IMA OBJECTS TO PATANJALI’S CORONIL CLAIMS - The Daily Guardian
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IMA OBJECTS TO PATANJALI’S CORONIL CLAIMS

Shalini Bhardwaj

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The Indian Medical Association has expressed dismay at the “blatant lie” of WHO certifying Patanjali’s Coronil, a medicine that founder Baba Ramdev claims as the first one against Covid-19.

Baba Ramdev has claimed that Coronil can be used for the prevention and treatment of Covid as well as in post-Covid phase treatment. It was also mentioned that it is the first evidence-based medicine. The claims were made at the launch of the medicine, in the presence of Union Health Minister Dr Harsh Vardhan.

However, WHO clarified in a tweet that it has not reviewed or certified the efficacy of Patanjali’s Covid-19. “WHO has not reviewed or certified the effectiveness of any traditional medicine for the treatment Covid19,” WHO’s regional office for South-east Asia posted on its official Twitter handle.

In a two-page statement, the IMA has demanded an answer from the Health Minister, asking, “How appropriate and rational is it to release such false projections in front of the whole country? Being a Health Minister of the country, how justified is it to release such falsely fabricated unscientific products? How ethical is it to promote the product in unethical, wrong and false ways to the whole country? Being a modern medicine doctor, how ethical is it to promote the unscientific product.”

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Medically Speaking

GUIDELINES FOR DM IN MEDICAL GENETICS RELEASED BY NMC

Shalini Bhardwaj

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The National Medical Commission has released guidelines for the new competency-based PG training programme for DM in Medical Genetics. This course provides a new opportunity of super specialisation for all those doctors who have completed their PG degree in Medicine, Paediatrics or Obstetrics and Gynaecology.

The guidelines include the specific objectives of the course stating that competency-based training for DM in Medical Genetics aims to produce a postgraduate student who after undergoing the required training should be able to deal effectively with the needs of the patients, community and should be competent enough to handle medical problems related to genetic disorders. These include clinical evaluation, investigations, genetic work-ups requiring pre-test and post-test counselling, up-to-date information and abilities to carry out novel treatments and skills for planning and implementation of population-based prevention programs. Last but not least, be ready for carrying out clinical practice of personalised medicine in the 21stcentury molecular medicine era. The post-graduate student should also acquire skills to teach Medical Genetics to undergraduates and paramedical students as well.

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DELHI HC SEEKS AFFIDAVITS FROM BHARAT BIOTECH AND SII ON CAPACITY

Shalini Bhardwaj

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The Delhi High Court has asked Serum Institute of India and Bharat Biotech to disclose the capacity they have to manufacture Covaxin and Covishield vaccines, respectively. A bench of the Delhi High Court comprising Justice Vipin Sanghi and Rekha Palli directed the Centre to explain in its affidavit the reasons behind keeping the vaccination drive strictly under the government’s control. The court directed the oganisations to file the affidavit to clarify the capacities to produce Covisiled and Covaxin per day/week/month. The court said, “We are either donating or selling off the vaccines to other countries without looking at our own needs. There has to be a sense of urgency about this.”

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SII WRITES TO PMO ON REFORMS IN DRUG REGULATORY SYSTEM

Shalini Bhardwaj

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The world’s largest vaccine production company, Serum Institute of India (SII), has written a letter to the PMO on reforms in the existing drug regulatory system, including allowing companies manufacturing and stockpiling of non-Covid vaccines while undergoing clinical trials. In the letter Prakash Kumar Singh, who is the Director of Government and Regulatory Affairs at the Pune-based SII referred to the Union Health Ministry’s 18 May 2020 gazette notification, saying it allowed manufacturing and stockpiling of Covid-19 vaccine under clinical trial for marketing authorisation sale or distribution.

In the letter, Prakash Kumar Sing wrote, “Because of this rule, it became possible for us to manufacture and stockpile the Covid-19 vaccine during clinical trials and we could make the vaccine available in such a span of time to protect millions of lives.”

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THERE’S NO CO-WIN MOBILE APP FOR COVID VACCINE REGISTRATION: R.S. SHARMA

Shalini Bhardwaj

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R.S. Sharma, chairman of Empowered Panel for Covid-19 Vaccination and chief of Co-WIN, exclusively spoke to The Sunday Guardian and clarified doubts about Covid-19 vaccine registration and complaints of technical glitches on the portal. 

Q. What are the problems people are facing? They are not aware and still confused about the Co-WIN. What information would you share?

A. I would like to inform the viewers that we have not created any app. There is no app called Co-WIN Mobile App. What happened is that the previous government App, Arogya Setu, the purpose of which was to track and trace the infection has got an extension called the Co-WIN registration and scheduling. We have created a portal www.cowin.gov.in which enables you to register yourself and your family members for vaccination. Up to four registrations linked to a mobile number has been allowed which is pretty simple: Enter your mobile number; you will get an OTP; and get registered along with 3 more individuals

There is a video with the instructions available on the website. All in all, there is an Arogya Setu app and a portal for registration.

Q. What are the identity proofs required for registration?

A. No Id proof is required for registration. At the time of registration, you will be asked as to which Id will you be bringing to the centre and there are 6-7 approved Id’s that can be brought, any of which contains your photograph, name, gender, and DOB. Some of these Id’s are: Aadhaar Card; Driving Licence; Passport; Voter Id Card; Pan Card.

When you enter the centre, you will be asked for your Id number. If you are above 60 years of age, you do not need any other document except the Id proof but if you are between 45-59, you will require a medical certificate for your co-morbidity in addition to your Id proof because as per the rules only these people can be essentially vaccinated. The document is necessary as it will be photocopied and uploaded.

Q. In many cases, people come across technical glitches while registering themselves with the app. Are you getting such complaints too?

A. I haven’t got any such complaint until now, the only condition is that you need to use the right platform. Many people are using an “app” that doesn’t exist. Otherwise, there is no scalability issue because our system can take as many registrations as possible. 

Q. If in case the registered beneficiary isn’t able to visit the centre at the time of vaccination due to any reason, what would be the other option?

A. In this case, please cancel and reschedule your appointment. If you can do it well in advance before the time of the visit, it will be better as someone else can take that vacancy. It is not advisable to occupy the vacancy and not go as you are wasting somebody else’s claim.

Q. Is walk-in also an option if somebody could not register?

A. Yes, walk-in is allowed but it is advised to register the appointment as it ensures the claim on your vaccine. If you do not register, maybe the vacancy might not be available and you may have to return without getting a jab.

Q. Earlier, we informed the Government of India about the fake apps. What would you say about this?

A. Awareness should be spread so that people are disbarred from using these fake apps. And as I explained, there are only two legitimate modes of registering onto the system, one is Arogya Setu, and the other one is the portal. These should be used.

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Vaccination is important, but more information needed on reactions: Experts

People with a history of serious allergies must undergo evaluation before getting the shots or avoid taking the vaccine, advise top medical experts and doctors.

Shalini Bhardwaj

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In an exclusive interview with The Sunday Guardian, Dr S.K. Sarin, Director, ILBS Hospital, Dr K.K. Agarwal, former president of the Indian Medical Association, Dr Sandeep Mishra, professor and cardiologist, AIIMS, and Dr D.S. Rana, Director, Sir Ganga Ram Hospital, talk about Covid vaccines, the process of getting them and the vaccines which are likely to be available in the near future.

Q: Many beneficiaries are still confused because they don’t know how to register for the vaccine. What is the procedure for it?

Dr Sarin: I think the process has been simplified now and online registration has been started. You can register yourself online, fill up the forms which are there and you can also choose the hospital. There is no bar if you are in another state. You don’t have to go back to your state to get a vaccination there.

Once you fulfil the criteria, which are also very clearly laid out—if you are above 60 or above 45 and fall in any of the 20 categories which are clearly listed on the form—you can certainly get registered. There is online registration for registering yourself or your society or organisation, or we can register you online if you are one of those who will get priority. After that there would be some space for walk-in registrations, but just to avoid crowds, I think it will be a slow process in the initial days. So, get yourself registered online.  

Q: What is the cost of the vaccines?

Dr Aggarwal: The cost has been fixed by the government. In a government hospital, it will not cost anything and in the private sector, it will be Rs 250 per vaccine, which will mean Rs 500 for two shots. An important thing is that in the private sector, out of the Rs 250 charge, Rs 100 are for providing a service. The private sector will also have to make a consent form. The government has not said whether the Consumer Protection Act will be applicable on this, therefore the private sector may have some hitches in preparing a consent form. The consent form should be transparent, it should mention in case the patient needs to be observed for six or eight hours or get admitted in the hospital. It also needs an undertaking from the patient because what happens is now there will be issues with insurance companies. The private sector will have to be very clear about such intricacies.

Q: Will private hospitals charge some extra money for the procedure or only what the vaccine costs, that is, Rs 250 or Rs 500 for two doses?

Dr Aggarwal: If a patient is asthmatic or if a patient needs an evaluation of whether he is fit or not, I don’t know whether the hospital will waive off those charges. If a patient is high-risk, if he needs observation for more than half an hour, or if the patient develops a delayed reaction after four hours and comes to the hospital for observation—these are things which we still don’t know. The hospital will have to decide that but they have to be transparent.

Q: How will people know about particular allergies? Do we have particular tests for that?

Dr Mishra: This area has not been investigated in great detail, so there is a need for more information on this. But there are some tests available which talk about some allergies. But on a mass scale, I don’t think they are practical. So, the basic thing is that if someone is not known to be allergic to anything, it is more or less no problem. But if somebody has had a history of a very serious allergy or anaphylaxis, then I think they need to get investigated. 

Dr Rana: I am not an expert on this but I know that people are likely to have a little reaction to any drug which includes vaccines. But on a large scale, as the doctor just said, it is not possible to know and test these things. Maybe people at risk may avoid the vaccine and stay at home.

Dr Aggarwal: People with kidney failure, people having transplants and younger people with ischemic heart disease are very prone as far as diseases are concerned. But this is also a big question which needs to be addressed. I hope after 3-4 months, we would know how to sort out this issue.

Q: Why is it so important to get vaccinated?

Dr Sarin: If this virus invades and you have no immunity, it will be fatal as it spreads fast. The vaccine gives you four kinds of benefits. If you have an immune reaction to the vaccine, the virus won’t be able to cause a major injury to the body. Second, if the person gets the infection and there is a low level of viremia, he will not be able to transmit. Third, the vaccinated person will have a benefit against the mutated virus, if not 95%, but at least 75%. Fourth, his/her family won’t catch any further infection due to the beneficiary. So, both the doses must be taken as one dose is not enough. We should pace up the vaccine drive but there is no question now upon its safety and efficacy as 12-13 million people have been vaccinated. In areas where there is a high aggregation, people should be closely watched. We should watch out for the five states showing a surge so that the containment and the prophylaxis by vaccination are given to everyone where there is a likelihood of the infection. Science has given you the vaccine. Now your work is to accept it.

Dr Aggarwal: I have a question for Dr Rana. If a patient gets a reaction and gets admitted for 8-12 hours, I don’t think private hospitals or the private sector is going to cover that cost.

Dr Rana: It is a very transparent episode and I think we should be able to handle it.

Dr Aggarwal: I don’t think you are going to vaccinate a person with a very high risk without evaluation. Suppose somebody’s blood pressure is very high at the time of vaccination or he is diabetic or comorbid, either you will refuse him or you will evaluate him. A hospital may say, ‘yes, we are going to do it for free’, but it should be transparent. So, for all the people who are very comorbid, if the evaluation is free, it is very good, but if it’s not, it should be transparent.

Dr Rana: I agree with you, but there is no policy right now. We will do whatever the government will say. You are right, but right now we have to take up that cost.

Dr Aggarwal: Another thing I am asking you is that if you are taking Rs. 100 as a service charge, you will be under Consumer Protection Act from tomorrow. Therefore, consent should be taken.

Dr Rana: Everything is being done in the interest of the general public.

Q: Why is consent important?

Dr Aggarwal: In the private sector, no consent is taken—that is my only concern. Make a consent form and let consent be taken.

Dr Sarin: I would like to clarify that once you register online, you are voluntarily giving consent and you are shown all the facts. To simplify, I would say that consent is not a part of the vaccination as it is a voluntary act.

Dr Mishra: When I got vaccinated at AIIMS, it was free, but still there was a consent form which contained the details of the vaccine. So, I think even if the service is free, a consent form should be signed. 

Q: Which are the other vaccine candidates in the pipeline?

Dr Sarin: You must have read about the J&J single-dose vaccine which was just approved by the FDA. I think it’s amazing what a single dose can give you. There is no other where you give just one dose because, normally, vaccines work on a principle of showing a trailer of the invader. So, they give you a small dose of an inactive virus, which enables the body to make immune cells against it. And the second dose provides the body with a full-blown machinery to tackle it. So, all vaccines are given in a number of doses. But the J&J vaccine is a very big scientific achievement.

Other than that, nasal vaccines are also on the way. India is likely to have Sputnik V which is a two-dose vaccine given three weeks apart. It has been developed by the Russian Institute and Dr. Reddy’s is making it. There are two other vaccines. One that the Serum Institute is making and another by Zydus Cadila which is likely to come into the market. They are also making a nasal vaccine.

I think by the next two months we may have 7-8 more vaccines available. The variant vaccines which are being developed by Moderna and Pfizer are also likely to be continued. But even if India vaccinates 30 crore people in the next two weeks, we are still far behind because it is only 30% of the population, where Israel is at 85% and the UK and the US are also far ahead. With such a huge population, India needs multiple safe, effective vaccines and more vaccination strategies.

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DELHI DOCTOR PERFORMED ENDOSCOPIC SURGERY ON A 14-YEAR-OLD BOY

Shalini Bhardwaj

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A team of surgeons at Indraprastha Apollo led by Dr Noor ul din Malik, Senior Consultant, ENT (Surgery), Indraprastha Apollo Hospital, successfully performed an endoscopic surgery on a 14-year-old boy who had developed a rare tumour (Juvenile Angiofibroma-JA) on his nostrils that was protruding on the external side of his nose. This kind of tumour is extremely rare and even the process of its surgical removal can be life threatening considering its location. The child was admitted to Indraprastha Apollo Hospital, with complaints of a progressively growing tumour on the nostril due to which he was unable to breathe properly.

“This is a rare tumour found only in young boys as it occurs only in adolescent males; male hormones can be attributed to the development of the tumor. In earlier years, external approaches were used for its removal but now endoscopy is the standard treatment. In this case, the endoscopic approach was difficult owing to the location of the tumor as there was no space and the tumour was protruding out of the external nares. We took the challenge and went ahead with an endoscopic approach using a technique called segmentalisation of tumour through which we were able to remove it completely without any external scar and without a preoperative embolisation. The procedure was a success and the patient was discharged within 3 days of the surgery on 28 January 2021.” said Dr Noor ul din Malik.

Majorly reported in young adolescent males, juvenile angiofibroma (JA) is a rare benign, locally aggressive vascular tumour of the nose. The management of this tumour is challenging because any surgical intervention can cause excessive blood loss as this tumour is located at the complex anatomy of the nose base. Out of all head and neck cancers, 0.05% account for angiofibroma.

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