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ARTIFICIAL INTELLIGENCE, HEALTHCARE AND LAW

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AI

International Law and Health Related International Standard Setting Instruments play an important role in evolution and development of International Health Law. Conventional International Law is the primary International Legal Instrument through which International Organisations can extend International Cooperation for improving the Global Health Status as also reducing the Global Burden of Diseases. In the recent times, there has been an increase in the Inter-Governmental Organisations in the domain of Health Care. Let us take the instance of the growing diversity of International Law relating to Public Health wherein a broad array of Inter-Governmental Organisations including United Nations and its agencies and other related bodies are contributing to the development of International Health Law. The International Health Law is therefore emerging in a fragmented and amorphous manner.

AI is having huge impact on Health Care and is transforming the Health Care Economy. AI has been defined as “the Development of Computers to engage Human Like thought processes such as Learning, Reasoning and Self-Correction”. While Machine Learning is a field of AI and in the context of Health Care has been put to varied uses ranging from classifying Health Care Data, to Diagnostic, Disease Predictions. Application of AI in Health Care can be broadly classified into:

• AI and Patient Care

• AI and Clinical Practice

• AI and Administration and Operations

• AI and Medical Research and Development

The International Health Law is a proliferation of multilateral organisations that often raise over lapping legal authority issues. However, International Health Law consolidates international standard setting instruments along with health-related legal rules, norms, and standards. The International Human Rights Law also plays an important role in International Health Law given the fact that right to health is also a significant human rights norm. While it can be argued that right to health features as a core parameter in the context of International Health Law since it emphasizes on the protection individual health care world-wide and strives for equity in health. The development of International Health Law in the context of AI also largely is an interplay of Privacy Laws, Cyber Laws, Cyber Security Laws, Civil Laws, Criminal Laws, Tort Laws, Medical & Health Laws.

AI primarily relies on data and data sets and makes use of the techniques like machine learning and natural language processing. AI is enabling better Health Care and Governance by analysing the Health Data in a precise and quick manner for a better detection, diagnosis, and treatment. AI driven technologies by way algorithms, facial recognition, chatbots bring forward various legal, regulatory, ethical and medico legal considerations when applied in the context of Health Care. The primary regulatory issue with regard to AI in Health Care is the archaic regulatory infrastructure.

Given the fact that AI is making use of machine learning techniques & the constant learning capabilities, AI algorithms keep evolving and by the time the regulatory approval is granted, the learning capacities of algorithms are increased making them entirely different.

Further, another aspect of AI is the black box, while we will be able to program an AI algorithm, but we do not have any clue how it works inside, this brings an issue of explicability and therefore making the regulatory challenges unique.

AI, HEALTHCARE AND LEGAL ASPECTS

• PRIVACY

Many AI systems collect, store, process transmit, huge amounts of data of which sensitive and personal data are an essential component. AI in the context of Health Care primarily handles a lot of personal data relating to the patients including electronic health & medical records, diagnostic reports, medical conditions, medical history, vitals related information, information relating to height, weight, Body Mass Index (BMI), psychological & human behaviour patterns. Various International, National, Federal, and state rules and common laws govern the collection, processing, handling, transmission of such personal data. While in the context protection of patient’s privacy assumes a lot of significance.

It is very interesting to understand if the outcome predicted by an AI algorithm consisting of any personal data of the patient amounts to privacy breach given the complexities of AI algorithms. Is the privacy of the patient protected adequately by AI algorithm is another question?

Further, in case of AI based Chatbots in the context of health care, the following privacy considerations are likely to arise. Is the chatbot authorised to collect personal data of patients? What is the legal status of the AI based Chatbots? Some limited amount of legal recognition shall be required to answer questions like this.

• INFORMED CONSENT

The AI Algorithms often make use of personal data of patients in the context of health care be it for analysis, predictions, counselling prescribing medicines and treatments, therapeutic sessions, and other areas. In the context of machine learning the clinical data of the patient is used for developing Algorithms for improvement of health care and for research and development activities. Initially the patients may provide informed and free consent with regard to collection, processing, sharing their sensitive and personal data specific for better diagnosis of their health and medical conditions. However, this becomes a challenge in case of large data sets. However, seeking Informed Consent shall be difficult in case of providing fine print terms and conditions in a manner not specifying about the future uses of the data. However, it may not be viable to seek Informed Consent at every stage where the Patients data is used given the kinds of complexity in which the AI Algorithms operate.

However, using the opt in and optout models may not be workable in the context of Al Algorithms as the AI Algorithms make use of machine learning and become more and more intelligent. It may not be possible to predict how and the manner in which the personal data possessed by the AI Algorithm is used. Informed Consent in the context of AI in health care becomes very important since the patient is required to be informed about the different options regarding his health and medical conditions and he is the decision maker with regard to the same. AI Algorithm must be designed in a manner to seek Informed Consent in a reasonable manner making the Patient aware of the different options and enabling them to choose thereof. There are however different kinds of approaches, different Jurisdictions, which have an emphasis on either patient or doctor’s role with regard to consent in a reasonable manner to determine the ground for baseline.

• DATA PROTECTION

One of the biggest limitations of AI in health care is involvement of machine learning and deep learning approaches which require huge amount of data sets for the purpose of analysing, testing, and predicting. These large sets of data definitely comprise of sensitive and personal data of patients including their health-related information, medical related information, personal information, and others. Removing all potentially identifiable- information from these data sets can be a herculean task. In this scenario, data protection assumes a greater significance. It may also be possible to identify individuals by linkage with other data sets even if the data sets are not including any medical images or medical related information or do not make use of any advanced or future technologies. Data sharing becomes another important aspect that requires legal considerations in the context of AI and health care. Data sharing involves sharing of sensitive and medical data which may increase the risk of data breaches.

However, having restrictive data sharing arrangements can reduce the widest possible patient benefit. It is advised that new regulations governing privacy must be created in the context of AI and health care to protect the sensitive and personal data of patients against inappropriate usage, accidental disclosures, and weakness in deidentification techniques. However, over protection of personal data may be detrimental to data driven technologies like AI. However, a balance needs to be struck between the adoptive technology and data protection.

• INTELLECTUAL PROPERTY RIGHTS

AI Algorithms largely are largely associated with data and data sets. In the context of AI in health care AI Algorithms possess large chunks of data which are created which are a result of using analysis and correlation of human created works. In this kind of scenario lots of Intellectual Property is created out of such Algorithms. In addition to the above, the AI Algorithms making use of machine learning and deep learning techniques, analyse and predict new outcomes which also are capable of being considered as Intellectual Property.

The Ownership of Intellectual Property rights in respect to the data possessed by the AI Algorithms assumes significance. Considering the fact that the creators and developers become the first owners of intellectual property. In this context, copyright becomes an important element with regard to protection of such data and data sets

Another aspect of intellectual property in the context of AI in health care is the analysis and predictions and outcomes generated by AI Algorithms. Are the machines capable of protecting the Intellectual Property created out of its Algorithms? Can an AI system license its Intellectual Property? This question becomes significant in the context of AI in health care in case AI is leveraged by various stake holders in the health care industry.

Let us take an example, in case, a doctor engaged by a hospital makes use of AI for the purpose of analysing the medical and health condition of a patient who owns the Intellectual Property of the output generated by the Algorithm.

In case an AI Algorithm comes up with unique invention or discovery in the field of health care subject to its analysis using the data through machine learning and deep learning, can such inventions be capable forgetting Patent protection? This becomes important since AI in health care is leveraged for research and development and further analysis.

In case of any data or datasets possessed by AI and Algorithm are copyrighted material, the legal accountability for IP related infringements will also have to analysed.

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Allahabad High Court Quashes POSCO Case: If Husband/Accused Is Convicted Then Victim/Wife’s Future Would Be Ruined

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Allahabad High Court Quashes POSCO Case: If Husband/Accused Is Convicted Then Victim/Wife’s Future Would Be Ruined

The Allahabad High Court recently in the case Rajiv Kumar v. State of U.P. And 2 Others observed and has recently quashed an FIR and criminal proceedings in a POCSO case registered against a man as it noted that the accused man and victim-wife (who was a minor at the time of the incident) married the accused/ applicant out of her own sweet will and is living a happy married life with him.
The bench comprising of Justice Manju Rani Chauhan observed that to punish punish the offenders for a crime, involved in the present case, is in the interest of society, but, at the same time, the husband is taking care of his wife and in case, the husband is sentenced and convicted for societal interest, then, the wife will be in great trouble and it would ruin their future. Thus, it is also in the interest of society to settle and resettle the family for their welfare, the bench quashed the rape-POCSO case against the accused.

Facts of the Case:
The Maternal Uncle of the Victim lodged an FIR against the accused under Sections 363, 366, and Section 376 of the Indian Penal Code, 1860and Section 3/4 of the POCSO Act, alleging that the accused had raped the victim (then a 17-year-old minor).
Further, the accused moved the instant Section 482 CrPC petition seeking to quash the instant FIR. Also, the victim appeared before the Court and had submitted that her maternal uncle had lodged the FIR in an attempt to ruin her married life.
It was further stated by her that she has entered into a compromise with the accused and has married him out of her free will, and consent, and without any external pressure, coercion, or threat of any kind. Before the court, it was also submitted that that out of their wedlock, they are blessed with a male child, who is presently four and half years old and as per her date of birth and at the time of marriage she was nearly 17 and half years old.
It was submitted by the Applicant-Accused that on account of the compromise entered into between the parties concerned, all disputes between them have come to an end, and therefore, further proceedings are liable to be quashed in the present case.

Observations Made By Court:
In the present case, the court noted that though the offence under the relevant sections 363, 366 and 376 of IPC and Sections 3/4 of POCSO Act are not compoundable under Section 320 Cr.P.C, however, adding to it, the court stated that the power of the High Court under Section 482 Cr.P.C is not inhibited by the provisions of Section 320 Cr.P.C and the criminal proceedings as well as the FIR can be quashed by exercising inherent powers under provision of Section 482 Cr.P.C, if warranted in given facts and circumstances of the case for ends of justice or to prevent abuse of the process of any Court, even including the cases which are not compoundable where parties have settled the matter between themselves.
The court while considering the facts and circumstances of the case, and also the submissions made by the counsel for the parties, the court came to the considered opinion that the victim herself, has stated before this Court that out of her own sweet will, she has married the applicant and is living a happy married life and out of their wedlock, the couple are blessed with a male child. However, no useful purpose shall be served by prolonging the proceedings of the criminal case as the parties have already settled their disputes.
Accordingly, the court quashed the charge sheet and the cognizance order as well as the entire proceedings of the Criminal Case were hereby quashed. Thus, the application was allowed.

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SC likely to hear next month pleas related to Article 370

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SC to hear Manoj Tiwari’s plea on firecracker

A Supreme Court constitution bench is expected to hear a slew of petitions related to Article 370 of the Constitution, which granted Jammu and Kashmir (J&K) semi-autonomous status before it was repealed in August 2019. Chief Justice of India (CJI) Uday Umesh Lalit said on Friday that the petitions will be heard after the Dussehra holiday.

When senior advocate Prashanth Sen asked the CJI to list the matter, Justice Lalit responded, “We will certainly list that…it will be listed after Dussehra break.” From October 3 to 10, the court will be closed for Dussehra.

The petitions were last heard in March 2020, when a five-judge panel declined to refer the case to a larger panel. The reference was requested because previous court decisions on the subject were in conflict with one another. This contention was rejected by the bench.

At the time, the bench was aware of an older batch of petitions pending in the Supreme Court challenging the constitutionality of Articles 370 and 35A, which granted J&K special status. It was stated that all issues concerning Article 370 should preferably be heard together.

National Conference legislators, former bureaucrats, and some organisations are among those who have objected to the repeal of Article 370. Some petitioners cited the Supreme Court’s 2018 decision, which stated that Article 370 had gained permanent status.

Many petitions have also been filed against the Jammu and Kashmir State Reorganization Act, which calls for the division of J&K into two Union Territories.

Despite opposition from the central government, which argued that Article 370 had international and cross-border implications, the Supreme Court issued notices on the petitions on August 28, 2019. The Centre also claimed that it is a highly sensitive issue, and that whatever happens in the country will be brought up at the United Nations. While issuing notices in 2019, the court referred the case to the five-judge constitution bench.

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Supreme Court: Fixed Term Sentences Exceeding 14 Years Can Be Alternative To Death Sentence In Certain Cases

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death penalty

The Supreme Court in the case State of Haryana vs Anand Kindoo observed and stated that fixed term sentences exceeding 14 years can be awared in appropriate cases to strike a delicate balance between the victims’ petition for justice and rehabilitative justice for the convicts.
The bench comprising of Justice Sanjay Kishan Kaul, Justice Abhay S. Oka and the Justice Vikram Nath observed that this fixed term sentence can only be by the High Court or this Court and not by the trial Court.
In the present case, the trial court awarded death sentence to the accused who were ‘trusted employees’ of the deceased. However, Major General Kailash Chand Dhingra (K.C. Dhingra) and his wife Smt. Sangeeta Dhingra, who were an aged couple and were killed by the accused while they were sleeping. It was refused by the High Court to confirm the death sentence and imposed life sentence on them.
In an appeal before the Apex Court, the complainant and the state contended that given the brutality of the crime, the court should impose a fixed term sentence before which the convicts are not liable to be considered for granting of remission. Thus, it was submitted that there should be at least a fixed term sentence.
The court observed that it was a pre-planned murder for gain and greed by somebody who was in a position of trust with the family.
The bench observed that at an advanced stage in such health respect, there is always an element of trust and faith in the person by a person who employs them as well as the family members. However, the work takes other family members elsewhere and with the joint family system having broken down, the role of such trusted help becomes even more significant. Also, it is the significance of the society where a wrong signal goes if a trusted person breaches that trust to kill the person who had employed them in such a gruesome manner. It has been stated by the trial Court, the society itself demands justice, apart from an utter element on deterrence which is in any aspect of conviction. Further, the approach cannot be the vindictive but lack of appropriate sentence leaves the cry of justice of the society un-addressed apart from the fact that other persons who may have the propensity to carry out the crime feel that they will get away with the lighter sentence, if in case they are caught. While, battering two sleeping people beyond recognition who imposed trust in their employee certainly calls for something more than merely a life sentence under Section 302, IPC, even if death sentence is not to be imposed.
Therefore, the court imposed a fixed term sentence of 30 years.
The bench while allowing the appeal observed in the case Shankar Kishanrao khade vs. State of Mahrashtra (2013) 5 SCC 546, wherein it was held that if there is any circumstance favouring the accused such as lack of intention to commit the crime, young age of the accused, possibility of reformation etc., accused not being a menance to the society, no previous criminal record etc., the accused may avoid capital punishment. It was opined by the court that the crime is important but so is the criminal and hence the Supreme Court in recent past has substituted death penalty with fixed term sentences exceeding 14 years. It stated that imposing a fixed term sentence creates a possibility for the convict to re-integrate into society after serving his/her sentence. A delicate balance is strike the balance between victims’ plea for justice.

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NCLAT Upholds Dismissal Of Section 7 Petition, Corporate Debtor Willing To Pay Full Amount, Opposed By Financial Creditor

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NCLAT Upholds Dismissal Of Section 7 Petition, Corporate Debtor Willing To Pay Full Amount, Opposed By Financial Creditor

The National Company Law Appellate Tribunal (“NCLAT”) in the case Reliance Commercial Finance Limited v Darode Jog Builder Private Limited, the Principal Bench, comprising of Justice Ashok Bhushan (Chairperson), Judicial Member, Justice M. Satyanarayana Murthy and the Technical Member, Mr. Barun Mitra observed while adjudicating an appeal filed in Reliance Commercial Finance Limited v Darode Jog Builder Pvt. Ltd., has upheld the Adjudicating Authority’s decision to not admit a petition under Section 7 of IBC, despite there being a default and a debt. It was recorded by the bench the Corporate Debtor an opportunity to pay/settle the full amount of default despite the Financial Creditor’s unwillingness to enter settlement.

Background Facts of the Case:
The Appellant/ Financial Creditor, Reliance Commercial Finance Limited had sanctioned Term-Loans of Rs. 19.5 Crores to the Corporate Debtor i.e., Darode Jog Builder Pvt. Ltd. on 29.07.2013. In 2017, the Loan Accounts were declared as the Non-Performing Assets. On 04.11.2019, a petition under Section 7 of Insolvency and Bankruptcy Code, 2016 (“IBC”) was filled by Financial Creditor, wherein seeking initiation of Corporate Insolvency Resolution Process (“CIRP”) over a default of Rs. 15,79,41,658/- against the Corporate Debtor.
It was observed that in an hearing held on 06.07.2022, the Corporate Debtor acknowledged its liability to pay and made an offer of Rs. 12.75 Crores, which is to be paid within 45 days. Thus, the Adjudicating Authority directed the Counsel for the Financial Creditor to obtain appropriate instructions. Thus, the court observed that if the Settlement did not take place, the Petition would automatically be admitted on the next date of hearing.
The court on the next date of hearing i.e. 11.07.2022, it was submitted by the Corporate Debtor that it is willing to deposit the entire amount of Rs. 15,79,41,658/- within 45 days. However, the Financial Creditor expressed its unwillingness for settling the matter. The Bank account details of the Financial Creditor were obtained by the Adjudicating Authority and alongside granted liberty to the latter to file for restoration of petition in case said amount is not deposited within 45 days. The court disposed of the appeal.
The Financial Creditor filed an appeal before the NCLAT, aggrieved by the order dated 11.07.2022.

Contentions Made By Appellant:
It was submitted by the Financial Creditor that the Adjudicating Authority committed error in disposing of the Petition, as it was not willing to settle the matter. However, the Adjudicating Authority could not have permitted the Corporate Debtor to deposit amount in Financial Creditor’s account.

Contentions Made By Respondent:
It was argued by the Corporate Debtor that Financial Creditor was unwilling to settle as earlier entire amount was not offered and settlement had not taken place despite several adjournments. Further, it was submitted that the Corporate Debtor has financial capacity to deposit the entire amount.

NCLAT Decision:
The Bench placed reliance on the Supreme Court judgment in the case Vidarbha Industries Power Limited Vs. Axis Bank Limited, Civil Appeal No. 4633 of 2021.
It was observed by the bench that as per the judgment, even after debt and default is there, Adjudicating Authority has to apply its mind to assess the feasibility of initiating CIRP.
It stated that when the Corporate Debtor has complied to deposit the entire defaulted amount of the Financial Creditor as permitted by the Adjudicating Authority and no purpose and occasion shall survive to still proceed with the Corporate Debtor Insolvency Resolution.
Accordingly, the bench observed that the proceedings under Section 7 are for resolution of insolvency. Adjudicating Authority had not erred in ascertaining whether the Corporate Debtor can comply to deposit the entire defaulted amount in bank account of Financial Creditor’s. Further, the court observed that the Financial Creditor’s interest was fully protected, since liberty was already given to revive the petition in case full amount was not received within 45 days.

The bench dismissed the appeal.

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IBBI Amends Liquidation Process Regulations: COC To Function As Stakeholder’s Consultation Committee For First 60 Days

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IBBI Amends Liquidation Process Regulations: COC To Function As Stakeholder’s Consultation Committee For First 60 Days

On 16.09.2022, the Insolvency and Bankruptcy Board of India (“IBBI”) has notified amendments for a second time to the IBBI (Voluntary Liquidation Process) Regulations, 2016 (“Voluntary Liquidation Regulations”) and IBBI (Liquidation Process) Regulations, 2016 (“Liquidation Regulations”).
Detailed Overview Of the Amendments:
the IBBI has introduced the following amendments to the Voluntary Liquidation Regulations and Liquidation Process regulations, in exercise of the powers conferred by Section 196(1)(t) read with Section 240 of the Insolvency and Bankruptcy Code, 2016.
For enabling better participation of stakeholders and streamline the liquidation process to reduce delays and realize better value, the following major modifications are made for the amendment in Liquidation Regulation.
The Committee of Creditors (CoC) constituted during Corporate Insolvency Resolution Process (CIRP) shall function as Stakeholders Consultation Committee (SCC) in the first 60 days and after the adjudication of claims and within 60 days of initiation of process, the SCC shall be reconstituted with respect to the admitted claims.
It has been mandated to the liquidator to conduct the meetings of SCC in a structured and time bound manner with better participation of stakeholders.
It has been enlarged the scope of mandatory consultation by liquidator with SCC and now SCC may even propose replacement of liquidator to the Adjudicating Authority (AA) and fix the fees of liquidator, if the same during CIRP is not fixed by the CoC.
The amount of claim collated during CIRP shall be verified by the liquidator, if any claim is not fixed during the liquidation process.
Whenever it is decided by the CoC that the process of compromise or arrangement may be explored during liquidation process, an application shall be filled by the liquidator only in such cases before Adjudicating Authority for considering the proposal of arrangement or compromise, if any, within thirty days of the order of liquidation.
For Auction process, specific event-based timelines have been stipulated.
SCC b Before filing of an application for dissolution or closure of the process shall advice the liquidator, the manner in which proceedings in respect of avoidance transactions or fraudulent or wrongful trading and shall be pursued after closure of liquidation proceedings.
Further, the Amendment Liquidation Regulations and Amendment Voluntary Liquidation Regulations lays down the manner and period of retention of records relating to liquidation and voluntary liquidation of a corporate debtor or corporate person, respectively.

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Supreme Court: Setting Aside NCDRC Order Awarding Compensation To Women Who Gave Birth Despite Undergoing Tubectomy Surgery

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Supreme Court: Setting Aside NCDRC Order Awarding Compensation To Women Who Gave Birth Despite Undergoing Tubectomy Surgery

The Supreme Court in the case Civil Hospital vs Manjit Singh observed and has set aside an NCDRC order that directed a hospital to pay compensation to a woman who delivered a child despite undergoing tubectomy procedure.
In the present case, a woman underwent tubectomy procedure twice, though both the procedures remained unsuccessful. In the year 2003, she gave birth to a male child. A complaint was filled by her before the District Consumer Disputes Redressal Forum alleging medical negligence on account of failed tubectomy surgery. Thus, the court dismissed the same on the ground that the hospital is not a consumer. The order was affirmed by the State Consumer Commission (SCDRC). Later, the revision petition was allowed by the National Consumer Commission and has directed to pay compensation as per the guidelines and the policy of the State.
Before the Apex Court, two contentions were raised by the hospital (1) that hospitals and Doctors who render service without any charge to every person availing of the service would not fall within the ambit of ‘service’ under Section 2(1)(o) of the Act relying on the case Indian Medical Association Vs. V.P. Shantha And Ors., (1995) 6 SCC 651 that the failed tubectomy surgery is not a case of medical negligence as the sterilized woman can become pregnant due to natural causes. [relying on the case State of Punjab Vs. Shiv Ram and Ors., 2005, 7 SCC 1].
The bench while taking notice of the law laid down in the decisions relied on by the appellants, allowed the appeal by setting aside the NCDRC order. However, if the respondent has been paid any amount in terms of the Order of the NCDRC, the same shall not be recovered by the State, the bench said.
It was observed in In V.P. Shantha that the Hospitals and Doctors who render service without any charge whatsoever to every person availing of the service would not fall within the ambit of ‘service’ under Section 2(1)(o) of the Act. Thus, the payment of a token amount for registration purposes only would not alter the position in respect of such doctors and hospitals.
The Apex Court regarding failed tubectomy surgery in Shiv Ram (supra), had observed that the cause of action in claiming compensation in cases of failed sterilization operation arises on account of negligence of the surgeon and not on the account of child birth. Further, the failure due to natural causes would not provide any ground for claim and it is the women who has conceived the child to go or not to go for medical termination of pregnancy. Thus, having gathered the knowledge of conception in spite of having undergone sterilization operation, if the couple opts for bearing the child, it ceases to be an unwanted child and the compensation for maintenance and upbringing of such a child cannot be claimed.

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