Health Law Capsule for October
New Criminal Code for Stricter Penalties for Medical Negligence
The new criminal code, Bhartiya Nyaya Sanhita (BNS), which replaces the Indian Penal Code (IPC), introduces stricter penalties for medical negligence. Under Section 106 of BNS, registered medical practitioners who cause death through negligence while performing medical procedures can face up to two years in jail and fines, effective July 1, 2024. Section 106(1) of the Bharatiya Nyaya Sanhita (BNS) outlines penalties for causing death due to rash or negligent acts not amounting to culpable homicide. If a person causes death through such acts, they may face imprisonment for up to five years and a fine. If a registered medical practitioner commits the act during a medical procedure, the punishment is reduced to a maximum of two years imprisonment and a fine. These stringent punishments aim to reduce negligence in medical practice and ensure better patient care. However, the burden of proof often lies with the patient. The “registered medical practitioner” means a medical practitioner with any medical qualification recognised under the National Medical Commission Act 2019 and whose name has been entered into the National Medical Register or a State Medical Register under that Act. Not all medical errors are criminal. Courts have often distinguished between genuine errors in medical judgment (which are not punishable) and gross negligence, where the doctor shows recklessness or disregard for the patient’s safety. In the Jacob Mathew v. State of Punjab (2005) case, the Supreme Court of India ruled that criminal liability should only apply to medical professionals if their actions demonstrate gross negligence.
Health Law Capsule for October
Court pushing for regulating E-Pharmacy Laws
India’s policy on the online sale of drugs is evolving to regulate the burgeoning e-pharmacy sector. While there is no finalised, comprehensive regulation yet, several steps have been taken to address the challenges. E-pharmacies in India operate in a grey area, governed by the Drugs and Cosmetics Act of 1940, which was not initially designed for online sales. This has led to calls for more specific regulations to ensure safety, proper dispensing of prescription medicines, and the prevention of drug misuse. The Indian government, through the Central Drugs Standard Control Organization (CDSCO), has been working on a draft e-pharmacy policy. The main objective of this policy is to ensure strict adherence to prescriptions for the sale of medicines online and regulate the storage, transportation, and sale of drugs to prevent misuse. It also protects patient data and ensures confidentiality in the online sale of drugs. Finally, it facilitates more accessible access to medicines, especially for those in rural areas, while maintaining solid checks on drug safety. The Delhi High Court has urged the government to speed up the process. A recent court order gave the government four months to finalize and implement a comprehensive policy addressing safety concerns.
- Key Features Expected in the Policy:
- Mandatory registration of e-pharmacies.
- Clear guidelines on prescription verification.
- Restrictions on selling habit-forming or controlled substances online.
- Defined penalties for non-compliance, including suspension or cancellation of licenses for violations.
A division bench of the Madras High Court, consisting of Justices SM Subramaniam and C Kumarapan, recently directed the Central Government to expedite and finalise its policy on online drug sales, as instructed by the Delhi High Court in March 2024, and to notify them accordingly. This directive was issued while resolving appeals filed by M/S Practo Technologies Pvt. Ltd. and others. The court stated that online drug sales are to be conducted only by licensed chemists and pharmacists until the Central Government finalises specific regulations or the Delhi High Court provides further guidance. This ruling maintains the status quo until a clear policy is established or the Delhi High Court issues new directions. Only licensed chemists and pharmacists can conduct online drug sales until further notice. The court has instructed the Central Government to expedite the development and notification of a policy on online drug sales.
Health Law Capsule for October
Reducing Animal Usage in Clinical Trials
India’s Health Ministry (MoH&FW) is considering a proposal to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019 with an aims to reduce animal usage and minimize sacrifices during drug testing procedures. The amendment aims to remove the requirement for applicants to submit sub-acute animal toxicity study data for intravenous infusions and injections when seeking permission to import or manufacture a new drug already approved in the country.
Source: bit.ly/4f88Plu
First Edition of Care Home Accreditation Standards
India’s National Accreditation Board for Hospitals and Healthcare Providers (NABH) has introduced its first edition of Care Home Accreditation Standards to enhance quality and safety in care home centres nationwide. This initiative ensures that even the most vulnerable populations receive top-tier care. These homes provide support to aged and disabled.
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Challenge to the Charges by the hospital
In this case, the District Consumer Court ruled in favour of Apollo Spectra Hospital, stating that the charges for the patient’s surgery were justified. The court emphasised that the complainant had been informed about the surgical expenses before the procedure. The case originated in 2018, when the patient visited the hospital to examine a small lump on the middle toe of his left foot. Following diagnostic tests (such as blood tests, X-rays, and ECG), the treating consultant, a general and laparoscopic surgeon, recommended a minor operation. The ruling suggests that the hospital acted transparently by providing the patient with information about the costs involved in the surgery beforehand. This transparency and the medical advice provided led the court to dismiss the complainant’s claims, affirming that no malpractice or hidden charges were involved. The case serves as a reminder of the importance of communication between healthcare providers and patients regarding medical expenses. This decision is consistent with how consumer courts in India assess medical disputes. They focus on whether the patient was fully informed and whether any negligence occurred during the medical process.
Mass Resignation of Senior Doctors
The West Bengal government said that the “mass resignation” of senior doctors in various state-run medical colleges and hospitals, which expressed solidarity with the junior doctors holding an indefinite hunger strike, has no legal value. A few hundred senior doctors in various state-run medical colleges and hospitals across West Bengal have tendered mass resignation over the past few days, expressing solidarity with the junior doctors holding an indefinite hunger strike.
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