Thursday, 25 December 2014

FDA to Lift Ban on Gay Men Donating Blood: IMA to come out with Indian guideline

The US Food and Drug Administration has decided to formally propose lifting a 31-year-old ban on blood donations from men who have sex with men, allowing them to give blood provided they have not had sex with other men during the previous year.

FDA instituted its ban in the early days of the AIDS epidemic on the basis of fears of HIV entering the blood supply.

An advisory committee of the Department of Health and Human Services in November recommended a blood donation deferral of 1 year after sexual activity, pointing to studies that show the practice to be safe.

As per the new policy Individuals cannot donate blood within a year of having sex with a prostitute or an intravenous drug user'

According to one recent study, allowing MSM to donate blood 12 months after their last sexual episode could add as many as 317,000 pints to the nation's supply each year.

The United Kingdom permits MSM to donate blood after a year of celibacy, and Canada allows it after the 5-year mark.

Indian Medical Association has called a meeting of experts to decide about the Indian Guidelines.

[The Author is Padma Shri Awardee, Honorary Secretary General Elect IMA and President Heart Care Foundation of India]

Wednesday, 24 December 2014

India slashes health budget

The government has ordered a cut of nearly 20 percent in its 2014/15 healthcare budget due to fiscal strains, putting at risk key disease control initiatives in a country whose public spending on health is already among the lowest in the world, reports Reuters. More than 60 billion rupees, or $948 million, has been slashed from their budget allocation of around $5 billion for the financial year ending on March 31.

India spends about 1 percent of its gross domestic product (GDP) on public health, compared to 3 percent in China and 8.3 percent in the United States. The United Nations estimates about one third of the world's 1.2 billion poorest people live in India.

The move reflects the government's struggle to achieve its 2014/15 fiscal deficit target of 4.1 percent of GDP.

The retrenchment could also derail an ambitious universal healthcare programme that Modi wants to launch in April. The plan aims to provide all citizens with free drugs and diagnostic treatments, as well as insurance benefits. The cost of that programme over the next four years had been estimated at 1.6 trillion rupees ($25 billion). The health ministry officials had been expecting a jump in their budget for the coming year, in part to pay for this extra cost.

In addition to the healthcare budget, the finance ministry has also ordered a spending cut for India's HIV/AIDS programme by about 30 percent to 13 billion rupees ($205.4 million). India had the third-largest number of people living with HIV in the world at the end of 2013, according to the U.N. AIDS programme, and it accounts for more than half of all AIDS-related deaths in the Asia-Pacific.

The move by the government is a retrograde step. The country should try cordial relationship with neighboring countries so that health and education budget is not compromised at the cost of increasing the defense budget. IMA will peruse the government to roll back.

For the time being at the IMA we will try to bring in a campaign to reduce the disease burden by 25-50% via implementing preventive and swachh bharat swasthya bharat movement. 

Tuesday, 23 December 2014

Pharma companies can no longer gift freebies to Indian doctors

Excerpts from a report by Rupali Mukherjee in TOI news dated Dec 23.

1. Doling out freebies, cruise tickets, paid vacations and sponsorship to educational conferences and seminars for doctors by pharmaceutical companies has been banned from January.

2. The government has woken up belatedly to curb unethical marketing practices of pharma companies by spelling out a uniform code of conduct for the industry. The code will be voluntary to start with, and kicks in from January 1. It will be reviewed after six months; if not implemented "effectively", the government will "consider"' making it mandatory, sources told TOI.

3. At present, the pharma industry follows a "self-regulatory'' code that curbs unethical sales promotion and marketing expenses, bans personal gifts, and all-expenses paid junkets for doctors and their families, but there have been several instances where companies have violated the code, industry experts say. They say the code exists only on paper as companies try to influence prescriptions through several ways.

4. This is the first time in years that the code has been finalized by the government, as earlier attempts to do so got mired in bureaucratic red tape.

5. Industry experts say that the government's Uniform Code of Pharmaceutical Marketing Practices has been modelled on the Medical Council of India (MCI) guidelines for doctors and healthcare professionals, which were further tightened in 2012.

6. The code clarifies the relationship with healthcare professionals. Regarding gifts, it says "no gifts, pecuniary advantages, or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply drugs, by a pharma company, or any of it agents including retailers, distributors or wholesalers".

7. It says "in any seminar, conference or meeting organized by a pharma company for promoting a drug or disseminating information, if a medical practitioner participates as a delegate, it will be on his/her own cost."

8. It further says that gifts for the personal benefit of healthcare professionals and family members (both immediate and extended) such as tickets to entertainment events are also not to be offered or provided by pharma companies, nor cash or monetary grants for individual purposes. Hospitality should also not be extended to any doctor or their family members.

9. The industry associations have to upload the Uniform Code on their websites and will be responsible for informing its members, and the government in case of violations.

10. The code also adds that "where there is any item missing, the code of MCI as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 as amended from time to time, will prevail''.

eMedinewS Comments: Dr K K Aggarwal

MCI code of ethics exists for doctors. Any violation can only be challenged in High Court.

Pharma companies until now were affected for any violation in the Income Tax exemptions.  Now pharma companies will also be governed by a similar ( like MCI) code of conduct.

Unless both pharma and doctors group are covered in their respective code of conduct the problem will not be over. So far the MCI code did not cover pharma companies violating MCI regulations'

It is same like, if doctors violate any MCI code they are punished under violation of MCI ethics regulations but same violations if done by medical establishments they are not punished. The need of the hour is to have uniform code of conduct for medical establishments' also.

Another answer is to bring medical establishments and pharma companies also under the preview of MCI ethics regulations.

Monday, 22 December 2014

Pharma Gifts are a Violation of both MCI and Income Tax Act

1.      A violation under Section 37 (1) of the income tax act: A CBDT Circular No. 5/2012 [F. No. 225/142/2012-ITA.II], dated 1-8-2012 was issued as under

 " 1. It has been brought to the notice of the Board that some pharmaceutical and allied health sector Industries are providing freebees (freebies) to medical practitioners and their professional associations in violation of the regulations issued by Medical Council of India (the ‘Council’) which is a regulatory body constituted under the Medical Council Act, 1956.

2. The council in exercise of  its statutory powers amended the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (the regulations) on 10-12-2009 imposing a prohibition on the medical practitioner and their professional associations from taking any Gift, Travel facility, Hospitality, Cash or monetary grant from the pharmaceutical and allied health sector Industries.

 3. Section 37(1) of Income Tax Act provides for deduction of any revenue expenditure (other than those failing under sections 30 to 36) from the business Income if such expense is laid out/expended wholly or exclusively for the purpose of business or profession. However, the explanation appended to this sub-section denies claim of any such expense, if the same has been incurred for a purpose which is either an offence or prohibited by law.

Thus, the claim of any expense incurred in providing above mentioned or similar freebees in violation of the provisions of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 shall be inadmissible under section 37(1) of the Income Tax Act being an expense prohibited by the law. This disallowance shall be made in the hands of such pharmaceutical or allied health sector Industries or other assesse which has provided aforesaid freebees and claimed it as a deductible expense in its accounts against income.

4. It is also clarified that the sum equivalent to value of freebees enjoyed by the aforesaid medical practitioner or professional associations is also taxable as business income or income from other sources as the case may be depending on the facts of each case. The Assessing Officers of such medical practitioner or professional associations should examine the same and take an appropriate action. This may be brought to the notice of all the officers of the charge for necessary action."

High court upheld the IT circular: The Himachal high court had upheld the income-tax department's decision to tax the amount pharmaceutical and allied health sector industries spend on freebies for medical practitioners and their professional associations. (March 2013)

High Court’s Ruling " The explanation to Section 37(1) makes it clear that any expenditure incurred by the taxpayer for any purpose which is prohibited by law shall not be deemed to have been incurred for the purpose of business or profession. The sum and substance of the circular is also the same.
In case the assessing authorities do not properly understand the circular then the remedy lies for each individual taxpayer to file appeal under the Act but the Circular which is totally in line with Section 37(1) cannot be said illegal."

The Circular also clarifies that the value of the freebies enjoyed by the medical practitioner is also taxable as business income or income from other sources depending on the facts of each case. Therefore, if the taxpayer satisfies the assessing authority that the expenditure is not in violation of the regulations framed by the medical council then it may legitimately claim a deduction. But, it is for the taxpayer to satisfy the assessing authority that the expenditure is not in violation of the Medical Council Regulations. Accordingly, the High Court rejected the petition.

Hospitals are not under MCI regulations: Max hospital had challenged the decision of the MCI where the Ethics Committee had made adverse observations against the hospital, by filing a writ petition being W.P.(C) 1334/2013 – Max Hospital, Pitampura Vs. Medical Council of India.

On behalf of Max Hospital, it was, inter alia, contended before the Hon’ble Delhi High Court that the MCI regulations do not govern or have any concern with the facilities, infrastructure or running of the Hospitals and that the Ethics Committee of the MCI acting under the Regulations had no jurisdiction to pass any direction or judgment on the infrastructure of any hospital which power rests solely with the concerned State Govt.

The MCI had filed an affidavit in this writ petition filed by Max Hospital before the Hon’ble Delhi High Court. In the MCI affidavit, it had been, inter alia, submitted as under:- “………..(iii) That the jurisdiction of MCI is limited only to take action against the registered medical professionals under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (hereinafter the 'Ethics Regulations') and has no jurisdiction to pass any order affecting rights/interests of any Hospital, therefore the MCI could not have passed and has not passed, any order against the petitioner which can be assailed before this Hon'ble Court in writ jurisdiction……………”

After consideration of the legal position and the affidavit submitted on behalf of the MCI, the Hon’ble High Court in its judgment dt. 10.01.14, in the above-mentioned writ petition filed by Max Hospital – held as under:- “………7. It is clearly admitted by the Respondent that it has no jurisdiction to pass any order against the Petitioner hospital under the 2002 Regulations. In fact, it is stated that it has not passed any order against the Petitioner hospital. Thus, I need not go into the question whether the adequate infrastructure facilities for appropriate postoperative care were infact in existence or not in the Petitioner hospital and whether the principles of natural justice had been followed or not while passing the impugned order. Suffice it to say that the observations dated 27.10.2012 made by the Ethics Committee do reflect upon the infrastructure facilities available in the Petitioner hospital and since it had no jurisdiction to go into the same, the observations were uncalled for and cannot be sustained.

Medical Associations are not under MCI regulation: In the High Court of Delhi; W.P.(C) 7987/2010 and CM 18254/2014; HARAM PRAKASH   Vs UOI and W.P.(C) 8188/2010 and CM 18242/2014- IMA vs MCI HON'BLE MR. JUSTICE VIBHU BAKHRU ordered as under “ These are applications filed by the petitioners inter alia praying as under: a).Quash/set aside order dated 23.11.2010 passed by the respondent approving the recommendations of the Ethics Committee of Medical Council of India dated 09.11.2010. b). Allow/dispose of the captioned writ petition in terms of letter dated 24.05.2010 of Government of India, judgment dated 10.01.2014 in Writ Petition No. 1334/2013 titled “Max Hospital Vs. Medical Council of India” and resolutions of 2nd Session (continued 138th Session) General Body meeting of MCI held on 28.03.14.

 The petitioner submits that the subject matter of the petition is covered by a judgment of this court titled “Max Hospital Vs. Medical Council of India” in W.P.(C) 1334/2013 decided on 10.01.2014.

It is asserted by the applicant that the Government of India had by a letter dated 24.05.2010 deleted the words ‘and professional association of doctors’ from the regulation 6.8 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.

 The approval for deletion of the aforesaid words was granted by the Central Government under Section 33 of the Indian Medical Council Act, 1956.

In addition, it is submitted that the MCI at its General Body meeting held on 28.03.2014 had accepted the recommendation of the Executive Committee and resolved as under:- In view of the above, the Council unanimously decided that the amendment to title of section 6.8 of the Indian Medical Council (Professional Conduct Etiquette and Ethics) Regulations, 2002vide notification dated 10/12/2009 and further amended by deletion of the words ‘and professional association of doctors’ duly approved, and authenticated by the Govt. of India vide their communication dated 24/5/2010 be notified forthwith in the official gazette of the Government of India.The aforesaid contentions are not disputed by the MCI. In view of the stand of the MCI as recorded in the General Body Resolution dated 28.03.2014 the present petitions are liable to be allowed. Accordingly, the order of MCI dated 23.11.2010 accepting the recommendation of the Ethical Committee of 09.11.2010 is set aside”.

2.      Violation of Section 28 in The Income- Tax Act, 1995: Recently the office of the Assistant Director of Income Tax (investigation) Unit-IV (2), Jhandewalan Extn., New Delhi procured information from MCI under Section 131 of the Income Tax Act, 1961.

The investigating agency took cognizance of the a news titled “Graft charge puts 300 does under MCI lens” reported in times of India on page no. 8 dated 18.11.2014 that the Medical Council of India is in possession of an anonymous complaint in regard to bribes paid by an Ahmedabad based pharma company to Doctors in the form of money as well as gifts in return for prescribing its medicines.
 As per the IT department this prima facie is a case of Income Tax evasion as the Doctors seemed to have received benefits in exercise of their profession.  As per the IT department the value of any benefit or perquisite, whether convertible into money or not, arising from business or the exercise of a profession is taxable as per section 28(iv) of the Income Tax Act. 1961.

 Section 28 in The Income- Tax Act, 1995: Profits and gains of business or profession: The following income shall be chargeable to income- tax under the head" Profits and gains of business or profession",- (iv) the value of any benefit or perquisite, whether convertible into money or not, arising from business or the exercise of a profession;]

[The author Dr K K Aggarwal is Senior National Vice President Indian Medical Association and President Heart Care Foundation of India]

Sunday, 21 December 2014

Not reporting TB a violation of MCI ethics regulation 7.14

 Wide letter number Z-28015/2/2012-TB, the Government of India, Ministry of Health and Family Welfare on 7th May 2012 declared TB as a notifiable disease. As pet the circular

" TB continues to be a major public health problem accounting for substantial morbidity and mortality in the country. Early diagnosis and complete treatment of TB is the corner-stone of TB  prevention  and  control  strategy.  Inappropriate  diagnosis and irregular/incomplete treatment with anti-TB drugs  may  contribute  to complications, disease spread and emergence of Drug Resistant TB.

In order to ensure proper TB diagnosis and case management, reduce TB transmission and address the problems of emergence and spread of Drug Resistant- TB, it is essential to have complete information of all TB cases. Therefore, the healthcare providers shall notify every TB case to local authorities i.e. District Health Officer I Chief Medical Officer of a district and Municipal health Officer of a Municipal Corporation / Municipality every month in a given format.

For the purpose of case notification, a TB case is defined as follows: A patient diagnosed with at least one sputum specimen positive for acid fast bacilli, or Culture-positive for Mycobacterium tuberculosis, or RNTCP endorsed  Rapid Diagnostic   molecular test positive for tuberculosis OR a patient diagnosed clinically as a case of tuberculosis, without microbiologic confirmation, and initiated on anti-TB drugs.

For the purpose of this notification, healthcare providers will include clinical establishments run or managed by the Government  (including  local  authorities), private or NGO sectors and/or individual practitioners.

For more detailed information, the concerned State TB Officers / District TB Officers, whose details are available on,  may be contacted.
(Manoj Sinha)  Under Secretary to the Government of India".

A copy of this circular was sent to all Principal Secretaries / Secretaries of Health of States / UTs With the request to kindly immediately; All Directors            of Health Services of bring  this  order  to  the  notice  of  all States / UTs                concerned   for          compliance,        in  their respective State / UT; All State TB Officers of States / UTs; PS to Union Minister HFW / Union Minister of HRD & CIT / MOS (HFW); PPS  to  Union  Secretary  HFW  /  DGHS  /  Union  Secretary  AYUSH/ Union Secretary HR (DG-ICMR) / union Secretary — NACO / DG-NIC; All Addl. Secretaries & Joint Secretaries in MOHFW / GOI All Dy. Director General / DteGHS / MOHFW / GOI; Director (Media) MOHFW / Got; All  Regional Directors (HFW/GOI) — with request to facilitate wide dissemination of this Govt. Order, for compliance,  in respective states / UTs; Websites of MOHFW/GOI ( and Central TB           Division (; DDG (NIC) & Sr. Technical Director (NIC) / MOHFW / GOI.
The above circular was not sent to Medical Council of India for reasons only known to them. Not reporting a notifiable disease is a violation of Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 under regulation 7.14 : "The registered medical practitioner shall not disclose the secrets of a patient that have been learnt in the exercise of his / her profession except –

1.            in a court of law under orders of the Presiding Judge;

2.    in circumstances where there is a serious and identified risk to a specific person and / or community; and notifiable diseases.

In case of communicable / notifiable diseases, concerned public health authorities should be informed immediately.

Under the regulation the word used is 'SHOULD' but under the notification the word used is 'SHALL.' It means it is mandatory to report but for the violation the MCI may take a lenient view if it is the first violation.

In most of the municipal corporation acts for example DMC Act ( Delhi) TB is defined as a dangerous disease under 2 (9) "dangerous disease" means— (a) Cholera, plague, chicken-pox, small-pox, tuberculosis, leprosy, enteric fever, cerebrospinal meningitis and diphtheria; and (b) any other epidemic, endemic or infectious disease which the Commissioner may, by notification in the Official Gazette, declare to be a dangerous disease for the purposes of this Act; Prevention of dangerous diseases.
The DMC act also mandates reporting under section  371. " Obligation to give information of dangerous disease: Any person being in charge of, or in attendance, whether as a medical practitioner or otherwise, upon any person whom he knows or has reason to believe to be suffering from a dangerous disease, or being the owner, lessee, or occupier of any building in which he knows that any such person is so suffering shall forthwith give information respecting the existence of such disease to the Municipal Health Officer.

[The author Dr K K Aggarwal is Senior National Vice President Indian Medical Association and President Heart Care Foundation of India]


Indian Medical Tourism Incomplete without Yoga Department in every Hospital

Recently in one of the interaction the Indian Tourism Minister Dr Mahesh Sharma said that India is going to be the hub of medical tourism because of its hospitality and culture.
It is correct but for that a slight paradigm shift is required in the way we practice medicine in the country.
Most western patients come to India to take advantage of Yoga and Ayurveda in addition to the western medicine.
Only for a lower cost we cannot attract medical tourists for long as sooner or later the China will over power us in future for medical treatments.
Our Prime Minister has convinced the world to have an international Yoga day. But unfortunately we do not have a yoga department in every government or a private medical institution.
Let India be the first country to have a yoga and an Ayurveda department in every hospital in addition to the western medicine.
The time is to promote traditional Yoga and Ayurveda. Unfortunately as they are not getting an uplifment they are ending up in cross pathy which is not on the interest of both their profession as well as the community.
Recently a review of studies examining the benefits of yoga suggests that Yoga practice provides significant benefits on cardiovascular risk factors, including LDL cholesterol and systolic blood pressure.
Those who practiced asana-based yoga reduced their LDL-cholesterol levels by 12.1 mg/dL and systolic blood pressure by 5.2 mm Hg and increased their HDL-cholesterol levels by 3.2 mg/dL.
In addition, the yoga practitioners also saw significant reductions in body-mass index, diastolic blood pressure, total cholesterol, triglycerides, and heart rate. Overall, the yogis lost 2.35 kg compared with non exercisers.
Individuals who cannot or prefer not to perform traditional aerobic exercise might still achieve similar benefits in cardiovascular-disease risk reduction by Yoga.
The review, which is published December 15, 2014 in the European Journal of Preventive Cardiology, included 32 randomized, controlled trials involving 2768 participants.

[The author Dr K K Aggarwal is Senior National Vice President Indian Medical Association and President Heart Care Foundation of India]

Paying high MBBS admission fee is not linked to producing dishonest doctors

It is often an argument that paying a high entrance fee for MBBS admission will produce a dishonest doctor. The activist says that they will have to recover the cost of capitation fee.

But it is not a reality. One does not buy a Mercedes car, travel in first class, buy a house in posh colony to grab money.

It is true that when the entrance fee is high for those seats only the rich will go and students from this class of the society will have enough money to build corporate practice which will be costly like any other corporate set ups.

Corporate culture of medical practice is not the need of hour in the country as still 80% of the people still lives in rural areas. We still need healers and not western cultured doctors.

Today the ethics of doctors and corporate culture are different

1.       For doctors there are  MCI ethics regulations but for corporate culture they do not come under MCI

2.        Corporate culture today are not under any medical regulations

3.       Doctors are not suppose to hire agents or touts but all corporate establishments have marketing departments.

4.       A doctor can be prosecuted under a criminal complaint but a company cannot.

5.       A doctors is not allowed to give rebates and commissions but to a corporate medical establishment there is no bar

6.       A doctor can not advertise but for a medical establishment there is no bar.

7.       If an estimate give is for 50,000 and bill comes to 150,000 the corporate culture is not blamed. The one who is blamed is the treating doctor.

[The author Dr K K Aggarwal is Senior National Vice President Indian Medical Association and President Heart Care Foundation of India]