 bill no 83 of  2018 the thalassemia prevention bill, 2018 bydr dharamvira gandhi, mp a billto promote awareness and prevent the incidence of thalassemia in newborn childrenwith a view to avoid lifelong suffering and hardship and for matters connectedtherewith or incidental theretobe  it enacted by parliament in the sixty-ninth year of the republic of india as follows:—1 (1) this act may be called the thalassemia prevention act,  2018(2) it extends to the whole of indiashort title, extent, and commencementdefinitions2 in this act, unless the context otherwise requires,—(a) "appropriate government" means,—541 of 2006(i) in relation to the central government or any establishment wholly or substantially financed by that government or a cantonment board constituted under the cantonments act, 2006, the central government;(ii) in relation to a state government or any establishment, wholly or substantially financed by that government or any local authority other than a cantonment board, the state government; and10(iii) in relation to a union territory with legislature, means the administrator of the union territory appointed by the president under article 239 of the constitution; (b) "couple" means the legally married indian man and woman including marriages solemnized under all personal laws;(c) "establishment" includes a government establishment and private establishment;15(d) "foetus" means a human organism during the period of its development, beginning on the fifty-seventh day following fertilisation or creation (excluding any time during which its development has been suspended) and ending at birth;2018 of 2013(e) "government establishment" means a corporation established by or under a central act or state act or an authority or a body owned or controlled or aided by the government or a local authority or a government company as defined in section 2 of the companies act, 2013 and includes a department of the government;2557 of 1994(f) "gynaecologist" shall have the same meaning as assigned to it in the preconception and pre-natal diagnostic techniques (prohibition of sex selection) act, 1994;(g) "medical institution" means any maternity nursing home or hospital offering maternity treatment and care;(h) "prescribed" means prescribed by rules made under this act; and (i) "thalassemia" means a disease in which a child or an adult becomes anaemic because of genetic defect of haemoglobin303 it shall be the responsibility  of the appropriate government to ensure implementation of the provisions of this actappropriate government to implement the provisions of this act 4 the central government shall, by notification in the official gazette, formulate a national policy for the prevention of thalassemia in the countryformulation of a national policy for prevention of thalassemia355 the gynaecologist or the head of the medical institution, who is consulted or approached by a pregnant woman for maternity treatment and care shall be responsible for prevention of birth of a child afflicted with thalassemia majorresponsibility of the gynaecologist or head of the medical institution for prevention of birth of child affected with thalassemia6 the gynaecologist or the head of the medical institution who is consulted or approached by a pregnant woman for maternity treatment and care, shall ensure that—accountability of medical institutions and gynaecologist(a) every woman who becomes pregnant for the first time shall, as soon as herpregnancy is confirmed, be tested for thalassemia carrier or trait;5(b) where the pregnant woman is tested positive for thalassemia carrier ortrait, her husband be advised to undergo a similar test, as soon as may be;10(c) where the husband is tested positive for thalassemia carrier or trait, thecouple stands a risk of carrying a thalassemia major foetus be counselled about thalassemia major and its lifelong implications for the unborn child and be referred to a genetics specialist for a further gene mapping study called family gene study (fgs), as part of the pre-natal diagnosis;34 of 1971(d) wherein the foetus is found to be afflicted with thalassemia major in the pre-nataldiagnosis,  the option of medical termination of pregnancy, according to the provisions of medical termination of pregnancy act, 1971 shall be offered to the pregnant woman15issuance of ante-natal health cards7  (1) the appropriate government shall ensure that the gynaecologist or the head of the medical institution issue to each individual in the couple, an ante-natal health card wherein the thalassemia carrier or trait information, along with cautionary notes for guidance in the case of future pregnancies  are clearly stated20(2) in addition to the issuing of ante-natal health card under sub-section (1), the gynaecologist or the head of the medical institution shall ensure that where the pregnant woman has already undergone a test for thalassemia carrier or trait during her earlier pregnancy and her husband has also been tested positive for thalassemia carrier or trait, the couple shall be counselled about the risk involved in the foetus likely to be thalassemia major whether the couple have an ante-natal health card or not:25provided that in case when no information is available about the couple's carrier or traitstatus, they shall be subjected to the procedure described under section 6 (as in the case of a first pregnancy)308 the appropriate government shall initiate, design and set up a strong and effectivesystem for genetic counselling and diagnostic centres across the country and shall take measures to educate the public, especially women, about thalassemia major and itsimplications for the life of the newborn, in order to facilitate informed making and to encourage thalassemia carrier or trait test at the first pregnancyappropriate government to set up genetic counselling and diagnostic centres for thalassemia359 the appropriate government shall be responsible for making available the requisitepathological facilities in all medical institutions to carry out thalassemia carrier or trait test, family gene studies, pre-natal diagnosis and medical termination of pregnancy where sufficient evidence is provided to the effect that the foetus is afflicted with thalassemia majorappropriate government to make available requisite pathological facilities4010 the central government shall, after due appropriation made by the parliament bylaw on this subject, provide adequate funds to such state governments which offers to implement similar schemes in their respective statescentral government to provide fundsoffences and penalties11 (1) whoever contravenes any of the provisions of this act or any rules madethereunder, for which no penalty has been elsewhere provided in this act, shall be punishable with imprisonment for a term which may extend upto three years or with fine which may extend upto ten thousand rupees or with both(2) an offence punishable under this act shall be bailable45(3) where a gynaecologist or the head of the medical institution contravenes any ofthe provisions of this act or rules made thereunder, he shall be punishable with imprisonmentfor a term which may extend upto three years or with fine which may extend upto fifty thousand rupees or with both5(4) in case it is established that a child afflicted with thalassemia major is born as aresult of contravention of provisions of this act or rules made thereunder, the court trying the offence may award a compensatory payment which may extend upto twenty lakh rupees in favour of the mother of that child to assist in the lifelong treatment of that child, including a bone marrow transplantation to be made by the person convicted of having contravened the provisions of this act or rules made thereunder, or by the appropriate government as may be decided and awarded by the court10offences by companies12 where any offence punishable under this act or rules made thereunder have beencommitted by a company, every person who, at the time the offence was committed was in charge of and was responsible to the company for the conduct of the business of the company, as well as the company, shall be deemed guilty of the offence and shall be liable to be prosecuted against and punished accordingly15cognizance of offences13 (1) no court shall take cognizance of an offence under this act except on acomplaint made by —(a) the appropriate government concerned or any officer authorised on thismatter by the appropriate government(b) a person who is directly or indirectly affected by the offence20explanation—for the purpose of this clause "person" includes a socialorganisation (2) no court other than that of a metropolitan magistrate or a judicial magistrate ofthe first class shall try any offence punishable under this act25(3) when a complaint has been made under clause (b) of sub-section (1) of section 14, the court may, on demand by such person, direct the appropriate government to make available copies of relevant records in its possession to such personmiscellaneous14 (1) the gynaecologist or the medical institution who is consulted or approachedby a pregnant woman under this act shall maintain all records, charts, forms, reports, consent letters and all other documents required to be maintained under this act30(2) every record maintained under sub-section (1) shall be preserved for a period offive years or for such period in such manner as may be prescribed(3) every record maintained under sub-section (1) shall, at all reasonable times, bemade available to the appropriate government or to any other person authorised by the appropriate government in this behalf in such manner as may be prescribed35protection of action taken in good faith15 no suit, prosecution or other legal proceeding shall lie against the central or stategovernment or any other officer authorised by the central or state government for anything which is in good faith, done or intended to be done in pursuance of the provisions of this actpower to remove difficulties4016 (1) in such a case where any difficulty arises in giving effect to the provisions ofthis act, the central government may by order published in the official gazette, make such provisions not inconsistent with the provisions of the act, as appear to it to be necessary or expedient for removing the difficultyprovided that no order shall be made under this section after expiry of a period of three years from the date of commencement of this act45(2) every order made under this section shall be laid, as soon as may be after it is made, before each house of parliament and be ratifiedpower to make rules17 (1)the central government may, by notification in the official gazette, make rules for carrying out the purposes of this act510(2) every rule made under this section shall be laid as soon as may be after it is made, before each house of parliament while it is in session for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both houses agree in making any modifications in the rule or both the houses agree that the rules should not be made, the rules shall thereafter have effect only in such modified form or be of no effect as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under the rule(3) in particular and without prejudice to the generality of the foregoing power, such rules may provide for:15(a) the manner in which the gynaecologist or head of the medical institutionshall keep records of the screening test and other procedures required under the provisions of section 8;(b) the form in which consent of the pregnant woman has to be obtained undersection 8;20(c) the facilities to be provided, equipments and other standards to be maintainedby the central and state governments for facilitating screening, family gene study, pre-natal diagnosis and medical termination of pregnancy;(d) the form in which ante-natal health card showing the thalassemia carrier ortrait status of the women is to be issued under section 7; and(e) any other matters that may be required to be prescribed statement of objects and reasonsthalassemia is one of the commonest inherited genetic disorders in our country one in every six hundred and twenty-five pregnancies ends in the birth of a thalassemia major child it is a cruel disease and the children afflicted by it have to undergo painful blood tests and blood transfusions every two or three weeks for the rest of their lives, starting six months of age the parents of these children also suffer psychological trauma from watching their child undergo repeated needle insertions furthermore, the disease entails a grave financial implication for the parents, as blood transfusion, filters and other devices, iron chelation medicines, etc which are needed, are very expensivethalassemia is a disorder of the haemoglobin molecule beta thalassemia (the commonest of the haemoglobin disorders that are seen in our country) is caused by a mutation in the haemoglobin gene of the parents in our country, four per cent of the population carries this mutation and such individuals are called thalassemia trait or carriers or thalassemia minors they are asymptomatic and lead normal lives it is not possible to identify who is a carrier without a blood testwhen two individuals who are both asymptomatic carriers marry and have a pregnancy there is a twenty-five per cent chance that the foetus inherits the mutated thalassemia gene from both the parents and thus develops thalassemia major soon after birth the foetus could however inherit one or both normal genes from the parents and be a carrier or absolutely normal the chance of this is seventy-five per centsince four per cent of the general population are thalassemia carriers, one in every twenty-five per cent individuals could be a carrier in some communities like sindhis, punjabis, gujaratis, marwaris, etc the incidence is even higher consanguineous marriages within their own communities add to the risk it is reported that about ten to twelve thousand children with thalassemia major, are born in our country every yearthalassemia major is preventable and medical science has the answers, but ignorance and social taboos have come in the way of effectively preventing the birth of such children therefore, there is a need to bring in statutory regulations to put in place an effective prevention programhence this billnew delhi;dharam vira gandhinovember  30, 2017 financial memorandumclause 4 of the bill provides for formulation of a national policy for prevention of thalassemia clause 6 provides for accountability of gynaecologist or the head of the medical institution for testing thalassemia carrier or trait to a pregnant woman clause 7 provides for issuance of ante-natal health cards containing information regarding thalassemia carrier or trait to a pregnant woman or the couple clause 8 provides for setting up of genetic counselling and diagnostic centres for thalassemia by the appropriate government clause 9 provides for making available requisite pathological facilities in all medical institutions to carry out thalassemia carrier or trait test by the appropriate government clause 10 provides that the central government shall provide adequate funds for state government for implementing similar schemes in their respective states clause 14 provides for maintenance of all records, charts, forms, reports, consent letters and all other documents of a pregnant woman by the gynaecologist or the medical institution the bill, therefore, if enacted will involve expenditure from the consolidated fund of india it is estimated that a sum of rupees fifty crore  would be involved as recurring expenditure per annuma non-recurring expenditure of about rupees  ten crore is also likely to be involved memorandum regarding delegated legislationclause 17 of the bill empowers the central government to make rules for carrying out the provisions of the bill as the rules will relate to matters of detail only, the delegation of legislative power is of a normal character———— a billto promote awareness and to prevent the incidence of thalassemia in newborn children, with a view to avoid lifelong suffering and hardship, and  matters connected or incidental thereto————mgipmrnd—3653ls(s3)—07032018