1. Fundamental rights of the patients violated :

a. Right of being Represented in a Court by a lawyer is a Fundamental Right under Article 21 of the Constitution

b. Right to appeal : It is a fundamental component of the Indian legal system and is intended to ensure equitable and impartial administration of justice

c. Right to health : Refusal of treatment for non-payment of fees permitted to the healthcare professionals and institutions is ambiguous as what is emergency for patients may not be emergency for doctors and hence may lead to violence or be challenged as violative of Right to Health under article 21. Law commission report 201 recommends Scheme for reimbursement to hospitals and medical practitioners, ambulance for transfer, etc., to be framed by State Governments, States to allocate Funds which has not been implemented by any State Government.

2. Fundamental rights of medical professionals violated :

a. Right of being Represented in a Court by a lawyer is a Fundamental Right under Article 21 of the Constitution

b. Right to profession 19(1)g : Medical profession considered under consumer protection Act, but right to profession is withdrawn as advertisement is prohibited

c. Contradictory legal provisions : NMC imposes confidentiality of medical information at the same time NMC imposes responsibility for digitization of medical records (which are likely to be leaked to third parties). NMC regulations impose legal obligation and Ayushman Bharat Digital Mission imposes financial burden for following the regulations. By not following NMC regulations RMP has legal liability and by violating the Digital Personal Data Protection (DPDP) Bill there will be a huge financial burden. Both these contradictory provisions are without offering any protection from action for leak of data as RMP will be considered data fiduciary instead of data collectors.

3. Right to life of patient protected while not protecting right to life of the doctors : In case of emergency (life and

limb saving procedure) an RMP shall provide first aid and other services to the patient according to his expertise and the available resources before referral. While this protects the right of the patient, there is no corresponding duty imposed on the patient not to indulge into violence. This is violative of the right to life of the RMP. There is a need for strong central law for prevention of violence against healthcare professionals. Violence in case of referral of the patient to another facility must be considered as a criminal offence by the Central Government. Right to life of a doctor also needs to be protected by adequate free insurance against risk of violence, HIV etc.

4. Right to profession of the RMP is violated while imposing duty to treat in emergency. This is against principles of jurisprudence where it is necessary to grant right while imposing duty. Government should make payment for treatment given to the patient by RMP in emergency situations. Hon’ble Supreme Court in Pt Parmanand Katara Judgment imposed such duty saying that the obligation being total, absolute and paramount and further said that the medical professionals should not be harassed by police, legal professionals and courts. In practice this is not followed. No State Government has followed the law commission report 201 which states that The State Government must frame a scheme for reimbursement to hospitals, medical practitioners, ambulances and those who provide vehicles for transport. The State must notify an authority which will deal with reimbursement. The State must set apart substantial money for the purpose of reimbursement. The scheme must provide for the procedure for reimbursement. The scheme must be published in the State Gazette.

5. NMC is crossing jurisdiction :

a. NMC has no jurisdiction for restricting autonomy of family

members of RMPs. Section 35 of NMC Regulations is ultra vires of article 21 of Constitution of India.

b. Prohibiting the RMP from involvement in scientific educational activities is against the Fundamental Duty of developing the scientific temper and thus against Article 51A (h) of Constitution of India.

6. Section 8 : Prescribing Generic medicines : is violative of Fundamental rights of citizens under Article 21 of constitution of India :

a. In Justice K.S. Puttaswamy (Retd.) v. Union of India (2017) case, the Supreme Court of India held that the right to privacy includes the right to make decisions about one’s own body, reproductive choices, and medical treatment without unwarranted interference from the state.

b. In Suchita Srivastava v. Chandigarh Administration (2009) and Common Cause v. Union of India (2018)-The Supreme Court recognized that individuals have the right to make decisions about their own bodies and medical treatment. The Court held that decisions about one’s body should be respected, and the state should provide necessary facilities and information to enable individuals to make informed decisions.

c. If a person wishes to have better quality Branded Medicine for his own Health, he has fundamental and constitutional right to decide for his bodily autonomy and to choose any type of Branded or Generic Medicine. Anyone who can afford , must have the right to choose the highest quality of consumer goods like in these examples.

d. Statement that Generic medicines improve access to quality care is not evidence based and compromises providing what is best for a given patient. NMC has no control over the quality of drugs manufactured by pharmaceutical companies which are sold as generic drugs, nor the RMP has any way to test the quality by himself.

e. NMC has no control over the pharmacy shops who may replace the generic medicines with substandard molecules under the guise of generic medicines, therefore it is essential that RMP be allowed to write a brand name and permit the

patient to purchase generic medicine equivalent to content and quality at his own risk and avail his right to health at subsidised price. Prescriptions can have disclaimer that doctors can prescribe the drug and dosage but are no more responsible/ are not responsible for the quality of the product dispensed by the chemist. Patients to Read the drug labels carefully before purchase and can take a substitute on their own responsibility.

f. For this guideline 1 in the NMC Regulations needs to be be replaced with a format which was approved by Maharashtra FDA in 2014 which is available on the link below for ready reference. (https://timesofindia.indiatimes.com/city/nagpur/fda-releas es-model-prescription-format-for-doctors/articleshow/35079 436.cms) Model prescription format is annexed herewith as Annexure A.

g. Prescribing generic medicines could create a liability of professional negligence on the doctor, when a better formulated branded product is available. If any side effects occur due to such drugs, who is medico legally and ethically responsible for it has not been specified in the regulations. If the quality of the medicine is substandard and the patient does not recover, the RMP is liable for prosecution for medical negligence. He may be exonerated, but has to go through the long, spiralling and exhausting legal battle in consumer, civil and criminal courts.

h. Words in the notification such as guidance, shall etc do not clarify whether use of generic medicines is mandatory or otherwise, leading to possibility of increased litigation.

i. In the National program for tuberculosis variable efficacy of the Anti Tubercular treatment is affecting outcome of treatment.

j. NMC has no control over millions of chemists shops all over India to dispense a good quality, good company drug and naot something which is the cheapest or where the chemist gets maximum margins/ commission.

k. RMP should be permitted to prescribe some life saving drugs which are patented or not available as generic medicines. For this a class of allowed branded drugs should be created. Telemedicine practice guidelines permit such classification of drugs e.g. List O, A, B and prohibited drugs. Such a list titled as “List P” can be added to indicate permitted branded drugs which can be updated from time to time by EMRB. Medicines which need to be highest quality should be classified accordingly and clinicians should be permitted to use Branded Drugs as List P :

1. Antibiotics : Penicillins , cephalosporins , carbapenems) .

2. Anti Neoplastic : Hormonal therapy , Anti metabolites ..

3. Anti-coagulation like Heparin LMWH

4. Anti Diabetic like Metformin SGLT 2 Inhibitors , INSULINS

long short acting

5. Anti Hypertensive of all classes like alpha / beta blocker ARB

/ ACE

6. All drugs used in Emergency Critical Care, Surgical and Post

Operative care

7. All drugs used in complex cardio, neuro, gyneac and other

interventions

8. Schedule X of Drug and Cosmetic Act and Rules : Narcotic

and Psychotropic substance listed in the Narcotic Drugs and

Psychotropic Substances Act, 1985

9. All medicine given by IV IM SC IO should be of highest

quality .

10. Anaesthesia related drugs and inhalational agents : We rely

on Standard companies with high quality as there is risk to

life.

l. Government should make the Jan Aushadhi drugs available

in all pharmacies / medical stores in addition to Jan Aushadhi outlets. Every strip of these drugs should bear a stamp of quality. Branded generic drugs are priced higher than other generics, but sold to retailers at a very cheap price. This difference should be reduced so that patients get cheaper medicines.

m. Alternatively, Govt. should impose a blanket ban on manufacturing of branded drugs by all pharmaceutical

companies. All medicines should come with generic names only and reimbursement of all branded medicines prescribed to legislators and government officials should be banned with immediate effect.

7. While NMC has created a situation where all RMP will have to face action for medical negligence for poor quality in medicines, the Government has not taken any steps to handle such complaints as prescribed by Supreme Court Judgment in Jacob Mathew vs State of Punjab. Hon’ble Supreme Court had directed the Government to make requisite enactment to protect doctors from frivolous complaints. Even in Lalita Kumari vs State of Uttar Pradesh, Supreme Court has recommended that there should be preliminary enquiry in certain cases vide120.6 in cases of medical negligence. Unfortunately NMC regulations do not take into account these judgments while imposing duties on the RMPs. We feel that formation of a “Medical Tribunal of India” is essential to handle all such complaints in which medical negligence is alleged against doctors, and most of the time it could be a medical accident or adverse reaction to drugs which may be spurious in nature.

8. Following suggestions were approved by NMC which indicates that Medico Legal Society of INDIA has applied its mind and submitted the suggestions after due deliberation.

2. Definitions (Removed) e. e) “Modern medicine” or “Allopathy” is a healthcare discipline… Shifted to No. 3 after e as a ** special item.

4. A. Only those RMPs who are registered under NMC Act, 2019, can use Medical Doctor (Med Dr.) as a prefix before their names. (Removed)

5. RMPs will be licensed to practise in the states after payment of requisite fee in States and their names will appear on state

medical register.(L2) (Added in response to the suggestion regarding practice of doctors across border of two states)

11. Restriction on Advertisement: (Word restriction removed)

13. Every self-employed RMP shall maintain medical records of patients (outpatients or inpatients) for 3 years from the date of the last contact with the patient for treatment, in a standard proforma laid down by the NMC. (Guideline) (Outpatients removed)

23. Use of Alcohol or other intoxicants during duty or off duty which can affect professional practice will constitute misconduct. (Word Off Duty Removed)

36. RMPs may be required to file an affidavit regarding their financial earnings and or benefits received in the past 5 past years from any pharmaceutical companies or allied health sector. (L3) (Removed as Not acceptable as violation of fundamental rights)

9. Suggestions/ discrepancies/ difference of opinion described here are not exhaustive and are illustrative only. Other suggestions which are not approved are given in detail in the table available on the link below. All suggestions are supported by documents annexed to the table. http://dataonweb.com/MLSI/uploads/00_NMC_RMP_Reg ulations_2022_Comments_Approved_and_Not_Approved.p df

10. Most important suggestion which is not accepted is the definition of Medical Accident which was given by erstwhile MCI is not included in this document. It is most important for betterment of doctor-patient relationship as per Medico Legal Society of India. Medical Accident Insurance is required to protect the interest of both patients as well as doctors.

Annexure A

Model Prescription format