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CHAPTER 1 LAW AND MEDICINE Right to health under the Constitution of India & Varieties of Medical Profession in India Question 1: Constitutional right to health right given by Constitution or Judiciary. Support your answer with case laws and the Constitutional Articles if any. Answer: Article 21: No person shall be deprived of his life or personal liberty except according to procedure established by law. The right to life has the widest possible interpretation. Under the canopy of Article 21, so many rights have found shelters. This right is the fundamental right, enforceable against the State and judicial decisions have imposed several obligations on the State e.g., a person who cannot pay for medical expenses must be provided with medical treatment and without delay. Case law: State of Punjab v. Mahinder Singh Chawla: The respondent had heart ailment which required replacement of two valves in the heart. Since the facility of the treatment was not available in the state hospitals of Punjab, permission was given by the director, with the approval of the Medical Board, to get the treatment outside the state. The respondent was sent for and had treatment in the AIIMS at New Delhi. The respondent submitted his medical bill for reimbursement. While granting reimbursement for the actual expenses incurred in the sum of Rs. 1,29,000/- the appellant rejected his bill for the room rent paid to the hospital as inadmissible. The respondent filed writ petition stating that when he undergone the treatment in the hospital as an inpatient, the payment of the room rent is an integral part of the expenses for treatment and, therefore, he is entitled to the reimbursement of the room rent paid. The Division Bench directed payment of the said amount. It was held that right to health is an integral to right to life. Government has constitutional obligation to provide the health facilities. If the Government servant had undergone such treatment therein, it is but duty of the State to bear the expenditure uncured by the Government servant. Thus the appeal was dismissed with no costs because it was incongruous that while the patient is admitted to undergo treatment and he is refused the reimbursement of the actual expenditure incurred towards room rent and is given the expenditure of the room rent chargeable in another institute whereat he had not actually undergone the treatment. Daljit Singh v. The State of Punjab: Self preservation is a necessary concomitant to the right to life as enshrined in Article 21 of the Constitution. Petitioner failed to get the amount from Government Senior Secondary School, Ludhiana though he went coronary bypass surgery in the Escorts Hospital, New Delhi. It was held that right to health being integral to the right to life as guaranteed under Article 21 of the Constitution, it cannot be said that the citizen is not entitled to claim reimbursement of the medical expenses. It is in fact the part of the rights under Article 21. Right to life induces: (1) Right to healthy environment i.e. pollution free air and water; (2) Emergency medical aid; (3) Right to health; (4) Timely medical aid in Government hospital; (5) Right to free legal aid where conviction of an offence may result into loss of life and personal liberty. Case law: Ratlam Municipal Corporation v. Vardhichand:

Case law: M. C. Mehta v. UOI: Case law: B. L. Wadhera v. UOI: The case is regarding pollution-free water. Case law: Pashim Bengal Khet Mazdoor Society v. State of West Bengal: The case is regarding failure to provide timely medical treatment to a patient who is in need of such treatment. Case law: Dr. Tekugha Yepthomo v. Apollo Hospital: The SC held that, if a self-respective spouse has an apprehension that the other (Prospective) spouse is suffering from AIDS, the former has a right to seek information about the latters illness from the hospital where blood reports of the latter is available. Case law: M. K. Sharma v. Bharat Electronics Ltd.: The workers of the Public Sector Undertaking claimed compensation for being exposed to the ill-effects of x-ray radiation. The SC issued directions as to check and safeguard to protect against radiation. Case law: Indian Council of Environmental Action v. UOI: If an industry is established without requisite permission and in blatant disregard of law to the detriment of citizens right of life, the SC can interfere to protect the right to life- It is the rule of absolute liability and polluter pay principle. Article 47: It is the duty of the state to raise the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties and, in particular, the State shall endeavour to bring about prohibition of the consumption, except for medical purposes, of intoxicating drinks and drugs which are injurious to health. Article 48A: The State shall endeavour to protect and improve the environment and to safeguard the forests and wild life of the country. Article 51A: It shall be the duty of every citizen of India:(a) To abide by the Constitution and respect its ideals and institutions, the National Flag and National Anthem. (g) To protect and improve the natural environment including forests, lakes, rivers and wild life and to have compassion for living creatures. (h) To develop scientific temper, humanism and the spirit of inquiry and reform; Case law: CESC Ltd. v. Subash Chandra Bose: The Apex Court observed on international instruments and concluded that right to health is a fundamental right. The Supreme Court went further and observed that health is not merely absence of sickness:The term health implies more than the absence of sickness. Case law: Paramanad Katara v. UOI: Accidental case requiring immediate attention was admitted in the hospital which was refused attention only because it was medico-legal case. It was held by Supreme Court that: Preserving human life is very important. It is the duty of every doctor, who is expert in protecting life, to give his services in emergency, to preserve the life. No law or statute should be allowed to prevent the medical practitioner from discharging his duties towards preserving human life. Medical practitioners do not extend their expertise to a dying person just because it was a medico-legal case, such deterrence prevents the availability of

timely medical help to a dying person. Preserving the human life should be a primary duty of medical practitioners and any recourse to any process of law can be followed afterwards. Question 2: Constitutional right to health has changed the health care system in India. Support your answer with case laws and Constitutional Articles if any. Answer: It is the fundamental right of every human being to maintain his health and to maintain good health he may require to live in a pollution-free environment. Case law: CERC v. UOI: The Apex Court was dealing with the rights of workers in asbestos manufacturing and health hazards related to it. It was dealing with asbestos mining and industry. Article 46 of the Constitution of India directs the State to protect the poor class from social injustice and all types of exploitations. Article 39(e) states about the policy of the State, that it shall secure the health and strength of the workers. Article 42 dictates that the States shall make all provisions, statutory or executive to secure just and humane conditions of work. Next Article 43 states about decent standard of life. Asbestos workers lead miserable, agonizing life. Also consider the Article 21, 47, 48A, 51A. Question 3: Discuss Judicial interpretation of Article 21 of the Constitution of India with reference to the health care system of India. Give case laws. Answer: Case law: State of Punjab v. Mohinder Singh Chawla: It is well settled in this case that health is integral to life. Government has Constitutional obligation to provide the health facilities. It should be noted that Constitutional framers have not used the words: Medicines anywhere, rather they have written about health and hygiene. Question 4: Explain reasons for including the medical profession into ambit of Consumer Protection Act. Answer: Many medical claims come before Consumer Courts due to medical negligence of the type civil or criminal. Medical negligence is also malpractice. It gives rise to breach of Contract law or law of tort. Negligence includes both omission i.e. not doing a thing which is required to be done or commission i.e. doing a thing which reasonable person under the given circumstances would not do. Where the negligence is the main component of the offence, the proposed negligence has to be proved by the prosecution as culpable or gross and not negligence merely based upon an error of judgement. Medical negligence or malpractice may be defined as: want of reasonable care and skill or willful negligence on the part of medical practitioner in the treatment of a patient which leads to his bodily injury or to the loss of his life. The injury as per the law of tort is negligence. A doctor is duty bound to be careful while treating his patient. Negligence may lead to death of the patient, diminishing chance of recovery, prolonging illness, increasing sufferings, losing organ, etc. Any kind of error such as wrong diagnosis and also treatment may be harmful to the patient. Any kind of wrong action or misjudgment may result in the death of the patient or permanent disability such as stroke.

Autonomy and its power: In Kantian theory autonomy is the power to set ones own rules to conduct its duties in the bonafide sense. The autonomy is mentioned because doctor has his own autonomy while treating the patient. However the action of the doctor should be justified i.e. (i) The patient must be sufficient informed (ii) The action of the doctor must be based on adequate and broad-based deliberations. (iii) Doctor must strive for patients ultimate good. Since stake is high both for the health centres and the patients, a number of litigations crop up for seemingly wrong diagnosis or medical negligence. People are aware that there rights are protected under the Consumer Protection Act. Thus, the law has become necessary for medical professional and related medical men. Primum non nocere is the motto of any medicinal branch. It means First do no harm, let the cure occur or may not occur but the condition of the patient should not worsen. Clearly if the condition of the patient becomes worse than previous then the doctor is inducing harm to the patient by his treatment procedure. This norm of no harm was laid down by the Father of medicine, the Hippocrates. Consumer is the patient in contemporary era. Any harm such as retinopathy, tardive dyskinesia or transmitted diseases is the threat to the life of the patient. The results of DNA test as an evidence before the Court need both the prosecution and the defence to know about the basics of genetic engineering. Again, stem cell therapy though already in use, but confidentiality of genetic information has to be preserved. There is public discussion that surrogacy as a profession should be legalized. So surrogate motherhood is pertinent. The enlarged scope of biotechnology in manufacturing antibiotics, anticancer and antidiabetic medicines are developing. There is new concept of test-tube babies. Deciding parenthood is the problem of the law in such circumstances. WHO has warned that AIDS may spread as an epidemic in the next quarter of a century. Allegation of negligence against physicians is made for wrong diagnosis and overdose of medicine, especially when death occurs for such mistakes, the doctor is required to show a considerate approach. Liability of doctors and hospitals under the Consumer Protection Act, 1986. The State medical council is statutorily vested with the power to exercise disciplinary control over registered medical practitioners. When the medical negligence of a practitioner is complained of and found justified by a body of experts, the medical council, on the gravity of negligence, may warn, suspend or strike off the name from the register. The doctor under suspension or name struck off, is barred from practicing his profession. But even if negligence is proved, the Council has no power of compensation for injury or death of a patient. Because of this shortcoming, the aggrieved party has to move the civil Court for compensation. The process is time consuming and costly. This factor has been partly instrumental in including medical services under the purview of the Consumer Protection Act, 1986. In April 1992, the Kerala State Commission made an appeal to the National Commission for inclusion of medical services under the Consumer Protection Act, 1986. The Doctor is liable for an act of negligence if he fails to exercise reasonable care and skill expected of a medical practitioner of his class. In the Act itself there is no mention of the services rendered by the doctors. But the Supreme Court in

Indian Medical Association v. V. P. Santha, held that doctors, hospitals and nursing homes who render service as medical practitioner are accountable for any act of medical neglect and ruled that they can be sued for compensation under the Consumer Protection Act provided that the service has not been rendered . Hence all medical service suffering from deficiency and negligence is covered by the provisions of the Act. Substandard health care to patients is major cause which is covered under ambit of Consumer Protection Act. Deterioration to patients health is either due to omission or commission of wrongful act in the treatment. Question 5: Discuss varieties of Medical professions in India. Answer: 1) Allopathy: Allopathy itself means Opposite suffering. It has high and dangerous side effects than curing. It causes spoiling, losing and mutilating the organs. Damage due to drugs is to the extent of debilitating conditions of vital organs such as: heart, kidneys, liver, pancreas, spleen and brain. It is the common practice to provide broacher or pamphlet which gives information about the side effects of the drug. It is the duty of the doctor to give information about the side effects. (i) Tabers cyclopedic medical dictionary; (ii) Mercks index; (iii) Dorlands through MerckSource; (iv) Martindales pharmacopeia; (v) Stedmans medical dictionary; (vi) Merriam-Webster medical dictionary; (vii) Mosbys medical dictionary, are full with descriptions of side-effects of the allopathic drugs. 2) Ayurved: Though age old therapy, nowadays it is mostly dependent on the ready to use medicines called asav, arirshta, globules, tablets, etc.. Number of medicines are prepared from Dattura, Bachnag, Kanher which are all poisonous and it also uses varieties of inorganic salts of mercury, sulfur, arsenic, lead, etc. Many of these are banned due to its corrosive effects viz. Tribhuvankirti, Arogysvardhini, etc. have got in them salts of mercury which are dangerous to neural system. Dr. Modi in his book Medical jurisprudence and toxicology (14/e) gives information about Dhatura. Also the book Taylors principles and practice of medical jurisprudence gives information about the same. Accordingly to Taylor: p. 551, Vol. 11: The active principle, a mixture of hyoscine, atropine and hyoscyamine, is extremely toxic. (http://www.indiankanoon.org/doc/845354/). Such combinations are common in Ayurved. Thorn-apple is toxic. 3) Homeopathy and bio-chemic: The founder of this pathy is Dr. Hanmann who was formerly allopathic doctor. He noticed that large doses cause number of side-effects of the allopathic medicines hence he made doses in infinitesimal small quantities which is minute-quantity of the dose. The names of the medicine are Arsenicum album, tobaccum, petroleum, leadem, etc. hence

there is no need to explain about the material used by the homeopathy. It is usually claimed by homeopaths that there is no remainder of the original medicine in the final preparation. However minute the dose may by Avogadro number itself is 10-23 and at that level the traces of the original source remains. Certain fundamentals of homeopathy: (1) Simila similibus curentur: It means poison kills the poison and hence it must be ingested under the name of homeopathy. Homeopaths also claim that, Their medicines contains untraceable traces of the starting medicine. Thus they agree with three components that: (i) There is starting ingredient which may be poisonous, irritant, toxic, carcinogen, etc. (ii) Its traces remain in the final product (due to incapability of the ultramodern gadgets such traces are undetectable, but Avagadros rule can prove its existence) (iii) The traces of the starting material are undetectable. All three statements are completely inconsistent. 4) Sidhha medicine: It is one of the oldest medical system. This system of medicine originates from south Indian Tamil Traditional Medicine, as a part of trio medicines i.e ayurved, sissha and unani. This is branch of Ayurveda where in medicines are used in the forms of decoctions. Fresh decoctions are given to drink the patients. CCRAS i.e. Central Council for Research in Ayurveda and Siddha established in 1978, by Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH), Ministry of Health and Family welfare, Government of India, coordinates and promotes research in the fields of Ayurveda and Siddha medicine. Also the Central Council of India Medicine (CCIM), a statutory body established in 1971 under AYUSH, monitors higher education in areas of Indian medicine, including Siddha. Drugs used by Siddha could be classified into three groups: Thavara (Herbal products), Dhathu (Inorganic substances) and Jangamam (Animal products). The Dhatu drugs are Uppu (Water soluble inorganic substances or drugs that give out vapour when put into fire). Pashanam (Drugs not dissolved in water but emit vapour when fired), Uparasam, Loham (Not dissolved in water but melt when fired), rasam, gandhagam (Drugs which are insoluble in water viz. sulfur). Medicines are made of mercury, sulfur viz parpam, chendooram, etc. 5) Panchkarma Chikitska: It means there are five types of maneuvers viz. vaman, virechan, nasya, shirodhara, massage, etc. 6) Naturopathy: This is the branch free from medicinal use. It simply uses natural principles to cure the disease, Viz. certain principles of chemistry wherein natural enzymes are useful e.g. peroxidase enzyme of radish reduces cholesterol and cures liver problems or amylase enzymes of the golden grams is useful for digestive problems, etc. It also makes use of water viz. water massage, cold water application, etc. 7) Acupressure: This has become popular because it is non-evasive therapy. The origin of the therapy is china though it is claimed that India used to have same with title Marma bindu dab Chikitsa. Suzok, reflexology, Alexander therapy, etc. are the branches of acupressure. 8) Folk medicines: History of the Folk medicines goes back to Egyptian culture. Greek documents were later translated to Arabic and medicine had continued to undergo further study

in the Islamic world. If heavy metals are used then there is risk of mineral toxicity and organ spoilage. 9) Quackery: It is the derogatory term used to describe the promotion of unproven or fraudulent medical practices. Random House dictionary describes a quack as a fraudulent or ignorant pretender to medical skill. However quackerys salient characteristic is aggressive promotion rather than fraud, greed or misinformation. Case laws: Poonam Verma v. Ashwin Patel: The doctor who has a qualifications in Ayurved prescribed allopathic treatment resulting in harm. Case law: Dr. Shiv Kumar Gautam v. Alima: Homeopathic doctor prescribing and administering glucose drip and giving injections. -----oXo-----

CHAPTER 2 Regulation and code of conduct, doctrine of informed consent Question 1: Write a short note on (1) Informed consent and (2) Implied consent Informed consent: Patients consent is necessary for carrying out every medical examination and maneuver done with the patient. The consent may be expressed in writing or implied by the conduct of the patient. A consent is said to be given when two or more persons agree upon the same time with same sense. Obviously the consent should be free from coercion, threat or any other type of moral or legal force. Thus , the consent should be free and voluntary. Doctor should inform the patient about the proposed treatment and involving all side effects on the human body. Usually every drug is accompanied by the pamphlet informing about the way of administration of the drug, anomalies, side effects, wrong combinations and care to be taken. It also indicates about discontinuation of the drug when contra-conditions exist. Importantly every patient of adult years and of sound mind has a right to decide what is to be done with his body. Informed consent is the legal concept, which gives right to every individual to take decision that may affect his well-being. Individual has right to analyze the risk and the potential benefits of the decision affecting his body. It is the duty of the doctor to give full information regarding the treatment to be given, and the patient has a right to decide in what manner his body should be treated. Medical information Consent requires that the patient be informed about all the risks involved and benefits of the suggested medical procedure for treatment, and also the information about the alternative methods of treatments. Thus, informed consent is obtained after the full disclosure of the method of treatment and risks involved in that method. National Consumer Disputes Redressal Commission (national Commission) observed that, informed consent means a consent which is obtained after giving all information which must be explained in comprehensible non-medical terms, preferably in the local language about the diagnosis, nature of treatment, risks involved, prospectus of success, prognosis if the procedure is not performed and alternative treatment. When evasive procedure of surgery is required, written consent is must. Case law: Salgo v. Leland Stanford Junior University Board of Trustees: In a malpractice action the jury awarded Martin Salgo the sum of $250,000 against defendants Leland Stanford Jr. University Board of Trustees, Stanford University Hospitals. Cr. Gerbode has been licensed to practice medicine in California since 1937. He specialized in surgery, heart surgery, major vessel surgery, and thoracic surgery with a special interest in cardiovascular surgery. The patient suffered from advanced arterio insufficiency of the legs. Due to the process of screening the patients leg became permanently paralyzed. Application of Res Ipsa Loquitur (A thing speaks of itself): The court instructed that the doctrine of Res Ipsa Loquitur be applied. The study of the cases both pro and con on the application of the doctrine in malpractice actions demonstrate that the doctrine is applicable only where it is a matter of common knowledge among laymen or medical men or both that the injury would not have occurred without negligence. It resulted in the following rights of the patients:-

1) Right to adequate information about the nature of proposed treatment to be given. 2) Right to know the risk involved in such treatment; 3) Right to know the alternative means of treatment available; 4) Right to take the decision whether to undergo the treatment or not. Case law: Canterbury v. Spence: It explains informed consent: Physician must seek and secure his patients consent before commencing an operation or other course of treatment. It is also clear that the consent, to be efficacious, must be free from imposition upon the patient. It is settled rule that therapy not authorized by the patient may amount to a tort-a common law battery-by the physician. And it is evident that it is normally impossible to obtain a consent worthy of the name unless the physician first elucidates the options and the perils for the patients edification. Thus the physician has long borne duty, on pain of liability for unauthorized treatment, to make adequate disclosure to the patient. Whereas informed consent as per Tabers cyclopedic medical dictionary thus:Consent that is given by a person after a receipt of the following information: the nature and purpose of the proposed procedure or treatment; the expected outcome and the likelihood of success; the risks; the alternatives to the procedure and supporting information regarding those alternatives; and the effect of no treatment or procedure, including the effect on the prognosis and the material risks associated with no treatment. Also included are instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful. Case law: T. T. Thomas v. Elisa: Certain enactments cast a statutory dity upon the Doctors to inform the patients about all the known side-effects and after-effects of the medical treatment which is proposed to be given to him. e.g.:1) Under pre-natal diagnostic technique Act-1994, a doctor is under a statutory duty to disclose all the dise-effects of pre-natal diagnostic procedures to the pregnant woman. 2) Under the transplantation of Human Organ Act, 1994, a doctor is statutorily bound to explain to both the donor and the recipient about the effects, hazards and complications associated with the removal and transplantation of the organ. Case law: Samira Kohli v. Dr. Prabha Manchanda The appellant an unmarried woman aged 44, visited the clinic for her problem of heavy bleeding through uterus. Consent was taken from the appellant for admission and discharge card, hospital admission and medical treatment and also for diagnostic and operative laparoscopy. Thereafter the appellant was put on general anesthesia. When appellant was still unconscious the consent was taken from appellants mother for performing hysterectomy under general anesthesia. Then uterus was removed and also ovaries and fallopian tube was removed. She was discharged after payment of the bill. Later respondent filed a complaint with the police that the appellant friend abused and threatened and appellant did not pay the bill of the hospital. Appellant filed a complaint against the respondent for (1) Alleged negligence and (2) Unauthorized removal of her reproductive organs. Respondent claimed the hospital bill whereas appellant claimed compensation of Rs. 25 lakhs for loss of opportunity to become mother and

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diminishing matrimonial prospects and physical injury. It was also claimed physical injury due to loss of vital organ and irreversible permanent damage, for pain, suffering emotional stress and trauma, and for decline in the health and increasing vulnerability to health hazards. High Court held that respondent was guilty of two distinct acts of negligence (i) Failure to take consent of the patient (ii) Failure to exhaust conservative treatment before resorting to radical surgery, particularly when such drastic irreversible surgical procedure was not warranted in her case. The respondent did not inform the appellant, of the possible risks, side effects and complications associated with such surgery, before undertaking the surgical procedure. Such surgery without appellants consent was violation of rules and medical ethics. Removal of her reproductive organ also resulted in a severe physical impairment, and necessitated prolonged further treatment. The respondent was also not qualified to claim to be a specialist in obstetrics and gynaecology and therefore could not have performed the surgery which only a qualified gynaecologist could perform. Question 2: What is medical negligence? Explain contributory negligence and Res ipsa loquitor. Answer: Medical negligence can be of two kinds namely civil negligence and criminal negligence. Civil negligence: The question of civil negligence or medical malpractice arises when a patient or, in the event of the death of the patient, his relative or next friend, files a suit against a doctor in a civil Court for compensation for the injury or death of the patient, as the case may be. It may also arise when the doctor brings a civil suit for realization of his professional fees from the patient or his relatives who refuse to pay the same on the grounds of malpractice. The liability of the doctor cannot be lessened because such negligence took place in a charitable hospital. The patient is to prove the negligence and the amount of damage is the measure of the extent of liability. The suit for negligence must be filed within two years from the date of alleged negligence to be valid. Res Judicata is applicable i.e. once a Court has decided a case, it cannot be reopened in other Court. Failure in regard to the contractual obligations by a doctor when he agreed to treat a patient constitutes a civil negligence. The burden of proving the negligence and the damage resulting there-from lies with the patient. The question is whether there has been a lack of reasonable care and competent skill to such an extent as to lead to cause such damage. It should be noted that plaintiff must establish the following elements of the tort of negligence for successful medical malpractice claim:1) A duty was owed: A legal duty exists whenever a hospital or health care provider undertakes care or treatment of a patient. 2) A duty was breached: The provider failed to conform to the relevant standard care. 3) The breach caused an injury: The breach of duty was a proximate cause of the injury.

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4) Damages: Without damages (Losses which may be pecuniary or emotional), there is no basis for a claim, regardless of whether the medicine provider was negligent. Likewise damages can occur without negligence, for example when someone dies from fatal disease. The trial: The plaintiff or his attorney files a lawsuit in a court with appropriate jurisdiction. Between the filing of suit and the trial, the parties are required to share information through discovery. Such information includes interrogations, requests for documents and depositions. If both parties agree, the case may be settled pre-trial on negotiated terms. If parties cannot agree, the case will proceed to trial. The plaintiff has the burden of proof to prove all the elements by a preponderance of evidence. At trial, both parties will usually present experts to testify as to the standard of care required, and other technical issues. The fact finder must then weigh all the evidence and determine which side is the most credible. Diagnosis: Failure to X-ray a case of injury to bones and joints in which there is a doubt about diagnosis and such a failure is frequently the basis of a successful plea in an action for negligence. Similarly, failure to suggest consultation with a specialist under certain special circumstances may be regarded as negligence. Treatment: Utmost care should be exercised while administering toxic drugs and excessive exposure of the patient to radiation should be avoided. A classic example of negligence can be cited: A boy sustained an injury by a pellet from an airgun. During an operation to remove it from his arm an unsuccessful attempt was made to locate the pellet by repeated X-ray screening. Five days later, there was arythema of the skin of his arm which was followed by a large chronic ulcer requiring a prolonged treatment and plastic surgery. He was left with a permanent scar mark an limitation of the movement of the arm. The case was settled for the compensation of 3,000 pounds. Duty to warn the patient: It is the duty of the doctor to warn patient of any known or possible side effects. He should also make aware the patient about any wrongful combinations of the drugs. Doctor should also inform the patient about any precautions to be taken such as viz. (i) The drug to be taken when the stomach is full or empty, etc. (ii) The drug to be discontinued in pregnancy or (iii) The drug not to be taken when there is giddiness. Failure to do so renders the practitioner liable for the harm suffered by the patient and the injuries caused to third parties. Thus a patient who has to take medicine causing him drowsy should be duly warned not to drive after taking that medicine. Issuing a certificate: It is necessary that certificate should be true and bonafide to the best of doctors knowledge and belief. The doctor should fully satisfy himself about the accuracy of the statement contained therein. This is especially so if the certificate is based on the statement made by others, as for example, in mental illness. Case law: State of Tripura v. Amrita Bala Sen: Two persons who were admitted to a Government hospital for cataract operation lost an eye each due to the operation. A writ petition was filed in the High Court by these two persons claiming compensation from the State. It was proved beyond doubt that there was negligence on the part of the doctor and the Court therefore

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ordered the State to pay to each of these two persons the compensation of Rs. 60,000/- with interest. After the Consumer Protection Act-1986, came into effect, many patients have started filing cases against doctors. Case law: State of Hariyana v. Smt. Santra: It was held by Supreme Court that every doctor has a duty to act with a reasonable degree of care and skill. Case law: Bolam v. Friern Hospital Management Committee:Mr. Bolam was a voluntary patient at the mental health institution run by the Friern Hospital Management Committee. He agreed to undergo electro-convulsive therapy. He was not given any muscle relaxant, his body was not restrained during the procedure and he was not warned about the risks involved. In consequence patient suffered serious injuries, including fracture of the acetabula. Patient sued hospital authorities for criminal negligence on their part. It was held that a person falls below the appropriate standard, and is negligent, if he fails to do what a reasonable person would in the circumstances. But when person professes to have professional skill, as doctors do, the standard of care must be higher. It reduced to a Bolam test which is just one stage in the fourfold test to determine negligence. 1) It must be established that there is a duty of care (between a doctor and patient this can be taken for granted). 2) It must be shown that the duty of care has been breached. This is where the Bolam test is relevant, because falling below the standard of a responsible body of medical men means that person will be considered negligent. 3) It must be shown that there was a causal link between the breach of duty and the harm suffered by the patient. 4) It must be also shown that the harm was not too remote. Poonam Verma v. Ashwin Patel:A doctor registered as medical practitioner and entitled to practice in homeopathy only, prescribed an allopathic medicine to the patient. The patient died. The doctor was held negligent and liable to compensate the wife of the deceased, since he trespassed into a prohibited field and prescribed the allopathic medicine to the patient causing the death, his conduct totaled to negligence per se actionable in civil law and law of tort. Case law: A. H. Khodwa v. State of Maharashtra: It was held that, in the very nature of medical profession, skills differ from doctor to doctor and where more than one alternative course of treatment are available, all alternatives are admissible. Criminal negligence: Criminal negligence occurs in case of death or serious injury. In case of death doctor may be prosecuted by the police and charged in the criminal Court with having caused the death of the patient by rash and negligent act not amounting to culpable homicide under section 304-A of IPC., if the death was the result of gross negligence, total carelessness and ignorance or undue interference by him in his professional duties. In case of serious injury, the doctor may be charged under section 336, 337 or 338. If the degree of the negligence is grave to the extent that

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it creates threat to the life of the patient then doctor deserves punishment. When the doctor flouts the penal provisions of law or a complaint case is filed, he is subject to prosecution by the State. There may be the following types of charges:1. A doctor is supposed to report to the police all cases of violence or criminal acts coming to his notice. If he fails to abide by the provision of law, he will be liable for prosecution under section 202 of IPC. 2. If a doctor issues a false birth or death certificate or prepares fraudulent affidavit for some purpose or willfully attempts to conceal the nature of a criminal act, he is liable to for criminal proceeding. 3. In case of the death of the patient due to gross negligence, carelessness or ignorance during administration of anesthesia or drug prescription of medicine or operation, the doctor is liable for prosecution for causing death by rash and negligent act under section 304-A of IPC and is punishable with imprisonment or file or with both. There are following cases too:(i) Not doing sensitivity test when indicated; (ii) Injecting basal, anesthesia in a fatal dose or in wrong tissues; (iii) Amputation of wrong finger, operation on wrong limb, removal of the wrong organ or errors in ligation of ducts; (iv) Operation on the wrong patient; (v) Leaving instruments or sponges in the abdomen or any other part of the body; (vi) Giving wrong or infested blood; (vii) Leaving tourniquets too long (To stop blood flow); (viii) Gangrene after too tight plastering or paralysis after splints (Hard strip to hold broken bone). (ix) Dressing with corrosive instead of bland liquids; (x) Performing a criminal abortion outside the scope of the medical termination of pregnancy Act, 1971 or a criminal operation; (xi) Mismanagement of delivery under the influence of alcohol or drug. Case laws: R v. Batesman: The death of the woman in labour was ascribed to gross negligence on the part of the doctor. The case was of that of the difficult labour. At the end the dead child was born and the patient was in grave poor condition. The doctor did not decide to send the patient until the 5th day. She died two days later. At postmortem, it was found that, a urinary bladder ruptured and large intestine crushed against the spine. Cr. Batesman was prosecuted for manslaughter (Culpable homicide) and was found guilty. Case law: Jaggan Khan v. State of M. P.:A registered homeopath practitioner prescribed the administration of a dose of stramonium to be taken with a leaf of Dhatura. In a consequence the patient died. Dhatura leaf is a poisonous substance and does not fall within the purview of homeopathic medicine. Hence its prescription without studying its effect was held as rash and negligent act punishable under section 304-A of IPC.

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Case law: Sukaroo Kaviraj v. Emperor: The Kaviraj who was not qualified surgeon, cut the internal piles of a patient by an ordinary knife. In consequence, the patient died of hemorrhage. The Kaviraj was convicted under section 304-A of IPC for his rash and negligent act. Case law: Woodward v. Emperor: A patient was given penicillin injection by a quack and the person so injected died. It was held as a rash and negligent act and the quack was convicted under Section 304-A of IPC. Case law: P. M. DSouza v. Emperor: The accused was in charge of a dispensary where the poisonous drugs were not stored properly. The accused dispensed strychnine hydrochloride instead of quinine by mistake as he did not care to read the label. In consequence, all the patients, except one died. The accused was convicted for rash and negligent act causing death under Section 304-A of IPC. Medical malpractice actions provide a legal venue for imposing financial liabilities on physicians, dentists, hospitals, health care organizations and other health care providers for iatrogenic injuries to patients or third parties that arise directly or vicariously from the provision of medical treatment. Question 3: Note on, Self regulation through code of conduct. Answer: (1) Primum non nocere: It is the motto and the goal of any of the pathy that, First do no harm(Premum non nocere). This norm of No harm is laid down by the Father of allopathy: Hippocrates. First do harm is the fundamental medical ethics. It further means that let the disease be not cured but at least it should not aggravate further with the help of medicine or medical treatment. However with all opinions of the experts, it is difficult to accept the premise in either allopathy or in any of the drugged pathy. Drug side effects are dangerous, threatening to the extent that there is special branch of allopathy called Iatrogenesis to study side-effects, adverse effects of the drug. It also studies the death occurring due to medicines viz. shock due to antibiotic injection, etc. Drugging is unnatural, unnecessary and catastrophic. It also leads to drug-resistant pathogens viz. TB pathogens which are drug-resistant, AID pathogens which are drug resistant or leprosy pathogen which are drug resistant. Question 4: Rights of registered Medical Practitioner. Answer: Registration is the proof of the skill of the doctor for his practicing medicine. It is because registration is given to the doctor only on his producing a satisfactory evidence of passing the qualifying examination. The registration is given by the respective state medical council on the powers vested in them statutorily. Thus for all doctors possessing a registered medical qualification, reasonable skill is presumed. The contrary has to be proved by the suitor. For this it has to be established that the doctor did not take or failed to take elementary precautions to prevent injury. It has also to be proved that he did not perform certain tests which would caution the patient before using certain medicines or undergoing certain procedures. For medical science it is acceptable that certain drugs and procedures may produce side-effects

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because of the uncertain physiological reactions. Under these circumstances, the benefit of doubt has to go to the doctor. Question 5: Explain inform consent and Right of self determination in medical profession. Support your answer with case law. Failure to obtain a patients informed consent is actionable in negligence and intentional tort. A patients right to determine his own medical treatment is premised on the common law of self-determination The informed consent doctrine: It requires patient assent to all risk bearing surgeries, medical interventions, procedures, and treatments. Providers must also disclose financial interests related to a patients care. Case law: Moore v. Regents of University of California: The plaintiff John Moore underwent treatment for hairy-cell leukemia at the medical Center of the University of California. It was recommended that Moores spleen be removed. Mr. Moore was informed about the splenectomy operation and there was fear for his life but operation was necessary to slow down the progress of his disease. Eventually the spleen was removed. It was revealed that the doctors were conducting research on Moores cells and planned to benefit financially and competitively by exploiting physician-patient relationship. Thus there was breach of fiduciary duty and lack of informed consent. There was the act of tort (Conversion) wherein the organs possessed by the Mr. Moore were used by the doctors for their private benefits. Case law: Canterbury v. Spence: Patient was informed about potential risk of the operation and also sued the hospital for not equipped his bed rail for not having nurse present to assist him at the time of his fall. It was held that physician should convey the risks of an operation when a reasonable person would be likely to attach significance to the risk in deciding whether or not to forgo the proposed therapy. There are two exceptions to this therapy:1) Where the patient is unconscious and harm from failure to treat is greater than any harm threatened by the proposed treatment, and ; 2) Where disclosing the risk to the patient poses a threat to the patients well being. Case law: Schloendorff v. Society of New York Hospital: Plaintiff, Mary Schloendorff, was admitted to New York Hospital and consented to being examined under ether to determine if a diagnosed fibroid tumour was malignant, but withheld consent for removal of the tumour. The tumour was removed without consent of the patient. This was treated as medical battery. It was held that every human being of adult years and sound mind has a right to determine what shall be done with his own body, and a surgeon who performs an operation without patients consent commits an assault for which he is liable in damages. This is true except in the cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained. Schloendorff, however, had sued the hospital itself, not the physicians. For this reason, the Court found that a non-profit hospital could not be held liable for the actions of its employees. The idea that a non-profit hospital could not be sued for actions of its employees

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became a principle that became known as the Schloendorff rule. However the Court would later rejuect the Schloendorff rule in the 1957 decision of Bing v. Thunig. Case law: In Re T (Adult refusal of medical treatment): The Court held that, patients have right to refuse treatment even if, as a result, the patient would die. Giving such a patient treatment may even amount to the doctor committing trespass on patients body. Clearly doctor or health care provider can treat the person only if he intends. Consent be valid and informed. Thus the doctor or health care provider should tell about the proposed treatment, the risks and benefits of it, and any alternative treatments, including no treatment. Every capable adult has the right to consent to medical care or refuse it for any reason including moral or religious reasons. Adults also have the right to change their decisions about medical treatment. One can refuse life support or other medical care, such as a blood transfusion, even if it means one will die. The law presumes that adult is capable of giving, refusing, or revoking their consent, unless it is clear that they are not capable of making those decisions. Case law: Re B (Adult: Refuses of medical treatment): The Court was concerned with a patient who was competent, conscious but was paralyzed and on a ventilator for number of years. She wanted the ventilators to be switched off but the doctor refused. She approached the Court and the Court allowed the ventilator to be switched off. Thus the patient may accept or reject a particular therapy as per his choice. Doctor cannot force or coerce for particular choice of the therapy. Rather patient has option of his own if he is competent and conscious. Bing v. Thunig: From the case Schloendorff v. New York Hospital, a body of law has been developed making the liability of a hospital for injuries suffered by a patient, through the negligence of its employees, depend on whether the injury-produced act was administrative or medical. The wisdom and workability of this rule exempting hospitals from the normal operation of the doctrine of respondent superior have in recent years come under increasing attack. Decision inn present case calls upon us to say whether the rule should longer endure. The plaintiff Bing was severely burnt during the course of an operation b y her own physician, for correction of a fissure of the anus. The tincture of zephiran which was inflammable fluid was applied to operative area. The nurses were fully aware that the inflammable antiseptic employed was potentially dangerous. They acknowledged that they had been instructed, not only to exercise care to see that none of the fluid dropped on the linen, but to inspect it and remove any that had become stained or contaminated. However, they made no inspection, and the sheets originally placed under the patient remained on the table throughout the operation. The surgeon was not in the operating room when the antiseptic was applied and at least fifteen minutes elapsed before he initiated the preoperative drapping process. The drapping completed, the doctor took a heated electric cautery and touched it to the fissure to mark it before beginning the actual searching of the tissue. There was smell of very hot singed linen and without waiting to see a flame or smoke, he doused the area with water. Assured that the fire was out, he proceeded with the operation. Subsequent examination of the patient revealed severe

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burns on her body, later inspection of the linen, several holes burned through the sheet under her. Clearly there was the problem of negligence as medical or administrative. - ----oXo-----

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CHAPTER 3 Pre-natal diagnostics techniques (Regulation and prevention of misuse) Act-1994. Experimentation with: Fetus of children, People of custody, people with psychiatric custody. Question 1: Explain the terms given below: (1) Gynaecologist: A person who possesses a post-graduate qualification in gynaecology and obstetrics. He is the medical practitioner who deals with the health of the female reproductive system (Uterus, vagina and ovaries) (2) Medical geneticist: A person who possesses a degree or diploma or certificate in medical genetics in the field of pre-natal diagnostic techniques or has experience of not less than two years in such field after obtaining:(i) Any of the medical qualifications recognized under the Indian Medical Council Act-1956, or (ii) A post-graduate degree in biological sciences. (3) Paediatrician: A person who possesses a post-graduate qualifications in paediatrics. (4) Pre-natal diagnostic procedures: It means all gynaecological or obstetrical or medical procedures such as ultra-sonography, foetoscopy, taking or removing samples of amniotic fluid, chorionic villi, blood or any tissue or a pregnant woman for being sent to a genetic laboratory or genetic clinic for conducting pre-natal diagnostic test. (5) Pre-natal diagnostic techniques: It includes all pre-natal diagnostic procedures and prenatal diagnostic tests. (6) Pre-natal diagnostic tests: It means ultra-sonography or any test or analysis of amniotic fluid, chorionic villi, blood or any tissue of a pregnant woman conducted to detect genetic or metabolic disorders or chromosomal abnormalities or congenital anomalies haemoglobinopathies or sex-linked diseases. (7) Registered medical practitioner: Means a medical practitioner who possesses any recognized medical qualification as defined in clause (h) of Section 2 of the Indian Medical Council Act, 1956, and whose name has been entered in a State Medical Register. 98) Brain-stem death: It means the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under sub-section (6) of Section 3. (8) deceased person; It means, a person in whom permanent disappearance of all evidence of life occurs, by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has taken place. Question 2: Who is neonatologist and nephrologist? Answer: Neonatologist: A physician performing a physical examination on a new born baby after caesarean section is called as neonatologist. He/She is subspecialty of pediatrics that consists of the medical care of newborn infants, especially the ill or premature newborn infants. Nephrologist: Nephros means kidneys. logy means study of. It is the branch of internal medicine and pediatrics dealing with the study of the function and diseases of the kidney. Nephrology concerns the diagnosis and treatment of kidney diseases.

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Question 3: what is Therapeutic abortion? Answer: Therapeutic abortion is allowed under the Medical Termination of Pregnancy Act, 1971. Obstetricians and gynecologists are the specialists and they come across large section of people. Though the Medical Termination of Pregnancy Act, 1971 has liberalized abortion, it has also entrusted much responsibility and observance. Violation of any of the provisions of the Act may land the erring doctor in troubles. Many a times for still born baby and baby born defective after cessarian operation, obstetricians are blamed. In the circumstances prior scanning is the defence. Question 4; Explain Helsinki Principles with relevance to children and insane persons Answer: Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document of human research ethics. The declaration was originally adopted in June 1964 in Helsinki, Finland. In the first revision the concept of informed consent was developed further. In second and third revision the consent of minors was made applicable wherever possible. In the fourth revision the concept of HIV was on the anvil with treatment of zidovudine. Fifth revision of year 2000 was also on much discussion on HIV. Sixth revision was in 2008. It was discussed the right to self determination and right to make informed decision. There was also discussion on the ethical views of medical research publications and good clinical practice. Although the declaration is primarily intended for physicians, the WMA encourages other participants in medical research involving human subjects to adopt these principles. It is the duty of the physician to promote and safeguard the health of the patient, including those who are involved in medical research. Applying ethical principles to research in pediatric populations:Patients participation in the medical research should not put him in the disadvantage. Clearly the child participating in the medical research then the child should not be put in the disadvantage. Certain groups, such as pregnant women, fetuses, prisoners and children and also insane are protected by specific regulations requiring quite safeguards in research. Such research should cause minimum risk to the children. Permission for the research participation of children can be sought from their parents. Concept of informed consent is very important in dealing with child research. Ethical principles and guidance for the conduct of human subjects should eb strictly exercised while dealing with research topics of children and insane. While dealing with children in the clinical trials the following considerations are very important:i) Coercion: It is because small kids can very easily be pressurized. ii) Exploitation: The kids can be exploited by various methods. Even a tempting object can exploit the children.

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iii) Deception: Deceptive techniques can very easily make fool of the child. Thus Helsinki declaration warns about all such techniques not to be used in the clinical research. - ----oXo-----

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CHAPTER 4 Doctor-patient relationship, confidentiality, side-effects of drugs. Question 1: Explain the doctor-patient relationship is a contract. Answer: People place their trust on doctors for medical care. This is an ethos which has been fostered and encouraged over the ages. There has to be more and more willingness among the patients to question the doctors about mode of treatment that the doctor proposes. There may be the conflicting interests in the treatment procedures. When doctor agrees to treat a patient, it constitutes an implied contract. Default on the part of the doctor to provide standard skill and care may render him liable to have the damages assessed. The default may result in either physical or mental injury and also monetary loss to the patient. Such default may include malpractice, wrong diagnosis, unnecessary surgery, wrong surgery, criminal abortion, divulging professional and personal secrets, wrong medication. There are two models in the area of patient-doctor relationship, namely: paternalism and the other is doctrine of informed consent. According to Dworkins standard definition of paternalism means interference with a persons liberty of action justified by reasons referring exclusively to the welfare, good, happiness, needs, interest or values of person coerced. Behaviour of a doctor plays a key role in shaping up his relations with his colleagues, subordinate staff, patient and relatives of patient. A tense and anxious patient and his relatives expect a doctor to be kind and responsive. The situation can be improved by showing considerate and polite attitude. On the other hand, arrogant and intemperate attitude aggravates the situation. To keep the staff in good spirit, the doctor should maintain a good relation with them. Illtreatment to them may invite hostility and even feeding information for allegations. Doctor is guilty if he crosses the limit of his qualification, experiences and available equipments. However doctor is not responsible for unavoidable complications. Records of the patient kept routinely indicate sincere efforts exerted by the doctor. Sudden death of a patient creates doubts in the minds of the relatives. It may be natural death during the treatment or a post-operation. In either of the case post-mortem will confirm the cause of the death. Majority cases of compensation for negligence are either against surgeons or anesthetists. The patient has to be examined whether he is fit for anesthesia and his consent must be obtained. If found fit, the cardio-vascular system and the congestion of the lungs must be examined before anesthesia is administered. In case of liver dysfunction the anesthetist needs to be careful and is likely to choose milder one. Patient should also be examined for high blood pressure and blood sugar. Report of blood for hemoglobin should also be available. Type of anesthesia to be administered should be recorded and it should be observed that his instructions are exactly followed. Doctor should also ensure the starting and ending of the intravenous drip. The duty of the doctor and surgeon and also of anesthetist stops only when the patient fully recovers and comes to conscience state.

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Question 2: Note on Medical confidentiality, Medical records, Medical examination Answer: It is duty of the doctor to keep all the information regarding his patient, which he acquires during the course of examination, investigation or treatment of the patient as confidential. The information which is confidential can be disclosed:1) only with the consent of the patient, or 2) Someone who is authorized to give such consent to disclose, or 3) In case of exceptional circumstances where such disclosure is of paramount importance. Confidentiality is required to maintain the loyalty with the patient otherwise patient would not confide in the doctor. The doctor will not disclose that information which the patient may feel like stigma and may embarrass him or which may expose him to humiliation. The patient has fear that he may lose the job or friends or personal esteem. Case law: X v. Y: Two doctors employed in the hospital contracted AIDS. They continued their employment even after this. A newspaper paid money to two hospital employees and obtained information about the two HIV infected doctors. This information was published. Court gave injunction on publishing the information and when breach of injunction obtained the contempt of the court fine was imposed of Pounds 10,000/-. It was held that the patients are entitled to expect that the hospital record in relation to their treatment shall be confidential. No individual or journalist can breach that confidence of the patient for his own gain. Question 3: What is the difference between communication and privileged communication? Answer: Case law: Uttaranchal Forest Hospital Trust v. Smt. Raisan The complainants organ was removed with diagnostics that it was cancerous and when the organ was sent for diagnosis no cancer was detected. The State Commission found the doctor guilty of negligence for performing surgery that was wholly unnecessary. In the circumstances let us check patients rights 1) He has a right to be told all the facts about his illness and medical records explained to the patient and to be made aware of risks and side effects, if any, of the treatment prescribed for him. Patient should not hesitate to question his doctor about any of these aspects. 2) When patient is being given a physical examination, he has a right to be handled with consideration and due regard for his modesty. This is invariably true for lady patients. 3) It is the right of the patient to know doctors qualifications and evaluate him directly or indirectly. 4) Patient has a right to complete confidentiality regarding his illness. 5) If patient is doubtful about the treatment prescribed and especially an operation suggested, he has a right to get a second opinion from any qualified specialist. 6) Patient has a right to be told in advance, what an operation is for and the possible future risks involved. If this is not possible due to unconscious state of the patient then his nearest relative must be told before they consent to the operation.

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7) If patient is discharged or moved to another hospital, he has a right to be informed in advanced and to make his own choice of hospital or nursing home, in consultation with the doctor. 8) Patient has right to get his case papers upon requests. -----oXo-----

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CHAPTER 5 Medical malpractices and Consumer Protection Act. Question 1: Explain: Inclusion of the medical profession into the ambit of Consumer Protection Act is the outcome of their own actions. Answer: Designer drug: It is new corporate technique developed which is production of synthetic and fancy drugs. Such drugs are psychoactive and new drug is base on side effects of old or previous drugs. Rather it is counter-act previous drugs. Obviously few more side effects start for which new designer drug is required and this race is unending till the end of the patient. Iatrogenic diseases and drugs: These are the drugs designed on theiatrogenic diseases which are also called medically induced diseases. The terror is caused due to side effects of the drugs, long term adverse effects of the drugs. Harmful drug combination is one more dangerous thing which patient never knows. Nosocomial diseases: These types of diseases are acquired in the hospital either due to hospitalization or hospital visits. Xenobiotics: It is the absorption of toxic and foreign chemicals in the body under the name of drugging and such medicine is called xenobiotics. Disguising and popularity drugs: The allopathic drug Prozack was very famous in the developed country USA. It was used there to relieve the subjects from stress, depression, tension and fear. Moreover to increase its acceptance and increase its popularity by advertisement among the masses, an attractive name Personality pill was given. However the drug proved dangerous after its use of 5 years. Cancer inducing drugs: DES (Diethylstibesterol) which was additive in cattle feeds and fodder was administered to women in attempt to prevent miscarriages. The daughters of these women started suffering from vaginal cancers. Embroyotoxic and teratogenic drugging: Thalidomide introduced in late 1050 in the drug market lead to defective fetus. About 10,000 children from 46 countries were found with malformation of limbs, phocomelia, etc. Sugar level increasing drugs: steroids namely cortisones, prednisone increase blood sugar level. It means that along with suppression of human immune system the drug also induces diabetes. Prednisone is used to treat arthritis, blood disorders, breathing problems, allergies, skin diseases, cancer, eye problems. Diuretics used to control high blood pressure increase blood sugar level and induce diabetes. Antidepressant and antipsychotic drugs also increase blood sugar level. Birth control pills are the cause of high blood sugar level. The term damage in action for negligence has a special meaning. Damage to the patient may be physical, mental or financial including the concept of pain and suffering. Damages are assessed by the Court for the loss of present and future earnings of the damaged person: Actual medical and surgical care costs and the reduction in quality of life which may be caused by lameness, deafness, blindness, etc. In order to succeed in the suit of negligence, a plaintiff must establish the following to the satisfaction of the Court:1. The defendant owed him duty to confirm to a particular standard of conduct.

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2. The defendant was derelict and failed to perform that duty. 3. The plaintiff suffered actual damage. 4. The defendants conduct was the direct or proximate cause of the inflicted damage. If the plaintiff can prove all these, he is entitled to be compensated in terms of money. It is essential for all medical practitioners to safeguard his interest and for this purpose the doctor is required to cover himself with Doctors indemnity Insurance policy. Usually speaking, it is form the patient in an action for negligence to establish the guilt of the doctor whose innocence is otherwise assumed. There are some circumstances in which the doctrine of res ipsa loquitur can be invoked. For this following three conditions are essential:1. The nature of injury suggests that without negligence it cannot happen. 2. The plaintiff must not add to his own injury. 3. The defendant must be in exclusive control of the instrumentalities. In such cases, the negligence is self-evident and if the case comes to trial, the doctor has to establish his innocence, rather than the patient having to prove doctors guilt. Case law: Cassidy v. Ministry of Health: The patient came for the treatment of his two stiff fingers but he left the hospital with four stiff fingers and his hand useless. That should not have happened if due care was taken. Case law: Mohan v. Osborne: The doctrine of res ipsa loquitur has been held applicable in negligence actions in cases of foreign materials and slipping instruments. The instrument slipped in the patients abdomen during surgical procedures, burns from the heating the procedures, injury to the portion of the patients body outside the area of treatment and gross prescription errors of toxic drugs. An action of negligence in such cases may be brought against a medical practitioner in a civil or criminal Court. The negligence is accordingly known as civil negligence or criminal negligence. It can also form the subject of inquiry by the Medical council and even action can be taken under the Consumer Protection Act, 1986. Question 2: Note: mens rea in medical negligence. Answer: Though medical profession is noble, certain medicos who want to earn quick and enormous by dubious means follow number of mal-practices and cut-practices. Trust reposed on doctors is sometimes betrayed by unnecessary and unwanted surgical operations and team of clinical testers. Number of deaths occur due to wrong diagnostics, error in treatment and negligence. Case law: Carlill v. Carbolic Gas Company: It is the milestone case law in the history of law. In this case carbolic Gas (Phenol: Most toxic, dangerous and known carcinogen) was used. Company experimented phenol (Carbolic acid) smoke ball for treating influenza and number of other diseases. It should be noted that phenol is known carcinogen and also cancer promoting agent. Thus, rather than curing the disease, it would have caused cancer of nasal cavity. Experiments with rodents of phenol, resulted in incidences of leukemia (Blood cancer)

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The word negligence has both meanings. It means omission i.e. not doing a thing which is required to be done at appropriate time and also commission means doing a thing which reasonable person under given circumstances would not do. Negligence is actionable under both civil and criminal. Negligence has to be proved beyond doubt. It should be proved as culpable or gross and not negligence merely based on an error of judgement. Medical negligence: It is a want of reasonable care and skill or willful negligence on the part of medical practitioner in the treatment of patient which leads to his bodily injury or to the loss of his life or limb. Doctor is duty bound while treating his patient. Failure in his duty results in patients death or injury or damage to organ. Types of negligence: (i) Error in diagnosis: (ii) Wrong medication: (iii) Wrong hospital treatment: (iv) Mistake in operation: Result of negligence: (1) Patients death: (2) Diminishes chance of his recovery: (3) Prolonging illness: (4) Increased suffering: (5) Loss of organ: In order to succeed in an action of negligence, a plaintiff must establish the following (a) The defendant (The doctor) owed him a duty to confirm to a particular standard of conduct. (b) The defendant failed to perform his duty. (c) The plaintiff suffered actual damage; (d) The defendants conduct was the direct or proximate cause of the inflicted damage. Civil negligence: It is the civil negligence when a patient or, in the event of his death, his relatives, file a suit against a doctor in the civil Court for compensation for the injury or death of the patient, due to negligence of doctor. On the other hand it may also arise from the doctor if patient or his relatives refuse to pay the fees. In the circumstances the patient has to prove the negligence and the amount of the damage is the measure of the extent of liability. The suit of negligence must be filed within two years from the date of alleged negligence to be valid. Res Judicata applies i.e, once the Court decided the case, it cannot be reopened in any other Court. Case law: Lakshman v. Trimbak: A doctor who holds himself ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person when consulted by patient owes him certain duties:1) A duty of care in deciding whether to undertake the case; 2) A duty of care in the administration of that treatment. 3) A breach of any of these duties gives a right of action for negligence to the patient. 4) A practitioner must bring to his task a reasonable degree of care and competence judges in the light of particular circumstances of each case is what law requires.

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5) The doctor, no doubt, has a discretion in choosing the treatment which he proposes to give to the patient and such discretion is relatively ampler in cases of emergency. 6) Wrong diagnosis. 7) Wrong treatment. At most care should be exercised while administering toxic drugs and excessive exposure of the patient to radiation should be avoided. 8) The practitioner must warn the patient of any known or possible side effects of a drug, device or operation. Failure to do so renders the practitioner liable for the harm suffered by the patient and the injuries caused to the third parties. 9) Issuing certificate: True certificate should be issued. Criminal negligence: Criminal negligence is the case when death of the patient or serious injury results to the patient. In case of death, a doctor may be prosecuted by the police and charged in the criminal Court with having caused death of his patient by rash and negligent act not amounting to culpable homicide under section 304-A of IPC. If the death was due to the result of gross negligence, gross carelessness, gross ignorance or undue interference by him in his professional duties, such cases are generally due to drunkenness or impaired efficiency from the use of the drugs by the doctor. In case of serious injury, the doctor may be charged under section 336, 337 or 338 of IPC. Case law: Spring Meadow Hospital (Noida, Delhi v. Hario Ahluwall: The child was treated in the hospital for seven days, the consultant physician prescribed chloromphenicol-injection. Lariago. The nurse injected Chloroquine 5 mg which was at least 3 times of the pediatric dose. The patient suffered irreversible brain damage. The patient was compelled to live in vegetative state. It was held that the hospital and nurse were jointly and severally responsible and liable. K. G. Jrishanan v. Praveen Kumar (Minor): The minor was admitted to the hospital, with fever. He was administered paracetomal injection by the nurse in a such way that his right side was paralyzed. In this case doctor was held vicariously liable for the injury and negligence. Mohd. Ishfaq v. Martin DSouza.: The patient was put on hemodialysis due to chronic renal failure and was put on broad spectrum antibiotic when he suffered from high fever. The creatininie went up to 13 mg. and blood urea 180 mg., hemoglobin 4.3%. His hearing was impaired and hence the respondent filed a complaint before the National Consumer Dispute Redressal Commission, New Delhi claiming compensation of an amount of Rs. 12,00,000/- due to the drug Amikacin which must have caused him deafness. Jacob Mathew v. State of Punjab: There was gross negligence and criminal liability. - ----oXo-----

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CHAPTER 6 Medico-Legal cases, Road accidents, sexual assaults, Mass disasters Question 1: Write a short note on Brain stem death. Answer: It is the clinical concept, implying an irreversibly unconscious patient, with irreversible apnea and irreversible loss of brain stem reflexes. The concept defines the core physiological basis for neurological diagnosis of death in the UK and elsewhere. Brain stem death was defined as: Irreversible loss of the capacity for consciousness, combined with irreversible loss of the capacity to breathe. It is the clinical state produced by the irreversible cessation of brain stem function which is called as brain stem death. Death: It is permanent termination of the biological functions that sustain a living organism. There is cessation of breathing. No pulse or cardiac arrest. The limbs of the corpse become stiff. There is no response to light by the eye pupil. Question 2: Write note on: Medical ethics, Medical negligence. Answer: Medical negligence: Under IPC 304-B, deals with causation of death due to rash and negligent act. Medical negligence comes under Section 304-A. The accused the homeopathic practitioner, administered to a patient suffering from guinea worm, 24 drops of stramonium and a leaf of dhatura without studying its effect; the patient died of poisoning. The accused was held guilty and punished. A compounder added some mixture from the bottles and seven patients out of eight died due to poisoning. Compounder was held guilty. 304-b is regarding the death of the woman caused by the burns or bodily injury or occurring otherwise within the seven years of her marriage. Under IPC 336, it is an offence to endanger human life or personal safety of others through a rash or negligent act. Under Section 76 of IPC: Case law: Spring Meadow Hospital (Noida) v. Hario Ahluwalia: The child was treated in the hospital for seven days. The consultant physician prescribed Chloromphenicol injection, Lariago. The nurse injected chloroquine 5 mg which was at least 3 times of the paediatric dose. The patient suffered irreversible brain damage. The patient was compelled to live in vegetative state. It was held that hospital and nurse were jointly and severally liable. Case law: K. G. Krishnan v. Praveen Kumar (Minor): The minor was admitted to the hospital with fever. He was administered paracetomal injection by the nurse in such a way that his right side was paralyzed. In this case the doctor was held vicariously liable for the injury and negligence. Case law: Mohd. Ishfaq v. Martin DSouza: The patient was put on haemodialysis and was asked to undergo a kidney transplant. He was administered medicine amicacin 500 mg. injections twice a day for about 10 days and at the end of which the patient lost his hearing power completely. Thus, it was the act of privation of hearing power from ears. Case law: Uttaranchal Forest Hospital v. Smt. Raisan: The complainants organ was removed with diagnostics that it was cancerous and when the organ was sent for diagnosis no cancer was

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detected. The State Commission found the doctor guilty of negligence for performing surgery that was wholly unnecessary. The Court will make greater allowance for a mistake on the part of surgeon when the operation is a race against time in emergency viz. case law: A. S. Mittal v. State of U. P. - ----oXo-----

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CHAPTER 7 Drugs and Magic Remedies(Objectionable advertisement) Act, 1954. Question 1: What is drug, megic remedies, advertisement under Drugs and Magic Remedies (Objectionable advertisement) Act, 1954? Answer: Drug and cosmetic Act, 1940: Definition of drug: i) Drug includes a medicine for internal or external use of human beings or animals; ii) Any substance intended to be used for or in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals; iii) Any article, other than food, intended to affect or influence anyway the structure or any organic function of the body of human beings or animals. Thus, It is the substance used in diagnosis, treatment or in the prevention of a disease and also used as a component of a medication. It describes in its Section 17 about misbranded drugs viz. if it is so coloured, coated powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or Section 17-A states in its subsection: that, if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health (e) If it contains any harmful or toxic substance which may render it injurious to health. Magic remedies: Magic remedies includes a talisman, mantra, kavacha, and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals or for affecting or influencing in any way the structure or any organic function of the body of human beings or animals. Advertisement: It includes any notice, circular, label, wrapper, or other document, and any announcement made orally or by any means of producing or transmitting light, sound or smoke. Case law: Zaffar Mahammad v. State of West Bengal: It was held by Supreme Court in this case that, Any article, other than food, which is intended to affect or influence in any way any organic function of the body of a human being is a drug within the meaning of Section 2(b)(iii). It should be remembered that Supreme Court has used the word: Anr article clearly means the gadget used can also be an article. Thus the drug is a medicine for the internal or external use of human beings or animals; It is any substance intended to be used for or in the diagnostic, cure, mitigation, treatment or prevention of disease in human beings or animals; It is any article, other than food, intended to affect or influence in any way the structure or any organic function of the body of human beings or animals; It is any article intended for use as a component of any medicine, substance or article, referred to in sub-clauses (i), (i) and (iii); Question 2: What is prohibited under Magic remedies Act?

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Answer: Subject to provision of this Act, no person shall take part in the publication of any advertisement referring to any drug in terms which suggest or are calculated to lead to the use of, that drug for:a) The procurement of miscarriage in women or prevention of conception in women; or b) The maintenance or improvement of the capacity of human beings for sexual pleasure; c) The correction of menstrual disorder in women; or d) The diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule, or any other disease, disorder or condition by whatsoever name called, which may be specified in the rules made under this Act; Provided that no such rule shall be made except:i) In respect of any disease, disorder or condition which requires timely treatment in consultation with a registered medical practitioner or for which there are normally no accepted remedies, and ii) After the consultation with the Drugs Technical Advisory Board constituted under the Drugs and Cosmetic Act, 1940 (23 of 1940), and, if the Central Government considers necessary, with such other persons having special knowledge or practical experience in respect of Ayurvedic or Unani systems of medicines as that Government deems fit. Section 4: Prohibition of misleading advertisements relating to drugs:Subject to the provisions of this Act, no person shall take any part in the publication of any advertisement relating to a drug if the advertisement contains any matter which:a) Directly or indirectly gives a false impression regarding the true character of the drug; Case law: Carllil v. Carbolic Gas Co. b) Makes a false claim for the drug; or c) Is otherwise false or misleading in any material particular. Under Section 5: Prohibition of advertisement of magic remedies for treatment of certain diseases and disorders:No person carrying on or purporting to carry on the profession of administering magic remedies shall take any part in the publication of any advertisement referring to any magic remedy which directly or indirectly claims to be efficacious for any of the purposes specified in Section 3. Under Section 6: Prohibition of import into, and export from India of certain advertisement:No person shall import into, or export from, the territories to which this Actextends, any document containing an advertisement of the nature referred to in Section 3, or Section 4, or Section 5, and any document containing any such advertisement shall be deemed to be goods of which the import or export has been prohibited under that Act shall have effect as if for the word shall therein the word may were substituted. - ----oXo-----

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CHAPTER 8 The transplantation of Human organ Act, 1994; The prenatal diagnostic techniques (Regulation and prevention of misuse) Act, 1954. Question 1: Write a note on; Transplantation of human organ Act Answer: Under Section 3: Authority for removal of human organs: (1) Any donor may, in such manner and subject to such conditions as may be prescribed, anuthorize the removal, before his death, of any human organs of his body for therapeutic purposes. (2) If any donor had, in writing and in the presence of two or more witnesses (at least one of whom is a near relative of such person), unequivocally authorize at any time before his death, the removal of human organ of his body, after his death, for the rapeutic purposes, the person in lawfully possession of the dead body of the donor shall, unless he has any reason to believe that the donor had subsequently revoked the authority aforesaid, grant to a registered medical practitioner all reasonable facilities for the removal, for therapeutic purposes, of that human organ from the dead body of the donor. (3) Where no such authority as is referred to in sub-section (2), was made by any person before his death but no objection was also expressed by such person to any of his human organs being used after his death for therapeutic purposes, the person lawfully in possession of the dead body of such person may, unless he has reason to believe that any near relative of the deceased person has objection to any of the deceased persons humans organs being used for therapeutic purposes, authorize the removal of any human organ of the deceased person for its use for therapeutic purposes. (4) The authority given under sub-section (1) or sub-section (2) or, as the case may be, subsection (3), shall be sufficient warrant for the removal, for the therapeutic purposes, of the human organ, but no such removal shall be made by any person other, but no such removal shall be made by any person other than the registered medical practitioner. (5) Where any human organ is to be removed from the body of a deceased person, the registered medical practitioner shall satisfy himself, before such removal, by a personal experimentation of a body from which any human organ is to be removed, that life is extinct in such body or, where it appears to be a case of brain-stem death, that such death has been certified under the subsection (6) (6) Where the human organ is to be removed from the body of a person in the event of his brainstem death, no such removal shall be undertaken unless such death is certified, in such form and in such manner and on satisfaction of such conditions and requirements as may be prescribed by a Board of medical experts consisting of the following, namely:(i) The registered medical practitioner in charge of the hospital in which brain-stem death has occurred; (ii) An independent registered medical practitioner, being a specialist, to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the Appropriate Authority;

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(iii) A neurologist or neurosurgeon to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the Appropriate Authority; and; (iv) The registered medical practitioner treating the person whose brain-stem death has occurred. (7) Notwithstanding anything contained in sub-section (3), where brain-stem death of any person, less than 18 years of age, occurs and is certified under sub-section (6), any of the parents of the deceased person may give authority, in such form and in such manner as may be prescribed, for the removal of any human organ from the body of the deceased person. Under Section 4: Removal of human organs not to be authorized in certain cases:(1) No facilities shall be granted under sub-section (2) of Section 3, and no authority shall be given under sub-section (3) of that Section for the removal of any human organ from the body of a deceased person, if the person required to grant such facilities, or empowered to give such authority, has reason to believe that an inquest may be required to be held in relation in such body in pursuance of the provisions of any law in the any time being in force. (2) No authority for the removal of any human organ from the body of the deceased person shall be given by a person a person to whom such body has been entrusted solely for the purpose of interment, cremation or other disposal. Under Section 5: Authority for removal of human organ in case of unclaimed bodies in hospital or prison:(1) In case of dead body lying in the hospital or prison and not claimed by any of the near relatives of the deceased person within the 48 hours from the time of the death of the concerned person, the authority for the removal of any human organ from the dead body which so remains unclaimed may be given, in the prescribed form, by the person in charge, for the time being, of the management or control of the hospital or prison, or by an employee of such hospital or prison authorized in this behalf by the person in charge of the management or control thereof. (2) No authority shall be given under sub-section (1) if the person empowered to give such authority has reason to believe that any near relative of the deceased person is likely to claim the dead body even though such near relative has not come forward to claim the body of the deceased person within the time specified in sub-section (1). Under Section 6: Authority for removal of human organs from bodies sent for post-mortem examination for medico-legal or pathological purpose:Where the body of the person has been sent for the post-mortem examination(a) For medico-legal purposes by reason of the death of such person having been caused by accident or any other unnatural cause; or (b) For pathological purposes. The person competent under this Act to give authority for the removal of any human organ from such dead body may, if he has reason to believe that such human organ will not be required for the purpose for which such body has been sent for post-mortem examination, authorities the removal, for therapeutical purpose, of that human organ of the deceased person provided that he is satisfied that the deceased person had not expressed, before his death, any

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objection to any of his human organs being used, for therapeutic purposes after his death or, where he had granted an authority for the use of any of his human organs for therapeutic purposes after his death, such authority had not been revoked by him before his death. Section 9: Restrictions on removal and transplantation of human organs:(1) Save as otherwise provided in sub-section (3), no human organ removed from the body of a donor before his death shall be transplanted into a recipient unless the donor is a near relative of the recipient. (2) Where any donor authorizes the removal of any of his human organs after his death under sub-section (2) of Section 3 or any person competent or empowered to give authority for the removal of any human organ from the body of any deceased person authorized such removal, the human organ may be removed and transplanted into the body of any recipient who may be in need of such human organ. (3) If any donor authorizes the removal of any of his human organs before his death under subsection (1) of Section 3 for transplantation into the body of such recipient, not being a near relative, as is prescribed by the donor by reason of affection or attachment towards the recipient or for any other special reasons, such human organ shall not be removed and transplanted without the prior approval of the authorization committee. (4) (a) The Central Government shall constitute by notification, one or more authorization committees consisting of such members as may be nominated by the Central Government on such terms and conditions as may be specified in the notification for each of the Union Territories for the purpose of the Section. (5) On an application, jointly made, in such form and in such manner as may be prescribed, by the donor and recipient, the authorization committee shall, after holding an inquiry and after satisfying itself that the applicants have complied with all requirements for this Act and the rules made thereunder, grant to the applicants approval for the removal and transplantation of the human organ. (6) If, after the inquiry and after giving an opportunity to the applicants of being heard, the authorization committee is satisfied that the applicants have not complied with the requirements of this Act and the rules made thereunder, it shall, for the reasons to be recorded in writing, reject the application for approval. Under Section 10: Regulation of hospitals conducting the removal, storage or transplantation of human organs:(1) On and from commencement of this Act,(a) No hospital, unless registered under this Act, shall conduct, or associate with, or help in, the removal, storage, or transplantation of any human organ; (b) No medical practitioner or any other person shall conduct, or cause to be conducted, or aid in conducting by himself or through any other person, any activity relating to the removal, storage or transplantation of any human organ at a place other than a place registered under this Act; and

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(c) No place including a hospital registered under sub-section (1) of Section 15 shall be used or cause to be used by any person for the removal, storage or transplantation of any human organ except for therapeutic purposes. (2) Notwithstanding anything contained in sub-section (1), the eyes or the ears may be removed at any place from the dead body of any donor, for therapeutic purpose, by a registered medical practitioner. For the purpose of this sub-section, ears includes ear-drums and ear-bones. Under Section 11: Prohibition of removal of transplantation of human organs for any purpose other than therapeutic purposes:No donor and no person empowered to give authority for the removal of any human organ shall authorize the removal of any human organ for any purpose other than therapeutic purposes. Under Section 12: Explaining effects, etc., to donor and recipientNo registered medical practitioner shall undertake the removal or transplantation of any human organ unless he has explained, in such manner as may be prescribed, all possible effects, complications and hazards connected with the removal and transplantation to the donor and the recipient respectively.

Case law: Charan Singh v. Healing Touch Hospital: The appellant had brought the claim of Rs. 34 lakhs for removal of his one of the kidneys without his consent during the course of his operation. The Supreme Court remarked that, It is not merely the alleged harm or mental pain, agony or physical discomfort, loss of salary, emolutions, etc., it is rather quality of conduct, committed by respondents upon which attention is required to be founded in the case of proven negligence. Question 2: Note on: Indications of prenatal diagnostic tests. Answer: For genetic disorders, abortion is accepted where a crippled child is likely to be born. In some other cases, the child may be treated to remove the defects, if so advised by the doctor. After the diagnostic results are known to the doctor in respect of genetic disorder, he is provide factual information regarding the nature of disorder and its mode of inheritance. While the information is communicated, the doctor should consider the psychological impact. In case of prenatal diagnosis, any inaccurate results may have devastating effects on the couple and may lead to moral and legal consequences. The decision of the couple should be based on qualified information regarding prenatal diagnostic procedure and further counseling after it. The counseling should be non-coercive and respectful of the views of the parents about abortion. Techniques Indications 1) Amniocentesus (a) Amniotic fluid Spina bifida and anoncephaly chromosomal abnormalities. (b) Amniotic fluid cells Metabolic disorders, foetal sensing and recombitant DNA studies.

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2) Chorionic Villus biopsy 3) Ultrasonography (a) CNS abnormalities (b) Renal abnormalities (c) Castointestinal abnormalities (d) Cardiac abnormalities 4) Foetos copy (a) Foetus blood sampling (b) Foetal morphology (c) Foetal biopsy

Chromosal abnormalities, biochemical and DNA studies. Spina bifida, anoncephaly, hydrocephaly and microcephaly Infantile polycytic kidneys and renal agencies. Intestinal atresias Chondrodystrophies, phocomelias, septal defects, etc.

Haemophilia, L3-anti-tripsin deficiency Facial defects, peripheral limb abnormalities Skin: epidermolysis bulloser Liver: Ornithine transcarbymylase deficiency 5) Radiography Skeletal dysplasias. Haemophilia: It is the group of bleeding disorders in which it takes a long time for the blood to clot. There are two types of hemophilia viz. Hemophilia A and hemophilia B. Hemophilia lowers blood plasma clotting factor levels of the coagulation factors needed for a normal clotting process. Wilsons disease: It is an inherited disorder in which there is too much copper in the bodys tissue. The excess copper damages the liver and nervous system. Case law: Maynard v. Midland: It is the tort law case concerning the Bolam test for professional negligence. The patient presented with symptoms of tuberculosis but both consulting physicians and the consultant surgeon took the view that Hodgkins disease, Carcinoma and sarcoidosis were also possibilities, the first of which if present would have required remedial steps to be taken in its early stage. Question 3: What is difference between sonography and radiography? Answer: Sonography is the ultrasound-based diagnostic imaging technique used for visualizing subcutaneous body structures including tendons, muscles, joints, vessels and internal organs for possible pathology or lesions. It is commonly used during pregnancy Radiography: It is the use of X-ray to view a non-uniformly composed material such as human body. Both of them are non-destructive testing. Though there is high damage to bone marrow in case of X-ray. Frequent use of radiography may lead to bone marrow damages. Sonography detected more joint and tendon sheath effusions than radiography. Sonography reveals more details of fractures than does radiography. Radiography is involved in CT, MR, Angiography etc. whereas sonographers perform ultrasounds. It is used in detection of gall-bladder stone and size, urinary-bladder stone and its size.

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Radiography is not allowed for the pregnant women because it adversely affects the growth of the fetus and may lead to bone marrow damage of the fetus developing in him the birth abnormalities. Sono-waves are utilized for crushing the kidney stone when it is in the bladder. Radio waves do not have such use for crushing. However for brain-damage or brain-clot radiographic techniques are useful whereas sonographic techniques are not of much diagnostic use. Accuracy of sonography is said to be more than radiography. Radiography is useful for detection of lung scars called as Koch scars whereas sonography does not help to detect Koch scar. - ----oXo-----

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CHAPTER 9 Various acts related to medical sciences Question 1: How the medical Acts developed in India? Answer: 1) Opium Act. 1878. 2) Vaccination Act, 1880 3) Epidemic Diseases Act, 1897 This Act was to provide power to exercise for the control and to prevent any epidemic or spread of epidemic in the State of Country. The States may authorize any of its officers or agency to take such measures if the state feels that the public at large is threaten with an outbreak of any dangerous epidemic. There was immunity as: No suit or legal proceeding shall lie against any person for anything done or in good faith intended to be done under this Act. 4) Medical Degrees Act, 1916 This was the licence to practice Western Medical science. 5) The Poisons Act, 1919 6) Dangerous Drugs Act, 1930 7) Drugs Enquiry Committee, 1931. The committee was established under the Chairmanship of Lt. Col. R. N. Chopra. 8) The Drugs and Cosmetic Act, 1940 The object of the Act is to regulate the import, manufacture, distribution and sale of the drugs. Under the province of this Act, the Central Government appoints the Drugs Technical Advisory Board to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act. The board can constitute subcommittees fro consideration of particular matters. 9) Pharmacy Act, 1948 The Act was amended in 1959, 1976 and 1984. The aim of the law is to regulate the profession of Pharmacy in India. 10) The Drug control Act, 1950 11) The rugs and Magic Remedies (Objectionable advertisements) Act, 1954. This Act was meant to control the Advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities and to provide for matters connected therewith. The drug and magic remedies Act prohibits a person from taking part in publication of any advertisement referring to any drug which suggests use of the drug for:(a) The procurement of miscarriage in women and prevention of conception in women; and (b) The maintenance and improvement of the capacity of the human being for sexual pleasure; (c) The correction of menstrual disorders in women; (d) The diagnosis, cure, mitigation, treatment or prevention of any venereal disease. It is prohibited to directly or indirectly give a false impression regarding the true character of the drug or make false claim for it or to convey any false or misleading information

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in any material particular about it. No person shall import into or export from India any document containing advertisement of this nature. 12) Indian Medical Council Act, 1956 13) The Medicinal and Toilet Preparations (Excise Duties) Act, 1956. 14) The Medical Termination of Pregnancy Act, 1971. 15) The cigarettes [Regulation of production, Supply and Distribution] Act, 1975 16) The Narcotic Drugs and Psychotropic substances Act, 1985. Case law: Durand Didier v. Chief Secretary, Union Territory Goa: The anguish of SC was expressed as: with deep concern we may point out that the organized activities of the underworld and the clandestine smuggling of narcotic drugs and psychotropic substances into this country and illegal trafficking in such drugs and substances have led to drug addiction among the sizable section of the public particularly in adolescence and students of both sexes and the menace has assumed serious and alarming proportion in the recent years. 17) Public Liability Insurance Act, 1991. 18) The Drugs (Prices control) Order 1995 (Under the essential commodities Act) There are also Indian Medical Degrees Act which was enacted in 1916, Indian Medical council act, 1933 and amended in 1956 and 1964. The narcotic drugs and psychotropic substances Act was enacted repealing the Dangerous Drugs Act 1930 and the Opium Act of 1878. Question 2: What is D. M. R. Act and objectionable remedies? Answer: D. M. R. : stands for Drugs and Magic Remedies (Objectionable advertisement) Act, 1954. The objectionable advertisements tend to cause to ignorant and unwary consumer to resort to slf-medication or to resort to quacks who indulge in such advertisements for treatments, which cause great harm. Question 3: Describe Drug and Cosmetic Act, 1940. Answer: It has in all five chapters. The first chapter describes the short title and long title and also definitions. It defines drug as: (i) All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; (ii) Such substances (other than food) intended to affect the structure or any function of human body or intended to be used for the destruction of (vermin) or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the official Gazette. (iii) All substances intended for use as components of a drug including empty gelatin capsules; and (iv) such devices intended for internal or expernal use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to

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time by the Central Government by notification in the official gazette, after consultation with the Board. Chapter II defines The drug technical advisory board, the central drug laboratory and the drugs consultative committee. The third chapter is about the import of drugs and cosmetics. Fourth chapter is about manufacture, sale and distribution of drugs and cosmetics. Chapter IVA is an additional chapter which informs about Ayurvedic, siddha and Unani drugs. Chapter V is the miscellaneous. - ----oxo-----