Crosspathy is not allowed.Kerala Ayurveda Paramparya Vaidya Forum Vs. State of Kerala and Others

From the SupremeCourt Judgement dated 13/04/2018,on the SLP of 'Parambarya Vaidyas'....Landmark Judgement...

"In our country, the qualified practitioners are much less
than the required number. Earlier, there were very few
Institutions imparting teaching and training to the Doctors,
Vaidyas and Hakimis but the situation has changed and there
are quite a good number of Institutions imparting education in
indigenous medicines. Even after 70 years of independence,
the persons having little knowledge or having no recognized or
approved qualification are practicing medicine and playing
24
with the lives of thousands and millions of people. The right
to practice any profession or to carry on any occupation, trade
or business is no doubt a fundamental right guaranteed under
the Constitution. But that right is subject to any law relating
to the professional or technical qualification necessary for
practicing any profession or carrying on any occupation or
trade or business. The regulatory measures on the exercise of
this right both with regard to the standard of professional
qualifications and professional conduct have been applied
keeping in view not only the right of the medical practitioners
but also the right to life and proper health care of persons who
need medical care and treatment".

For complete judgement and other details,please find link below.

http://www.supremecourtofindia.nic.in/supremecourt/2003/10091/10091_2003_Judgement_13-Apr-2018.pdf

http://www.advocatekhoj.com/library/judgments/announcement.php?WID=9976

Courtasy: IMA emills and advocate khoj

Generic Drugs: IMA Perspective-Things in black and white

Dr KK Aggarwal, Dr R N Tandon, Dr A Marthanda Pillai, Dr Vinay Aggarwal &   Dr R V Asokan

Preface

Hon’ble Prime Minister, Sh. Narendra Modi Ji has said that the Government is contemplating a legislation that will make it mandatoryfor the registered medical practitioners to prescribe generic only drugs (generic- generic drugs or writing a generic drug without a brand name).

IMA, in principle, welcomes usage of generic-generic drugs yet hasvery serious concerns regarding quality assurance and other complex issues involved.

To understand the whole issue, we first need to understand various terms used in the law In India, a generic drug can be marketed with following business model:-

 1. Generic-Generic or Generic only drug (without brand name) and usually is supplied in institutional supplies.

“Generic name of the drug” is not same as generic drug and means the chemical name of the drug only.

Generic-Generic is made and marketed by local companies in theunorganized sector as the preparation with questionable quality.

2. Trade Generic (Generic marketed under a brand name) and usually is marketed and promoted through the trade chemists in theunorganized sector without any Medical Sales Representative and other Marketing Staff, no R&D set up, Lack of current Good Manufacturing Practices (cGMP) assurance in manufacturing plants with high margins to the chemists etc.

3. Branded Generic (Generic marketed under a brand name) and is usually marketed and promoted through the doctors using organized set up of well-trained medical sales representatives, marketing, medical staff, R&D set up, cGMP assurance in manufacturing set up called organized sector etc.

A single company may pursue one, two or all the three business models. If manufactured by the same company in the organized sector and/or if procured from other manufacturers in the unorganized sector, the quality may not be the same but the price may vary with very high trade margin in trade generic as compared to branded generic.

WHO and Generic drugs:

WHO and Schedule M of Drugs and Cosmetics Act, 1947 provides a comprehensive set of guidelines including recommendations on cGMP, inspection, product assessment, licensing, quality assurance, manufacturing, good laboratory practices, quality control, testing and release etc.  

The most important characteristics of any drug is its Bioequivalence (BE) to the innovator product to prove its safety, clinical efficacy equivalence and cGMP compliance on continuous basis for sustainable supply. The BE of any drug depends on its formulation process, choice of excipients, dissolution profile, stability under different conditions to prove its claimed shelf life, in process manufacturing and quality controls, packaging, storage conditions, transportation, validation studies, annual stability data review, analytical testing validated procedures, continuous engineering maintenance of every equipment in the plant, continuous training and development of people, reviewing regularly manufacturing/plant/site data, taking action on deviations eg. Out Of Specifications, Out Of Limit, batch specific deviations, change control, presence of impurities and mode of release of the drug etc. to name a few.

While the manufacturing practices of a company in the organized sector making all three versions may be the same but those making the ‘generic only’ and Trade Generic version in the unorganized sector may not and usually does not comply with the cGMP of WHO and schedule M, especially if the company is a local company catering to the State/Region and not national market through the state licensing system.

A 2014 study has shown that 10.9% of the products tested were of poor-quality with presence of none or less than the required dosage of active pharmaceutical ingredients. Of this 10.9 percent, 7 percent contained less than the required dosage of active ingredients, while 3.9 percent were drugs without any of the necessary active ingredients.

It is worthwhile to mention here that testing some samples of a batch does not provide assurance of the product quality and safety.  Batch to batch reproducibility, stability of the product is possible only through a comprehensively designed Quality Management System in a company complying to cGMP standards.

India and Generic drugs:-

As discussed above ‘trade generics’ are sold at significantly higher prices in India with very high margin to chemist.

It is also true that given the widespread poverty, making available reasonably priced quality medicines in the market would benefit everyone. This led to the origin of "Pradhan Mantri Bhartiya Janaushadhi Pariyojana" in 2008  under the concept “Quality Medicines at affordable prices for all”. It was envisaged that the scheme would run on a self-sustaining business model. It was to be run on the principle of "No Profit, No Loss".

BPPI (Bureau of Pharma PSUs of India), under the administrative control of the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India is the Implementing quality assurance agency of PMBJP.

In April 2010, BPPI got registered as an independent society under the Societies Registration Act, 1860 as a separate legal entity.

The vision of the project is to bring down the healthcare budget of every citizen of India through providing quality generic- generic medicines at affordable prices. Unfortunately, this initiative failed to benefit the public. It has not addressed the purpose for which it was launched since there were few takers due to lack of faith in quality.

IMA and Jan Aushadhi: India Medical Association (IMA) is for affordable, accessible and quality healthcare. IMA policy is to prescribe quality drugs at affordable cost. IMA promotes usage of drugs from NLEM (National List of Essential Medicines).

To promote Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana, IMA has opened a Pradhan Mantri Bhartiya Jan Aushadhi Kendra (PMBJK) in its head quarter premises and recommends such Kendras should be opened in all the IMA buildings in India.

Medical Council and Generic drugs:

The clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 has been amended in 2016 and notified in the Gazette of India on 21.09.2016, which reads as under:

"1.5 - Use of Generic names of drugs: Every physician SHOULDprescribe drugs with generic names legibly and preferably in capital letters and he/ she SHALL ensure that there is a rational prescription and use of drugs."

MCI by a circular dated 21.04.2017 has reinstated that all the Registered Medical Practitioners under the IMC Act to comply with the aforesaid provisions of the Regulations in its letter and spirit and has warned that any violation will attract disciplinary action by the concerned SMC/MCI.

In an RTI reply MCI has admitted that it does not have even the definition of generic drug.

MCI circular neither make it mandatory to write the generic name of the drug nor does it mentions not to write the name of the brand. 

IMA does not feel that the current circular of MCI is for mandating not writing the brand name.  If that was so, then the ‘Jan Aushidhi’ drugs would not have been marketed in the country as it is also a brand for the purpose of marketing.

Even if we interpret MCI circular as mandating writing generic name of the drug without a brand name then the MCI circular is out of touch with realities on the ground and is bound to cause havoc in patient care and patient safety. 

In India where substantial population of manufacturer operate in the unorganized sector, quality of the final product may not be assured and the law enforcement on quality of drugs needs substantial improvement, mere ordering the doctors to write generic drugs without a brand name is not in the interest of the society.

The objective of MCI is to regulate and prescribe minimum standards in medical education and the yardstick of ethics cannot be applied on this matter of usage of generic drugs with or without a brand name.

Doctors and Generic drugs:

If the Government’s intention is to have doctors write only the generic name without the brand name for making drugs affordable, just shifting the onus on to the doctors alone will not help the purpose.

The root cause of the problem has to be analysed and solved by a multi-pronged approach.

It is well known that from the same company the generic-generic and trade- generic versions of a drug may be less expensive than the branded- generic ones but with very high distribution and retail margins sometimes more than 1,000% of the manufacturer's price.  Distributors Retailers have a strong financial incentive to push generic- generic or trade – generic drugs, even if doctors prescribe branded drugs.  Such high discounts and price variations must be stopped.

Therefore the rout cause of the challenge is when there is a differential pricing of generic- generic, trade- generic, and branded generic from the same company. If there is one price of the same drug from one company doctors can be sure about the affordability part and can then choose the brand offering consistent quality assurance.

The quality assurance mechanism in our country is very weak.   India has more than 67,000 drug formulations, the quality assurance mechanism in our country can ascertain the quality control of only 15753 drugs annually (Combined testing capacity of all the Central Drugs Testing Laboratories).

Time and again, major adverse events including death occur due to poor quality of drugs or contaminated drugs. e.g. one of the major reasons for number of deaths that had occurred in the sterilization camp held in Chhattisgarh was due to generic drugs used. The verdict of the Chhattisgarh High Court in this issue has gone in favor of the doctor. He has been exonerated and the deaths had been found due to sub-standard generic drugs used during the operative course.

It is not Government Laboratory testing the product that will assure quality of the product but strong overview, oversight by the regulator with strong teeth to act on the pharmaceutical manufacturers should they not comply to cGMP norms.

When generic name only prescriptions are insisted, anyone can buy any medicine from chemist stores even without prescription (Over The Counter sale of drugs).

Even if doctors prescribe in generic name, it will be the sales person (may not be qualified pharmacist) in the chemist shop who has no knowledge about drugs will decide which brand or form of drug is to be given. By shifting the responsibility of choosing the brand to the salesperson in the chemist shop, the objective of reducing the cost of drug is not going to be achieved and other risks of safety and lack of efficacy due to poor quality will additionally emerge. 

Eventually what is appearing to be economical or affordable potentially may not a quality product and its pharmacoeconomic cost will be far higher.

The Government is serious about making drugs affordable, hence should insist with policy to ensure manufacturers market drugs underone drug- one price- one company policy. The Government should ban irrational combinations. Even our day to day commodities carry ISI mark before they come into the market. But no batch of drugs available in the market carries the seal of quality. Government should strengthen the licensing, inspection, cGMP compliance, quality assurance mechanism in drug manufacturing and ensure that each batch of drug available in the market is quality assured on sustainable basis.

IMA FOMA Delhi Resolutions (Federation of Medical Associations):

1.      The judgement to choose a rational drug and its format vests only with the Registered Medical Practitioners. This right of the medical profession is sacrosanct.

2.      IMA- FOMA also wants the Government to strengthen Quality Assurance mechanisms to ensure adherence to cGMP standards whether generic - generic or branded generic for patient safety.

3.     For a rational prescription, doctors should choose drugsgeneric - generic or branded generic based on quality, efficacy, safety and affordability and write legibly and preferably in capital letters.

4.     IMA-FOMA recommends that Government should ban differential pricing of a drug under different brand names (generic generic, trade generic or branded generic) by one company i.e. allow only  one chemical drug, one company, one price)

5.     IMA FOMA will be meeting the President of MCI, Union Health Minister and Prime Minister of India about the views of the medical fraternity on this issue. All the constituent members of IMA-FOMA shall communicate these IMA-FOMA Delhi Resolutions to its members.

IMA demands:

1)   Generic drugs (whether generic-generic or branded generic)  should comply with:

a. Efficient and effective quality assurance mechanism where every batch of the drug is of assured quality on sustainable basis. 

b. Uniform process of manufacturing, quality control and release with strong regulatory oversight.

c. Ensured pharmaceutical equivalent and bioequivalence to      innovator product.

d. Ensured adequate storage conditions and shelf life duly supported by adequate stability studies.

e. Uniform price of generic drugs irrespective of their formats

 f. Has the same clinical indications

Seven steps for Government of India

1.    Raise the Government expenditure on Health to 2.5 % of GDP from the current abysmal 1.1%.

2.    Strong overview and oversight by DCGI and State Drug Controllers on compliance to cGMP practices in drug industry.

3.    Strengthen the quality assurance infrastructure to the required level so that the quality of every batch of drugs is assured.

4.    Deploy adequate regulatory manpower to enforce the laws regarding drugs.

5.    Stop the Over the Counter (OTC) sale of prescription drugs without prescription and do not allow a company to market same drug in different prices under different brands.

6.    Prevent quacks and alternative system from using modern medicine drugs.

7.    Initiate awareness movement amongst doctors and patients to buy quality affordable drugs.

Conclusion:

Doctors are committed to the welfare and safety of patients. Economy of drugs is only one dimension of the issue. The multiple concerns as enlisted above have to be addressed first. IMA shall remain the voice of voiceless and continue its service in nation building diligently.

Supreme Court held that an error of judgement is not amount to Criminal Negligence.

Summary

In a very recent judgement pronounced by Hon’ble Supreme Court of India on 6 April 2014 in Criminal Appeal No. 636 of 2017 titled “Dr. Sou Jayshree Ujwal Ingole vs State of Maharashtra & Anr.”  Hon’ble court quashed the criminal proceedings against the appellant doctor thereby holding that an error of judgement is not amount to criminal negligence.

The appellant doctor filed appeal before Hon’ble Supreme Court of India against order dated 18 June 2014 passed by Hon’ble High Court of Mumbai, Nagpur bench whereby the petition filed by the appellant doctor under section 482 of the Code of Criminal Procedure for quashing of the criminal proceedings/FIR, was dismissed by Hon’ble High Court.

The Hon’ble Supreme Court referred to its earlier decision titled “Jacob Mathew versus State of Punjab and Anr.” reported at (2005) 6 SCC 1 and reiterated the principles laid down in the said judgement and held that an error of judgement does not amount to criminal negligence and set aside the order and judgement passed by Hon’ble High Court and quashed the entire criminal proceedings against the appellant doctor.

Regards

Shekhar Gupta (Advocate) and Dr K K Aggarwal (National President IMA)

Judgment:

Dr. Jayshree Ujwal Ingole vs State Of Maharashtra & Anr on 6 April, 2017

Bench: Madan B. Lokur, Deepak Gupta

                                                                                                      IN THE SUPREME COURT OF INDIA, CRIMINAL APPELLATE JURISDICTION,                      CRIMINAL APPEAL NO. 636 OF 2017, Arising out of SLP (Crl.) No. 7186 of 2014]

Dr. Sou Jayshree Ujwal Ingole    Appellant(s) vs State of Maharashtra & Anr.                  . . . Respondent(s)

                               J U D G M E N T

Deepak Gupta, J.

2. The appellant herein is a doctor and has challenged the Order dated 18.06.2014 passed by the High Court of Judicature of Bombay, Nagpur Bench in Criminal Application (APL) No. 354 of 2012, whereby the petition filed by the appellant under Section 482 CrPC for quashing the criminal proceedings initiated against her under Section 304-A IPC was dismissed.

3. Briefly stated the facts of the case are that one Shrikrishna Gawai (hereinafter referred to as the ‘deceased’) was admitted on account of injuries suffered in a road accident, in the Irvin Hospital, Amravati on 29.08.1997 for medical treatment. It is the admitted case of the parties that the deceased was suffering from Haemophilia, a disease in which there is impairment of blood clotting. Therefore, special attention was required to be paid during the treatment of the patient. It is not disputed that one Dr. Manohar Mohod was on duty as an Emergency Medical Officer. On 29.08.1997 the patient was treated both by the appellant and Dr. Mohod. On 30 & 31.08.1997, the deceased was attended upon by Dr. Dhirendra Wagh. Thereafter also, the deceased remained in the Hospital under the treatment of the appellant and Dr. Mohod.

4. Dr. Mohod, the Emergency Medical Officer attended upon the deceased on 05.09.1997 at 9.00 p.m. and found that he was suffering from abdominal pain and, thereafter, a call was sent to the appellant, who was Surgeon on Call. It is not disputed that the appellant went to the Hospital on being called. She attended upon the deceased and made a note that a Physician be called. Thereafter, she left the Hospital. In the morning on 06.09.1997, the condition of the deceased worsened and he died.

5. The main allegation against the appellant is that after having called for a Physician, she did not wait in the hospital and did not attend upon the patient, especially when the patient was suffering from Haemophilia. The Physician, Dr. Avinash Choudhary, who is accused No. 1, did not turn up in the hospital. Even next morning on 06.09.1997, when Dr. Mohod again attended upon the deceased, the Physician Dr. Choudhary was not present and, unfortunately, the patient died. Thereafter, a complaint was lodged in the police station, wherein it was alleged by the brother of the deceased that the deceased died as a result of negligence of the three doctors. The complaint was investigated as Crime No. 317 of 1997 which was initially filed against Dr. Avinash Choudhary only but, later on, the names of the appellant Dr. Jayshree Ujwal Ingole and Dr. Manohar Mohod were also included.

6. A separate Departmental Enquiry was also carried out and, in that enquiry, all the three doctors were held negligent in performing their duties. Dr. Mohod was debarred from an annual increment as penalty; the appellant Dr. Jayshree Ingole was permanently prohibited from entering Irvin Hospital, Amravati, and Dr. Avinash Choudhary was transferred. It would be pertinent to mention that Dr. Mohod was discharged in the criminal case on the ground that no case of negligence was made out against him.

7. The appellant herein filed a petition for quashing the charge against her, but this petition was rejected by the learned Single Judge of the High Court of Bombay at Nagpur mainly on the ground that the question whether inaction of the appellant in leaving the deceased at about 11.00 p.m. and not waiting for the Physician to turn up, amounted to a rash and negligent act on her behalf, would be decided during trial.

8. We have heard learned counsel for the parties. Learned counsel for the appellant has placed reliance on the judgment of this Court in Jacob Mathew v. State of Punjab & Anr.[1], wherein this Court held that the court should be circumspect before instituting criminal proceedings against a medical professional.

This Court has held that negligence comprises of (i) a legal duty to exercise due care on the part of the party complained of; (ii) breach of the said duty ; and (iii) consequential damage.

It was held that in cases where negligence is alleged against professionals like doctors the court should be careful before instituting criminal proceedings. It is not possible for any doctor to assure or guarantee that the result of treatment would invariably be positive. The only assurance which a professional can give is that he is professionally competent, has requisite skill and has undertaken the task entrusted to him with reasonable care. It would be pertinent to quote the following relevant observations made in Jacob Mathew’s case (supra):

26. No sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitur is not of universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors. Else it would be counter-productive. Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per se by applying the doctrine of res ipsa loquitur.

28. A medical practitioner faced with an emergency ordinarily tries his best to redeem the patient out of his suffering. He does not gain anything by acting with negligence or by omitting to do an act. Obviously, therefore, it will be for the complainant to clearly make out a case of negligence before a medical practitioner is charged with or proceeded against criminally. A surgeon with shaky hands under fear of legal action cannot perform a successful operation and a quivering physician cannot administer the end-dose of medicine to his patient.

29. If the hands be trembling with the dangling fear of facing a criminal prosecution in the event of failure for whatever reason — whether attributable to himself or not, neither can a surgeon successfully wield his life-saving scalpel to perform an essential surgery, nor can a physician successfully administer the life-saving dose of medicine. Discretion being the better part of valour, a medical professional would feel better advised to leave a terminal patient to his own fate in the case of emergency where the chance of success may be 10% (or so), rather than taking the risk of making a last ditch effort towards saving the subject and facing a criminal prosecution if his effort fails. Such timidity forced upon a doctor would be a disservice to society.

30. The purpose of holding a professional liable for his act or omission, if negligent, is to make life safer and to eliminate the possibility of recurrence of negligence in future. The human body and medical science, both are too complex to be easily understood. To hold in favour of existence of negligence, associated with the action or inaction of a medical professional, requires an in-depth understanding of the working of a professional as also the nature of the job and of errors committed by chance, which do not necessarily involve the element of culpability.

After discussing the entire law on the subject, this Court concluded as follows:

“48. We sum up our conclusions as under:

(1) Negligence is the breach of a duty caused by omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something which a prudent and reasonable man would not do. The definition of negligence as given in Law of Torts, Ratanlal & Dhirajlal (edited by Justice G.P. Singh), referred to hereinabove, holds good. Negligence becomes actionable on account of injury resulting from the act or omission amounting to negligence attributable to the person sued. The essential components of negligence are three: “duty”, “breach” and “resulting damage”.

(2) Negligence in the context of the medical profession necessarily calls for a treatment with a difference. To infer rashness or negligence on the part of a professional, in particular a doctor, additional considerations apply. A case of occupational negligence is different from one of professional negligence. A simple lack of care, an error of judgment or an accident, is not proof of negligence on the part of a medical professional. So long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course or method of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed. When it comes to the failure of taking precautions, what has to be seen is whether those precautions were taken which the ordinary experience of men has found to be sufficient; a failure to use special or extraordinary precautions which might have prevented the particular happening cannot be the standard for judging the alleged negligence. So also, the standard of care, while assessing the practice as adopted, is judged in the light of knowledge available at the time of the incident, and not at the date of trial. Similarly, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that particular time (that is, the time of the incident) at which it is suggested it should have been used.

(3) A professional may be held liable for negligence on one of the two findings: either he was not possessed of the requisite skill which he professed to have possessed, or, he did not exercise, with reasonable competence in the given case, the skill which he did possess. The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence.

(4) The test for determining medical negligence as laid down in Bolam vs. Friern Hospital Management Committee (1957) 1 WLR 582 at p. 586 holds good in its applicability in India.

(5) The jurisprudential concept of negligence differs in civil and criminal law. What may be negligence in civil law may not necessarily be negligence in criminal law. For negligence to amount to an offence, the element of mens rea must be shown to exist. For an act to amount to criminal negligence, the degree of negligence should be much higher i.e. gross or of a very high degree. Negligence which is neither gross nor of a higher degree may 

provide a ground for action in civil law but cannot form the basis for prosecution.

(6) The word “gross” has not been used in Section 304-A IPC, yet it is settled that in criminal law negligence or recklessness, to be so held, must be of such a high degree as to be “gross”. The expression “rash or negligent act” as occurring in Section 304-A IPC has to be read as qualified by the word “grossly”.

(7) To prosecute a medical professional for negligence under criminal law it must be shown that the accused did something or failed to do something which in the given facts and circumstances no medical professional in his ordinary senses and prudence would have done or failed to do. The hazard taken by the accused doctor should be of such a nature that the injury which resulted was most likely imminent.

(8) Res ipsa loquitur is only a rule of evidence and operates in the domain of civil law, specially in cases of torts and helps in determining the onus of proof in actions relating to negligence. It cannot be pressed in service for determining per se the liability for negligence within the domain of criminal law. Res ipsa loquitur has, if at all, a limited application in trial on a charge of criminal negligence.”

9. Applying the law laid down in Jacob Mathew’s case (supra), we are of the view that this is not a case where the appellant should face trial especially when 20 years have already elapsed. The only allegation against the appellant is that she left the patient. We must remember that the appellant was a Surgeon on Call. She came to the hospital when she was called and examined the patient. As per her judgment, she could find no evidence of bleeding or injury and, therefore, she had noted that a Physician be called. Thereafter, she left the hospital at about 11.00 p.m. True it is that she did not wait for the Physician to come, but it can be assumed that she would have expected that the Physician would come soon. This may be an error in judgment but is definitely not a rash and negligent act contemplated under Section 304-A IPC.

It is nobody’s case that she was called again by the Nursing staff on duty. If the condition of the patient had worsened between 11.00 p.m. and 5.00 a.m., the next morning, the Nursing staff could have again called for the appellant, but they did not do so. Next morning, the doctor on Emergency Duty, Dr. Mohod attended upon the patient but, unfortunately, he died.

10. In the facts and circumstance of this case, it cannot be said that the appellant is guilty of criminal negligence. At best it is an error of judgment.

11. In view of the above discussion, we are of the view that no case of committing a rash and negligent act contemplated under Section 304-A IPC is made out against the appellant. Her case is similar to that of Dr. Mohod who has been discharged. We, accordingly, allow the appeal, set aside the judgment dated 18.06.2014, passed by the learned Single Judge of the High Court of Bombay, Nagpur Bench in Criminal Application (APL) No.354 of 2012 and quash the criminal proceedings initiated against the appellant vide order dated 28.02.2001, passed by the Judicial Magistrate, First Class, Court No.6, Amravati in Regular Criminal Case No. 310 of 1999 in FIR Crime No.317 of 1997. Pending application(s), if any, stand(s) disposed of.

IMA white paper on organ transplant

Content courtasy-IMA

What is a competent authority?

It means the Head of the institution or hospital carrying out transplantation or committee constituted by the head of the institution or hospital for the purpose.

What is its role?

To give clearance to all near relative based transplants. The competent authority may seek the assistance of the Authorisation Committee in its decision making, if required.

What is authorisation committee?

For giving clearances in case of transplant is between other than near relatives and all cases where the donor or recipient is foreign national (irrespective of them being near relative or otherwise), the approval will be granted by the Authorisation Committee of the hospital or if hospital based Authorisation Committee is not constituted, then by the District or State level Authorisation Committee.

What is the composition of Authorisation Committees?

1.       There shall be one State level Authorisation Committee.

2.       Additional Authorisation Committees in the districts or Institutions or hospitals may be set up as per norms given which may be revised from time to time by the concerned State Government or Union territory Administration by notification.

3.       No member from transplant team of the institution should be a member of the respective Authorisation Committee.

4.       Authorisation Committee should be hospital based if the number of transplants is twenty five or more in a year at the respective transplantation centres, and if the number of organ transplants in an institution or hospital are less than twenty-five in a year, then the State or District level Authorisation Committee would grant approval(s).

What constitutes hospital based Authorisation Committee?

The hospital based Authorisation Committee shall, as notified by the State Government in case of State and by the Union territory Administration in case of Union territory, consist of

(a) The Medical Director or Medical Superintendent or Head of the institution or hospital or a senior medical person officiating as Head - Chairperson;

(b) Two senior medical practitioners from the same hospital who are not part of the transplant team – Member;

(c) two persons (preferably one woman) of high integrity, social standing and credibility, who have served in high ranking Government positions, such as in higher judiciary, senior cadre of police service or who have served as a reader or professor in University Grants Commission approved University or are self-employed professionals of repute such as lawyers, chartered accountants, doctors of Indian Medical Association, reputed non-Government organisation or renowned social worker - Member;

(d) Secretary (Health) or nominee and Director Health Services or nominee from State Government or Union territory Administration - Member.

What constitutes State or District Level Authorisation Committees?

The State or District Level Authorisation Committee shall, as notified by the State Government in case of State and by the Union territory Administration in case of Union territory, consist of,—

(a) A Medical Practitioner officiating as Chief Medical Officer or any other equivalent post in the main or major Government hospital of the District – Chairperson;

(b) Two senior registered medical practitioners to be chosen from the pool of such medical practitioners who are residing in the concerned District and who are not part of any transplant team– Member;

(c) Two persons (preferably one woman) of high integrity, social standing and credibility, who have served in high ranking Government positions, such as in higher judiciary, senior cadre of police service or who have served as a reader or professor in University Grants Commission approved University or are self-employed professionals of repute such as lawyers, chartered accountants, doctors of Indian Medical Association, reputed non-Government organisation or renowned social worker - Member;

(d) Secretary (Health) or nominee and Director Health Services or nominee from State Government or Union territory Administration–Member: Provided that effort shall be made by the State Government concerned to have most of the members’ ex-officio so that the need to change the composition of Committee is less frequent.

What is the Quorum of Authorisation Committee?

The quorum of the Authorisation Committee should be minimum four and the quorum shall not be complete without the participation of the Chairman, the presence of Secretary (Health) or nominee and Director of Health Services or nominee.

Can the committee be manipulated?

It’s unlikely. The quorum makes its mandatory to have minimum two government representatives.

Can the medical officer of case incharge be a member of any committee?

The medical practitioner who will be part of the organ transplantation team for carrying out transplantation operation shall not be a member of the Authorisation Committee constituted under the provisions of clauses (a) and (b) of sub-section(4) of section 9 of the Act or of the competent authority.

What about if the donor and recipients are both foreign nationals?

When the proposed donor or recipient or both are not Indian nationals or citizens whether near relatives or otherwise, the Authorisation Committee shall consider all such requests and the transplantation shall not be permitted if the recipient is a foreign national and donor is an Indian national unless they are near relatives.

What is to be seen by the authorisation committee if the donors and recipients are not related?

The Authorisation Committee shall evaluate nine points-

·         Evaluate that there is no commercial transaction between the recipient and the donor and that no payment has been made to the donor or promised to be made to the donor or any other person

·          Prepare an explanation of the link between them and the circumstances which led to the offer being made

·          Examine the reasons why the donor wishes to donate

·          Examine the documentary evidence of the link, e.g. proof that they have lived together, etc.

·          Examine old photographs showing the donor and the recipient together

·          Evaluate that there is no middleman or tout involved

·          Evaluate that financial status of the donor and the recipient by asking them to give appropriate evidence of their vocation and income for the previous three financial years and any gross disparity between the status of the two must be evaluated in the backdrop of the objective of preventing commercial dealing

·          Ensure that the donor is not a drug addict

·          Ensure that the near relative or if near relative is not available, any adult person related to donor by blood or marriage of the proposed unrelated donor is interviewed regarding awareness about his or her intention to donate an organ or tissue, the authenticity of the link between the donor and the recipient, and the reasons for donation, and any strong views or disagreement or objection of such kin shall also be recorded and taken note of.

Who will approve the SWAP cases?

Cases of swap donation shall be approved by Authorisation Committee of hospital or district or State in which transplantation is proposed to be done and the donation of organs shall be permissible only from near relatives of the swap recipients.

Can the process be expedited?

When the recipient is in a critical condition in need of life saving organ transplantation within a week, the donor or recipient may approach hospital in-charge to expedite evaluation by the Authorisation Committee.

Who is a near relative?

A: Grandmother, grandfather, mother, father, brother, sister, son, daughter, grandson and granddaughter, above the age of eighteen years. They have to be related genetically.

Who gives clearance in cases of near relatives?

Where the proposed transplant of organs is between near relatives related genetically the competent authority or the Authorisation Committee (in case donor or recipient is a foreigner)

What is their role?

The committee shall evaluate;

(i)                  Documentary evidence of relationship

Relevant birth certificates

Marriage certificate

Other relationship certificate from Tehsildar or Sub-divisional magistrate or Metropolitan Magistrate or Sarpanch of the Panchayat

Similar other identity certificates like Electors Photo Identity Card or AADHAAR card  

(ii)                Documentary evidence of identity and residence of the proposed donor

Ration card

Voter identity card

Passport

Driving license

PAN card

Bank account

Family photograph depicting the proposed donor and the proposed recipient along with another near relative

Similar other identity certificates like AADHAAR Card (issued by Unique Identification Authority of India).

If in the opinion of the competent authority, the relationship is not conclusively established after evaluating the above evidence, it may in its discretion direct DNA Profiling from NABL certified lab.

Can the competent authority be misled?

Only if the above documents are forged. It may be difficult for the competent authority to scrutinise forged documents.

What is the procedure when the donor is a spouse?

Where the proposed transplant is between a married couple the competent authority or Authorisation Committee (in case donor or recipient is a foreigner) must evaluate the factum and duration of marriage and ensure that documents such as marriage certificate, marriage photograph etc. are kept for records along with the information on the number and age of children and a family photograph depicting the entire family, birth certificate of children containing the particulars of parents.

Dr K K Aggarwal