discussion on 'Drug regulatory Laws'

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Hello everyone for today I have chosen MTP and Pre-natalDiagnostics Techniques act for now:would bring up few others by evening.so tocontinue with-The Medical termination of Pregnancy (MTP)(Act 1971:Objective:To provide for the termination ofcertain pregnancies by registered medical practitioner (RMP){medicalpractitioner who possesse any recognized medical qualification as defined inclause [h] of section 2 of the Indian Medical Council Act,1956[102] whose nameis entered in the State Medical register and who has experience or training inGynaecology & obstetrics as may be prescribed by rules under this Act} andfor matters connected therewith or incidental thereto.Pre-requisites:a. length/period of pregnancy does not exceed 12 weeks if such ;medical practitioner is-.. ,orb. where the length of the pregnancyexceeds 12 weeks but does not exceed 20 weeks ,if not <than 2 RMP are of the opinion ,formed ingood faith, that (i) the continuance of the pregnancy wouldinvolve a risk to the life of the pregnant woman or of grave injury to herphysical or mental health.(ii) there is a substantial riskthat if the child were born , it would suffer from such physical / mentalabnormalities to be seriously handicapped.These provisions are not applicableor exception where in `term pregnancy' aRMP is of the opinion ,formed in good faith that the termination of thepregnancy is immediately necessary to save the life of the pregnant woman.OrIf the pregnancy has been caused byrape or has occurred as a result of failure of any device or method used by anymarried woman or her husband for the purpose of limiting the no. of children, theanguish caused by such pregnancy shall be presumed to constitute a grave injuryto the mental health of the pregnant woman.Here in all the conditions it ismandatory to obtain the consent of the pregnant woman however in the case ofminor(person who under the provision o the Indian Majority Act 1875{9}is deemednot to have attained majority)/mentally ill person(person in need of treatmentby reason of any mental disorder other than mental retardation)consent ofguardian(person in charge or taking care of a minor/mentally ill person) isrequired.Also:It is to be performed only at ahospital established/maintained by govt./place approved by govt. or a districtlevel committee constituted by the govt. with the Chief medical officer (CMO)or District health officer (DHO) as the chairperson of the committee.Offences and penalties:I . Fine extendable upto a thousandrupees.ii. punishment of 2 yearsimprisonment extendable upto 7 years to a person performing termination at aplace other than approved.iii. Rigorous imprisonment for aterm not<2 years or extendable upto 7 years of a person who performs MTP butis not RMP.iv. Imprisonment of 2 yearsextendable upto 7 years of a personowning the place unapproved by the above mentioned committee.The Pre-Natal diagnostic Techniques(Regulation andprevention of misuse)Act,1994:Objective:To provide for the regulation of theuse of pre-natal diagnostic technique for the purpose of detecting genetic ormetabolic disorders or chromosomal abnormalities or certain congenitalmalformations or sex linked disoreders and for the prevention of the misuse ofsuch techniques for the purpose of pre-natal sex determination leading tofemale foeticide.Provisions:A . To conduct /associate with orhelp in conducting activities relating to prenatal diagnostic techniques onlythose Genetic counseling Centre ,Genetic Laboratory or Genetic Clinic registered under this act areentitled.B . Any pre-natal diagnostictechnique to be performed/conducted only at a place registered under thisplace.C . The pre-natal diagnostictechnique shall be conducted only for the following purposes of detection of any of the followingabnormalities,namely:i-chromosomal abnormalitiesii.genetic metabolic diseasesiii.haemoglobinopathiesiv.sex-linked genetic diseasesv.congenital anomaliesvi.any other abnormality or diseaseas may be specified by the Central Supervisory Board.D . The act categorically prohibitsuse of pre-natal diagnostic techniques including ultrasonography for thepurpose of determining the sex of foetus.E . All therecords,charts,forms,reports, consent letters and all other documents requiredto be maintained under this Act and theRules shall be made available for inspection to the appropriate authority or toany other person authorized by the appropriate authority in its behalf and bepreserved for a period of 2 years or for such period as may be prescribed.However in case of any legal proceedings,such records are to be preserved tillthe final disposal of such proceedings.F .Any Genetic counselling centre,Genetic laboratory or Genetic clinic can be entered and searched. Records,register, document ,book, pamphlet ,advertisement or any other material orobject found therein can be examined and seized, if the appropriate authorityor officer, Empowered under this act ,has reason to believe that it may furnishevidence of the commission of an offence punishable under this act.Pre-requisites:Purposes mentioned in the Act:A . Age of the pregnant woman isabove 35 years.B .the pregnant woman has undergone 2 or more spontaneous abortions or foetal loss.C . the pregnant woman had beenexposed to potentially teratogenic agents such as drugs ,radiation, infectionor chemicals.D .The pregnant woman has a familyhistory of mental retardation or physical deformities such as spasticity or anyother genetic disease.E . Any other condition as may bespecified by the Central supervisory Board.Important to tell the pregnant womanthe after and side effects of such procedures andwritten consent to be obtainedin prescribed form or in the language she understands.Offences and Penalties:Offence of any type under this actis cognizable, non – bailable and non–compoundable .The offences are triable by aMetropolitan Magistrate or a judicial Magistrate of the 1st class.