Maha FDA asks DCGI to include balloon catheters and guiding catheters under NLEM

The Maharashtra Food and Drug Administration has reportedly urged the Drug Controller General of India and the National Pharmaceutical Pricing Authority to include balloon catheters and guiding catheters under National List of Essential Medicines as was done for coronary stents. Balloon catheter and guiding catheters are accessories used during the stenting procedure to ease the pathway for flow of blood, as per a report in pharmabitz.

Capping the price of stents has obviously ended with increasing the prices of accessories to cover the margins. Earlier NPPA had also noted that “it had been found that after the price control of cardiac stents, several hospitals have increased the various procedure charges in order to compensate for their losses. NPPA has also found some specific complaints that several hospitals have increased the prices of balloons and the cardiac catheters which have not been included in NLEM, 2015.

In some cases, the cost of balloons and catheters have been charged at a much higher level than the cost of stent itself.

Standard practice followed in hospitals is that consumables like guide wire and balloon are not covered by the cost of the stent. So, they are billed separately. During an angioplasty procedure, a number of different peripherals are used like guiding catheters, balloons, inflators and stents.

As of today, only 23 categories of medical devices are regulated which cover around 400 medical devices amongst the 5,000 odd unregulated medical devices in the country.

The move is right. If you cap device, it is expected you also cap prices for all the accessories required to that procedure.

You cannot eat dosa without sambhar? You can not subsidize dosa but charge more for the sambhar. It is the end result of the stent procedure which matters and not the cots of stent alone.

The four Ds of medical malpractice

Duty, dereliction (negligence or deviation from the standard of care), damages, and direct cause.

Each of these four elements must be proved to have been present, based on a preponderance of the evidence, for malpractice to be found.

The principles of psychopharmacology and the information in the package insert for a drug often play a central role in deciding whether dereliction and direct cause for damages were or were not applicable in a particular case.

Happy Mother’s day

Vedic Saying:

ātma-mātā guroḥ patnī brāhmaṇī rāja-patnikā dhenur dhātrī tathā pṛthvī saptaitā mātaraḥ smṛtāḥ

Vedas describe seven types of mother with special mention in the Bhagawat Puran.

1.Atma Mata: The mother who has given birth to us

2.Guru Patni: The wife of our Guru

3.Brahmini: The wife of the Brahmin

4.Raja Patnika: The queen or the first lady

5.Dhenur: The Cow

6.Dhatri: The Nurse or the Doctor

7.Tatha Prithvi: The Mother Earth

Current Temperature Status and Warning for next 24 hours

Heat Wave and Temperature observed yesterday (Past 24 hours from 0830 hrs IST of 13 May to 0830 hrs IST of 14 May, 2019)

Heat Wave:

Yesterday, heat wave conditions were observed in isolated pockets over Vidarbha and Tamil Nadu.

Maximum Temperature

Maximum temperature more than 40.0°C were recorded at most places over West Rajasthan, Haryana, Chandigarh & Delhi, Marathwada, Vidarbha and Telangana; at many places over East Uttar Pradesh, Jharkhand, Chhattisgarh, East Madhya Pradesh and Rayalaseema; at a few places over West Uttar Pradesh, Odisha, West Madhya Pradesh and North Interior Karnataka and at isolated places over East Rajasthan, Gujarat state, Madhya Maharashtra, Coastal Andhra Pradesh and Tamil Nadu & Puducherry.

Maximum temperature departures as on 13-05-2019: Maximum temperatures were appreciably above normal (3.1°C to 5.0°C) at isolated places over Gangetic West Bengal, Vidarbha, Rayalaseema, Tamil Nadu & Puducherry and Andaman & Nicobar Islands; above normal (1.6°C to 3.0°C) at most places over Jammu & Kashmir, Telangana, North Interior Karnataka and Nagaland, Manipur, Mizoram & Tripura; at many places over Assam & Meghalaya, Odisha and Kerala; at a few places over Madhya Maharashtra and at isolated places over Himachal Pradesh, West Uttar Pradesh, Sub-Himalayan West Bengal & Sikkim, Bihar, Jharkhand, East Madhya Pradesh, Saurashtra & Kutch, Coastal Karnataka and South Interior Karnataka. They were below normal (-1.6°C to -3.0°C) at isolated places over Rajasthan and West Madhya Pradesh and near normal over rest of the country.

The highest maximum temperature of 45.8°C was recorded at Chandrapur (Vidarbha).

Heat Wave Warnings for next 24 hours (From 0830 hrs IST of 14 May to 0830 hrs IST of 15 May 2019)

Heat wave conditions at isolated places very likely over Vidarbha, Telangana, Chhattisgarh and Tamil Nadu & Puducherry.

Lybrate Healthcare Monitor

Pharma News

7 Indian pharma cos face lawsuits from over 40 US states

The Times of India- Rupali Mukherjee

More than 40 US states filed lawsuits against pharma majors, including seven domestic companies, over collusion in inflating prices of widely prescribed generic medicines, in certain cases as high as 1,000%. The 500-page case filed by US states on May 10 charged global biggies like Teva, Pfizer, Sandoz and Mylan, as well as domestic companies like Sun Pharma’s US arm Taro, Zydus, Lupin, Aurobindo, Dr Reddy’s, Wockhardt and Glenmark with conspiring to inflate prices of medicines, and stifling competition for generic drugs. The lawsuit widens a complaint of price collusion filed in 2016, which is still pending in US courts after being first investigated in 2014. Domestic companies said they would defend these allegations. A Sun Pharma spokesperson said, “We believe the allegations made in these lawsuits are without merit, and we will continue to vigorously defend against them.” The US probe on price-fixing seems to have impacted the domestic pharma sector overall, with stock prices of most companies witnessing a drop on the BSE in the range of 4-9% on Monday. Sun Pharma’s scrip tanked the most by nearly 10% to Rs 397.

Expanded in 2016, Delhi’s free medicine list has shrunk again

Hindustan Times- Anonna Dutt

Two years after expanding the state essential drugs list (EDL) from 406 to include 1,390 medicines in 2016, Delhi government has whittled it down to 920 medicines in 2017, and 816 medicines in 2018, according to data from Delhi government’s outcome budget report. The EDL catalogues all medicines and consumables that are available for free in Delhi government hospitals and dispensaries. In 2016, the state government expanded its EDL following the AAP government’s announcement that all state-run hospitals will dispense all medicines free. “At that time, all the departments in state government hospitals were asked to provide a list of medicines that were being prescribed by them and a committee of clinicians compiled them to create the essential drug list. It was later observed that some of the medicines were required in very small quantities, so it made no sense to add them to the EDL. The hospitals have local purchasing power and can procure these medicines as and when needed,” a senior Delhi government’s health department official, said.

Indian drug-companies too hit in US lawsuit on price manipulation

The Hindu Business Line- PT Jyothi Datta

At a time when governments across the world crack down on healthcare costs, generic drugmakers in India took a hit as details of a case filed by 44 US states on alleged drug price manipulation emerged. Among the twenty drugmakers named in the case are Indian generic drugmakers including Sun Pharma, Aurobindo, Lupin, Zydus, and Glenmark. A foreign media report quoting state attorneys general said, “The complaint, filed on Friday in the US District Court in Connecticut, said the drug companies engaged in numerous illegal conspiracies in order to unreasonably restrain trade, artificially inflate and manipulate prices and reduce competition.” The price inflation and manipulation was across products and treatments and according to the report, in some cases the price collusion was more than 1,000 per cent. Price-collusion allegations in the US have cast a deep long shadow over generic drugmakers for about five years now involving companies Mylan, and India’s Emcure Pharma, whose Heritage Pharmaceuticals was in the dock.

Zydus Cadila gets USFDA nod for Chlorthalidone tablets to treat high BP

Medical dialogues- Farhat Nasim

Zydus Cadila said Chlorthalidone tablets will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Drug firm Zydus Cadila Monday said it has received the final nod from the US health regulator to market Chlorthalidone tablets, used to treat high blood pressure. New Delhi: Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Chlorthalidone tablets in the strengths of 25 mg and 50 mg, the company said in a BSE filing. Chlorthalidone is used to treat high blood pressure (hypertension). It is also used to treat fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver or kidney disorders or edema caused by taking steroids or estrogen. Zydus Cadila said the product will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.

Naidu urges Vietnam to support entry of Indian pharma firms in their market

KNN

The Vice President of India, M Venkaiah Naidu has urged Vietnam to support entry of Indian pharmaceutical firms. Seeking Vietnam Prime Minister’s personal intervention in facilitating the entry of Indian pharmaceutical products into their country, the Vice President assured him that the Indian companies can provide high tech health systems and medicines for public health in Vietnam at an affordable cost. This will make health services more affordable and reduce the insurance burden on the Government of Vietnam, he added.

Healthcare News

Bundi doctors remove 116 iron nails, wire from man’s stomach

The Times of India

Surgeons of a government hospital were shocked when they removed 116 iron nails, iron pellets and wire from stomach of a 42-year-old person, a resident of Bundi, on Monday. Patient Bhola Shankar is psychologically unwell and he was not able to narrate how he swallowed iron nails. The doctors, who performed the surgery claimed that it might be possible that he was in the habit of swallowing iron objects like nails, iron pellets and wire leading to accumulation of such objects in his stomach. A team of doctors headed by Dr Anil Saini, surgeon at Bundi district government hospital, took one-and-a-half hour to remove 116 iron nails, an iron pellet and a long iron wire from the patient’s stomach. Each nail was 6.5cms long.

Government Medical College and Hospital invites fresh MD/MS applications

The Times of India- Shimona Kanwar

After Supreme Court’s stay on Punjab and Haryana high court order on MD/MS admission in Government Medical College and Hospital, the college has invited fresh applications for the 64 seats under UT and institutional pool. While no specific schedule has been fixed for course counselling, the dates are likely to be announced once Lok Sabha elections get over. Candidates securing below 50 percentile (general category) and 40 percentile (SC category) who had already applied till April 1, need not register for counselling. “As the application process for the MD/MS seats will start afresh, only the eligible candidates as per the revised percentile can apply. This is for the 64 seats of the institution and UT pool and also the remaining vacant all India seats,” said a GMCH official.

AI project eyes early stage diabetic retinopathy

The Hindu- Jyoti Shelar

In a first for Mumbai, early stage diabetic retinopathy has been detected using artificial intelligence (AI) at civic-run dispensaries. The unique project is being implemented by the Aditya Jyot Foundation for Twinkling Little Eyes (AJFTLE) and, in a span of eight months, nearly 1,300 diabetes patients have been screened on a retinal imaging device attached to a smartphone. Commenced in August 2018, the Foundation has screened patients in 18 civic-run dispensaries across the city. Till March this year, 92 patients were diagnosed with early stage diabetic retinopathy and referred to municipal hospitals or the Aditya Jyot Eye Hospital for further treatment. “Diabetic retinopathy is tricky because there are no early signs. That’s why screening is the only way to detect the complication early and prevent diabetic blindness,” said eye surgeon Dr. S Natarajan, also managing trustee of AJFTLE.

Indian woman dies after hip replacement surgery at Dubai hospital

Hindustan Times

An Indian woman chef has died in Dubai due to complications allegedly arising after a hip replacement surgery at a private hospital here, according to media reports. Betty Rita Fernandes, 42-year-old mother of two, was admitted for the two-hour left hip replacement surgery at the Al Zahra Hospital on May 9, Gulf News reported. “In reference to the demise of Betty Rita Fernandes on May 9 after her surgery in Al Zahra Hospital Dubai (AZHD), we have made the family transparently aware of all the developments and ongoing reviews,” Mohayem Abdelghany, Chief Executive Officer of the hospital, said in a statement. “This incident is currently being dealt with multi-level in-depth reviews as per the hospital, Dubai Health Authority (DHA) and Joint Commission International (JCI) guidelines. It was also notified to the relevant authorities and DHA for their independent assessment and review and we will keep the patient’s family updated,” the statement read. Fernandes had a congenital issue and her hip was slightly displaced when she was born, the report said.

27 govt hospitals can now issue disability certificates

Hindustan Times- Anonna Dutt

The Delhi government has designated 27 government hospitals in all 11 districts to issue disability certificates under the new central Rights of Persons with Disabilities Act, 2016, for 21 conditions. The May 2 circular also clarifies the composition of the medical board that will issue the certificates. “Hospitals under the previous act were still issuing certificates, but the number of disabilities went up in the new act and these hospitals did not have the department or specialists to diagnose them,” said a senior official from Delhi government’s health department. The newly designated hospitals will ensure that people do not have to go from hospital to hospital to get the certificates. The Rights of Persons with Disabilities Act, 2016, now includes conditions like dwarfism, multiple sclerosis, and acid attack.

‘Don’t shave patient’s beard without consent’:Doc

Hindustan Times

Responding to claims from members of the Muslim community that staff at BYL Nair Municipal Hospital, Mumbai Central, unnecessarily shaved off the beard of a patient, the hospital administration has directed doctors not to shave off beards without the patient’s permission. The alleged incident came to light after Ummat Foundation wrote to the hospital dean and municipal corporator Rais Shaikh that a 38-year-old man was told that his beard had to be shaved before he underwent lower limb surgery. “This is the second such incident reported within a year,” read the Ummat Foundation letter. Shaikh said he raised the issue with the Brihanmumbai Municipal Corporation’s (BMC) health department and mentioned the religious significance of the beard. “Beards should not be shaved off ahead of surgeries because they are an important part of Islamic practice. They keep saying that there is a standard operating procedure that has to be followed, but it isn’t followed. What is required is that more awareness should be created about such issues,” Shaikh said.

Ahmedabad: Illegal canteen of hospital catches fire

Daily News & Analysis

About 18 newborns and infants along with 400 others inside Dev Building had a narrow escape after a massive fire broke out in an illegally constructed canteen of a hospital. The fire was caused due to cylinder leak. No casualty was reported in the fire. The incident occurred at around 1 pm, at Apple Multi Speciality Pediatric Hospital terrace that is a part of Dev Building, near Parimal Cross Road. The canteen and waiting area in the building were illegally constructed on the terrace for patients and visitors. The hospital is jointly owned by Dr Paresh Dangli, Dr Abhishek Bansal and Dr Nirav Modi. Incidentally, the hospital on the fourth floor building had been warned time and again to not carry out cooking activities on the terrace.

Need more allied health professionals

The New Indian Express- R Kannan

People the world over have become more conscious of their health in recent decades. The life expectancy of Indians has increased considerably due to modern medical advances and intake of nutritious food. Despite the positive scenario, unforeseen accidents are also on the rise. In such situations the urgency of medical attention has to be complemented by timely care of paramedical personnel, or allied healthcare professionals as they are now called. When a person is in a hopeless condition after an accident or when old age takes a heavy toll on an individual with vital organs not functioning well, it is a paramedical professional who helps the victim reach near-normal status. No doubt the medical professional happens to be the saviour. But once the patient reaches the convalescent stage, the service of an allied healthcare professional is paramount in restoring the essential basics of living through the promotive and rehabilitative dimensions.

Nine dengue cases reported in Delhi, doctors advise precautions

India Today

At least nine dengue cases have been reported in Delhi this year, even though the vector-borne disease is usually reported between July and November, according to a municipal report released Monday. Last year, 2,798 dengue cases and four deaths were recorded by the South Delhi Municipal Corporation (SDMC), which tabulates data on vector-borne diseases in the city. According to the report, a case was reported in May, two in April, four in March and one each in February and January this year. Cases of vector-borne diseases are usually reported between July and November, but the period may stretch to mid-December. Four cases of malaria have been reported till May 11 -- three in May and one in April, and five cases of chikungunya have been recorded this year, two in February and one each in March, April and May.

What moves the needle in favour of a Stent ? Dr. Rishi Gupta

ET Healthworld

Transforming lifestyles have led to shifting disease profiles. Cardiovascular diseases have become the leading cause of disease burden and deaths globally. In the Indian context, the number of angioplasties performed in India went up by 42 percent in 2015 as compared to the previous year with cardiac stents now becoming a frontier in addressing the challenge of this rising percentage. Moreover, in a market that was once dominated by globally manufactured stents, India is creating its own indigenous versions. While it is encouraging to see the progress of the domestic market, I’d like to emphasize here, for a stent to qualify as a preferred choice, the benchmarks of safety, efficacy and quality checks must be met with. As a doctor, I would say, we cannot foster one and stifle the other. A stent can only achieve these benchmarks through extensive and exhaustive clinical research.

Artificial Intelligence overtakes humans in predicting death, heart attack risk

IndiaTV

Scientists have developed an artificial intelligence (AI) system that is better than human doctors at predicting the risk of heart attack or death. By repeatedly analysing 85 variables in 950 patients with known six-year outcomes, an algorithm "learned" how imaging data interacts. It then identified patterns correlating the variables to death and heart attack with more than 90 per cent accuracy. Machine learning, the modern bedrock of artificial intelligence, is used every day, researchers said. Googles search engine, face recognition on smartphones, self-driving cars, Netflix and Spotify recommendation systems all use machine learning algorithms to adapt to the individual user.

27 govt hospitals can now issue disability certificates

Hindustan Times – Anonna Dutt

The Delhi government has designated 27 government hospitals in all 11 districts to issue disability certificates under the new central Rights of Persons with Disabilities Act, 2016, for 21 conditions. The May 2 circular also clarifies the composition of the medical board that will issue the certificates. “Hospitals under the previous act were still issuing certificates, but the number of disabilities went up in the new act and these hospitals did not have the department or specialists to diagnose them,” said a senior official from Delhi government’s health department. The newly designated hospitals will ensure that people do not have to go from hospital to hospital to get the certificates. The Rights of Persons with Disabilities Act, 2016, now includes conditions like dwarfism, multiple sclerosis, and acid attack.

CMCH docs to get sensitized on new MBBS curriculum

TNN

Coimbatore: With the MBBS syllabus set to change, doctors at the Coimbatore Medical College Hospital will be sensitized on the requirements of the new curriculum and on how to train and teach students. Senior doctors and professors are likely to play a crucial role in implementing the curriculum as it focuses on students’ clinical competencies rather than knowledge. The doctors will be sensitized next week by the curriculum committee on how they should train students who come to the hospital for clinical hours. “The new syllabus focuses on the ability of students to observe their core competences, skills in handling patients, clinical exposure, communications skills, among others, and will test them on those bases rather than their book knowledge. So, our doctors should focus on giving the students more exposure and skill training,” CMCH dean Dr B Ashokan said. “Only if they achieve core competencies at every level, they can move to the next level,” he added. The examination pattern is also likely to change from essay questions and short answer questions to one-word answers.

BD-India Organises ‘Heal-O-Nomics’ to Address Issues of Hospital Acquired Infections

EH News Bureau

The programme is conceptualised to apprehend challenges of preventing HAIs with the aim to achieve better health outcomes at optimised costs

With a steep rise in hospital acquired infections (HAI) in the country, BD-India, organised ‘Heal-o-nomics’ a programme conceptualised to apprehend the challenge of preventing HAIs with the aim to achieve better health outcomes at optimised cost. Sharing his expertise on the issues related to HAIs, the President of the International Nosocomial Infection Control Consortium (INICC), Dr Victor D Rosenthal, presented findings on the epidemiology and prevention of BSI, to the Hospital Infection Control Committee (HICC) of prominent health institutes in Delhi and Bangalore.

Dr Rosenthal said, “Over the years, we have seen an increase in HAIs among patients. The infections are caused due to the lack of compliance with infection control guidelines, such as hand hygiene, use of outdated technology, misuse or excessive use of antibiotics and more. These infections are further leading to morbidity, mortality and increased financial burden among patients. Therefore, there is an essential need to bring down the incidence of HAIs by implementing proper guidelines and preventing the infection with bacterial resistance rather than treating it with antibiotics. Through initiatives like ‘Heal-o-nomics’, our aim is to educate healthcare institutes to follow guidelines which may help in better treatment and care.”