PROTECTION OF BREAST-FEEDING RULES, 2009

PROTECTION OF BREAST-FEEDING RULES, 2009

[Gazette of Pakistan, Extraordinary, Part II,

2nd November, 2009]

S.R.O.945(I)/2009., dated 9-10-2009.---In exercise of the powers conferred by subsection (1) of section 19 of the Protection of Breast-Feeding and Child Nutrition Ordinance, 2002 (XCIII of 2002) the Federal Government is pleased to make the following Rules, namely:-

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1. Short title and commencement.----(1)These Rules may be called the Protection of Breast-Feeding Rules, 2009.

(2) They extend to the whole of Pakistan.

(3) They shall come into force at once.

2. Definitions.----In these Rules, unless there is anything repugnant in the subject or context,----

(a) "Ordinance^" means the Protection of Breast-feeding and Child Nutrition Ordinance,2002 (XCIII of 2002);

(b) "member^" means a member of the Board; and

(c) ^"Secretary" means the Secretary of the National Infant Feeding Board appointed under subsection (2) of section 3 of the Ordinance.

(2) The words used but not defined herein shall have the same meaning as are assigned to them in the Ordinance.

National infant feeding board

3. Constitution of the Board.----(1)The Minister of Health shall be the Chairperson and the Deputy Director General Health (Nutrition)shall be the Secretary of the Board.

(2) The Board shall consist of those members notified in the official Gazette by the Federal Government, in accordance with the provisions of subsection (1) of section 3.

(3) The Board shall be located for administrative purposes within the Nutrition Wing of the Health Division of the Government of Pakistan in Islamabad.

(4) The Federal Government may provide such secretariat support to the Board as it may deem fit.

4. Tenure and qualification of the members.---(l) The members shall hold office for a term of two calendar years starting from the 1st of January following the date of their nomination or until their respective successor is nominated whichever is longer. The members may be re-appointed by the Federal Government.

(2) No person shall be appointed as member who has any direct or indirect financial interest in any designated product, except for the sole representative nominated by the Baby Foods Manufacturers and Marketers Association Pakistan. All members in this regard, before their appointment on the Board, shall furnish to the Secretary an undertaking that they do not, and shall not have in the future, any financial or other interest associated with the designated product industry, except for the member representing the aforesaid Association.

(3) Except for the member representing the designated product industry, no member shall be legally permitted to hold any appointment, or be connected in any manner with the management or administration of a designated product industry for a period of two years after the said member has ceased to be a member of the Board.

(4) Any member other than the ex officio member may, at any time, resign his office by writing to the Chairperson. An ex officio member shall vacate his office if the Federal Government so directs. A vacancy shall be filled in the same manner as the original appointment for the balance of the unexpired term.

(5) A member shall cease to be a member if he absents himself from three consecutive meetings of the Board without leave of absence from the Chairperson or in the absence of the Chairperson, or the Secretary.

5. Powers and functions of the Board.---The Board shall have the same powers as provided for in section 4 and explained hereunder,--

(a) receive reports of violations of provisions of the Ordinance or these Rules and to recommend investigation of cases against manufacturers, distributors or health workers found to be violating these provisions;

(b) advise the Federal Government on designing a national strategy for developing communication and public education programs for the promotion of breast-feeding; informational and educational materials on the topic of infant and young child' feeding; continuing education for health workers on lactation management and the requirements of the Ordinance; curricula for health workers that include lactation management and to ensure widespread distribution of and publicity concerning the Ordinance; make recommendations to the Federal and Provincial Governments in respect of laws, rules or regulations affecting in any manner the field of breast-feeding and nutrition for infants and young children;

(d) encourage through extensive public awareness programs and otherwise promotion, support and protection of breast-feeding;

(e) consider requests for donations to health care facilities of designated products and recommend to the Federal Government the acceptance or denial of such requests according to guidelines as may be specified from time to time, by the Board in the context of the Infant and Young Child Feeding in Emergencies Guidelines;

(f) for the purpose of implementation of these Rules, the Federal Government may call for consultation with Provincial Governments, and other stake holders or persons to ensure implementation and strict compliance with the provisions of the Ordinance and Rules;

(g) call for consultations with the Provincial Governments, and amongst various ministries of the Government and other governmental agencies and stake holders, in order to ensure implementation and strict compliance with the provisions of the Ordinance and these Rules; and

(h) call for any information and recommend any research to be made for the furtherance of the objects of the Ordinance.

6. Meetings of the Board.---(1) The Board shall meet at least once in every four months.

(2) The meetings of the Board shall normally be held in Islamabad, unless the Chairperson decides to hold it anywhere else.

(3) The Secretary shall call meetings at the direction of the Chairperson. Notice of not less than ten days shall be given to every member present in Pakistan of the time and place fixed for each ordinary meeting of the Board, and each member shall be furnished with the agenda of the meeting. This notice requirement, however, can be waived for convening an urgent meeting by the Chairperson.

(4) The Secretary shall take minutes of the meetings, certify decisions of the Board and perform such other duties as directed by the Board. The minutes of each meeting shall be signed by the Chairperson and the Secretary, and circulated to all members present in Pakistan and shall also be kept with the Secretary for permanent record in a minutes file.

(5) The Chairperson shall chair every meeting at which he is present. If hp is absent, then the member nominated by him for the purpose shall preside at the meeting and the member so nominated shall at that meeting exercise all the powers of the Chairperson.

(6) Majority of the members of the Board shall constitute a quorum for a meeting. If a quorum is not present at any meeting, the Chairperson may, adjourn the meeting to a date not later than ten days informing the members who are present, and later notifying the absent members, that the business of the adjourned meeting shall be disposed of, irrespective of there being a quorum. Thereupon, the agenda shall be disposed of at such adjourned meeting, irrespective of the number of members present at the meeting.

(7) The decision of the Board shall be expressed in terms of the opinion of the majority of the members present and voting at a meeting; in the event of equality of votes, the Chairperson or other person 'presiding shall have a casting vote.

(8) No act done by the Board shall be invalid on the ground merely of the existence of any vacancy in or any defect in the constitution of the Board or the Provincial Committee, as the case may be.

7. Disposal of business.---(1) Every question which the Board is required to take into consideration shall be considered either at its meeting or, if the Chairperson so directs, by sending by necessary papers to all members for their opinion.

(2) he Chairperson shall place before the Board any matter if a request to that effect is made by not less than five members.

(3) The Chairperson may refer any matter within the competence of the Board, either before or after it has been considered by the Board, to the Federal Government for directions and the directions of the Federal Government in that behalf shall be binding on the Board.

(4) A resolution-in-writing signed by at least the majority of the total members of the Board, including the Chairperson, shall be as valid and effective as if it had been passed at a meeting of the Board duly called and constituted. All such resolutions, however, must be placed before the Board for confirmation at its next meeting.

8. Disqualifications.---A person shall not be qualified to be appointed, elected or to remain a member of the Board if he is,---

(a) found to have acquired such financial or other interest which is likely to affect prejudicially his functions as a member of the Board.

(b) a minor;

(c) found to be of unsound mind;

(d) adjudicated insolvent; or

(e) at any time has been convicted to an offence which in the opinion of the Federal Government is an offence involving moral turpitude.

Labeling

9. Prohibition and guidance.---(1) No designated produced shall be marked or sold in Pakistan unless its label is in accordance with the provisions of the Ordinance and the rules.

(2) Label of a designated product shall be designed to encourage breast-feeding and not to discourage it.

(3) Every container shall have a clear and easily understood message printed on it or on a label that cannot be separated from it, which shall be written in Urdu and if so desired, by the manufactures, in English as well; and which shall,

(a) not contain anything that may discourage breast-feeding;

(b) contain a conspicuous notice in bold character in the height specified the Board stating the following, namely:

"MOTHER'S MILK IS BEST FOOD FOR YOUR

BABY AND HELPS IN PREVENTING DIARRHOEA

AND OTHER ILLNESSESS^";

(c) instead of or in addition to the notice specified in clause, (b), contain any other message as may be specified by the Board with respect to any designated product;

(d) neither uses expression such as^"materialized" or humanized" or equivalent nor contains any comparison with mother's milk;

(e)not show photographs, drawings or graphics except that graphics may be used to illustrate the correct method of preparation, provided that bottle shall not be shown in any such drawing;

(f) contain the name and address of manufacturer and of wholesale distributor if a designated product is an imported item; and

(g) except for bottles, teats, pacifiers and nipple shields, contain appropriate instructions in Urdu for the correct preparation in words and easily understood graphics and indicate the ingredients, composition and analysis of a designated product, required storage conditions, batch number and expiry date and contain any warning as may be stipulated by the Board for the implementation of the Ordinance in characters of the height stipulated by the Board in Urdu or any regional language or both.

10. Label of infant formulas and bottle feeding complementary food.---(l) In addition to the requirements mentioned in rule 9 above, every container of infant formula complementary food or other designated product marketed to be fed by feeding bottle shall include all of the following information, namely:

(a) the words ^"Important Notice" or equivalent;

(b) a statement that the designated product must be used only on the advice of a health worker as to the need for its use and the proper method of use;

(c) a warning about the health hazards of inappropriate preparation, including the potential hazards associated, with using a feeding bottle, particularly when it is improperly sterilized;

(d) a statement that feeding with a cup and spoon is safer than bottle-feeding;

(e) the quantity of the products that will be required to properly feed the infant in proportion to his weight; and

(f) the age in months, which except for infant formulas shall in no case be less than six months, after which the designated product may be used.

11. Label of milk products.---(1) Any type of milk that does not meet all the nutritional requirements of an infant formula, but can be modified to do so, must contain on its label a warning that the product alone must not be the sole source of the infant's nourishment and that it must not be used to feed infants, except under the guidance of a health worker.

(2) Labels of sweetened condensed milk shall contain a warning that it shall not be used for infant feeding.

HEALTH WORKERS AND HEALTH CASE FACILITIES

12. Measures to guarantee safe and adequate nutrition.---The Federal and Provincial Government, health authorities, the Board and officials of the health care facilities shall take appropriate measures to guarantee safe^' and adequate nutrition for infants through the promotion and protection of breast-feeding, through the regulation of the marketing of designated products and by adhering to the principles of the Ordinance and these Rules.

13. Health workers to promote breast-feeding.---(l) The health workers shall be expected to endeavor their best to implement the provisions of the Ordinance and these rules, whenever possible.

(2) The health workers shall work to eliminate practices that directly or indirectly retard the initiation and continuation of breast-feeding.

14. No gift---(1) The health workers or members of their families, shall not accept any gift, contribution or benefit, financial or otherwise, of whatever value from a manufacturer or distributor or any person on its behalf.

(2) The health workers engaged in maternal and child health shall neither accept from nor give samples of designated products to any person; or demonstrate the use of infant formula, except to individual mothers or members of their families in special cases of need and in such cases, shall• give a clear explanation of the hazards of the use of infant formula.

15. Information and educational materials.---(l) The manufacturers and distributors may, subject to the provisions of sections 9 and 10 of the Ordinance, provide information about designated products to health professional if such information is restricted to scientific and factual matters regarding the technical aspects and methods of use of designated products and is otherwise in accordance with the provisions of the Ordinance and these Rules. Such information must not imply or create the belief that bottle-feeding is equivalent to or superior to breast-feeding.

(2) All such information and educational materials, whether written, audio or visual including but not limited to the material mentioned in sub-rule (1) above, must contain the following, namely:

(a) the benefits and superiority of breast-feeding;

(b) the preparation for and maintenance of breast-feeding including maternal nutrition;

(c) the negative effect on breast-feeding of introducing partial bottle-feeding; and

(d) the difficulty of reversing the decision not to breast-feed, even if bottle-feed is limited to a few bottles.

(3) Information and educational materials that include the topic of feeding infants with infant formula, follow-up formula or any order food or drink by bottle must explain, in addition to the information specified in sub-rule (2) of rule 15 the following points in respect of the products mentioned in this sub-rule, namely:---

(a) the proper preparation and use of the products and the health hazards associated with the use of a bottle particularly when it is improperly sterilized;

(b) the social and financial implications of feeding an infant with the product;

(c) the health hazards of inappropriate feeding methods and of unnecessary or improper use of the products; and

(d) how to feed infants with a cup and spoon.

(4) Information and educational materials that include the topic of feeding infants with complementary foods must explain, in addition to the information specified in sub-rules (2) and (3) above, the following points, namely:--

(a) the health hazards of introducing complementary foods at an early stage;

(b) that complementary foods can easily be prepared at home; and

(c) that it must be given to infants above the age of six months with cup and spoon not in a feeding bottle.

(5) Information and educational material shall contain only correct and current information and shall not use any pictures, graphics or text that encourage bottle-feeding or discourage breast-feeding.

(6) Information and educational materials shall be written in Urdu and in such other languages as may be deemed necessary by the Board.

(7) Except for purposes of copyright, informational and educational materials shall not make reference to any designated product not contain the name or logo of any manufacturer or distributor of a designated product.

INSPECTION

16. Complaint procedure.---(1) Under section 15 of the Ordinance, any person may make an application in writing to the Board or a Provincial Committee concerning contravention of any of the provisions of the Ordinance or the rules. The application, amongst others, may comply with the following, namely:--

(a) it shall be in writing and may be addressed to the Chairperson or Secretary;

(b) it shall mention the name and address of both the alleged violator and of the applicant;

(c) it may mention in numbered paragraphs a description of the alleged contravention of the provisions of the Ordinance or the rules, including where applicable, the date and the venue of the breach, and the relief claimed by the applicant;

(d) copies of the documents in support of the allegations contained in the application can be attached; and

(e) the application can be sent by mail, email, courier or any other means of communication.

(2) In the event the investigation reveals an offence, the Board or a Provincial Committee, as the case may be, shall follow the procedure specified in section 13 for recommending prosecution.

17. Confiscation of designated_, products.---When any person has been convicted under the Ordinance, then the stock of the designated product in respect of which the contravention has been made may be confiscated if the Court so directs. The Court may after trial punish the accused under section 17 of the Ordinance.

18. Duties of Federal Inspector.---(1) The Federal Government may, by notification in the official Gazette, delegate its authority to designate Inspectors to the concerned Provincial Government.

(2) While designating the Inspectors, the Federal Government, shall specify the area in which the Inspector shall have jurisdiction.

(3) It shall be the duty of an Inspector, within the local limits for which he is designated:--

(a) To inspect premises to satisfy himself that the conditions of the license and the provisions of the Ordinance and the rules are being observed;

(b) To inspect from time to time establishments licensed for the import, export or sale of designated products and to satisfy him that the conditions of the licence are being observed;

(c) To send forthwith to the Secretary after each inspection a detailed-report indicating the provisions of the Ordinance and the Rules which are not being observed?

(d) To take samples of any designated product which he has reason to suspect that it is being manufactured, stocked, sold, labeled or exhibited for sale in contravention of the provisions of the Ordinance or the Rules and send them for test or analysis to the Board;

(e) To send any complaint that he receives from anybody to the Secretary;

(f) To recommend the initiation of prosecution in respect of breaches of the Ordinance and the Rules upon instructions and directions received from the Board;

(g) to give advice to the designated product industry on matters pertaining to the provisions of the Ordinance and the rules regarding baby friendly practices with a view to improve the standard of industry and in order improve the quality of infant's health; and

(h) To conduct surveillance of the marketed designated products for ensuring quality control and compliance of the various provisions of the Ordinance and these rules.

19. Procedure for dispatch of sample.---The portion of sample, packet or the container sent by an Inspect to the Secretary for analysis shall be sent by courier or by hand is a sealed packet enclosed together with a memorandum in Form I in an outer cover addressed to the Secretary.

20. Prohibition of disclosure of information.---Except for the purpose of official business or when required by a Court of law, an Inspector shall not, without the sanction in writing of his official superior, disclose to any person any information acquired by him in the course of his official duties.

21. Repeal.---The National Infant Feeding Board Rules, 2004 are hereby repealed.