A Workshop on involvement of Consumer Associations/NGO's in the
programme of Food and Drug Safety and Quality Control was held at New
Delhi on 14th and 15th January, 1997.

5.4.4. (b) Goal set for 1998-99: During the next Annual Plan, following schemes have
been contemplated utilising external aid from the World bank.

(i) Strengthening of PFA units in the Directorate General of Heath Services so as

to set up a National Food (Health) Authority with a full-fledged Secretariat for
Central Committee for Food Standards (CCFS) and National Codex
Committee.

(ii) Setting up of three Central Food Laboratories at Kandla, Mumbai and Channai
and Zonal Offices/Import Quality Control units in Mumbai, Calcutta, Chennai,
Kandla and North Zone.

(iii) Augmentation of laboratory facilities of Food Research and Standardisation

Laboratory, Ghaziabad with staff, equipment and construction of building.

(iv) Augmentation of laboratory facilities at Central Food Laboratory, Calcutta.

(v) Financial assistance to State/UTs for strengthening their Food Testing

Laboratories working under PFA Act, 1954 under Centrally Sponsored
Schemes (100%).

(vi) Setting up of Management Information System.

(vii) Active involvement of Consumer Organisations in the programme.

5.5. Central Drug Standard Control Organisation

5.5.1. The main functions of the Central Drugs Standard Control Organisation (CDSCO)
include control of the quality of drugs imported into the country, co-ordination of the
activities of the States/UT drug control authorities, approval of new drugs proposed to be
imported or manufactured in the country, laying down of regulatory measures and
standards of drugs and acting as the Central licence Approving Authority in respect of
whole human blood, blood products, large volume parenterals, sera and vaccines. The
CDSCO functions from Head-quarters office in New Delhi, 4 zonal offices, 3 sub-zonal
offices besides 5 port offices. The four Central Drug Laboratories carry out tests of
samples for specified classes of drugs.

5.5.2. Quality Control Over Imported Drugs: The statutory control on imported drugs is
exercised by various ports and airports offices of CDSCO located at Mumbai,
Nhavasheva, Calcutta, Chnnai, New Delhi and Cochin, During the period from January,
1997 to March, 1998 the value of imported drugs, drug intermediates, finished
formulations, chemical solvents, etc. was Rs. 3000 crore approximately and export during
this period was upto Rs. 61000 crore.

5.5.3. Co-ordination and Liaison with the States: Four Zonal Offices located at Mumbai,
Calcutta, Chennai, and Ghaziabad, and sub-zonal offices at Lucknow, Patna and
Hyderabad co-ordinate with the State Drug Control Authorities under their jurisdiction
for uniform standard of inspection and enforcement of the Drugs Rules. The Zonal
Officers inspected, either jointly with the State Drugs Control Authorities or
independently, as many as 405 manufacturing units, 568 blood banks and 55 approved
laboratories during the period from January, 1997 to March, 1998. The State Drug
Control Authorities were informed of the deficiencies observed during these inspections.

5.5.4. Approval of New Drugs: Voluminous literature in relation to Pharmaceutical

information, Pharmacology, Pharmacodynamics, Pharmacokinetic studies, acute and
long-term toxicity studies in different species in animals, special toxicity studies
including reproductive studies, mutogenecity and carcinogenecity, clinical trial, reports
on new drugs for safety, efficacy of a new drug molecule, are examined before
considering grant of permission for clinical trial of new drugs in India. The clinical trail
reports conducted in India are examined including bio-availability studies to establish
bio-equivalence of different brands of a new drug before granting approval for marketing.
The approval for a new drug includes examination of package insert, promotional
literature, label claims etc. and also testing of bulk drugs at the Central Drugs Laboratory,
Calcutta.

5.5.5. During the period, January, 1997 to March, 1998, permissions were granted to
import 49 new drugs either in Bulk form and or in finished form. Permission was also
granted to manufacture 14 entirely new drug formulations during this period.

5.6. Central Drugs Laboratory, Calcutta

5.6.1. The main functions of this Laboratory are to test the samples of imported drugs to
act as appelate laboratory under Drugs and Cosmetics Act and act as Government
Analyst for 21 States/Union Territories as well as for samples drawn by the Central Drug
Inspectors. It also supplies reference standard of various drugs to drug manufacturers.
Samples were tested and 340 smaples were found not of standard quality during the
period January, 97 to March, 98. 439 tested samples related to National Survey on
Quality of Essential Drugs Programmes, of these, 18 samples were found to be not of
standard quality. Five training programmes on various advanced methods of testing of
drugs were conducted in which 23 participants were trained.

5.7. Central Indian Pharmacopoeia Laboratory, Ghaziabad

5.7.1. It is the statutory appellate laboratory for testing of condoms and functions as
Government Analyst for 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 January, 97 to march, 1998, a total of 2,580 samples were tested out of
which 394 were found not to conform to standard quality. Two workshops on Good
Laboratory Practices and new techniques were conducted in which, 32 Drug Analysts
were trained.

5.8. Central Drug Testing Laboratory, Chennai

5.8.1. This Laboratory tests the drug samples received from Drug Inspectors of Central
Drugs Standard Control Organisation, South Zone, Chennai ADC (I), Chennai, Sub-zone,
Hyderabad and Technical Officers, Cochin. 1207 samples were tested from January, 97
to March, 1998 out of which 13 samples were found to be not of standard quality.

5.9. Central Drug Testing Laboratory, Mumbai

5.9.1. The laboratory acts as Government Analyst and assists CDSCO in the analysis of
drug formulations and drug substances. During January, 97 to March, 1998, 1589 drug
samples were analysed of which 213 samples were found as being not of Standard
Quality.

5.10. Drug Consultative Committee

5.10.1. It is a statutory body under the Drug & Cosmetics Act to provide advice regarding
uniform implementation of the drug and Cosmetics Act throughout the Country. The 31st
Meeting of the DCC was held in August, 1997 in which important matters relating to
quality control, manufacture and distribution of drug including diagnostic kits and re-
agents were discussed.

5.10.2. Licences to import biologicals and other special products: 940 Licences in Form
10 to import Schedule C & C (1) Drugs were issued and 440 Licences were renewed
during the period January, 1997 to March, 1998. 1196 Test Licences were issued to
various manufacturers/Hospitals/centres for test and examinations.

5.11. Central Licence Approving Authority

5.11.1. Licences were granted/renewed in respect of 512 Blood Banks, 37 large volume
Parentals and 11 sera and vaccine units during the period January, 1997 to March, 1998.

5.12. India Pharmacopoeia

5.12.1. Three amendment lists were issued in respect of certain monographs included in
the Indian Pharmacopoeia, 1996. One meeting of IP Committee was held to approve
these amendment lists and to review the progress in publication of a Veterinary
supplement to the IP 1996 containing 55 monographs of veterinary biologicals and 113
monographs of non-biologicals which is under process.
5.13. Training

5.13.1. 36 Drug Inspector were trained on General aspects of Quality Control of Drugs in
2 training programmes conducted at DITS, Mumbai during the year 1997 under WHO
assistance. One training programme on Inspections of sera and Vaccine units was
conducted at CRI, Kasuali under WHO assistance in which 19 Drug Inspectors/Asst.
Drugs Controllers participated. Two workshops were also held under WHO assistance in
September, 1997 for (i) drafting mannual on Herbal Medicine and (ii) Drawing up a Drug
Master File on Raw-substances and formulations in Delhi and Mumbai respectively. Ten
Drug Inspectors were trained in inspections of blood banks at the North Zone, Ghaziabad
with assistance from NACO.

5.13.2. The Core Group constituted by the Supreme Court to consider the rationality of
certain drug formulations met under the Chairpersonship of the Director General of
Health Services on 28.10.1997. The question of rationalising the combination of Iron
Tonic with Vitamin and/or Minerals and enzymes preparations was considered.

5.14. Drugs Technical Advisory Board

5.14.1. Three final notifications of amendments to the Drugs and Cosmetics Rules, 1945
have been published during the period, January, 1997 to March, 1998. A notification
under Sec. 26 A of the Drugs and Cosmetics Act was issued prohibiting the manufacture
and sale of parenteral preparations containing fixed dose combination of streptomycin
with pencillins with effect from 1.1.1998. The 46th meeting of the Drugs Technical
advisory Board was held on 1st December, 1997.

5.15. Legislation on Blood Banks

5.15.1. Consequent upon the directions of Supreme Court of India, the office of Drugs
Controller of India prepared a draft legislation covering collection, storage, testing and
distribution of blood and its products. This legislation includes prohibition of collection
of blood from professional paid donors. The final notification is being issued.

5.16. Medial stores organisation

5.16.1. Organisation: The Medical Stores Organisation consists of Seven Depots located
at New Delhi, Mumbai, Calcutta, Chennai, Karnal, Guwahati & Hyderabad. It 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.
The organisation has three Chemical Laboratories attached to the Medical Stores Depots
at Mumbai, Calcutta and Chennai for conducting the quality control tests. Steps for
improvement in its functioning by way of providing in-house testing facilities in various
Medical Stores Depots is also being taken in a phased manner in addition to introducing
computerisation for inventory control and financial accounting. Besides these, action to
provide adequate cold storage facilities in various Medical Store Depots is also being
taken.
5.16.2. Main Activities: The Medical Stores Organisation also caters to the needs of
hospitals and dispensaries located in rural & sub-urban areas. There are 1,800 regular
indentors, namely, Government Hospitals and dispensaries in various States, Union
Territories, P & T, BSF, CRPF etc. who draw their requirements from these Depots.
Medical Store Organisation plays a vital role in the implementation of various National
Health Programmes for which a sum of Rs. 40 crore (approx.) has been earmarked for the
year 1997-98 for supply of drugs for TB Control, NMEP, NLEP, Blindness Control etc.
The indentors operate through a list of items displayed on vocabulary on Medical Stores
for stocks in Depots fro-onward supply to them. The Organisation also receives supplies
from international agencies like UNICEF, SIDA, WHO, USAID etc. and distributes them
to various parts of the country. It arranges relief supplies to the victims of natural &
national calamities. MSO supplies emergency medicines to the affected states for natural
calamatis like floods, cyclones, droughts, epidemic etc. The Organisation arranges gift
supplies to various countries at the instance of the Ministry of External Affairs on behalf
of the Government of India.

5.16.3. Achievements: Out of the sanctioned budget of Rs. 151 crore under the Head
"Material Purchase in India & Abroad" a sum of Rs. 114 crores has since been spent till
date for procurment of medicines and supplied to the various hospitals, namely, State
Governments, Union Territories, CGHS, Paramilitary forces, etc. A proposal for Ninth
Plan for Institutional Strengthening of Medical Stores Depots with the assistance of
World Bank is under formulation. Last year, the Ministry of Health & Family Welfare
had set-up an Expert Committee headed by Sh. C.R. Vaidyanathan, former Health
Secretary, to streamline the purchase procedure and to strengthen the Medical Stores
Organisation and its various Depots. The Report submitted by the above committee is
under examination.

5.17. Drug De-addiction Programme

5.17.1. The role of the Ministry of Health & Family Welfare in the Area of Drug
addiction is the Demand Reduction by way of providng treatment services which also
includes preventive health and after care. To combat drug addiction problem the,
Ministry has taken the following steps:

5.17.2. The Drug De-addiction Programme has commenced in 1987-88 by establishing a

30-bedded Drug De-addiction Centre at A.I.I.M.S., New Delhi. Thereafter, four more
Centres were established in Central Institutes/Hospitals viz. PGI Chandigarh, JIPMER,
Pondicherry, Lady Hardinge Medical College & Hospital, New Delhi and Dr. R.M.L.
Hospital, New Delhi. 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, Calcutta. The above Centres, besides providing
treatment services, also provide training to Medical/Para-medical personnel, prepare
health education material and render community out-reach services.

5.17.3. In order to tackle the problem at the grassroot-level origin and in the most
vulnerable areas, it was decided in 1992-93 to provide assistance to State Governments to
develop basic infrastructure for establishment of De-addiction Centre at identified
Medical College-District level Hospitals. Upto 31.3.1998, in addition to the 5 Central
Institutions and 2 Regional Level Centres, 71 Centres would have been provided
assistance in various states. Out of these, 24 Centres are in North Eastern States (Assam-6
Manipur-7, Nagaland-6, Mizoram-3, Meghalaya-1 and Tripura-1). The assistance to these
states has been provided in the shape of construction grant, equipment, training of
Doctors/Para-medics, etc. The Centres in North-Eastern States are also being provided
recurring grant for medicines, liner, diet, etc.

5.17.4. During 1997-98, three Pilot Projects initiated in 1995-96 at Barabanki (UP),
Mandsaur (MP) and Churachandpur (Manipur) were further consolidated and are being
continued. These Pilot projects aim at providing comprehensive services with community
based approach involving NGOs, Panchayats/Zila Parishads, religious bodies and the
concerned Government sectors achieve in the area. Two Workshops, viz. One on Harm
Minimuzation at M.E.M. Hospital, Bombay and another on Alcohol Policy – Health
Perspective at AIIMS, New Delhi were organised by the Ministry. An International
Worshop on Relapse Prevention for SAARC countries was organised at AIIMS, New
Delhi. Proposed activities during the current year include conduct of Rapid Assessment
Survey in anther two districts, 1 each in North Eastern and Western/Central parts of the
country in addition to three Districts namely Siliguri (West Bengal), Kohima (Nagaland)
and Aizawl (Mizoram) where Rapid Assessment Survey has already started. Similar
surveys are already under way in Pilot Project areas sites at Barabanki, Mandsaur and
Churachandpur. Special attention is being given to North Easter States by further
strengthening the existing Centres/activites.

5.17.5. The B.E. allocation for 1997-98 is Rs. 4 crores of which Rs. 2.25 crore is for
Central Institutes and Rs. 1.75 crore for providing assistance to State Governments.