UNIT IGood health, free from disease, is not only the very foundation for a healthy life, but equally recognized as a human right and a constitutional fundamental. Health, being one of the essential components of an adequate standard of living is always accompanied by the legal regulations.

a. What is right to health:The right to health includes healthy environment to live or work in, and access to adequate health care facilities including medical, preventative, and mental, nutrition, sanitation, and to clean water and air.

While the availability, accessibility, acceptability and quality of these is important, the question of access to drugs stands out in the context of the TRIPs Agreement.

b. Constitutional Provisions: The humbler the Indian human, the higher the state's duty to protect the person

The obligation on the State to ensure the creation and the sustaining of conditions congenial to good health is cast by the Constitutional directives contained in various articles viz: .

The Preamble to the Constitution which gives a broad direction for the Indian Republic, refers to social, economic and political justice and also equality of status and of opportunity. Under the term Social Justice, one can bring in the question of access to health care facilities and the principle of justice involved in the equality of access to these facilities

Article 21 of the Constitution guarantees protection of life and personal liberty by providing that, No person shall be deprived of his life or personal liberty except according to the procedure established by law.As a result of liberal interpretation of the words life and liberty, Article 21 has now come to be invoked almost as a residuary right. Public interest petitions have been founded on this provision for providing special treatment to children in jail; against health hazards due to pollution; against health hazards from harmful drugs; for redress against failure to provide immediate medical aid to injured persons; against starvation deaths; against inhuman conditions in after-care home and on scores of other aspects which make life meaningful and not a mere vegetative existence. A positive thrust is given to the nature and content of this right by the Apex Court imposing a positive obligation upon the State to take effective steps for ensuring to the individual a better enjoyment of his life. The Supreme Court has held that the right to live with human dignity enshrined in Article 21 derives its life and breath from the directive principles of State. Few of the landmark cases are as under:

Parmananda Katara v. Union of India AIR 1989 SC 2039Article 21 of the Constitution casts the obligation on the State to preserve life.

Paschim Bang Khet Mazdoor Samiti v. State of W.B. (1996) 4 SCC 37 The Supreme Court held that Art. 21 imposes an obligation on the State to provide medical assistance to every injured person. Preservation of human life is of paramount importance.

Consumer Education and Research Centre v. Union of India (1995) 3 SCC 42 Right to Life in Art. 21 does not connote mere animal existence. It has a much wider meaning which includes right to livelihood, better standard of life, hygienic conditions in workplace and leisure.

Kirloskar Brothers Ltd. v. Employees State Insurance Corporation (1996) 2 SCC 682.The Supreme Court, following the above case, held that right to health is a fundamental right. The Court further held that it is a right not only available against the State and its instrumentalities but even private industries State of Punjab v. Mohinder Singh Chawla AIR 1997 SC 1225right to health has been declared a fundamental right under the Constitution of India and State is obliged to provide adequate condition for healthy life.

Article 39(e)- health and strength of workers, men and women, and the tender age of children are not abused and that citizens are not forced by economic necessity to enter avocations unsuited to their age or strength

Article 39(f)- children are given opportunities and facilities to develop in a healthy manner and in conditions of freedom and dignity and that childhood and youth are protected against exploitation and against moral and material abandonment.

Article 42- The State is required to make provision for just and humane conditions of work and for maternity benefit.

Article 47 - It is the primary duty of the State to endeavor the raising of the level of nutrition and standard of living of its people and improvement of public health and to bring about prohibition of the consumption, except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health.

ARTILCE 51A(a)It shall be the duty of every citizen to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creaturesArticle 243G and 243W empowers panchayats and municipalities respectively , with such powers and authority and may be necessary to enable them to function appropiatley for the preparation of plans for economic development and social justice;

VII Schedule:

State List- Entry 6 : State legislature is empowered to make laws with respect to public health and sanitation, hospitals and dispensaries.

Concurrent List Entries 23, 26 and 29 : Both the Centre and the States have power to legislate in the matters of social security and social insurance, medical professions, and, prevention of the extension from one State to another of infections or contagious diseases or pests affecting man, animals or plants, by entries 23, 26 and 29 respectively contained in the concurrent list of the Seventh Schedule.International Scenario on Right to health

Right to health has also been a concern at the international community and the same can be seen from the various declarations and conventions.

Universal Declaration of Human Rights, 1948: Article 25 guarantees a right to adequate standard of living for the health and well-being of a person and his family including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.

International Convention on the Elimination of All Forms of Racial Discrimination 1965: Under article 5 (e) (iv) the right to health is recognized.

International Convention on the Elimination of All Forms of Racial Discrimination, 1969: Article 5 in compliance with the fundamental obligations laid down in article 2 of this Convention, requires the States Parties to prohibit and to eliminate racial discrimination in all its forms; guarantees social, economic and cultural right of everyone, without distinction as to race, colour, or national or ethnic origin Article 7, 11 and 12 recognize the right of everyone to ... just and favourable conditions of work.

International Covenant on Economic, Social & Cultural Rights, 1976: Article 12 recognizes the right of everyone to the enjoyment of the highest attainable standard of physical and mental health... and also requires the State to take necessary steps for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child; for the improvement of environmental and industrial hygiene; for the prevention, treatment and control of epidemic, endemic, occupational and other diseases, etc.

Committee on Economic, Social & Cultural Rights : General Comment 14: Article 12 guarantees the highest attainable standard of health.

Convention on the Elimination of All Forms of Discrimination against Women, 1979: Article 11, 12 and 14 assures the safety in working conditions, appropriate measures to eliminate discrimination against women and providing special attention and care to women. Convention on the Rights of the Child, 1989: Article 24 requires the State to ensure that no child is deprived of his/ her right of highest attainable standard of health and access to such health care services set forth in the present Convention and in other international human rights or humanitarian instruments to which the said States are Parties.

African [Banjul] Charter on Human and Peoples' Rights: Article 16 recognises the right of everyone to enjoy the best attainable state of physical and mental health.

Similarly the entire Constitution of the World Health Organization is relevant to the right to health without distinction of race, religion, political belief, economic or social condition."

Several regional human rights instruments also recognize the right to health, such as the European Social Charter of 1961 as revised (art. 11), the African Charter on Human and Peoples' Rights of 1981 (art. 16) and the Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social and Cultural Rights of 1988 (art. 10). Similarly, the right to health has been proclaimed by the Commission on Human Rights as well as in the Vienna Declaration and Programme of Action of 1993 and other international instruments.

Thus, various Conferences, Treaties, Declarations, Conventions, etc have been made at the international era to recognize the right to health and a duty has been caste upon the state to provide such adequate means and conditions for the enjoyment of such right. India is also a member of most of the above.

Thus, on the one hand, it is the duty of the Government to provide adequate facilities for a healthy life, while on the other hand, TRIPS requires the states to provide for the product patent resulting in the hike of the drug prices and ultimately posing a severe question of affordability. Thus, it is difficult to determine, whether right to health is a myth or reality?

UNIT II (Narcotic Drugs & Psychotropic Substances Act,1985)

Narcotic Drugs and Psychotropic Substances have several medical and scientific uses. However, they can be and are also abused and trafficked. India's approach towards Narcotic Drugs and Psychotropic Substances is enshrined in Article 47 of the Constitution of India which mandates that the State shall endeavour to bring about prohibition of the consumption except formedicinal purposes of intoxicating drinks and of drugs which are injurious tohealth. The system of control of Narcotic Drugs in India has been put in place considering the requirement of narcotic drugs and psychotropic substances for medical use and the countrys obligations towards the UN conventions. India is a signatory to The UN Single Convention on Narcotics Drugs 1961, The Convention on Psychotropic Substances, 1971 and The Convention on Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 which prescribe various forms of control aimed to achieve the dual objective of limiting the use of narcotics drugs and psychotropic substances for medical and scientific purposes as well as preventing the abuse of the same.

The administrative and legislative setup in the field of Narcotics has been put in place in the country in accordance with the aforesaid spirit of the UN Conventions. The basic legislative instrument of the Government of India in the regard is the Narcotics Drugs and Psychotropic Substances (NDPS) Act, 1985. Various Ministries and Departments under the Government of India as well as the State Governments exercise various functions pertaining to drug demand and supply reduction. The aspect of drug supply reduction is looked after by various enforcement agencies under the Ministry of Finance, Ministry of Home Affairs and State Governments. The aspect of drug demand reduction is handled by the Ministry of Social Justice & Empowerment and that of treatment of drug addicts and their rehabilitation falls under the domain of the Ministry of Health. The NDPS Act defines offences, prescribes the procedure for investigation including searches, seizure, and arrests, and provides for punishments for each offence Hence aim and objective is to1. to consolidate and amend the lawrelating to narcotic drugs & psychotropic substances.

2. to make stringent provisionsfor control, forfeiture of property,derived from or used in illicit traffic

3. to implement the provisions of the international conventions nds&pss.

4. all the matters related there to.

Drugs that are abused can be classified into:

1. Natural drugs{Opium poppy, Cannabis and Coca)1. Semi-synthetic drugs; and

2. Synthetic drugs.

Effects of drugs

When abused, drugs produce a variety of effects depending upon the drug:

1. Stimulants increase the activity of the abuser and make him more lively and active. Some stimulants such as amphetamines were used in wars to make the soldiers more active.2. Sedatives make the person feel sleepy and reduce his activity. Opium and opiates are good examples of sedatives.

3. Hallucinogens create hallucinations in the abuser. LSD is one of the well known hallucinogens.

4. Tranquilisers calm the nerves of the addict without making him feel sleepy.5. Drugs of abuse are smoked, snorted, consumed orally or injected. Injecting drug users (IDUs) often share needles and syringes and infections spread through them. If a member of the group of addicts is HIV positive, the infection spreads to others through needles and syringes

Relevant provision prohibiting,controlling and preventing use of drug(sec8-14)

Section 10 of the NDPS Act empowers the State Government to permit and regulate, transport, sale, use, etc. of poppy straw. This power of the State Governments is subject to the restriction under Section 8 by which no narcotic drug or psychotropic substance can be used except for medical or scientific purposes . Section 9 of the NDPS Act empowers the Central Government to licence cultivation of coca bush for medical and scientific purposes.Amendment in 2014

The amendments 2014 make important, path breaking changes for medical access to narcotic drugs by removing barriers that date back to 1985, when the Act was first introduced. The amendments also include provisions to improve treatment and care for people dependent on drugs, moving away from abstinence oriented services to treating drug dependence as a chronic, yet manageable condition. The amendments broaden the object of the NDPS Act from containing illicit use to also promoting the medical and scientific use of narcotic drugs and psychotropic substances. The language incorporated in section 4, which is an overarching provision, reflects the principle of balance between control and availability of narcotic drugs, which is at the heart of international drug control Parliament has adopted a new category of essential narcotic drugs in section 2(viiia) of the Act a list, which the Central Government can notify on the basis of expediency in medical practiceS. 71 of the amended Act, it is concluded that there is a move to protect the interests of drug addicts affirmatively.Unit III

Doctor patient relationship and duty to take care and duty to treatPhysicians and surgeons are medical practitioners who treat illness and injury by prescribing medication, performing diagnostic tests and evaluations, performing surgery, and providing other medical services and advice. Physicians and surgeons are highly trained and duly authorized by law to practice medicine.

A physician stands in a fiduciary relationship to her patients, meaning that the physician must always exercise the utmost Good Faith and trust when dealing with patients. A confidential relationship exists between the parties: because a patient must feel free to disclose any information that might pertain to treatment and diagnosis, the physician has the professional obligation to keep information confidential absent a patient's consent. But a physician cannot attempt to shield his own incompetence by refusing to disclose information. Moreover, a physician may have a statutory duty to reveal information concerning a patient. Doctors are required to provide authorities with information regarding birth and death, Child Abuse, and contagious or infectious diseases. A physician may also have a duty to disclose confidential information to third parties in other circumstances.

Physicians and their patients have a contractual relationship. The relationship continues until treatment is completed or upon agreement by the parties. The physician agrees to treat the patient but rarely promises a specific outcome or cure. If a doctor promises a specific outcome but fails to deliver it, the doctor may be liable for breach of contract. One example would be a surgeon who promises that cosmetic surgery will produce certain results.

A physician's conduct must always meet the standard of care set by the profession, or he may be liable for Malpractice. Physicians and surgeons must possess and exercise the same level of skill and learning ordinarily possessed and exercised by other members of their profession under similar circumstances.

Although not absolute in every instance, some of the responsibilities a physician or surgeon has toward a patient include a duty to

Fully inform a patient of her condition;

Notify a patient of the results of a diagnosis or test;

Inform the patient of the need for different treatment or refer the patient to a specialist or other qualified practitioner;

Continue medical care until proper termination of the relationship;

Give proper notice before withdrawal from treatment;

Not abandon a patient, including making arrangements for treatment during absences;

Treat nonpaying patients the same as those who pay;

Use diligence in treatment in providing all necessary care;

Obtain a patient's informed consent before performing a medical procedure;

Instruct others as to the care and treatment of a patient;

Warn others of exposure to communicable and infectious diseases.

A patient has a duty to cooperate with a physician and participate in treatment and diagnosis. For example, a patient does not have a general duty to volunteer unsolicited information but is required to disclose a complete and accurate medical history upon questioning by a physician. A patient also must return for further treatment when required. Failure to cooperate or participate in treatment may result in a limited recovery for a physician's malpractice or completely bar recovery, depending upon the circumstances of the case.

Medical negligence and malpractice Negligence is the event in which an individual does not do something in a situation in which a helpful action is needed. Medical negligence, however, is slightly different, due to the fact that these situations involve medical professionals, who have been trained in their field. Medical negligence is the event in which a medical professional fails to take an action that otherwise would have prevented harm upon their patient. Some examples of medical negligence are ignoring the individual, avoiding answering questions of the patient or those of their family, operating on the wrong limb, or even not performing enough tests to determine a correct diagnosis.

Medical negligence most often gets confused with medical malpractice. The two are very much related, but they are not the same entity. Both consist of the same four elements of the duty, the breach, the damage, and the injury, but the difference between the two is an unfortunate accident that could have been prevented, and information that was kept from the patient who needs to know their condition. Medical malpractice is also the event in which the patient experiences unnecessary procedures or trauma. While medical negligence is negligence in the medical field by a professional who should have known better, medical malpractice is a foolish action that could have been corrected with knowledge of their actions and their field.

Duty: A medical professional owes a duty to his or her patient. That duty is to perform with reasonable care, as per the medical standards, to prevent injuries.

Breach: Once duty is established, it needs to be determined whether there was a breach of that duty.

Causation: For a negligence claim, it is not enough that a duty was breached. The injured party must also show that the breach of duty was the cause of the injuries sustained.

Damages: The damages were talking about are pecuniary damages, placing a value on the harm done to the patient. The damages might include lost wages and medical bills. They could include general damages, such as pain and suffering. Punitive damages, which are intended to punish the negligent party for his or her actions, could be included as well.

Medical Malpractice

Medical malpractice is the illegal event in which the bond of trust between medical professional and client has in some form been breached with intention. It is under the umbrella of negligence, as it is the occurrence in which the malign negligence is committed by a health care provider. Health care providers refer to most professionals in the medical field, such as physicians, doctors, dentists, nurses, and therapists. The malpractice exists when treatment is not provided as is standard and safe procedure, which thus results in injury or even death to the patient.

Medical negligence can lead to a medical malpractice claim if the even of malpractice is proven to be involved in four areas with intent: a duty was owed and was never followed through; a professional responsibility was breached and the care was not standard; the breach caused an injury or death; and the patient was negatively affected in some form by the damage. In shorter terms, medical malpractice occurs when any medical professional does not provide the standard legal care to their patient in regards to their profession. The element of damage refers to any damages that affected the client in any way, including monetary, physically, or emotionally. The time frame required from the incident to the case filing varies between locations and type of medical malpractice.

juggankhan v. The State of Madhya Pradesh

it was a rash and negligent act to prescribe poisonous medicines without studying their probable effect. The Court also held that though it was true,as ruled in , John Oni v King [AIR (1943) 30 PC 72], that care should be taken before imputing criminal negligence to a professional man acting in the course of his profession, even then it was clear that the appellant was guilty of a rash and negligent act and hence liable for conviction under s. 304A, IPC.

Dr. Laxman Balkrishna Joshi v Dr. Trimbak Bapu Godbole & AnotherThe medical practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence, judged in the light of the particular circumstances of each case was what the law required

A.S. Mittal and another V State of UP and Others

the Court went to observe that a mistake by a medical practitioner which no reasonably competent and careful practitioner would have committed was a negligent one

Jacob Mathew v. State of Punjab three Judge Bench of Supreme Court by order quashed prosecution of a medical professional under Section 304-A/34 IPC and disposed of all the interlocutory applications that doctors should not be held criminally responsible unless there is a prima-facie evidence before the Court in the form of a credible opinion from another competent doctor, preferably a Government doctor in the same field of medicine supporting the charges of rash and negligent act.Indian Medical Association v V.P. Shanta and Others

state of Rajasthan v Vidhyawati, N Nagendra Rao and Co. v Slate of A..P , State maharashtra v Kanchanmala Vijaysing Shirke, and in Bolam v. FeiernHospital Management Committee the Supreme Court held that running of hospitals by the Government was a welfare activity and not a function carried out in exercise of its sovereign power.

Spring Meadows Hospital & another v Harjol Ahluwalia through K.S. Ahluwalia & AnotherThe Court also indicated thatuse of wrong drug or gas during anesthesia or delegation of responsibility knowing that the delegatee was incapable of performing his duties properly were some instances of tortious negligence.

Unit 4Surrogacy or Surrogate means substitute. In medical parlance, the term surrogacy means using of a substitute mother in the place of the natural mother.

Commercial surrogacy has been legal in India since 2002.

India is emerging as a leader in international surrogacy and a sought after destination in surrogacy-related fertility tourism. Indian surrogates have been increasingly popular with fertile couples in industrialized nations because of the relatively low cost. Indian clinics are at the same time becoming more competitive, not just in the pricing, but in the hiring and retention of Indian females as surrogates. Clinics charge patients roughly a third of the price compared with going through the procedure in the UK.

International Surrogacy involves bilateral issues, where the laws of both the nations have to be at par/uniformity else the concerns and interests of parties involved will remain unresolved and thus, giving due regard to the concerns and in order to prevent the commercialization of the Human Reproductive system, exploitation of women and the commodification of Children, the law commission has submitted its report with the relevant suggestion:

The Law Commission of India has submitted the 228th Report on NEED FOR LEGISLATION TO REGULATE ASSISTED REPRODUCTIVE TECHNOLOGY CLINICS AS WELL AS RIGHTS AND OBLIGATIONS OF PARTIES TO A SURROGACY. The following observations had been made by the Law Commission: -

(a) Surrogacy arrangement will continue to be governed by contract amongst parties, which will contain all the terms requiring consent of surrogate mother to bear child, agreement of her husband and other family members for the same, medical procedures of artificial insemination, reimbursement of all reasonable expenses for carrying child to full term, willingness to hand over the child born to the commissioning parent(s), etc. But such an arrangement should not be for commercial purposes.

(b) A surrogacy arrangement should provide for financial support for surrogate child in the event of death of the commissioning couple or individual before delivery of the child, or divorce between the intended parents and subsequent willingness of none to take delivery of the child.

(c) A surrogacy contract should necessarily take care of life insurance cover for surrogate mother.

(d) One of the intended parents should be a donor as well, because the bond of love and affection with a child primarily emanates from biological relationship. Also, the chances of various kinds of child-abuse, which have been noticed in cases of adoptions, will be reduced. In case the intended parent is single, he or she should be a donor to be able to have a surrogate child. Otherwise, adoption is the way to have a child which is resorted to if biological (natural) parents and adoptive parents are different.

(e) Legislation itself should recognize a surrogate child to be the legitimate child of the commissioning parent(s) without there being any need for adoption or even declaration of guardian.

(f) The birth certificate of the surrogate child should contain the name(s) of the commissioning parent(s) only.

(g) Right to privacy of donor as well as surrogate mother should be protected.

(h) Sex-selective surrogacy should be prohibited.

(i)Cases of abortions should be governed by the Medical Termination of Pregnancy Act 1971 only.InJan Balaz v Union of India, theGujarat High Court conferredIndian citizenship on two twin babies fathered through compensated surrogacy by a German national inAnand district in Gujarat.The Report has come largely in support of the Surrogacy in India, highlighting a proper way of operating surrogacy in Indian conditions. Exploitation of the women through surrogacy is another worrying factor, which the law has to address. The Law Commission has strongly recommended against Commercial Surrogacy. However, this is a great step forward to the present situation. We can expect a legislation to come by early 2011 with the passing of the Assisted Reproductive Technology Bill aiming to regulate the surrogacy business. Prevalence and success of surrogacy in IndiaPrevalence in India is hard to predict as there are no exact figures available and prevalence is also dependent on specialised centres that cater to surrogacy as an option to couples that have no other way of getting a baby of their own.

However, the success rate of surrogacy is almost 45% with fresh embryos and 25% with frozen embryos.

The package for surrogacy in India almost costs 50% less as compared to other countries and can vary between Rs 8,00,000 to 15,00,000 approximately.The surrogacy package price estimate above, covers doctor fees, legal fees, surrogate work up, antenatal care, delivery charges, surrogate compensation, egg donor, drugs and consumables, & IVF costs.

Unit VTreatment and Disposal of Bio-Medical Wastes The methods of treatment and disposal of Bio-Medical Wastes are the main aspects of these Rules. Schedule I has laid down the categories of wastes and their methods of treatment while the scientific standards for operating technical instruments like incinerators, autoclaves and microwaves are prescribed in Schedule V.According to Schedule VI of the BWM 2011 Rules, a time-frame was envisaged for the use of Bio-Medical Waste treatment facilities of incineration, microwaving and autoclaving system. India has been a pioneer in the South Asian Region to have a legal control of Bio-Medical Waste Management, known as the Bio-Medical Waste (Management and Handling) Rules, 1998 as they are the first of its kind of national law in the whole of South-East Asian region. However, since national legislation is the only basis for improving healthcare waste management practices in any country, there should be a clear foresight of the enforcement of the provisions, even before the law is enacted. Unfortunately, the Indian law failed to have such a foresight and it even failed to come up to the standard prescribed by the WHO, namely for alternatives to incineration. In common parlance, Bio-Medical Wastes are most often referred to as hospital waste or healthcare waste and consequently, would not include wastes from research activities and veterinary care. Therefore these wastes being outside the strict mainstream of Bio-Medical Waste as commonly understood, the definition of Bio-Medical Waste ought to have excluded these aspects. A separate categorization of these wastes could have been done since such wastes are scientifically bio-medical in nature and their ill-effects can be harmful.

The Rules are very wide and includes the Occupier of an institution who generates Bio-Medical Waste(rule 4) .However there is a direction mentioning that all steps are to be taken to handle such waste without any adverse effect to health and the environment. As far as the treatment and disposal of various categories of BioMedical Wastes are concerned, Schedule I of the rules provide for several modes of treatment and disposal options. Amongst these rules, there is mention about setting up of incinerator or any other alternative mechanism in a hospital.320

The Pollution Control Board(rule 5) is not equipped with enough infrastructures to check each and every incinerator of a hospital in relation to its operation and emission standards as provided in Schedule V. Strangely, the rules even imposed deadlines regarding setting up of incinerators amongst any other methods,(schedule 6) even after they had been discarded by western countries.323 Besides, in the use of incineration, there is reportedly emission of dioxins and furans, which are carcinogenic In a hospital environment, technologies like incineration fail because untrained janitor staff runs them. The incinerator should be used at its optimum level otherwise the waste may not be treated properly. In most of the surveys carried out, incinerators run at temperatures lower than those specified in the rules and due to this poor operation and maintenance, these incinerators do not destroy the waste, need a lot of fuel to run, and are often out of order. When every hospital uses an incinerator, it is underutilized since the amount of infectious waste of a single hospital is not sufficient for the optimum use of the machine, thereby leading improper treatment of BioMedical Waste. Therefore on the whole, it is not feasible for every hospital to use an incinerator and it is preferable to have centralized incinerators instead.

The Rules6(6) provide that treated Bio-Medical Wastes are to be picked up and transported by municipal bodies as also segregated non bio-medical solid waste.Rule requires reconsideration to ensure the objectives of segregation since, as of now, segregation of the BioMedical Waste into specific categories of Bio-Medical Waste and storage in different colour coded containers is not being implemented to an appreciable extent, as observed.rule 6(2)There are no means to distinguish with an absolute precision between the two types of wastes. A small carelessness of throwing a syringe or a needle contaminated by infectious waste will pose great danger as the waste which is assumed to be non bio-medical solid waste could in fact be infectious waste as a result. Therefore this Rule is not at all feasible as utmost care is required while segregating and findings reveal that the required standard of care is not present. Hence this Rule6(5) requires reconsideration to ensure the objectives of segregation since, as of now, segregation of the BioMedical Waste into specific categories of Bio-Medical Waste and storage in different colour coded containers is not being implemented to an appreciable extent, as observed.There is a specific direction in the Rules that the maximum permissible period of storage of untreated Bio-Medical Waste is 48 hours. At present the Rules are concentrating only upon the hospitals in the objective of treatment and disposal of Bio-Medical Wastes. This is evident upon perusal of the Rule that directs all Occupiers of institutions handling Bio-Medical Wastes in different ways to apply for grant of authorisation, but excludes specifically Occupier of clinics, dispensaries, pathological laboratories, blood banks providing treatment/service to less than 1000 (one thousand) patients per month. Firstly, the prescribed authority has no means to verify the number of patients provided with services in these apparently smaller Occupiers. Secondly, while it is true that medical practitioners and dental clinics generate small quantities of Bio-Medical Waste when compared to the hospitals, the numbers of such medical practitioners and dental clinics is getting enormously huge and all these result in huge quantities of BioMedical Waste being generated. There is an inherent policy contradiction in these Rules, since on the one hand, the Rules require all medical practitioners to safely handle Bio-Medical Wastes;rule 4 on the other hand the Rules keep outside their purview smaller Occupiers, even though they collectively contribute significantly to the quantum of Bio-Medical Wastes generated. Therefore, the law is at present concentrating on medium and large polluters and leaving aside the marginal polluters, which are great in number and which in effect outweigh other polluters.Analysis

The scenario of Bio-Medical Waste demands better management. The present rules appear ineffective to manage the volumes of Bio-Medical Waste. Law has stumbled in performing its duty; much of attribute from the lack of proper implementation mechanism. Although the law relating to BioMedical Waste Management is in infant stage, the time has come to act seriously and implement the rules effectively. Greater commitment is required on the part of the Government looking into the magnitude of the problem. The regulatory body should be strengthened. There is certainly a need to re-look at the rules.