SRINAGAR: Starting next month, the prices of necessary medications, such as painkillers, antibiotics, and anti-infectives, will begin to increase by over 12%.
The decision made by India’s drug pricing authority will affect over 800 drugs listed as essential medicines. This increase is the highest on record since the implementation of the Drugs (Price Control) Order in 2013.
Additionally, this is the second consecutive year that the Wholesale Price Index has surpassed the non-scheduled formulation’s annual permissible price increase of 10%. While a pharma lobby group had requested a 10% immediate increase for scheduled formulations and a 20% increase for non-scheduled drugs, the decision rests with the government.
New Delhi: The Supreme Court on Wednesday quashed criminal proceedings against a doctor accused of stocking medicines for sale, saying the “extremely small” quantity of medicines which was seized can easily be found in the house or consultation room of a medical practitioner.
The apex court observed that considering the small quantity of medicines, most of which were in the category of lotions and ointments, it cannot be said by any stretch of imagination that they could be stocked for sale.
It noted that the appellant is a senior doctor who is engaged as an associate professor and head of the dermatology department in a government medical college in Chennai.
“When small quantity of medicine has been found in the premises of a registered medical practitioner, it would not amount to selling their medicines across the counter in an open shop,” a bench of Justices Krishna Murari and Sudhanshu Dhulia said.
The bench delivered its verdict on a plea filed by the doctor against a June 2022 order of the Madras High Court which had dismissed her petition seeking quashing of criminal proceedings.
The top court observed it is permissible for her under the law to practise medicine when she is not performing her official duties.
It noted that the doctor, in her individual and independent capacity, was carrying on her medical practice at a premises in Chennai and an inspection was made there by the drugs inspector in March 2016.
The bench further noted that as per the inspection report, the drugs inspector found some medicines like lotions and ointment in the inner room of her premises and he had also referred to certain sale bills of medicines.
The bench noted the drugs inspector thereafter moved an application for obtaining sanction from the office of the Director of Drugs Control, Tamil Nadu, which was given in January 2018 and consequently, a complaint was filed before a court for prosecuting her under section 18(c) of the Drugs and Cosmetics Act, 1940.
It said the prohibition under section 18(c) of the Act is on the manufacturing, distribution, stocking or exhibition of medicines for the purpose of sale.
“The charge in the present case is that the appellant (doctor) had ‘stocked’ medicines for ‘sale’. The entire emphasis is on ‘sale’ of these medicines,” the bench noted.
It said what the director of drugs control and the high court lost sight of is the fact that she is a registered medical practitioner and her area of specialisation being dermatology.
“It is not a case that she had opened a shop in her premises from where she was selling drugs and cosmetics across the counter! It is possible that she was distributing these drugs to her patients for emergency uses and thus she is protected by the Act itself,” the apex court said.
The bench observed it is not the case of the prosecution that she was selling drugs from an open shop across the counter.
“But given the facts and circumstances of the case and considering that the appellant is a registered medical practitioner, along with the fact that the quantity of medicines which have been seized is extremely small, a quantity which can be easily found in the house or a consultation room of a doctor, in our considered view no offence is made out in the present case,” it said.
The bench noted that the search was carried out in March 2016 and the sanction for prosecution was sought in September 2016.
It said the sanction was given in January 2018 and there is no explanation given for this delay in getting the approval.
“The sanction for prosecution given in the present case appears, prima facie, to suffer from the vice of non -application of mind. There is no reference to any of the documents, evidence or the submissions submitted by either of the parties, no reasons assigned or even an explanation pertaining to the delay which indicates it has been passed in a mechanical manner,” the bench said.
While allowing the appeal, it set aside the order of the high court and quashed the criminal proceedings in the case.
Hyderabad: Union minister Kishan Reddy on Tuesday said that instead of buying branded medicines, people should buy generic medicines which have the same impact.
On the occasion of Jan Aushadhi Divas, Union Minister Kishan Reddy participated in the Jan Aushadhi Divas program organized at NIMS Hospital in Panjagutta, Hyderabad.
Kishan Reddy while speaking to the media said that after 2014, Prime Minister Narendra Modi has taken many steps in the Health sector.
“New Medical colleges, additional PG seats, additional medical seats and AIIMS hospitals in every state capital and 5 lakh rupees are given for the treatment to the middle class and lower middle class working community in private corporate hospitals,” Minister said.
Minister Reddy said that people are seeing that PM Jan Aushadi scheme was introduced and implemented successfully.
He informed that there are around 9,500 Janaushadhi Kendras with 1,759 generic medicines available. He also said that the medicines here are more efficient and have the same impact like the branded medicines.
“The Indian government is trying to promote the Janaushadhi Kendras for the poor people and common people. Instead of buying branded medicines, buy generic medicines which have the same impact,” the minister added.
Every year Jan Aushadi diwas is celebrated on March 7th.
The sixth day of Jan Aushadhi Diwas, 2023 was celebrated as “Aao Jan Aushadhi Mitra Banein” on Tuesday. On this occasion, a large number of people took the pledge ‘Jan Aushadhi Shapath’ digitally on the MyGov platform to promote the use of generic medicines.
With an objective of making quality generic medicines available at affordable prices to all, Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) was launched by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India.
Under this scheme, dedicated outlets known as Janaushadhi Kendras are opened to provide generic medicines. The Jan Aushadhi scheme was launched in November 2008 with the objective of having at least one Jan Aushadhi Store in each district of the country.
The European Union regulates all sorts of banks: money banks, blood banks, sperm banks.
Its next target? Breast milk banks.
Brussels bureaucrats want to homogenize the rules overseeing the donation and use of donor breast milk across the bloc.
It’s part of the European Commission’s proposed revamp of the laws covering safety and quality standards for substances of human origin (SoHO) intended for human use. Currently, the laws cover blood, tissues and cells, but the EU wants to extend coverage to all SoHO — including donor breast milk.
While, at first glance, it might seem like the EU is trying to milk its regulatory powers, experts are largely in favor of the plan to set EU-wide standards, saying it will improve its availability and safety.
With lawmakers and EU countries debating the revamp, POLITICO walks you through the issue.
What are breast milk banks?
Women who make more breast milk than their babies need can donate it to a breast milk bank.
These banks screen donors and collect, process and distribute the milk to infants in need — those whose mother’s own milk is not available or sufficient.
While exclusive breastfeeding is recommended for all babies in the first six months of their life, it’s especially important for premature or sick newborns, experts say.
Among many other benefits, breast milk contains antibodies that are important for newborns’ immune systems. Babies born before 30 weeks of pregnancy are especially susceptible to infections, particularly from necrotizing enterocolitis, a type of gut inflammation that can be fatal. Their survival rates improve when they get human milk as compared with formula, said Elien Rouw, a breastfeeding medicine specialist in Germany and president-elect of the Academy of Breastfeeding Medicine.
There are currently 282 breast milk banks in Europe, including Turkey and Ukraine, according to the European Milk Bank Association.
Aren’t they already regulated?
Donor breast milk is regulated differently in different countries. For example, it’s considered a health product in France, a food in Germany, and is uncategorized and unregulated in Romania. And while the safety standards are set at the national level in France, for instance, they are setat the regional level in Belgium.
The Commission wants to harmonize breast milk safety standardsacross the EU | Kenzo Tribouillard/AFP via Getty Images
There is some level of convergence though. For example, most national guidelines in the world recommend donor breast milk should be pasteurized, according to the European Milk Bank Association.
In France, for example, the milk is first tested for bacteria and highly contaminated milk is thrown out, explains Jean-Charles Picaud, professor of pediatrics specialized in neonatology at Hôpital de la Croix-Rousse in Lyon, and president of the French Human Milk Bank Association. The rest is then pasteurized at precisely 62.5 degrees Celsius for exactly 30 minutes and then retested before being made available for babies.
What does the Commission want to do?
The Commission wants to harmonize safety standardsacross the EU, not only to ensure the safety of the babies that consume breast milk, but also to make it easier for donor breast milk — and other SoHO — to cross borders.
Donor milk banks are unevenly spread out across the Continent. There are over 30 in France, for example, but only four in Belgium and one in Romania.And parts of Europe are facing a shortage of donor breast milk, while it remains in limited supply elsewhere.
“There are children dying in Germany because they didn’t have, or didn’t have enough, human milk,”Rouw, the breastfeeding medicine specialist in Germany, said. Centers in Germany caring for extremely premature babies without direct access to a milk bank are buying it in part from Belgium and the United States, she added.
Experts agree that having harmonized safety standards would make the cross-border exchange of breast milk easier, improving babies’ access to it. These include things like donor selection criteria, maternal blood tests for infections, hygiene standards during collection, cold chain conditions during transport, and testing the milk for bacteria, said Picaud, president of the French Human Milk Bank Association.
However, while the Commission is setting out the principle of bloc-wide standards in its regulation, it aims to leave it to expert bodies — the European Centre for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) — to hammer out the precise scientific and technical details so that these can be more easily updated should the need arise.
Should donors get paid?
The debate over paying for substances of human origin is a divisive one. Germany’s Human Milk Bank Initiative, a nongovernmental organization that promotes nonprofit donor milk banks, warned in a position statement to the Commission in 2020that “ethically questionable approaches” have been used globally to acquire human milk from “lactating mothers in resource-limited regions or from socio-economically disadvantaged populations.”
EU countries take varying approaches when it comes to donor compensation for breast milk. Donors in France, for instance, receive no financial compensation. In Sweden, donating mothers receive a nominal 250 Swedish krona (€22.56) per liter of donated milk.
The Commission’s proposed revision includes guidance on compensation for all SoHO donors, to allow any financial losses to be covered — but leaves it to EU countries to determine whether to allow it and if so, the conditions for it, ensuring they remain “financially neutral.”
As well as human milk banks, the new law would also apply to any company looking to commercialize breast milk as an ingredient.
A nurse checks reserves of breast milk in the Sant’Anna hospital in Turin, Italy | Diana Bagnoli/Getty Images
Given the growing body of research showing the clinical benefits of donor breast milk for premature babies, hospital-affiliated milk banks around the world are expanding their activities — and there’s also growing commercial interest, a Commission spokesperson told POLITICO.
At least one company is using breast milk to make fortifiers for sick and premature babies in the neonatal intensive care unit, which are then added to either a mother’s milk or donor milk.
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( With inputs from : www.politico.eu )
The total number of demat accounts in India is significantly increasing everyday as more and more people build trust on the share market. SIPs are the most preferred investment among people. However, some people are going overboard with their investment plans and are cutting their regular expenses to buy shares and SIPs.
Seeing a post on LinkedIn about compounding magic, Abhishek bought shares of a Pharma company instead of the medicines prescribed by the doctor and his health kept deteriorating while his investment kept getting healthier. Unfortunately, on Friday the man succumbed to the poor health and healthy investment.
Speaking to The Fauxy, Abhishek’s friend, Rohan said “He read a post on Linkedin about compounding magic that compared the share price and cost of Britannia biscuits over a period of ten years, and Abhishek wouldn’t stop talking about it. He went so crazy that whenever he would buy something he would first check if the company of that product is listed in the BSE or NSE.”
Abhishek’s Doctor told The Fauxy “Abhishek was diabetic and his BP was shooting up, I prescribed him the medicines, but I guess he bought the share of that Pharma company instead”
“Abhishek isn’t with us but his investments are wish he had taken term insurance too” said Abhishek’s wife.
[ Disclaimer: With inputs from The Fauxy, an entertainment portal. The content is purely for entertainment purpose and readers are advised not to confuse the articles as genuine and true, these Articles are Fictitious meant only for entertainment purposes. ]
Chandigarh: Punjab Assembly Speaker Kultar Singh Sandhawan on Sunday said a meeting to discuss the public interest issue of selling medicines at “exorbitant rates”, which is leading to “public loot”, will be held on Tuesday.
It would be attended by Cabinet ministers, MLAs, health experts and representatives of various NGOs.
As part of the series of discussions pertaining to public issues, the Speaker said the discussion will be held on this burning matter because it is a common belief that due to high prices, people are being robbed and medicines are going beyond the reach of the poor.
He said the meeting would enable MLAs, who work as a link between the public and the government, to have a meaningful debate in the Assembly on this burning issue of public interest so that suitable steps for its proper solution could be taken.
When you’re feeling under the weather, the last thing you want to do is trek from pharmacy to pharmacy searching for basic medicines like cough syrup and antibiotics. Yet many people across Europe — faced with a particularly harsh winter bug season— are having to do just that.
Since late 2022, EU countries have been reporting serious problems trying to source certain important drugs, with a majority now experiencing shortages. So just how bad is the situation and, crucially, what’s being done about it? POLITICO walks you through the main points.
How bad are the shortages?
In a survey of groups representing pharmacies in 29 European countries, including EU members as well as Turkey, Kosovo, Norway and North Macedonia, almost a quarter of countries reported more than 600 drugs in short supply, and 20 percent reported 200-300 drug shortages. Three-quarters of the countries said shortages were worse this winter than a year ago. Groups in four countries said that shortages had been linked to deaths.
It’s a portrait backed by data from regulators. Belgian authorities report nearly 300 medicines in short supply. In Germany that number is 408, while in Austria more than 600 medicines can’t be bought in pharmacies at the moment. Italy’s list is even longer — with over 3,000 drugs included, though many are different formulations of the same medicine.
Which medicines are affected?
Antibiotics — particularly amoxicillin, which is used to treat respiratory infections — are in short supply. Other classes of drugs, including cough syrup, children’s paracetamol, and blood pressure medicine, are also scarce.
Why is this happening?
It’s a mix of increased demand and reduced supply.
Seasonal infections — influenza and respiratory syncytial virus (RSV)first and foremost — started early and are stronger than usual. There’s also an unusual outbreak of throat disease Strep A in children. Experts think the unusually high level of disease activity is linked to weaker immune systems that are no longer familiar with the soup of germs surrounding us in daily life, due to lockdowns. This difficult winter, after a couple of quiet years (with the exception of COVID-19), caught drugmakers unprepared.
Inflation and the energy crisis have also been weighing on pharmaceutical companies, affecting supply.
Last year, Centrient Pharmaceuticals, a Dutch producer of active pharmaceutical ingredients, said its plant was producing a quarter lessoutput than in 2021 due to high energy costs. In December, InnoGenerics, another manufacturer from the Netherlands, was bailed out by the government after declaring bankruptcy to keep its factory open.
Commissioner Stella Kyriakides wrote to Greece’s health minister asking him to take into consideration the effects of bans on third countries | Stephanie Lecocq/EPA-EFE
The result, according to Sandoz, one of the largest producers on the European generics market, is an especially “tight supply situation.” A spokesperson told POLITICO that other culprits include scarcity of raw materials and manufacturing capacity constraints.They added that Sandoz is able to meet demand at the moment, but is “facing challenges.”
How are governments reacting?
Some countries are slamming the brakes on exports to protect domestic supplies. In November, Greece’s drugs regulator expanded the list of medicine whose resale to other countries — known as parallel trade — is banned. Romania has temporarily stopped exports of certain antibiotics and kids’ painkillers. Earlier in January, Belgium published a decree that allows the authorities to halt exports in case of a crisis.
These freezes can have knock-on effects. A letter from European Health Commissioner Stella Kyriakides addressed to Greece’s Health Minister Thanos Plevris asked him to take into consideration the effects of bans on third countries. “Member States must refrain from taking national measures that could affect the EU internal market and prevent access to medicines for those in need in other Member States,” wrote Kyriakides.
Germany’s government is considering changing the law to ease procurement requirements, which currently force health insurers to buy medicines where they are cheapest, concentrating the supply into the hands of a few of the most price-competitive producers. The new law would have buyers purchase medicines from multiple suppliers, including more expensive ones, to make supply more reliable. The Netherlands recently introduced a law requiring vendors to keep six weeks of stockpiles to bridge shortages, and in Sweden the government is proposing similar rules.
At a more granular level, a committee led by the EU’s drugs regulator, the European Medicines Agency (EMA), has recommended that rules be loosened to allow pharmacies to dispense pills or medicine doses individually, among other measures. In Germany, the president of the German Medical Association went so far as to call for the creation of informal “flea markets” for medicines, where people could give their unused drugs to patients who needed them. And in France and Germany, pharmacists have started producing their own medicines — though this is unlikely to make a big difference, given the extent of the shortfall.
Can the EU fix it?
In theory, the EU should be more ready thanever to tackle a bloc-wide crisis. It has recently upgraded its legislation to deal with health threats, including a lack of pharmaceuticals. The EMA has been given expanded powers to monitor drug shortages. And a whole new body, the Health Emergency Preparedness and Response Authority (HERA) has been set up, with the power to go on the market and purchase drugs for the entire bloc.
But not everyone agrees that it’s that bad yet.
Last Thursday, the EMA decided not to ask the Commission to declare the amoxycillin shortage a “major event” — an official label that would have triggered some (limited) EU-wide action— saying that current measures are improving the situation.
A European Medicines Agency’s working group on shortages could decide on Thursday whether to recommend that the Commission declares the drug shortages a“major event” — an official label that would trigger some (limited) EU-wide action. An EMA steering group for shortages would have the power to request data on drug stocks of the drugs and production capacity from suppliers, and issue recommendations on how to mitigate shortages.
At an appearance before the European Parliament’s health committee, the Commission’s top health official, Sandra Gallina, said she wanted to “dismiss a bit the idea that there is a huge shortage,” and said that alternative medications are available to use.
And others believe the situation will get better with time. “I think it will sort itself out, but that depends on the peak of infections,” said Adrian van den Hoven, director general of generics medicines lobby Medicines for Europe. “If we have reached the peak, supply will catch up quickly. If not, probably not a good scenario.”
Helen Collis and Sarah-Taïssir Bencharif contributed reporting.
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( With inputs from : www.politico.eu )
Srinagar, Jan 23: Despite constitution of divisional level Prescriptions Audit Committee (PAC), doctors in several hospitals of Jammu and Kashmir aren’t prescribing generic medicines to patients available at the hospital.
Health officials on condition of anonymity told news agency—Kashmir News Observer (KNO), that doctors at various hospitals are not prescribing generic medicines to the patients so as to give benefit to private clinics and to give their percentage as well.
They said directions given doctors to mention, unit/department name on the prescription is also thrown to the winds so that identity of doctors not prescribing generic medicines won’t get disclosed.
Meanwhile, attendants as well as patients talking to KNO said that the nexus between doctors and private clinics is still active and in order to get benefit doctors are prescribing costly drugs and unnecessary diagnostic tests.
“Unnecessary diagnostic tests/procedures are prescribed and patients are referred to the private clinics/specialists without requirement,” they said.
They added that despite the availability of generic drugs at the hospital, doctors are prescribing costly drugs which are not available at the hospital stores so that patients can get them from private clinics and the doctor will get his share.
A health official acknowledged that drugs are prescribed in contravention to the provisions of Drugs & Cosmetic Act & Regularizations.
He said that the government has already taken a serious note of it and recommendations, highlighting actionable points will be sought from concerned authorities in this regard so that this practice can be stopped fully.
“The prescription Audit report submitted by the Nodal Officer has raised serious issues regarding prescription of patients where doctors are not writing Generic drugs and does not mention the name, unit/department on the prescription.” Medical Superintendent Associated Hospital GMC Anantnag has recently written to all doctors of the hospital.
“Accordingly it is once again intimated to prescribe Generic Drugs for which Jan Aushadhi Kendra and AMRIT Stores are already functional in the hospital so that patients will be benefitted and make proper signatures, write full name and unit/department on each and every prescription.” It reads further.
Notably, Directorate of Health Service Kashmir last year ordered for constitution of divisional level Prescriptions Audit Committee (PAC) and asked Chief Medical Officers and Medical Superintendents to nominate one Nodal Officer besides constituting similar committees at district level.
DHSK had also asked all the CMOs and Medical Superintendents to nominate one Nodal Officer for each district and sub-district hospital and shall collect photocopies of at least 1 percent of prescriptions by doctors in OPDs on a random basis.
CMOs were also asked to constitute district-level PAC comprising doctors on administrative posts, excluding consultants.
“These prescriptions collected by the Nodal Officer shall be scrutinized by PAC whether the prescriptions are written in capital letters with the name of doctor, signature and registration number besides that generic drugs are prescribed and preference is given to the drugs, which are available free in hospital supplies,” DHSK had directed—(KNO)
