Coming down heavily on the Union government and the National Pharmaceutical Pricing Authority (NPPA), the Bombay High Court (BHC) on Tuesday asked the regulator to relook and pass appropriate order about capping price of N95 masks, in accordance with law, as per clause 20 of the Drug Price Control Order (DPCO). In addition, NPPA has been directed to take a decision as early as possible, preferably within 10 days but not beyond two weeks and inform its decision to the petitioners, the BHC says.
The bench of chief justice Dipankar Datta and justice SS Shinde says, “The NPPA cannot allow an increase in the price of a drug beyond 10% of the price in the preceding 12 months, so long as the statute is there. It cannot be left to the manufacturers.”
The bench was hearing a public interest litigation (PIL) filed by Sucheta Dalal, founder-trustee of Moneylife Foundation and Anjali Damania, founder-trustee of Voice of Indian Taxpayers, a non-government organisation (NGO).
The PIL sought relief from black marketeering, hoarding and profiteering of N95 masks in Maharashtra, despite N95 masks being declared as essential commodity under the Essential Commodities Act, 1955. The petition also alleged that Maharashtra state had failed to take adequate measures to ensure that sufficient availability of surgical masks and other masks at fair prices.
During previous hearing, the BHC had told additional solicitor general (ASG) Anil C Singh to take instructions from the Union government on capping prices for N95 masks and respond by 22 May 2020 on two letters sent by Maharashtra government on the same subject.
However, in its reply, the NPPA submitted that on 15 May 2020, it had organised a meeting for a holistic understanding about the types and standards of N95 masks that are available and concomitant pricing issues. Representatives from the ministry of textiles, BIS and HLL Life Care Ltd attended the meeting.
Also during the meeting, HLL informed that it procures N95 masks from eight manufacturers, with majority coming from Venus Safety. The price of CV N95+ mask with expiratory valve is Rs60 plus GST and of N99 mask is Rs68 plus GST, the minutes of the meeting reveals, NPPA says.
On 21 May 2020, NPPA contended that it issued an advisory, following which major manufacturers and importers of N95 masks have reduced their prices significantly up to 47%.
However, the BHC pointed out that the NPPA, has not taken into consideration a statutory provision as mentioned in DPCO.
The para 20 of the DPCO says the maximum retail prices (MRPs) of all the medical devices would be monitored by the government to ensure that no manufacturer or importer increases the MRP of a drug more than 10% of MRP during preceding 12 month and where the increase is beyond 10% of maximum retail price, it shall reduce the same to the level of 10% of maximum retail price for next 12 months.
However, in its rejoinder, filed by Ms Damania, it was submitted before the Court that how the advisory issued by NPPA failed to implement the DPCO and manufactures of N95 masks were allowed to increase prices substantially. She says, “Maharashtra Food and Drugs Administration (FDA)’s letter dated 15 May 2020, clearly show that though the MRP of N95 masks have been bloated to Rs199 per mask, the average rate charged of the said masks was Rs28.57 per mask in the fourth quarter of financial year 2019-2020 and had increased to Rs42.95 per mask and Rs46.40 per mask in the months of April and May 2020 respectively. Thus, it is clear that the maximum retail price (MRP) as set by the manufacturers are almost 300% higher than the average price at which these masks were being sold. Thus, it is no surprise that these manufacturers have been more than willing to reduce these MRP by close to 50% without any protest.”
NPPA also submitted that the government is major purchaser of N95 masks directly from the manufacturers. It has placed an order for 2.44 crore N95 Masks till June 2020, against which 1.06 crore N95 masks have procured till 27 May 2020. A status of distribution of N95 masks for COVID19 to the states and union territories (UTs) as on 28th May is 1.16 crore masks, the affidavit says.
Senior advocate Mihir Desai appeared for the petitioners, assisted by advocate Mihir Joshi while the state government was represented by advocate general Ashutosh Kumbhakoni.
A recent analysis of patients, who have died or been admitted to intensive care with coronavirus (COVID-19) has revealed them to be deficient in vitamin K. This revelation supports a growing theory in the scientific community that a simple dietary change might partly be the answer in fighting the disease.
Researchers have drawn this conclusion after studying patients who were admitted to the Cansius Wilhelmina Hospital in the Dutch city of Niljmegen and have praised the benefits of vitamin K after discovering a link between deficiency and the worst COVID-19 outcomes.
This study, was undertaken in partnership with the Cardiovascular Research Institute Maastricht, one of Europe’s largest heart and vascular research institutes. It studied 134 patients hospitalised for COVID -19 between 12th March and 11 April 2020, alongside a control group of 184 age-matched patients who do not have the disease.
As we know, COVID-19 causes blood clots and eventually leads to the degradation of elastic fibres in the lungs. Vitamin K, which is found in spinach, eggs, hard and blue cheeses, is key to the production of proteins that regulate clotting and can protect against lung disease, suggests the study.
The Guardian, in the UK has stated that, “Dutch researchers are now seeking funding for a clinical trial, but Dr Rob Janssen, a scientist working on the project, has encouraged a healthy intake of vitamin K, except to those on blood-thinning medications such as warfarin.”
Speaking with The Guardian, Dr Janssen said, “We are in a terrible, horrible situation in the world. We do have an intervention which does not have any side effects, even less than a placebo. There is one major exception: people on anti-clotting medication. It is completely safe in other people.”
“My advice would be to take those vitamin K supplements. Even if it does not help against severe COVID-19, it is good for your blood vessels, bones and probably also for the lungs. We have vitamin K1 and K2. K1 is in spinach, broccoli, green vegetables, blueberries, all types of fruit and vegetables. K2 is better absorbed by the body. It is in Dutch cheese, I have to say, and French cheese as well,” Dr Janssen further explained.
The Guardian, has also mentioned a Japanese delicacy of fermented soya beans called natto, which is particularly high in the second type of vitamin K, and Dr Janssen believes there may be cause for further studies into its health benefits.
“I have worked with a Japanese scientist in London and she said it was remarkable that in the regions in Japan where they eat a lot of natto, there is not a single person to die of COVID-19; so that is something to dive into,” he said in an interview with The Guardian.
Researchers who worked on this study are now hoping to examine very sick COVID-19 patients and randomise the trials so that they either consume a placebo or vitamin K, to positively confirm their findings.
The study has been submitted for peer review on 5th June.
The coronavirus (COVID-19) pandemic continues to create panic among people, who have become wary about touching anything. However, as per new guidelines from US Centers for Disease Control and Prevention (CDC), COVID-19 is thought to spread mainly through close contact from person-to-person. "Some people without symptoms may be able to spread the virus and we are still learning about how the virus spreads and the severity of illness it causes," the CDC says.
Other key change the CDC has made is saying that other modes of the spread may not be serious risk. It says, "It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes. This is not thought to be the main way the virus spreads, but we are still learning more about how this virus spreads."
CDC also clarified that the risk of COVID-19 spreading from animals to people is considered to be low. “It appears that the virus that causes COVID-19 can spread from people to animals in some situations. CDC is aware of a small number of pets worldwide, including cats and dogs, reported to be infected with the virus that causes COVID-19, mostly after close contact with people with COVID-19,” it says.
The virus is thought to spread mainly from person-to-person.
•There is currently no vaccine to prevent coronavirus disease 2019 (COVID-19).
•The best way to prevent illness is to avoid being exposed to this virus.
oBetween people who are in close contact with one another (within about 6 feet).
oThrough respiratory droplets produced when an infected person coughs, sneezes or talks.
oThese droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.
oSome recent studies have suggested that COVID-19 may be spread by people who are not showing symptoms.
The Virus Spreads Easily between People
How easily a virus spreads from person-to-person can vary. Some viruses are highly contagious, like measles, while other viruses do not spread as easily. Another factor is whether the spread is sustained, which means it goes from person-to-person without stopping.
The virus that causes COVID-19 is spreading very easily and sustainably between people. Information from the ongoing COVID-19 pandemic suggest that this virus is spreading more efficiently than influenza, but not as efficiently as measles, which is highly contagious.
The virus may be spread in other ways
It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes. This is not thought to be the main way the virus spreads, but we are still learning more about how this virus spreads.
Protect Yourself and Others
The best way to prevent illness is to avoid being exposed to this virus. You can take steps to slow the spread.