Theme: Health & Environment

A medical record provided by a doctor to a patient should contain the following information(( Annexure 7, Clinical Establishments Act ,2010 (Standards for Hospital Level 1A & 1B, 2010.)):

• Name and registration number of treating doctor
• Name, demographic details and contact number of patient
• Relevant clinical history, assessment and reassessment findings, nursing notes, diagnosis
• Investigation reports
• Details of medical treatment, invasive procedures, surgery and other care provided
• Applicable consents
• Discharge summary
• Cause-of-death certificate & Death Summary (where applicable)

No. Doing so is irresponsible on the part of the doctor, if the doctor does not conduct any tests to establish the extent of your condition and only relies on your word. Prescribing medication based on such half-baked knowledge can be dangerous and lead to complications or even death. It has been held by Courts that a prescription without diagnosis would amount to medical negligence, and a criminal case may be filed against the doctor.((  Deepa Sanjeev Pawaskar & Anr v. State of Maharashtra 2018 SCC OnLine Bom 1841.))

While patients generally depend on word-of-mouth or personal recommendations when choosing a doctor, it is not a fool-proof method. You can find reliable information about credible doctors registered in the Indian Medical Registry. The Indian Medical Registry  publishes the list of doctors registered with the various State Medical Councils across India up to 2019. You can search the database for registered doctors using their name, qualification, registration year, registration no, registered council etc.

The Consumer Protection Act, 2019 does not expressly mention healthcare as a ‘service’(( Section 2(42), Consumer Protection Act, 2019.)), like its predecessor did (The Consumer Protection Act. 1968). So, it is unclear at the moment whether healthcare is covered by the 2019 Act and whether patients will be considered as ‘consumers’. The courts will clarify whether the new law would apply, as they did earlier with the Consumer Protection Act, 1986.(( Indian Medical Association v. VP Shantha (1995) 6 SCC 651.))

The National Essential Medicines List or NLEM is a government-notified list of medicines, and is based on WHO’s(World Health Organization’s) model of an Essentials Medicines List. You can find the list of medicines here. The contents of the list are chosen on the basis of:

• Disease prevalence in a country
• Essentiality of a medicine in treating a specific disease
• Efficacy proven by unequivocal evidence and wide acceptance in medical science
• More benefits than risks from the widespread use of the medicine
• Cost effectiveness
• Preference for single compound medicines over Fixed Dose Combination(FDC) drugs
• Essentiality on the basis of different tiers of the healthcare system (i.e. Primary, Secondary and Tertiary)

The medicines contained in this list are intended to be to made available:

• In ample stocks
• In correct dosage strengths
• In assured quality

In India, it is the responsibility of the Ministry of Health and Family Welfare to notify and periodically update the NLEM.

To be included in the list, a medicine must fulfill the following criteria, among others:

• Approved/licensed in India
• Useful in a disease which is a public health issue in India
• Efficacy and safety profile proven by valid scientific evidence
• Cost effective
• Aligned with the current treatment guidelines for the disease

In 2013, the Government of India issued(( Section 3, Essential Commodities Act, 1955.)) the Drug Price Control Order, 2013 to regulate the prices of drugs enlisted in the NLEM by prescribing ceiling rates for them.

Doctors are ethically obliged to maintain strict confidentiality to protect the privacy and dignity of the patients they treat. Therefore, they cannot divulge any secrets learnt during the treatment of a patient, except in some cases. For instance, if a Court orders it or there is a risk to the community. For the same reason, they are also not allowed to publish pictures of patients from which they can be identified, without their consent.(( Section 7.17, Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002.)) If the identity of the patient is not revealed from the picture or consent is given by them, then the doctor may use it for publication.

Doctors are free to choose whom they treat. However, there are some situations where they are obligated to help:

• In an emergency case
• When the refusal is only on a discriminatory basis

Refusal to treat a patient should not be arbitrary. It should be done only if(( Section 2.2, Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.)):

• The doctor does not possess the skills or qualifications required
• In the doctor’s opinion, the patient would benefit from referral to a specialist

When a patient is discharged from the care of a doctor, the patient must be provided with a discharge summary containing the following information(( Annexure 10, Clinical Establishments Act (Standards for Hospital Level 1A & 1B), 2010.)):

• Name & Registration number of treating doctor
• Name, demographic details & contact number of patient, if available
• Date of admission and discharge
• Relevant clinical history, assessment findings and diagnosis
• Investigation results
• Details of medical treatment
• invasive procedures, surgery and other care provided
• Discharge advice (medications and other instructions)
• Instruction about when and how to obtain urgent care

Yes, the Charter of Patients Rights by the Ministry of Health and Family Welfare envisages responsibilities and duties((  Annexure 8, Clinical Establishments Act, 2010 (Standards for Hospital Level 1A & 1B). )) to be undertaken by patients and their caregivers when interacting with medical practitioners or doctors. Patients have the duty to:

• Provide all relevant health-related information to the doctor, completely and truthfully to facilitate correct treatment
• Cooperate with the doctor in tests and diagnostics and following their advice, while remembering their own right to choose the course of treatment
• Patients should be compassionate towards others seeking treatment near them. They should maintain discipline and avoid creating disturbance for other patients. They should also not litter and keep the hospital clean.
• If a patient has a grievance, it must be presented respectfully, keeping in mind the dignity of the doctors and hospital staff. Patients or their caregivers should not resort to violence or damage hospital property as they will incur criminal liability for such actions. If such violent acts are done with government medical personnel, it will amount to violence caused to a public servant. Some instances are:
  • Obstructing public servants in discharge of public functions(( Section 186, Indian Penal Code, 1860.)) that they are responsible for. Such obstruction may be physical or by any other means.  You may face jail time upto 3 months or fine of INR 500 or both.
  • Threat of injury to public servant(( Section 189, Indian Penal Code, 1860.)) to force them to do something or forbid or delay them in doing something which pertains to their public function. You may face jail time upto 2 years  or fine or both.
  • Voluntarily causing hurt to deter public servants from duty(( Section 332, Indian Penal Code, 1860.)). You may face jail time upto 3 years or fine or both.
  • Voluntarily causing grievous hurt to deter public servant from duty.(( Section 333, Indian Penal Code, 1860.)) You may face jail time upto 10 years or fine or both.
  • Assault or criminal force to deter public servants from discharge of duty. You may face jail time upto 2 years or fine or both.(( Section 353, Indian Penal Code, 1860.))

In addition, the latest ordinance by the Government of India enumerates ‘acts of violence’(( The Epidemic Diseases (Amendment) Ordinance, 2020.)), which if done by any person to a healthcare service personnel, will be punishable with a jail term up to 5 years, with fine.(( Section 6, The Epidemic Diseases (Amendment) Ordinance, 2020.))  It also expressly prohibits violence against healthcare service personnel during an epidemic.(( Section 5, The Epidemic Diseases (Amendment) Ordinance, 2020.))

To ensure that clinical trials are conducted ethically, an Ethics Committee(( Section 2(o), New Drugs and Clinical Trials Rules, 2019.)) is constituted with a  minimum of 7 members.(( Section 7 & 8, New Drugs and Clinical Trials Rules, 2019 (for clinical trials); Section 15 &16, New Drugs and Clinical Trials Rules, 2019 (for biomedical research))) This committee comprises of:(( Section 7, New Drugs and Clinical Trials Rules, 2019.))

• one lay person or any citizen
• one woman member
• one legal expert
• one independent member from any other related field such as social scientist or representative of a non-governmental voluntary agency or philosopher or ethicist or theologian

At least 50% of the members should be those who are not associated with the organisation or institute where the Ethics Committee is formed.(( Section 7(2), New Drugs and Clinical Trials Rules, 2019.)) It is then to be registered with the Central Licensing Authority to become functional.(( Section 8, New Drugs and Clinical Trials Rules, 2019.))

The Ethics Committee is meant to supervise a clinical trial or biomedical research to ensure that the human participants involved are treated with due care. Its approval is a necessary requirement for a clinical trial or biomedical research to begin. Its functions(( Section 11, New Drugs and Clinical Trials Rules, 2019.)) include:

• Suspension of the trial at any stage if it may compromise the rights or safety of the trial participants
• Supervision of the trial premises by an officer authorised by the Central Licensing Authority(( Section 3, New Drugs and Clinical Trials Rules, 2019.)) (Drugs Controller, India)
• Safeguarding the rights and safety of trial participants by ensuring that safety standards are maintained.

Private hospitals and clinics are required to provide access to medical records on the request of patients. The RTI Act defines ‘information’(( Section 2(f), Right to Information Act, 2005.)) such that records held even by a private medical establishment can be accessed by a public authority. So a patient can file an RTI with the concerned state or central authority and through them, obtain their medical records from a private hospital.  The right of a patient to have access to his medical records is a fundamental right under the Constitution of India, 1950.(( Article 19 and 21, Constitution of India, 1950; Nisha Priya Bhatia Vs. Institute of HB&AS, GNCTD 2014 SCC OnLine CIC 3155.))

To file an RTI, read more here.

A  ‘clinical establishment’ refers to:(( Section 2(c), Clinical Establishments (Registration and Regulation) Act, 2010.))

• A hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution that offers services and facilities for:
  • diagnosis, treatment
  •  care for illness, injury, deformity, abnormality or pregnancy(( Section 2(h), Clinical Establishments (Registration and Regulation) Act, 2010.)) 
• Diagnostic lab, pathology lab or another establishment where such investigative services are conducted, and it is established either independently or as part of another establishment.

Such clinical establishments may be owned, controlled or managed by(( Section 2(c)(ii), Clinical Establishments (Registration and Regulation) Act, 2010.)):

• the Government or a department of the Government
• a trust, whether public or private
• a corporation (including a society) registered under a Central, Provincial or State Act, whether or not owned by the Government
• a local authority
• a single doctor

Clinical establishments are recognised and registered under the Clinical Establishments  (Registration and Regulation) Act, 2010. The law aims to ensure that places that provide medical services uphold a minimum standard of facilities and care. However, clinical establishments owned, controlled or managed by the Armed Forces are separately managed.