Friday, 17 February 2017
Sameer Malik Heart Care Foundation of India an initiative by the Heart Care Foundation of India, celebrates its third anniversary
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Thursday, 16 February 2017
The eight-year cycle of Chanakya
The eight-year cycle of Chanakya
Chanakya in his neeti wrote that the cycle of corruption does not last for more than eight years. He said that people who acquire money by unethical means will have to pay back to the society within eight years. Right or wrong, whether you believe in Chanakya Neeti or not it provides a good message for the youngsters in the society to follow the right path of truthfulness.
Lord Krishna in Bhagavad Gita has written that everybody has to pay the price of their bad deeds or karmas sooner or later. It is the sum total of bad and good karmas, which decides the ultimate fate. Chanakya probably meant that all those who keep on earning money by unethical means and not doing simultaneously good deeds will have to suffer within eight years.
The eight-year cycle is also seen in public bhedchal. Public cannot be befooled for more than eight years in a succession.
The number eight is an arbitrary number and may mean six or ten years. If we look back over the years, we can see the change in public behavior every 6-10 years as far as their preference for a particular type of health wave is concerned.
There was the time of Sherry Lewis weight management program which came like a storm, stayed in the market for 6-8 years and then vanished altogether. Everybody wanted to manage their weight the Sherry Lewis way. Then came the era of Personal Point, which saw a chain of weight management programs coming up and which lasting for a few more years. This was followed by weight management the Vandana Luthra way.
The weight management era was followed by the era of “Reiki”. During this period all the newspapers were carried reiki advertisements and every second person in the family wanted to become a reiki master. Today no such advertisements appear in the newspapers and nobody wants to learn reiki.
Then came the trend of drinking ghiya juice and doing anulom-vilom Pranayama. In spirituality, we also saw a wave of transcendental meditation by Maharishi Mahesh Yogi but the movement did not last long as he quickly realized that selling spirituality in India was not easy and it was not the right time.
In terms of public behavior too, we have witnessed phases of craze for cycling, exercising, jogging, aerobic dancing, gym, western dancing, etc.
From health point of view the required era is that of walking. An era where everybody from child to adult takes up walking. Medical science has shown that walking 10,000 steps a day, routine walking 60 minutes, or brisk walking 40 minutes a day (continuous or divided into four walks of 10 minutes each) are health-friendly and can reduce the burden of diseases like high blood pressure, diabetes, obesity and heart disease.
Following the Vyapam scam, the Supreme Court cancelled degrees of 634 doctors for corruption in MBBS admissions in Madhya Pradesh between 2008 and 2012 and said admissions obtained through a mass fraud called "Vyapam scam" could not be condoned. The cycle of stents has also shown a reverse gear now with its coming under price control.
Things, just as life, come a full circle, completing a full cycle.
Dr KK Aggarwal
National President IMA and HCFI
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Wednesday, 15 February 2017
NPPA Stent Notification
NPPA Stent Notification
(Published in Part II, Section 3, Sub Section (ii) of the Gazette of India Extraordinary)
Government of India
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
National Pharmaceuticals Pricing Authority
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
National Pharmaceuticals Pricing Authority
New Delhi. The 13. February 2017
S.O.
412(E) Whereas the Government of India in the Ministry of Health and
Family Welfare included Coronary Stents in the National List of
Essential Medicines. 2015 (NLEM, 2015) by notification
No. X-11035/344/2015-DFQC dated 19th July 2016.
No. X-11035/344/2015-DFQC dated 19th July 2016.
2.
And whereas the Government of India in the Ministry of Chemicals and
Fertilizers, Department of Pharmaceuticals, by notification No. S.O.
4100 (E) dated 21st December 2016 has incorporated Coronary Stents at
serial no. 31 of Schedule I of the Drug Prices Control Order, 2013
(DPCO, 2013) and therefore, Coronary Stems arc 'scheduled formulations
under the provisions of the DPCO, 2013.
3.
And whereas die National Pharmaceutical Pricing Authority (NPPA) was
established by Resolution No. 33/7/97-PI.I dated 29. August 1997 of the
Government of India in the Ministry of Chemicals and Fertilizers to
fix/revise, monitor prices of drugs/formulations and oversee the
implementation of the DPCO; and whereas the Government of India by S.O.
1349(E) dated 30th May 2013 in exercise of the powers conferred by
Section 3 and 5 of the Essential Commodities Act, 1955 (10 of 1955) has
delegated the powers in respect of paragraphs 4, 5, 6, 7, 8, 9,10, 11,
12, 13, 14, 15, 16, 18, 19, 20, 21, 23, 24, 25, 26, 27, 28, 29,30 and 32
of the DPCO, 2013 to the NPPA to exercise the functions of the Central
Government.
4.
And whereas the aim of the DPC. 2013 issued under section 3 of
Essential Commodities Act, 1955, is to ensure that essential drugs are
available to all at affordable prices. Whereas the Hon'ble Supreme Court
of India by order dated 12th November 2002 in SLP no. 3668/2003 (Union
of India vs. K.S. Gopinath & others) directed the Government to
ensure that life saving drugs do not fall out of price control.
5.
And whereas the Core Committee which examined the issues relating to
the essentiality of Coronary Stems in its report to the Government in
April 2016 observed that there is very high incidence of coronary artery
disease (CAD) in India associated with high morbidity and mortality;
and that CAD has become a major public health problem; and that
Percutaneous Coronary Intervention (PCI) procedure requiring coronary
stent implantation is an important treatment modality for the management
of CAD, and hence coronary stents are 'essential' for public health.
6.
And whereas NPPA carried out an exhaustive exercise of consultation
with stakeholders for fixing the ceiling price of Coronary Stents on 4th
January 2017, 5th January 2017 and 6th January 2017, as per office
memorandum no. 19(837)/2016/Div.11/DP/NPPA dated 23rd December 2016; and whereas NPPA considered all available information and data on prices of Coronary Stents in its 40th Authority
Meeting held on 23rd January 2017. During deliberations, it was found
that huge unethical markups are charged at each stage in the supply
chain of Coronary Stents resulting in irrational, restrictive and
exorbitant prices in a failed market system driven by information
asymmetry between the patient and doctors pushing patients to financial
misery; and whereas under such extraordinary circumstances, there is an
urgent necessity, in public interest, to fix ceiling price of Coronary
Stents to bring respite to patients.
7.
And whereas the Hon’ble Supreme Court of India in its judgment in Glaxo
India Limited vs UOI reported in (2014)2 SCC 753, while dealing with
the implementation of notified prices for the benefit of consumers,
referred to the prefatory statement made by the Hon’ble Supreme Court in
Cynamide India Limited (1987) 2 SCC 722 as worth noticing, wherein the
Court observed:
“2.
Profiteering by itself. is evil Profiteering in the scares resources of
the community, much needed life-sustaining foodstuffs and life-saving
drugs is diabolic It is a menace which has to be fettered and curbed.
One of the principal objectives of the Essential Commodities Act. 1955
is precisely that. It must be remembered that Article 39(b), enjoins a
duty on the State towards securing 'that the ownership and control of
the material resources of the community are so distributed as best to
subserve the common good”.
8.
And whereas the Government is under constitutional obligation to provide
fair, reasonable and affordable price for Coronary Stents and therefore
its immediate intervention is imperative to check unethical
profiteering and exploitive pricing; and whereas Paragraph 19 of the
DPCO, 2013 inter- alia authorises the Government, extraordinary
circumstances, if it considers necessary so to do in public interest, to
fix the ceiling price or retail price of any drug for such period, as
it deems fit.
9.
And whereas price fixation notifications issued for certain
formulations under paragraph 19 of the DPCO, 2013 by the NPPA on 10th
July 2014 have been upheld by the Hon'ble High Court of Bombay in its
judgment dated 26th September 2016 in W.P.(C) No. 2700 of 2014 (Indian
Pharmaceutical Alliance vs. Union of India) wherein the Hon'ble High
Court. inter-alia, observed:
“20……
when such failure is considered in the context of role the
pharmaceuticals play in the area of public health, which is a social
right, the Government intervention becomes necessary especially when
exploitive pricing makes medicines tin-affordable and beyond the reach
of most and also puts huge financial burden in terms of out of pocket
expenditure on healthcare....”
and
whereas SLP (C) 30089/2016 filed by Indian Pharmaceutical Alliance has
been dismissed on 24th October 2016 by the Hon’ble Supreme Court of
India.
10.
And whereas W.P.(C) 1772/2015 (PIL) and W.P. (C)11085/2016 have been
filed in nature of Public Interest Litigation (PIL) including Cont. Case
(C.) 815/2015 before the Hon’ble High Court of Delhi seeking directions
to the Respondents (Union of India) to include Coronary Stents in the
National List of Essential Medicines (NLEM) and thereby control the sale
price of Coronary Stents.
11.
And whereas, the NPPA in its Authority Meeting held on 13th February
2017, after duly examining in detail and considering all available
information/data and all relevant options for price fixation of Coronary
Stents, under present extraordinary circumstances of a failed and
exploitative market system has decided that it is immediately necessary
to fix ceding prices of Coronary stents in order to protect public
interest.
12.
Now, therefore, in the exercise of the powers delegated by Government
of India in the Ministry of Chemicals and Fertilizers under paragraph 19
of the Drugs (Prices Control) Order. 2013 by S.O. No. 1394(E) dated
30th May 2013, the Government having been satisfied in view of
extraordinary circumstances as explained above, that it is necessary to
do in public interest, hereby fixes and notifies the ceiling prices,
exclusive of local tax applicable, if any, in respect of Coronary
Stents, as specified below:
TABLE
Sl. No.
|
Coronary Stents (Sl. 31 in Schedule I of DPCO, 2013
|
Unit (In Number)
|
Ceiling Price (In Rs.)
|
(1)
|
(2)
|
(3)
|
(4)
|
1.
|
Bare Metal Stents
|
1
|
7260
|
2.
|
Drug Eluting Dents (DES) including metallic DES and Bioresorbable Vascular Scaffold (BSV), Biodegradable Stents
|
1
|
29600
|
Note:
(a)
The ceiling prices specified in column (4) of the above table shall be
applicable from the date of publication of notification in the Gazette
of India Extraordinary and shall also be applicable to all the stocks of
Coronary Stents available for sale in the trade channel.
(b)
All manufacturers of Coronary stents, selling branded or non-branded or
both versions of gents at prices higher than the ceiling price (plus
local taxes as applicable) so fixed and notified by the Government,
shall revise the price of all such stems downward not exceeding the
ceiling price specified in column (4) in the above table, plus local
taxes as applicable and paid, if any
(c)
All manufacturers/marketers of Coronary Stents having MRP lower than
the ceiling price specified in column (4) in the above table plus local
taxes as applicable and paid, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(d)
The manufactures may add local taxes/VAT and no other charges in the
calculation of MRP if they have actually paid such taxes or if it is
payable to the Government on the ceiling price specified in column (4)
of the above said table in paragraph (12) of this order.
(e)
The ceiling price for a pack of coronary stent shall be arrived at by
concerned manufacturer/importer in accordance with the ceiling price
specified in column (4) of the above table as per the provisions under
DPCO, 2013.
(f)
The manufacturers under Paragraph 24 of DPCO, 2013 shall issue price
list in Form—V as prescribed in Schedule II of the DPCO, 2013 to the
NPPA online through Integrated Pharmaceutical Database Management System
(IPDMS) and submit a copy to all State Drug Controllers and all
distributors/dealers/retailers . They shall also furnish quarterly
return to the NPPA, in respect of production / import and sale of
Coronary Stents in Form - III as prescribed in Schedule-II of the DPCO,
2013 through IPDMS.
(g)
As per paragraph 24(4) of DPCO 2013, every retailer and dealer shall
display price list and the supplement, price list, if any, as furnished
by the manufacturer/importer, on a conspicuous part of the premises
where he carries on business in a manner so as to be easily accessible
to any person wishing to consult the same.
(h)
Wherever institutions such as hospitals/nursing homes/clinics
performing cardiac procedures using Coronary Stents are billing directly
to the patients, they shall be required to comply with the ceiling
prices notified hereinabove and follow the applicable provisions of the
DPCO, 2013 including(g) above.
(i)
Institutions such as hospitals/nursing homes/clinics utilizing Coronary
Stents shall specifically and separately mention the cost of coronary
gent along with its brand name, name of the manufacturer/importer/batch
no. and other details, if any, in their billing to the patients or their
representatives.
4)
The ‘manufacturer’ for the purpose of this order means person who
manufactures or imports or markets Coronary Stents for distribution or
sale in the country.
(k)
Any manufacturer or institution or person not complying with the
ceiling price and notes specified hereinabove shall be liable to deposit
the overcharged amount along with interest thereon under the provisions
of the Drugs (Prices Control) Order. 2013 read with Essential
Commodities Act, 1955.
13.
The ceiling price fixed hereinabove shall be maintained for a period of
one year from date of this notification, unless revised by another
gazette notification.
14.
Any manufacturer intending to discontinue production or import of
Coronary Stents shall furnish information to the NPPA, in respect of
discontinuation of production and /or import in Forrn-1V of Schedule-II
of the DPCO, 2013 at least six months prior to the intended date of
discontinuation as prescribed under paragraph 21(2) of the DPCO, 2013
and follow the ceiling price till clearance from the Government.
PN/I73/41/2017
F.No.8 (4I)/2017/DP/NPPA/Div II
(Dr. Sharmila Mary Joseph K)
Member Secretary,
National Pharmaceutical Pricing Authority
New guideline for preventive care in inflammatory bowel disease
New guideline for preventive care in inflammatory bowel disease
New Delhi, Feb 14, 2017: IBD is characterised by the chronic inflammation of gut and other parts of the digestive tract. A new clinical guideline from the American College of Gastroenterology has said that the primary care physician (PCP) should also be involved in the management of a patient with inflammatory bowel disease (IBD), especially with regard to preventive health maintenance such as vaccinations.
The guideline published in the February 2017 issue of the American Journal of Gastroenterology says, “To improve the care delivered to IBD patients, health maintenance issues need to be co-managed by both the gastroenterologist and primary care team. It is equally important to educate the primary care clinician to the unique health maintenance needs of the IBD patient, especially those on immunomodulators and biologic agents.” The guideline includes 14 recommendations to address the preventive care needs of these patients.
Padma Shri Awardee Dr K K Aggarwal, National President Indian Medical Association (IMA) and President Heart Care Foundation of India (HCFI) and Dr RN Tandon – Honorary Secretary General IMA in a joint statement stated that, “PCPs when integrated with routine practice for treating patients with IBD can help bridge an essential care gap. Coherence between evidence-based guidelines and clinical practice exist at several stages in this regard; low rates of colorectal cancer screening, suboptimal testing and treatment of Helicobacter pylori infection, inappropriate use of proton pump inhibitors are to name a few. Most PCPs still approach irritable bowel disease as a diagnosis of exclusion, this creates further problems.”
“PCPs have a crucial and fundamental role in management of patients with IBD. Collaboration with PCPs can prompt knowledge on when to suspect and refer patients with IBD, how to screen and treat for bone loss, update all vaccinations, screen and treat for depression and anxiety, when to consider screening for self-image, and how to monitor and treat nutritional deficiencies. PCPs are critical to optimizing patient care and outcomes”, added Dr K K Aggarwal.
With evolving strategies of therapy in the care of IBD patients, evidence now suggests that outcomes are dependent on the quality of management, particularly in early years of diagnosis. Early referral to a gastroenterologist for diagnosis and a structured management plan in collaboration with a primary care team therefore, is vital.
The following tips should help manage the symptoms of IBD:
1. Try taking small but frequent meals, this will also help with low appetite issues.
2. Smoking can worsen the symptoms of IBD, now is the best time to quit.
3. Exercise regularly followed by a healthy diet and sleep, this will also help with fatigue and tiredness.
4. Avoid alcohol if you are taking antibiotics for managing your symptoms.
5. IBD differs from person to person; your diet and treatment schedule needs to be tailored to suit your personal needs. Talk to your healthcare provider.
6. IBD can put you at high risk of dehydration, especially in summer months. Make sure you stay optimally hydrated at all times.
7. Maintain a food diary to track which food products trigger your symptoms.
8. Ask your doctor about vitaminB12, calcium and folate supplements.
9. Those taking steroid based medications for managing IBD also need to be vigilant.
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New ACP guidelines on noninvasive treatment of low back pain
New ACP guidelines on noninvasive treatment of low back pain
The American College of Physicians (ACP) has published new clinical practice guideline on noninvasive treatments for acute, subacute and chronic low back pain in primary care. The guidelines recommend use of non drug therapies such as exercise, mindfulness, acupuncture or yoga before prescribing drugs, NSAIDs or muscle relaxants. The use of opioids has strongly been discouraged. Acute back pain has been defined as lasting less than 4 weeks, subacute back pain as lasting 4 to 12 weeks and chronic back pain lasting for more than 12 weeks. The three recommendations by ACP are as follows:
• Recommendation 1: Nonpharmacologic treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence) should be selected by both physicians and patients. Nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants should be selected if pharmacologic treatment is desired (moderate-quality evidence). (Grade: strong recommendation)
• Recommendation 2: For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (low-quality evidence). (Grade: strong recommendation)
• Recommendation 3: In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, NSAIDs should be considered as first-line therapy, or tramadol or duloxetine as second-line therapy. Opioids should only be an option in patients who have failed the above treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence)
(Source: Annals of Internal Medicine, 14th February, 2017)
Dr KK Aggarwal
National President IMA & HCFI
Tuesday, 14 February 2017
Thank you for not smoking: Run a positive campaign
Thank you for not smoking: Run a positive campaign
The prevalence of tobacco use in India is very high in India as shown by the Global Adult Tobacco Survey India (GATS India) 2009-2010, more than one-third (35%) of adults in India use tobacco in some form or the other. Of these, 21% adults use only smokeless tobacco, 9% only smoke and 5% smoke as well as use smokeless tobacco. The survey also showed that 52% of adults were exposed to second-hand smoke (SHS) at home.
Tobacco use is associated with many adverse health effects and is a major preventable cause of morbidity and mortality. As per the CDC, smoking increases the risk of coronary heart disease by 2 to 4 times, for stroke by 2 to 4 times, lung cancer by about 25 times. In addition, it reduces quality of life, and increases health care utilization and cost. India has a ‘National Tobacco Control Programme’ in place to make the public aware about the harmful effects of tobacco use, control tobacco consumption and minimize the deaths.
“Smoking kills” has been the message that has been conveyed in the campaigns on tobacco control with the expectation that highlighting the potentially life-threatening health consequences would deter people from smoking or using tobacco products. It’s time to alter the tone of such public health campaigns, from negative to positive.
Quite often, we may rebuke a patient for failing in his efforts to quit smoking and say, “If you do not quit, you may die”. A statement worded as this may inadvertently sound discouraging to the patient. While it is important that people know the dangers of smoking or using tobacco products, a positive communication approach may have a more fruitful impact than a critical approach.
Avoid violent communication. Do not condemn, criticise and complaint, the 3 Cs of violent communication. Instead use a nonviolent communication approach to help and support your patient in his efforts to give up smoking. Tell your patient, who is trying to quit smoking or other tobacco products “Thank you for not smoking”. Appreciate the hard work put in by him and his perseverance. This way the patient knows that he has your support and will have trust and faith in you. The chances that the patient would adhere to the lifestyle modifications are higher if communicated in an empathetic and supportive manner.
IMA is committed to working closely with all National Health Programs alongside the government. As individual doctors, we too can contribute to the success of National Tobacco Control Program. Counsel your patients who smoke about quitting smoking but with a difference… Turn a negative situation to a more positive action.
Dr KK Aggarwal
National President IMA & HCFI
National President IMA & HCFI
Monday, 13 February 2017
Air pollution increases risk of childhood obesity and diabetes
Air pollution increases risk of childhood obesity and diabetes
There is increasing evidence for the role of environment in pathogenesis in many diseases. Children below 5 years of age and adults older than 50 years are most at risk. A global assessment of the burden of disease from environmental risks by the WHO has shown that 23% of global deaths and 26% of deaths among children under five are due to modifiable environmental factors. The harmful effects of air pollution on respiratory health are well-known to us and well-established. Air pollution has been linked to many non communicable diseases such as cardiovascular diseases, obesity, cancers and type 2 diabetes.
A new study has again underscored the dire need for a healthier environment. This study has suggested that exposure to ambient air pollution may contribute to development of type 2 diabetes through direct effects on insulin sensitivity and β-cell function. The study reported in the January 2017 issue of the journal Diabetes investigated whether exposure to elevated concentrations of nitrogen dioxide (NO2) and particulate matter (PM 2.5) had adverse effects on longitudinal measures of insulin sensitivity, β-cell function, and obesity in children at high risk for developing diabetes.
Although this was not a cause and effect study, an association between air pollution and risk of obesity and type 2 diabetes in children was observed in the study.
• Higher NO2 and PM2.5 were associated with a faster decline as well as a lower insulin sensitivity at age 18 independent of adiposity.
• NO2 exposure negatively affected β-cell function evidenced by a faster decline in disposition index (DI) and a lower DI at age 18.
• Higher NO2 and PM2.5 exposures over follow-up were also associated with a higher BMI at age 18.
(Source: WHO, Diabetes 2017 Jan; db161416. https://doi.org/10.2337/db16-1416)
Dr KK Aggarwal
National President IMA & HCFI
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