WHO to include 'gaming disorder' in its list of mental health conditions

 1.       Healthy fats and healthy carbs:  Just as there are "good carbs" and "bad carbs," there are good fats and bad fats. Saturated fat, trans fats, and cholesterol are the bad guys. Good fats are monounsaturated and polyunsaturated.

2.       Do you know? In pleural effusion, 75 mL of fluid is needed to obliterate the posterior costophrenic sulcus; 175 mL to obscure the lateral costophrenic sulcus; 500 mL to obscure the diaphragmatic contour on an upright chest radiograph but on decubitus radiographs, less than 10 mL (as little as 2 mL) can be identified.  If pleural effusion reaches the level of the fourth anterior rib, 1000 mL of fluid is present.

3.       Useful tip in diabetes management: Dividing 1500 with the total daily insulin dose will give one the change in blood sugar levels with one unit of insulin and if you divide 500 with total daily dose of insulin and it will give one the grams of carbohydrates required to neutralize none unit of insulin.

4.       MRI scan safe for most people with older pacemakers, defibrillators: A new study in the New England Journal of Medicine “confirms that pretty much anybody who has a pacemaker or implanted defibrillator can, with very few restrictions, safely get an MRI scan if they need it,” as long as the devices are properly adjusted before the scan and safeguards are in place. To prevent problems, the researchers reprogrammed the devices to adopt a standard heart rhythm for people whose hearts won’t beat on their own and disabled functions that might cause the pacemaker to fire improperly if the MRI produced erratic signals in the heart. After the MRI, the devices were returned to their original settings (Source: bit.ly/2pGopkv The New England Journal of Medicine, online December 27, 2017).

5.       NMC Update: It has been said that NMC Bill need not go to the standing committee because it was brought on the recommendation of standing committee. But, this argument is not correct as Niti Aayog has been working on this document since 2014 and the standing committee only recommended it in 2016. The Bill should be referred to the standing committee.

6.       In 2018, playing video games obsessively might lead to a diagnosis of a mental health disorder. In the beta draft of its forthcoming 11th International Classification of Diseases, the WHO includes "gaming disorder" in its list of mental health conditions. The WHO defines the disorder as a "persistent or recurrent" behavior pattern of "sufficient severity to result in significant impairment in personal, family, social, educational, occupational or other important areas of functioning." The disorder is characterized by "impaired control" with increasing priority given to gaming and "escalation," despite "negative consequences." Video game playing, either online or offline, must be "normally evident over a period of at least 12 months" for this diagnosis to be made, according to the beta draft guidance. However, if symptoms are severe and all requirements are met, health care professionals may include people who have been playing for shorter periods of time, the draft reads.

7.       The National Human Rights Commission (NHRC), taking suo moto cognizance of the sheer negligence, wherein, over 30 persons were operated for cataract in torchlight at a Unnao community health centre, has issued a notice to Uttar Pradesh government. The Commission has observed that it was a case of medical negligence and sheer carelessness on the part of the doctors and district health authorities.

8.       For patients with mild cognitive impairment (MCI), regular exercise is likely to improve cognitive functioning, an updated guideline from the American Academy of Neurology (AAN) concludes. The new AAN guideline on MCI, which is endorsed by the Alzheimer's Association, was published online December 27 in Neurology.

9.       To develop a mechanism for eradicating cuts and commissions in medical practice: Payment made to all doctors for services provided should be transparent and reflected in the bill. Any charges paid to doctors without the knowledge of the patient and not reflecting in the patient’s bill should be considered a professional misconduct.

10.    Dear Dr KK Aggarwal: I deem it my pleasure to record my heartfelt compliments to you on the 1st Dr Ketan Desai Medical Statesman of the Highest Order Oration delivered by your good self, which was not only inspiring but also a humble depiction of committed creativity and indicative of futuristic direction as well. It is indeed worth of a publication by the IMA. With warm regards, Yours sincerely, Dr Ved Prakash Mishra, Chancellor, Krishna Institute of Medical Sciences (Deemed University), Karad.

Dr KK Aggarwal

Vice President CMAAO
Immediate Past National President IMA
President HCFI and Group Editor-in-Chief IJCP Group

Exercise may improve memory in patients with mild cognitive impairment

A practice guideline released by the American Academy of Neurology (AAN) has recommended exercise for patients with mild cognitive impairment (MCI) as part of approach to managing symptoms. The guidelines endorsed by the Alzheimer’s Association say that exercising twice a week may improve thinking ability and memory in such patients.

Mild cognitive impairment is a medical condition that is common with aging. While it is linked to problems with thinking ability and memory, it is not the same as dementia. However, there is strong evidence that MCI can lead to dementia. Hence, early diagnosis of MCI is important.

Other major recommendations include:

·         Evaluation of patients with MCI for modifiable risk factors, functional impairment including behavioral/neuropsychiatric symptoms (Level B).

·         Monitoring of cognitive status (Level B).

·         Discontinue cognitive impairing medications should be discontinued where possible and treat behavioral symptoms (Level B).

·         If clinicians choose to offer cholinesterase inhibitors, they must first discuss lack of evidence

·         Cognitive training may also be recommended. There is weak evidence that cognitive training may be beneficial in improving measures of cognitive function (Level C).

·         Clinicians should discuss diagnosis, prognosis, long-term planning, and the lack of effective medicine options (Level B), and may discuss biomarker research with patients with MCI and families (Level C).

The guidelines are published December 27, 2017 online in the journal Neurology.

(AAN News Release, December 27, 2017)

Straight from the Heart: Time to say Thank You

Dear Friends, it is time for me to say ‘Thank you’ for all your support, friendship, views and wise counsel during these last three years of my term in office.

During these years, I found strength in the general membership of IMA and could further strengthen my bond with them through transparency and my daily communications. I could communicate practically with every IMA member, who is digitally connected. I did bi-weekly webcasts as a part of my e-connect strategy. The viewership crossed one lakh on three such occasions.

At an individual level, I earned a good mentor in Dr Ketan Desai – an intelligent man, a keen observer, a tough taskmaster, yet a soft emotional man from inside who opens up his heart like a child only with trusted old friends.

I found an erudite guide in Dr Ved Prakash Mishra - with his excellent command of the Vedas, the English language, Drafting and Medical Education; a philosopher in Dr Ajay Kumar - a person who is honest to his commitments; a genuine leader in Dr A Marthanda Pillai, with his quality of remaining calm and positive, especially in difficult situations; a trusted friend in Dr Ravi Wankhedkar and a true guide in Dr RV Asokan.

My thanks to Dr Jayshree Mehta, President MCI and Dr Vinay Aggarwal for all the guidance.

Special thanks to the National Vice Presidents - Dr Roy Abraham Kallivayalil, Dr Prakasam K,
Dr Mahendra H Choudhary and Dr Parmanand Prasad Pal.

Throughout these years, my main strength has been my right-hand Dr RN Tandon, very ably supported by Dr VK Monga. Dr Tandon is a thorough gentleman and a lovable person to work with.

I also take a moment here to remember Late Dr VCV Pillai, who left us in August this year. Dr Pillai taught me the importance of wearing the IMA Pin with pride. When I was elected the National President IMA, he gifted me his personal IMA pin.

Thank you Dr Sudipto, may God give you a long life. Thank you, Dr Ashok Adhao for according me the respect of a son-in-law of Nagpur and Dr Arul Rhaj for your continuous inputs.

Thanks Dr Vijay Kumar for all the inputs. Thank you, Dr KV Babu, for your constructive criticisms.

Thank You Dr Narottam Puri, Dr Naresh Trehan, Dr Shubnum Singh, Dr Anupam Sibal, Dr KK Kalra, Dr Girdhar Gyani, Bejon Misra, Dr NV Kamat, Dr Vijay Agarwal, Dr Alex Thomas, Dr Alex Franklin, Dr AK Agarwal, Dr Arun Gupta, Dr Shiv Utture, Dr Jayesh Lele, Dr Sanjay Dudhat, Dr Dinesh Thakre, Dr Parthiv, Dr Chacker, Dr DD Chaudhury, Dr Jayalal, Dr Ravi Shankar, Dr Jaya Krishan, Dr Pradeep, Dr M Ashraf, Dr Murugunathan, and many more including Team Digital IMA.

Thank you Dr Ashwani Dalmiya, Dr Girish Tyagi, Dr BB Gupta, Dr Rajiv Dhir, Dr Ramesh Datta, Dr Vinod Khetrapal, Dr Naresh Chawla, and Dr Anil Goyal.

I must also acknowledge here Sanjay, Meena, Neeru and Dogra from IMA; Dr Sanchita Sharma, Dr Major Prachi Garg, Dr Uday Kakroo, Geeta Anand, Nidhi, Tanuja, Yogesh, Sanjeev, Dheeraj, Sanjiv, Deepak, Adib, Pranay, Manoj, Ram Singh, and Sapna from my personal staff for their help in various activities of IMA. I thank each one of them.

I would also like to express my thanks and appreciation to the IMA legal team Rahul Gupta, Ira Gupta, Aanchal Dhingra, and Shekhar Gupta.

I take this opportunity to say a special thank you to my daughter Naina, my son Nilesh, my wife Dr Veena Aggarwal, my nephew Saurabh and my future son-in-law Ankit for their constant support and encouragement in all my endeavors.

My special thanks to Shri JP Nadda, Dr Henk Bekedam, Dr Mahesh Sharma, Dr Jitendra Singh, Shri Mukul Rohatgi, Shri CK Mishra and Ms Preeti Sudan, Sanjeeva Kumar, Arun Jha, Shri Arun Panda, Dr Soumya Swaminathan, Dr Anuj Sharma, Dr SY Quarishi, HE AR Kohli and Dr AC Dhariwal for all their help during these years. 

A big thank you to Dr Vinit Ahuja and Dr R Guleria, who ensured that my health did not come in the way of my work for the Association.

Thank you to those, whose names I have not been able to mention all names here; you are always in my heart. 

Friends, these years have been a period of self-learning. And, all that I have learned, I want to pass on as my legacy to Dr Ravi Wankhedkar. I will be there right by his side whenever needed.

The English philosopher and writer Thomas Paine said, “It is not in numbers, but in unity, that our great strength lies.”

I seek forgiveness from all of you: “If in trying to achieve my goals during these years in IMA, knowingly or unknowingly, I have hurt your consciousness in my writings, speech, actions, or thoughts, kindly forgive me.” 

Why should everyone oppose the National Medical Commission Bill 2017?

Dr K K Aggarwal

National President IMA and HCFI

Composition of the National Medical Commission

One of the sections of the proposed Bill provides for the composition of the National Medical Commission, which will have a) a chairperson b) 12 Ex-officio Members c) 11-part time members d) an Ex-Officio Member Secretary. Thus, it would have an effective membership of 25 along with the Chairman of which only 5 members will be elected (Part Time Members who will be elected by the registered medical practitioners from among themselves from such regional constituencies and in such manner as may be prescribed.

Therefore, the proposed commission will have 1/5th members (20% elected members and 80% appointed / nominated members). It is for this reason it will not have a desired ‘representative character’ with reference to ‘elected and nominated / appointed members’

The composition of the four autonomous boards (Ethics and Medical Registration [EMR] Board, Medical Assessment and Rating [MAR] Board, Postgraduate Medical Education [PGME] Board, Undergraduate Medical Education [UGME] Board) prescribed under the Bill does not include any elected member there under.  Each board will have only three nominated members, one president and two members and that to with full powers to recognize or derecognize a medical college, powers today vested with 130 members.

The present MCI is a representative body with representatives from central government (8), state representatives (one from each state), state council’s professional doctors (one each), representatives from each health university etc. covering all stake holders.

Functions of the Commission

The functions vested with the Commission under the Act are generic, advisory and cosmetic in character. There under it is to exercise appellate jurisdiction with respect to decisions of the autonomous boards except that of the EMR Board as brought out in the proposed Bill. However, in one of the sections, it is stated that a medical practitioner or professional who is aggrieved by the decision of the EMR board may prefer an appeal to the Commission within 60 days of the communication of such decision, which is contradictory.

One of the sections of the proposed act provides an appellate jurisdiction exclusively to a medical practitioner or professional to prefer an appeal with the commission if aggrieved with the decision of the EMR Board. However, the said clause is absolutely silent in regard to providing appellate jurisdiction to the complainant, which is a substantial omission with reference to equity and providence for justice.

Functionally commission would be framing guidelines for determination of Fee in respect of such proportion of seats not exceeding 40% in the private medical institutions and deemed universities which are governed under the provisions of this Act. This operationally means that the fee regulation would be limited to a maximum of 40% seats in the private medical institutions and deemed universities, which is difficult to understand as to why such a ceiling and furthermore it could be anything from nil up to 40% which is paradoxical in nature. This will also have political implications and can be a root cause of future corruptions.

Separate National Register

The Bill states that the EMR Board shall maintain a separate National Register including the names of licensed Ayush Practitioners who qualifies the bridge course referred in one of the sections in such manner as may be specified by Regulations. By an explanation, Ayush Practitioner has been defined as a person who is a practitioner of Homeopathy or a practitioner of Indian Medicine as defined in Clause (e) of Sub-section 1 of section 2 of the Indian Medicine Central Council Act, 1970.

One of the sections of the proposed Bill contemplates bridge courses even for the practitioners of homeopathy to enable them to prescribe such modern medicines at such level as may be prescribed. This is materially inconsistent with the definition of the word ‘medicine’ as depicted in one of the sections wherein it is defined as ‘medicine means modern scientific medicine in all its branches and include surgery and obstetrics but does not include veterinary medicine and surgery’.

As such these are the flood gates that have been opened up in terms of the statutory provisions for backdoor entry into medical profession entitling practicing modern medicine.

Dismantling Screening Test

In one section, the proposed Bill clearly stipulates that ‘no person who has obtained medical qualification from a medical institution established in any country outside India and is recognized as a medical practitioner in that country shall, after the commencement of this Act and the National Licentiate Examinations becomes operational, be enrolled in the National register unless he qualifies the National Licentiate Examinations.

It is strange that, a filter in the name of screening test, was placed to ensure that the degree holders from medical institutions outside country are tested in regard to their required level of knowledge and upon clearance of the screening test were required to do one-year internship for the hands-on training under supervision in a recognized medical college to ensure that he is capable of rendering healthcare services to the people at large in the Indian context. Upon the promulgation of the National Medical Commission Bill 2017, the Indian Medical Council Act, 1956 would stand repealed and therefore the clause 13 thereat prescribing screening test would be rendered to nullity.

The proposed bill stipulates in one of the sections that “The National Licentiate examination shall become operational on such date, within three years from the date of commencement of this act, as may be appointed by the Central Govt., by Notification. This operationally means that till such time the National Licentiate examination is notified, the Indian possessing foreign Medical qualification would be entitled to seek permanent registration and practice medicine without any screening rider or filter. As such, during the interregnum a vacuum would be created, and the same would be filled in what manner is not provided for anywhere in the proposed Bill. This may amount to backdoor entry of over one lakh foreign graduates.

It is imperative to note that there are several students who have sought admission to medical institutions outside India after procuring eligibility certificate by the Medical Council of India and therefore, are legitimately entitled to appear for the screening test after acquiring foreign graduate medical qualification. Further, the foreign qualifications which are there in the existing schedule in a limited number appended to the Indian Medical Council Act, 1956, with the annulment of the said Act would also become redundant.

By removal of the said filter and in the teeth of the liberal provision incorporated one of the sections of the Bill, it will open floodgates for the compromised degree holders to practice without they being tested for the desired levels and country will be flooded with half- baked and ill-equipped medical practitioners playing havoc with the health of Indian population at large.

UG-NEET exam will be in English or other languages with common counselling.  There will be a uniform National Licentiate Examination operational within three years with no PG NEET and with common counselling.

Licentiate exam will be a hindrance to students who have passed MBBS from North East States and or who belong to SC/ST or other backward classes. They will never be able to pass such common exams. Also, there is no provision for AYUSH doctors practicing modern medicine to undergo licentiate exam.  This amounts to restricting post MBBS students to practice and allowing half-baked AYUSH doctors to start practicing modern medicine with a ‘bridge course’.

Composition of Autonomous Board

One of the sections of the proposed Act stipulates that each autonomous board shall consist of President and two members. The composition does not provide for inclusion of any elected member therein which goes to indicate that the membership of the said Boards would be totally appointed / nominated without any representation of an elected member and thus they would not have any representative character as is desired and warranted.

Discretionary Powers for relaxing prescribed regulatory conditions

In one of the sections of the Bill, a proviso is provided, which entitles the MAR Board to relax the criteria for opening of the medical colleges at its discretion with the previous approval from the Central Government which yields not only a wide authority but also provides adequate scope for availing the discretion for extraneous considerations. More so the regulatory stipulations which are mandatory in nature and binding in character cannot be open for any concession or condonation vide discretionary authority.

The said discretionary authority is not only vested with the autonomous board but also is with the Central Govt. as well. Such dual / double discretions to waive the applicability of statutory stipulations governing prescribed requirements per seis bad in the eyes of the law.

Permission to practice without qualifying the National Licentiate Examination

Proviso to one of the sections stipulates that ‘the commission may permit a medical professional to perform surgery or practice medicine without qualifying the National Licentiate Examination, in such circumstances and for such period as may be specified by regulations’. This operationally means that without ascertaining of the required levels and certification thereto the commission would be permitting people to practice surgery and medicine is nothing less than legalizing quackery in an operational sense.

Removal of embargo on Foreign Citizens practicing in India

‘A foreign citizen who is enrolled in his country as a medical practitioner in accordance with the law regulating the registration of medical practitioners in that country may be permitted temporary registration in India for such period and in such manner as may be specified by a Regulation’ as clearly stipulated in a proviso to one of the sections. An uninhibited permission to practice medicine by a foreign citizen without any reasonable restrictions is harboring intrinsic dangers in itself.

Imposition of Penalty

The Bill provides in one of the sections that MAR Board take such measure, including imposition of monetary penalty, against a medical institution for failure to maintain the minimum essential standards specified by the UGME Board or the PGME Board, as the case may be, in accordance with the regulations made under this Act.

It is further provided that the “medical institution which has been imposed a first-time monetary penalty fails to take any corrective action, the MAR Board may impose a second-time monetary penalty for continued failure which shall be higher than the first- time penalty and on continued failure, impose a third-time monetary penalty which shall be higher than the second-time penalty:

Provided further that all the three monetary penalties imposed under the first proviso shall not be less than one-half, and not more than ten times, the total amount charged, by whatever name called, by such institution for one full batch of students of undergraduate course or postgraduate course, as the case may be:

Provided also that even after the imposition of third-time penalty, if the failure continues, the MAR Board shall forward its report to the Commission recommending to withdraw the recognition granted to the medical qualification awarded by that medical institution.

The material point for consideration is that all the three monetary penalties are not to be less than one half and not more than ten times the total amount charged by such a institution for one full batch of students of undergraduate course or postgraduate course as the case may be. Apart from the heavy computation the contemplation of batch of students of undergraduate course or postgraduate course fall short of indicating required specifics.

For example, the penalty can range from 5 crore to 100 crore, enough variation to have political implications or root cause for corrupt practices.

Also, a medical college which has not been compliant for want of financial resources how will the college pay the fine and if closes down what will happen to these students admitted for these three years.

Central Govt. empowered to issue directions

Although, autonomy is expected to be a hallmark of the National Medical Commission Bill, 2017 and the Boards there under are called as, “Autonomous Boards” in reality the same is a misnomer as under one of the sections in the said proposed Bill the Central Govt. would be entitled to give directions to the Commission and autonomous boards on all the questions of policy which would be binding for the commission and autonomous Boards to comply.

Further it is clearly stipulated that the decision of the Central Govt. whether question is one of the policy or not would be final and is not open for any require of any type.

In one of the sections, the proposed bill further stipulates that the Central Govt. would be within its rights to give such direction it may deem necessary to the State Govt. for carrying out all or any of the provisions of this Act and State Govt. shall comply with such directions is also undermining the authority of the State Govt. and is inconsistent with the cardinal principles governing the federal polity as stipulated in the Constitution of India.

The proposed Bill takes away the autonomous status of state medical councils “(d) promote, co-ordinate and frame guidelines and lay down policies by making necessary regulations for the proper functioning of the Commission, the Autonomous Boards and the State Medical Councils; and (f) take such measures, as may be necessary, to ensure compliance by the State Medical Councils of the guidelines framed and regulations made under this Act for their effective functioning under this Act.

Straight from the Heart: IMA ICMR Initiatives - Annual Round Up

IMA endorses National Guidelines for Stem Cell Research (NGSCR): The NGSCR-2013 covers only stem cell research, both basic and translational, and not therapy as the same is experimental as on date. Any stem cell use in patients, other than that for hematopoietic stem cell reconstitution for approved indications, is investigational and must only be done within the purview of an approved and monitored clinical trial. Every use of stem cells in patients outside an approved clinical trial is malpractice.

Points about stem cell therapy every IMA member must know

·         There are no approved indications for stem cell therapy other than the hematopoietic stem cell transplantation (HSCT) for haematological disorders. Stem cell therapies other than HSCT are investigational and can be conducted only in the form of a clinical trial following ICMR guidelines for clinical research after obtaining necessary regulatory approvals. Use of stem cells for any other purpose outside the domain of clinical trial is unethical (Clause 10.3.1)

·         Any violation of ICMR Clinical Research Guideline are actionable professional misconduct under “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 7.22 “Research: Clinical drug trials or other research involving patients or volunteers as per the guidelines of ICMR can be undertaken, provided ethical considerations are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy which is not as per the guidelines shall also be construed as misconduct.”

·         One dealing with pharmaceuticals and or allied industry one also need to follow 6.8.1 e regulation of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations:” Medical Research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is obliged to know that the fulfilment of the following items (i) to (vii) will be an imperative for undertaking any research assignment / project funded by industry – for being proper and ethical. Thus, in accepting such a position a medical practitioner shall:- (i) Ensure that the particular research proposal(s) has the due permission from the competent concerned authorities. (ii) Ensure that such a research project(s) has the clearance of national/ state / institutional ethics committees / bodies. (iii) Ensure that it fulfils all the legal requirements prescribed for medical research. (iv) Ensure that the source and amount of funding is publicly disclosed at the beginning itself. (v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research project(s). (vi) Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way. (vii) Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document / agreement for any such assignment”

The MCI ethics violation will attract “First time censure, and thereafter removal of name from Indian Medical Register or State Medical Register for a period depending upon the violation of the clause.”

·         Stem cells clinical trials for conditions other HSCT will require approval from Institutional Ethics Committee (IEC) and Institutional Committee for Stem Cell Research (IC-SCR) and CDSCO. The IEC should be registered with Central Drug Standards Control Organization DSSCO and IC-SCR with National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT). Only registered entities are permitted to conduct these trails. Stem cells used for intervention should be processed/developed under CDSCO certified GMP facility.

·         Clinical trials using human stem cells should be in compliance with Schedule Y of Drugs and Cosmetics Act and GCP Guidelines of CDSCO (www.cdsco.nic.in) as well as ICMR-Ethical Guidelines for Biomedical Research involving Human Participants (http://www.icmr.nic.in/ethical_guidelines.pdf). All clinical trials on stem cells shall be registered with Clinical Trial Registry India (CTRI). (Clause 10.2)

o    Any violation will be a professional misconduct as per MCI ethics regulation 1.9  to be read with regulation 7.1

o    1.9: “Evasion of Legal Restrictions: The physician shall observe the laws of the country in regulating the practice of medicine and shall also not assist others to evade such laws. He should be cooperative in observance and enforcement of sanitary laws and regulations in the interest of public health. A physician should observe the provisions of the State Acts like Drugs and Cosmetics Act, 1940; Pharmacy Act, 1948; Narcotic Drugs and Psychotropic substances Act, 1985; Medical Termination of Pregnancy Act, 1971; Transplantation of Human Organ Act, 1994; Mental Health Act, 1987; Environmental Protection Act, 1986; Pre–natal Sex Determination Test Act, 1994; Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954; Persons with Disabilities (Equal Opportunities and Full Participation) Act, 1995 and Bio-Medical Waste (Management and Handling) Rules, 1998 and such other Acts, Rules, Regulations made by the Central/State Governments or local Administrative Bodies or any other relevant Act relating to the protection and promotion of public health”.

o    MISCONDUCT: The following acts of commission or omission on the part of a physician shall constitute professional misconduct rendering him/her liable for disciplinary action

o    7.1   Violation of the Regulations: If he/she commits any violation of these Regulations. 

·         The physician/scientist engaged in stem cell research shall avoid any activity that leads to unnecessary hype, or unrealistic expectations in theminds of study participants or public at large regarding stem cell therapy. The study participant and other responsible family members must be given adequate and unbiased information about the trial protocol, its limitations and potential adverse effects. (Clause 7.5). The same is also actionable under The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

o    Promotional advertisements by private banks offering storage of cord blood for possible- future use are misleading. As there is no scientific basis for preservation of cord blood for future self-use at present, this practice is not recommended. The only exception is when there is a child with a haematological disease curable by HPSC and the mother is pregnant. In such situation storage and release of stem cells from cord blood of the new-born sibling,  subject to HLA match shall be recommended. On the other hand, parents should be encouraged for voluntary donation to public cord blood banks for allogeneic transplantation and research purposes. (Clause 12.2)

o    "Disclaimers / Qualifiers" the advertisements should carry so that there is a standard declaration which is unambiguous to a lay consumer?

·         The IC-SCR and IEC shall ensure that the patients/participants recruited under clinical trial shall not be charged including hospital stay and laboratory based investigations. (Clause 10.2.5.5)

·         Prior to enrolment of subjects in clinical trials or procurement of stem cells for research, it is mandatory to obtain informed consent from thedonor. (Clause 4.1)

·         Independent informed consent in advance should be obtained for termination pregnancy and for donation of the foetal material for research.  There should be no inducement for donation of gametes/embryos/somatic cells by way of payment or in of lieu of medical services, except for reimbursement of reasonable expenses for travel and loss of wages incurred by the person (amount to be decided by IC-SCR/ IEC). (Clause 13.1.2)

·         Use of Umbilical cord blood stem cells (except when the HPSCs are used for conditions approved for bone marrow HPSC transplantation) , HSC or MSC is experimental at present and shall be permitted only under conditions of controlled clinical trial by the IC-SCR/IEC (Clause 12.2)

o    In most of the haematological/genetic disorders, child’s own stored cord blood stem cells cannot be used for the same child as those will carry the same defect. 

·         An institution or laboratory developing or processing stem cells for human use should obtain NABL accreditation for all laboratory procedures required for product development.

Presidential address on 28^th December I spoke “IMA also wants the government to declare a special fund for rare diseases and orphan drugs.”

ICMR set up a registry of rare diseases. Apart from maintaining a database, the registry, set up on April 28 2017, will also help formulate policies on funding, treatment and more. A disease is defined as rare when it affects less than one in 2,500 individuals. Over 70mn Indians suffer from such disorders and live with them throughout their lives.   There are only 500 FDA-approved drugs for over 7,000 rare diseases globally.  There is often no cure, only supportive care. Treatment is extremely costly too, ranging from lakhs to crores a year.  The health ministry is currently discussing a draft policy for treatment of rare diseases.

In Gorakhpur issue IMA raised the absence of autopsies in such cases

The under-five mortality rate in India stands at 50 per 1000 live births. The pilot project that will begin in January, 2018, at New Delhi’s Safdarjung hospital, is a part of the global CHAMPS— Child Health and Mortality Prevention Surveillance, project, wherein tissue biopsies of the brain, liver, spleen and other tissues are taken in a minimally invasive way. This will benefit in districts like Gorakhpur where child deaths are high. For six months— January to June, all child deaths that take place at Safdarjung hospital will be examined. Informed consent will be taken from the parents.

IMA Women Life Time Achievement Award to ICMR DG

Other issues: C. auris ICMR advisory, AMR, NCD

May Measurement Month