Mother's Milk Subsitutes (Control of Sale and Distribution) Act, 2049 (1992) 1
Mother’s Milk Substitutes (Control of Sale and Distribution) Act, 2049 (1992)
Date of Authetication and Publication
2049.8.29 (14 Dec. 1992)
Act No. 39 of 2049 (1992)
An Act Made to Provide for the Control of Sale and Distribution of Mother’s Milk
Substitutes
Preamble: Whereas, it is expedient to provide for safe and adequate nutrition to the
infant by protecting and promoting the breastfeeding a d regulating the mother’s milk
substitutes as well as the sale and distribution of i fant foods;
Now, therefore, be it enacted by Parliament in the tw nty-first year of the reign of
His Majesty King Birendra Bir Bikram Shah Dev.
1. Short title, extent and commencement: (1) This Act may be called as the
"Mother’s Milk Substitutes (Control of Sale and Distr bution) Act, 2049 (1992)."
(2) This Act shall come into force on such date as Government of Nepal
may, by a notification in the Nepal Gazette, appoint.∇
2. Definitions: In this Act, Unless the subject or the context otherwise requires:
(a) "Mother’s milk substitute" means any food marketed or otherwise
distributed as a partial or total replacement for m ther's milk.
(b) "Container" means any kind of package in which any product is placed for
sale or distribution in a retail unit and this expression also includes a
wrapper.
(c) "Committee" means the Breastfeeding Protection and Promotion
Committee formed under section 4.
(d) "Product" means any of the following things:
(1) mother’s milk substitute,
(2) any kind of such milk marketed or otherwise distributed as is
∇ This Act came into force on 2051.11.15 (27 Feb.1995) by a notification published in the Nepal Gazette.
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suitable for feeding to the infant, with or without any conversion in
such milk,
(3) any other such food or beverage marketed or otherwise distributed as
is suitable for feeding to the infant,
(4) milk bottle and nipple.
(e) "Distributor" means a person involved in the sale and distribution of any
product by wholesale or retail and this expression also includes a person
involved in the process of public relation services or information related
with any process.
(f) "Health care system" means a governmental, non-governmental or private
institution or organization or person engaged directly or indirectly in health
care activities, and this expression also includes a nursery and other child
care institution.
(g) "Medical practitioner' means a doctor, registered nurse, nutrition expert or
such other person as may be specified by Government of Nepal on a
notification in the Nepal Gazette.
(h) "Health worker" means a person who is working in a health care system or
a trainee to work in that system and engaged in health care activities for
remuneration or otherwise.
(i) "infant" means a baby below the age of twelve months.
(j) "infant formula (balsutra)" means an mother’s milk substitute which is so
prepared in conformity with the prevailing Nepalese tandards which is
suitable to the physical structure of the infants from four to six months of
age and with a view to the fulfillment of the general nutritional requirement
of such infant.
(k) "Label" means a tag, symbol, picture or other dscriptive matter written,
printed, lithographed, marked, embossed, included or otherwise displayed
on a container containing a product.
(l) "Manufacturer" means a person who is directly or through an agent or an
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agreement or through a person controlled under an agreement involved in
the production or manufacturing business.
(m) "sale or distribution" means the marketing or selling of such product,
inclusive of any act related with the promotion, distribution,
advertisement, sample distribution, public relation and information
service of such product.
(n) "Sample" means one unit or small quantity of aproduct to be provided for
free of cost.
(o) "Complementary food" means such appropriate food substance as to be used as a
complementary substance in cases where the mother's milk or mother’s milk
substitute is inadequate to meet the nutritional requirement of the infant.
(p) "Ministry" means the Ministry of Health, the Government of the Nepal.
(q) "Prescribed" or "as prescribed" means prescribed or as prescribed in the
Rules framed under this Act.
3. Implementation and supervision: (1) The Ministry shall have the main
responsibility to enforce and implement this Act.
(2) The Ministry may, as per necessity, obtain assistance of other
Ministries in order to ensure the implementation of this Act.
(3) The functions and powers of the Ministry shall be as follows, for
purposes of the implementation of this Act:
(a) To issue Rules to implement this Act,
(b) To hold consultations with governmental and nongovernmental
bodies to ensure the implementation and full compliance of this Act
and the Rules issued under this Act,
(c) To enforce this Act,
(d) To perform similar other functions that are required to attain, or
incidental to the attainment of, the objectives of this Act.
4. Breastfeeding protection and promotion committee: (1) The Government
of Nepal shall form a Breastfeeding Protection and Promotion Committee to
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supervise whether this Act is being complied with, to protect and promote the
breastfeeding and to control the sale and distribution of the product.
(2) The committee shall consist of the following members:






















(3) The tenure of office of the nominated members shall be of two
years; and they may be re-nominated as determined by the committee.
(4) The committee may invite any native or foreign expert to attend its
meeting as an observer.
(a) Secretary, Ministry of Health Chairperson
(b) Representative (Gazetted first class), Ministry of
Industries Member
(c) Representative (Gazetted first class), Ministry of
Supplies Member
(d) Representative (Gazetted first class), Ministry of
Commerce Member
(e) Representative (Gazetted first class), Ministry of
Education and Culture Member
(f) Representative (Gazetted first class), Ministry of Labor
and Social welfare Member
(g) Representative, Nepal Pediatrician Association Member
(h) Representative, Nepal Chamber of Commerce and
Industries Member
(i) Two persons nominated by the committee from amongst
the renowned persons engaged in the maternal and child
health sector Member
(j) Renowned nutritional expert nominated by the
Government of Nepal Member
(k) One nominated by the Government of Nepal from
amongst the mothers having experiences related with the
child care and maintenance Member
(l) A person designated by the Government of Nepal Member secretary
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(5) Government of Nepal may, by a notification in the Nepal Gazette,
make alteration in the members of the committee.
5. Meeting of committee: (1) The member secretary shall, at the direction of
the chairperson, call a meeting of the committee.
(2) The presence of two-thirds members of the committee at the meeting
shall be deemed to constitute a quorum for the meeting.
(3) A majority opinion of the attending members on a matter presented
to the meeting of the committee shall be deemed as a decision of the committee.
(4) The member secretary shall authenticate the decision of the
committee.
(5) The other procedures on the meeting of the committee shall be as
determined by the committee on its own.
6. Functions, duties and powers of committee: The functions, duties and
powers of the committee shall be as follows, subject to the approved policies of
the Government of Nepal:
(a) To supervise, as prescribed, the compliance with th s Act,
(b) To make recommendation for making investigation and instituting a
case against the manufacturer, distributor or healt worker who
violates the provisions of this Act,
(c) To consider a request for the provision of any product as a grant, and
accept or reject such request, as prescribed,
(d) To consider a request made by the health workers to obtain
assistance from manufacturers or distributors for research works,
scholarships, participation in professional symposia or conferences
or for holding such symposia or conferences, and accept or reject
such request, as prescribed,
(e) To review the labels submitted by the manufacturers and distributors
and approve those labels which are in conformity with the provisions
of this Act,
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(f) To coordinate the activities related with the publicity of information
and educational materials on infant food,
(g) To formulate a national policy for the protection and promotion of
breastfeeding,
(h) To form sub-committees, as per necessity, for purposes of
implementation, supervision and control.
7. Information and education on infant food: (1) The Ministry may, on advice
of the committee, give approval to publicize any iformation and educational
materials related with the infant food.
(2) Every information and education material, in written or audio or
visual form, dealing with the infant food shall include clear information relating to
the following matters:
(a) The benefits and superiority of breastfeeding,
(b) The preparation for and the continuation of breastfeeding including
mother's nutrition,
(c) The harmful effects on breastfeeding due to the partial adoption of
bottle feeding or complementary food feeding,
(d) The difficulties in reverting to breastfeeding after a period of feeding
by mother’s milk substitute.
(3) The information and educational material containing the matters of
feeding a complementary food or mother’s milk substitute to the infants shall also
make the following matters clear, in addition to the matters as referred to in Sub-
section (2):
(a) proper use of mother’s milk substitutes,
(b) expenditures to be incurred in feeding mother’s milk substitutes in
comparison with the expenditures to be incurred in breastfeeding to
infants,
(c) the health hazards of improper use of mother’s milk substitutes,
improper food and feeding bottles,
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(d) methods of feeding infants with a cup or spoon,
(e) methods of preparing complementary food at home.
(4) The information and education material shall contain correct and
usual information only; and no picture or statement of a nature to discourage
breastfeeding or encourage bottle-feeding habit.
8. Health care system and health worker: (1)The chiefs of health care systems
and national and local health officials shall adopt proper measures to promote the
principles of this Act, protect and encourage breastf eding and give proper
information and advice to the health workers about their responsibilities.
Information as to all the matters contained in section 7 shall certainly be given to
the health workers.
(2) The health workers shall protect, promote and encourage
breastfeeding. They shall have knowledge of the provisions of this Act;
particularly the matters contained in section 7, and implement them to the extent
possible.
(3) The health workers shall not allow any act inhibiting the
commencement and expansion of breastfeeding, whether directly or indirectly.
(4) No health worker shall accept any financial or in-kind gift in any
manner for a manufacturer or distributor.
(5) No health worker shall give a sample of a product to any person.
(6) No health worker shall promote the product in any manner.
(7) If a health worker gets information that any manufacturer or
distributor intends to give any gift or other financial facility or that any person has
violated any other provision of this Act, the health worker shall give a report
thereof in writing to the chief of his/ her organization; and the chief shall also give
information thereof to the committee.


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9. Acts prohibited from being done by manufacturer and
distributor: (1) No manufacturer or distributor shall make an advertis ment in
the following manner: (a) promoting any product,
(b) giving an impression or creating a belief that the feeding of
mother’s milk substitutes is equivalent to, or better than, mother's
milk.
(2) For purposes of this section, "advertisement" includes any
advertisement made as follows:
(a) by any publication or television, radio, film, video or telephone,
(b) by a symbol, billboard, notice or exhibition f goods,
(c) by exhibition of pictures or miniatures,
(d) in any other manner.
(3) Notwithstanding anything contained in Sub-section (1), those
publications reaching the medical practitioners only may contain an advertisement of
a product.
Provided that, such advertisement shall be limited only to the factual and
scientific matters and shall not be of such a nature as to give an impression or create a
belief that the feeding of mother’s milk substitutes is equivalent to, or better
than, mother's milk. Such advertisement shall include the information as referred to in
Section 7.
(4) No manufacturer or distributor shall give or distribute samples of
product to any person.
(5) No manufacturer or distributor shall promote any product in the
health care system.
(6) For purposes of this section, "promotion" means to introduce a
product to any person or make any person acquainted with a product in any
manner including the following manner:
(a) by making advertisement,
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(b) by using a book, pamphlet or poster as well as printed material
containing the name or logo of the manufacturer or
distributor or the name, logo, graphic or other miniature of a
proprietary product,
(c) by giving or distributing, free of cost or at nominal price, any matter
containing the name or logo of the manufacturer or distributor or the
name, logo, graphic or other miniature of a proprieta y product,
(d) by demonstrating products, or
(e) in any other manner.
(7) Except in cases where a health care system or an ther institution or
organization makes a request for a grant or contribution from a manufacturer or
distributor in the prescribed format and the committee approves the request as
prescribed, no product shall be provided or donated to the health care system or
institution or organization.
(8) No manufacturer or distributor shall make contact with the general
public in the health care system to increase own business or for such purpose.
(9) No manufacturer or distributor shall donate any equipment or goods to
the health care system without obtaining the approval f the committee.
(10) No manufacturer or distributor shall present ay gift or cause any
financial or other benefits to a health worker.
(11) Except in cases where a manufacturer or distibutor or health worker
makes a request in the prescribed format andthe committee approves such
request as prescribed, no scholarship or research grant shall be given to the health
worker nor shall such amount as required to organize a professional
symposium or conference or as required for the health worker to participate in the
symposium or conference be provided to the health worker.
10. Certification of product : (1) Prior to the marketing of any product other than
a feeding bottle and nipple in Nepal, its manufacturer or distributor shall get the
product tested by the Central Food Laboratory and obtain certification.
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(2) In the case of a product already marketed in Nepal, its manufacturer
or distributor shall obtain certification from the Central Food Laboratory no later
than ninety days after the date of commencement of this Act.
(3) The manufacturer or distributor shall, for puoses of Sub-sections
(1) and (2), make an application, accompanied by a sample of product and the
required fee, to the Central Food Laboratory, in the prescribed format.
11. Labeling: (1) Prior to the marketing of any product in Nepal, its manufacturer or
distributor shall submit a label of such product, along with the application, as
prescribed, to the committee for its approval.
(2) In the case of a product already marketed in Nepal, its manufacturer
or distributor shall obtain approval of the committee for the label of such product
no later than ninety days after the date of commencement of this Act.
(3) The label of a product shall be prepared in such a manner as to give
necessary information about the proper uses of the product and not to discourage
breastfeeding.
(4) No label or container of a product shall have ny picture, drawing or
other miniature other than a graphic describing the manufacturing process.
(5) The label of product shall contain the name and ddress of its
manufacturer and of its distributor, wherever possible.
(6) Every container of an mother’s milk substitute or any other milk
substance falling within the purview of this Act or label affixed thereto shall
indicate, in a clear, conspicuous and in an easily understandable manner, a
statement containing all the following particulars in the Nepalese language:
(a) the words "important notice" or similar other matters,
(b) a statement that mother's milk is best for infants,
(c) a statement that a product should be used only on the advice of a
health worker as to the need for its use and the method of its use,
(d) the instructions for its appropriate preparation in easily
understandable graphs or words, and
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(e) the quantity of a mother’s milk substitute or other milk substance
required to properly feed an infant each month.
(7) The word "humanized" or "materialized" or any other similar word
shall not be used.
(8) The label of, or any thing affixed to the outer part of a container of, a such
milk that does not meet all nutritional requirements of an infant formula but can be
converted for that purpose shall contain a warning that the product is not the sole source
of nourishment of an infant and that the product should not be used or fed to infants
without on the advice of a health worker.
(9) The label of a sweetened condensed milk shall contain a clear and
conspicuous warning that it should not be used for infant feeding.
(10) The label of a product other than a milk bottle or nipple shall also
contain the following matters:
(a) the ingredients used,
(b) the composition or analysis of product,
(c) the storage conditions required,
(d) the batch number, storage condition, date of its manufacture and the
date before which it is to be consumed, taking in account the
climatic conditions.
(11) The label of a feeding bottle or nipple shall also contain the name
and address of the manufacturer and distributor as well as the statements that
mother's milk is the best milk for infants and that it is safer to feed with a pot or
spoon than with a bottle.
12. Standard: (1) A product shall conform to the standards specifi d or
recommended by the Nepal Bureau of Standards when it is manufactured, sold or
otherwise distributed.
(2) The central food laboratory shall have the powers to test whether a
product marketed in Nepal is fit for consumption by a human being.
(3) No product which does not conform to the standards in the country
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of its manufacture shall be sold in Nepal.
(4) No product of which expiry date has expired shall be marketed, sold
or distributed.
(5) Any product, other than a feeding bottle and nipple, shall be sold
only in its original container in order to prevent quality deterioration, adulteration
and contamination.
13. Inspection: (1) The Ministry may, on recommendation of the committee, appoint
the inspectors in the required number in order to inspect and inquire into whether
the manufacturer, distributor, health care system and health worker have observed
this Act or the Rules framed under this Act and take necessary action or may, with
the approval of the concerned body of Government of Nepal, designate any
employees to act as inspector.
(2) The inspector appointed or designated under Sub-section (10) shall
inspect and inquire into, as prescribed, whether t manufacturer, distributor,
health care system and health worker have observed this Act or the Rules framed
under this Act and submit a report thereof to the committee.
14. Powers to suspend or cancel license, permit or authorization: If, based on
the report submitted by the inspector under Sub-section (2) of Section 13, it
appears that any manufacturer, distributor, health care system or health worker
have not observed this Act or the Rules framed under this Act, the Ministry may,
on recommendation of the committee, write to the concerned body to suspend or
cancel the license, permit or authorization which they have obtained from the
Government of Nepal or any other body.
15. Functions and powers of inspector: The functions and powers of the
inspector, other than those mentioned in this Act, shall be as prescribed.
16. Penalties: (1) A health worker who violates Sub-sections (4), (5) or (6) of
Section 8 shall be punished with a fine not exceeding One Thousand Rupees or
with imprisonment for a term not exceeding one month or with both.
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(2) A manufacturer or distributor who violates Sub-sections (1), (4), (5),
(7), (8), (9), (10) or (11) of Section 9 shall be punished with a fine not exceeding
Ten Thousand Rupees or with imprisonment for a term not exceeding three
months or with both.
(3) A manufacturer or distributor who violates Section 10 or 11 shall be
punished with a fine not exceeding Fifteen Thousand Rupees or with
imprisonment for a term not exceeding four months or with both.
(4) A person who violates the provisions of this Act, other than those
contained in Sub-sections (1), (2) or (3), or the Rules framed under this Act shall
be punished with a fine not exceeding Two Thousand Rupees or with
imprisonment for a term not exceeding one month or with both, according to the
gravity of the offense.
(5) The court may, while awarding punishment to any person for the
commission of any offense under this Section, also order that offender to pay
compensation in a sum from Twenty Five Thousand to One Hundred Thousand
Rupees to the person aggrieved from such offense or to his/her successor.
17. Liability of firm or body corporate : If any firm or body corporate violates
this Act or the Rules framed under this Act, in thecase of a firm, its owner or
partner, and in the case of a body corporate, the chi f administrative officer
carrying out the functions of that body, shall be liable to the punishment as
referred to in section 16.
18. Government to be the plaintiff : Government of Nepal shall be plaintiff in the
cases of under this Act.
19. Investigation and filing of case: (1) The inspector shall investigate a case
related with an offense punishable under this Act and, after completion of such
investigation, file a case in the District Court.
(2) In investigating and filing the case pursuant to sub-section (1), the
inspector may seek advice of the government attorney. After the filing of the case,
the government attorney shall plead the case.
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20. Powers to frame Rules: Government of Nepal may frame necessary Rules in order
to implement the objectives of this Act.