Wednesday, February 10, 2016

Putting Household Water Treatment Products to the Test

WHO’s new International Scheme to Evaluate Household Water Treatment (HWT) Technologies ensures that products used to treat water in homes are effective in protecting health.

Globally, an estimated 1.9 billion people rely on water supplies that are contaminated with faeces. This requires many to use household water treatment (HWT) technologies to help prevent disease and make water safe for drinking.

The global market for HWT products has now become flooded with products. From chlorination to filtration systems and solar disinfection, the options for purifying water are endless. Manufacturers claim their products make water safe for drinking, but in low-income countries, where many of these devices are essential, labs lack the capacity to verify these claims.

But, times are changing.

“The primary benefit from household water treatment is protecting health,” says WHO's Dr Batsi Majuru.

Now, the health benefits of HWT are increasingly recognized and the need for independent and rigorous evaluation is essential, adds Dr Majuru.

It is estimated that when used correctly and consistently, HWT and safe storage of water can reduce diarrhoeal diseases by as much as 45%, and save thousands of young children every year.

An international evaluation scheme

The International Scheme to Evaluate Household Water Treatment Technologies was established in 2014 to independently and consistently assess the performance of HWT products against WHO health-based criteria - an evaluation system similar to how pharmaceuticals and insecticide-treated bed nets are pre-qualified.

WHO International Scheme to Evaluate Household Water Treatment Technologies
Under the Scheme, a product can be evaluated if it is low-cost, appropriate for low-income settings, free standing and able to treat enough water to serve a limited number of individuals for a day. Products that meet these requirements are tested to see how well they remove microbiological contaminants, such as bacteria, viruses and protozoa, from drinking water. Product performance is classified based a 3 tiered system and those that achieve the highest removal of pathogens are given a 3-star rating.

Recently, WHO released the first round of results on 10 HWT technologies ranging from ultrafiltration to chemical disinfection and found 8 met performance targets. These products reach an estimated 60 countries and millions of users. Every year, WHO plans to test new technologies and release results to help countries like Ethiopia that are working to scale-up HWTselect the technologies that meet WHO performance criteria.

Improving regulation in Ethiopia

Ethiopia is often affected by droughts and floods, meaning that safe drinking water can be hard to come by and diarrhoeal diseases are common. To address the situation, the Government launched the ‘One WASH Programme’, which aims to achieve universal access to safe water, sanitation and hygiene, and improve safe storage and treatment practices in the household.

Prior to WHO’s scheme, many laboratories tried to evaluate HWT products, but there were no standard protocols or test processes. Now, the Ethiopian Food, Medicine and Health Care Administration Control Authority, which is mandated to test the safety of pharmaceuticals, food and beverages, is also mandated to regulate HWT products.

“Previously, we only conducted document reviews and chemical testing on chlorine-based HWT technologies being used in the country,” says Bikila Bayissa, Deputy Director General of Food & Medicines Quality Assessment, Ethiopian Food, Medicine and Health Care Administration & Control Authority. “Now, through WHO’s Scheme, we are also focusing on the microbiology, which is critical to ensuring drinking water is safe.”

WHO is working with the Government of Ethiopia to train staff from various government laboratories, ministries and regulatory bodies on how to do the microbiological testing to evaluate product performance, as well as implementing WHO Guidelines on Drinking-water Quality.

“Many HWT products are imported from other countries, but no one knows if they are good or bad,” says Dr Almaz Gonfa, coordinator, Food Microbiology and Food Safety Research Lab at Ethiopian Public Health Institute. “The WHO Scheme will help Ethiopians know the products they are using are actually cleaning their water and protecting their health.”

Scaling-up in more countries

Universal access to safe drinking water is called for in the Sustainable Development Goals. By strengthening protection and management of water supplies, including at the household level, WHO and governments are taking steps to achieve this goal.

This year, WHO is working with the Government of Ghana to develop HWT performance standards and a certification and product labeling system to aid users in making informed purchases. Once launched, the certification programme will support the Government’s National Strategy for Household Water Treatment and Safe Storage, aimed at reducing waterborne diseases by 2025.

“WHO’s scheme will help make sure the technologies in Ghana effectively clean water, are appropriate for local households and meet international standards,” says Kweku Quansah, programme officer, Ghanaian Ministry of Local Government & Rural Development.

“Once we pass technologies through the evaluation process, individuals will have the assurance that these technologies are internationally verified,” he adds.

Wednesday, February 3, 2016

Gliptin New Anti Diabetes Drug Cuts Treatment Cost by 80%

There's a new diabetes drug in the market which apparently cuts cost by 80%. We kid you not. This comes as good news for millions of diabetics tackling the debilitating disease.

By lowering the cost of therapy for patients by 80%, the new drug in the 'gliptin' family has disrupted the anti-diabetes market. With 15 companies offering offering the drugs, cost for a day's treatment is down from Rs 45 to an average daily price of Rs 9. This miracle drug could make life easier for the people tackling with the disease which gradually attacks and weakens all body organs.

The cost of gliptin treatment amounted to Rs 16,200 per year (at Rs 1,350 per month). With the entry of the new molecule and subsequently aggressive pricing by domestic companies over the past six months, the cost of therapy has dropped to approximately Rs 3,285 a year (at Rs 270 a month), translating into national savings of roughly Rs 1,300 crore for patients. The new entrant teneligliptin is also the fastest selling in the Rs 1,430 crore gliptin family which occupies 20% of the total anti-diabetic market.

Diabetics in the country have something to cheer about. A new drug in the 'gliptin' family has disrupted the anti-diabetes market by lowering the cost of therapy for patients by 80%, making it easier for millions of diabetics to tackle the debilitating disease which gradually attacks and weakens all body organs.

With the launch of teneligliptin molecule, the popular gliptin category has witnessed a price erosion of over 80% in the last six months, bringing down the cost from 45 for a day's treatment to an average of 9, with over 15 companies now offering it.

Most gliptins are priced around 45 for a day's therapy, taking the cost of treatment for patients to nearly 16,500 a year ( 1,350 a month).

The entry of the new molecule and subsequent aggressive pricing has led to the cost of therapy coming down to approximately 3,285 a year (or 270 a month), translating into savings of roughly 1,300 crore for patients.

The new entrant teneligliptin is also the fastest selling in the 1,430 crore gliptin family, which occupies 20% of the anti-diabetic market.

Teneligliptin, a third-generation new oral anti-diabetic drug manufactured by Mumbai-based Glenmark, received regulatory approval and was priced aggressively at nearly 20 for a day's therapy when it was first launched in June last year.

The launch of Zita Plus and Ziten (teneligliptin brands) by Glenmark paved the way for the entry of a host of other players to launch the molecule in the oral diabetic market, which is valued around 6,000 crore.

As per AIOCD data (December 2015), there are 16 teneligliptin brands in the market, with total sale of 36 crore.

The economic burden of diabetes is high in India as most patients pay out-of-pocket, and due to lack of medical reimbursement.

Worse, the cost of treatment also includes consultation, investigations, drugs, monitoring, complications, while the complications related to the disease may increase it substantially.
Dr Anoop Misra, chairman Fortis-C-DOC Hospital for Diabetes says, "Low cost medications are surely needed in India, however, all of us look at safety data before prescribing any medication. For teneligliptin, safety data is not long term, and confined to patients from far eastern countries, hence confidence to prescribe this medication viz-a-viz other gliptins is lower."
With the entry of the new molecule, the cost of therapy has dropped to approximatelyRs 3,285 a year (at Rs 270 a month), translating into national savings of roughly Rs 1,300 crore for patients.

Price war breaks out among anti-diabetes drug Gliptin in Market

Teneligliptin, a drug to control diabetes, is in the middle of an intense price war. While Mankind Pharma reduced its price by 50 per cent within 24 hours of a launch, Glenmark is evaluating the option of decreasing the price. A week ago, Zydus Cadila, another prominent player, already launched the lowest-priced Teneligliptin.

India's Gliptin market, estimated at Rs 2,000 crore yearly, is growing at around 60 per cent annually. Of the 68 million diabetics in India, about 1.85 million are on the Gliptin therapy to manage their type-2 diabetes.

According to October data from the All-India Organisation of Chemists and Druggists (AIOCD), the country's anti-diabetic drug market is seeing a growth of 25 per cent at Rs 7,638 crore.

"We are evaluating the option of lowering the price of our two Teneligliptin brands (Ziten and Zita Plus) to get more patients in the advanced Gliptin therapy fold," says Sujesh Vasudevan, president and head of India Business, Glenmark Pharmaceuticals.

Glenmark had launched these two drugs earlier this year at Rs 20 a tablet, half the price of the medicine sold by many multinational drug firms. Last year, anti-diabetes drugs accounted for only Rs 100 crore to Glenmark's overall revenue of Rs 6,600 crore. While it is a dominant player in dermatology, the company is now planning to expand its product portfolio in other therapeutic areas like diabetes.

Mankind Pharma, which launched its own Teneligliptin generic 'Dynaglipt' on November 23 at Rs 20 a tablet, decreased the drug's price a day later to Rs 8.60 a tablet.

"Diabetes is a growing epidemic; to cater to it, we are targeting the middle-class and rural diabetic patients, so that it becomes affordable and more economical. The change in prices will help reduce the cost of medicines by about half," said R C Juneja, chairman & founder, Mankind Pharma. The company is targeting at least Rs 200 crore in annual revenue from this drug.

Zydus Cadila, which launched its own generic drug 'Tenglyn' at Rs 7 a tablet a week ago, has no immediate plans to reduce the price further, according to a senior company executive.

"Considering the incidence of the disease, benefits of the drug, and price, Gliptin could become a large-volume drug and face further price erosion as volumes grow," says D G Shah, secretary-general, Indian Pharmaceutical Alliance (IPA).

The Organisation of Pharmaceutical Producers of India, representing multinational companies, refused to comment on the subject.


Glenmark to reduce teneligliptin prices (Rs 20 per tablet at present)

Mankind & Zydus Cadila have priced these below Rs 10 a tablet

Teneligliptin is a drug of gliptin category that has shown significant results in controlling blood sugar in type-2 diabetics

Tuesday, January 12, 2016

India Adds More HIV/AIDS, Cancer Drugs To Essential Medicines List

The government has revised its list of essential medicines to add drugs for diseases ranging from cancer and HIV/AIDS to hepatitis C, in a move aimed at making them more affordable.

The update to the National List of Essential Medicines (NLEM) is just the third since it was compiled in 1996.

It increased the list to 376 medicines from 348 and includes drugs ranging from analgesics and antivirals to contraceptives, cardiovascular and anti-tuberculosis drugs.

Reuters reported in April that more HIV/AIDS and tuberculosis medicines were likely to be added to list, which is posted on the Central Drug Standard Control Organisation's (CDSCO) website.

"The NLEM 2015 has been prepared adhering to the basic principles of efficacy, safety, cost-effectiveness; consideration of diseases as public health problems in India," a notice on the website said.

India had been criticised because the former list left out some life-saving drugs.

The new list takes cues from the World Health Organisation's 2015 list of essential drugs, which the United Nations agency defines as those that satisfy the priority healthcare needs of people and ensure affordability.

The revision comes after months of deliberations by a committee of experts formed by the government last May. Views of the pharmaceutical industry and NGOs were also considered, the CDSCO said.

The committee recommended that the list, which is effective immediately, be revised every three years.

In initial thoughts, industry executives said they were yet to study the list's impact.

"We will be seeking clarification and a better understanding of its implications," said Ranjana Smetacek, director general of the Organisation of Pharmaceutical Producers of India (OPPI) which represents large foreign drugmakers.

The Indian Pharmaceuticals Alliance, which represents large local drugmakers, did not respond to requests for immediate comment.

It is likely that medicines in the new list will be brought under price control, as was done with the previous list, some in the industry said.

Drug pricing is a contentious issue in the country, as nearly 70 percent of the population lives on less than $2 a day and health insurance is inadequate.

India contributes roughly 1 percent of its total gross domestic product to healthcare, among the lowest levels of funding in the world.

Industry executives say drug prices in the country are also among the lowest in the world.

India's drug pricing regulator has struggled in the past year to implement price caps and expand them to cover more drugs.

When it fixed prices of about 100 medicines citing public interest last year, the industry fired back with lawsuits.

The government soon curbed the National Pharmaceutical Pricing Authority's (NPPA) powers, restricting it from fixing the price of medicines not on the essential medicines list.

Price caps cover roughly 30 percent of the drugs sold in the country.

India reports 32 percent declining in HIV/AIDS

India is estimated to have registered a 66 per cent decline in new HIV infections from 2000 and 32 per cent decline from 2007, according to the latest round of HIV sentinel surveillance and estimations conducted by the National AIDS Control Organisation (NACO), released by the Union Health Ministry.

There were around 86,000 new HIV infections in 2015. The report noted that Andhra Pradesh and Telangana, Bihar, Gujarat and Uttar Pradesh currently account for 47 per cent of the number of total new infections among adults with each of these States contributing 7,500 or more new infections in 2015.

West Bengal and Rajasthan registered more than 5,000 new HIV infections, but less than 7,500 new infections, while Maharastra, Odisha and Tamil Nadu have new infections in the range of 3,000-4,000. Chhattisgarh, Delhi, Haryana, Jharkhand, Karnataka, Madhya Pradesh and Punjab have 1,000-2,400 new infections among adults and the rest of the States have less than 1,000 new adult HIV infections in 2015.

New infections among adults have declined by 50 percent or more in the State of Andhra Pradesh and Telangana, Karnataka, Maharashtra, Manipur and Odisha during 2007-2015. Bihar, Jharkhand, Kerala, Mizoram, Nagaland, Rajasthan and Uttarakhand are the states where annual new infections declined by 32-47 percent during the same period.

However a rising trend in new infections among adults during 2007-2015 has been detected in Assam, Chandigarh, Chhattisgarh, Gujarat, Sikkim, Tripura and Uttar Pradesh.

The report further noted that since 2007, the number of AIDS-related deaths declined by 54 percent in 2015 with an estimated 67,600 people dying of AIDS-related causes nationally.

The annual number of AIDS deaths has declined by 70-81 per cent during 2007-2015 in Karnataka, Maharashtra and Tamil Nadu. Annual AIDS related deaths declined by 60-70 percent from baseline values of 2007 in Andhra Pradesh and Telangana, Goa, Himachal Pradesh and Nagaland, while a decline of 40-47 percent was estimated in Chhattisgarh, Gujarat and Punjab.

Injectable HIV Treatment Would Change Lives

This month ViiV Healthcare and Janssen Sciences announced that Phase III trials for a bimonthly HIV treatment injection would begin in mid-2016. This year the two 

companies will be evaluating the commercialization of a long-acting formulation to be used as an injectable maintenance treatment for patients who have achieved viral suppression. 

Injectable treatments have been the buzz in HIV treatment research for a while, but this announcement represents a tangible hope that a new form of treatment is within our grasp. In a few years, many people living with HIV might be able to throw away their pillboxes for good.

The current oral regimen continues to be a reason for poor adherence to HIV treatment. Also, the daily pill can sometimes be viewed as a symbol of second-class status. 

No matter how healthy I am, people still see someone whose health is subpar.

In the U.S., the majority of people living with HIV are not able to stay on treatment and maintain viral suppression. The possibility of a bimonthly injection wouldn’t just improve adherence to medication and reduce transmission, it would revolutionize the lives of HIV-positive people.

If you are not living with HIV, just try to imagine it for a second. Imagine being a young person and being told that you can still live a long and healthy life, but only if you adhere to this daily regimen with few to no mistakes. Sounds simple enough, but factor in trying to carry the enormous weight of HIV stigma and concealing 

your diagnosis to the outside world — as most initially try to do — and you have 365 reasons to fail. For so many, a bottle of pills isn’t just a bottle of pills, but an embarrassing reminder to yourself and others, that you contracted a virus that is avoidable.

That sounds harsh. HIV shouldn’t have to be something people are ashamed of. But what should be does not change the reality of the majority of people with HIV who are utterly mortified and almost paralyzed by the idea of people finding out their status.

Now, imagine being told that all it will take to keep you healthy and living the life you want is six doctor visits a year. Sure, it may not still ideal, but what disease is? It is a hell of a lot better than the alternative. An HIV injectable treatment represents an opportunity to resume life knowing that you are virally 

suppressed even if you are not quite ready or able to take on managing your virus full time.

Today, managing HIV doesn’t just require a daily pill. It requires a person to develop an entirely new state of mind — one that requires strength, an awareness of what it means to be positive today, and the support of friends and loved ones. If that were so easy to come by, HIV wouldn’t still be the problem that it is.

An injectable treatment would remove the daily reminder of a disease that shouldn’t but often does hold people back. It would mean the freedom of waking up and going about your day without a siege of panic because you forgot to take your medication. It would mean the removal of shackles to a pill bottle so sleepovers can be spontaneous and packing for vacations is done sans stress. Frankly, an injectable treatment would simply mean a better life.

Indiana town adopts B.C.’s HIV-treatment model after outbreak

A small Indiana community where two out of every five residents are considered at high risk of HIV infection is reaching out to B.C. experts for help.

Austin, Ind., is suffering through an unprecedented outbreak of the disease. With a population of 4,200, 10 per cent are currently injecting prescription opioid drugs on a daily basis, said Diane Janowicz, assistant professor at the Indiana University School of Medicine.

Since last year, 184 new HIV infections have been identified.

“Thirty-nine per cent of the population are identified as high risk. That’s an incredibly high prevalence compared to other parts in the U.S.,” Dr. Janowicz said.

The university, working with the National Institute on Drug Abuse, has asked for help from the BC Centre for Excellence in HIV/AIDS. The intention is for the centre to bring its so-called treatment-as-prevention model of health care to the beleaguered community. Treatment-as-prevention is a collection of antiretroviral treatments that reduce the HIV virus load in blood and vaginal and rectal fluids, to decrease the risk of HIV transmission.

B.C. has seen a steady decrease in the number of deaths resulting from HIV since the introduction of an intense antiretroviral therapy program that began in 1996. There has been a 90-per-cent decrease in the number of new cases since 30 years ago.

As of last year, only 250 cases of HIV were recorded in B.C.

In Austin, the outbreak began last year and is linked to intravenous injection of opiate pain medication that users crush. It has prompted a warning from the U.S. Centers for Disease Control and Prevention to alert health officials to be on guard against clusters of HIV and hepatitis C infections.

“Indiana University will bring their colleagues here to see how we implemented our strategies in British Columbia, to learn about our treatment programs and to see how we have made the improvement happen,” said Julio Montaner, director of the BC Centre for Excellence of AIDS/HIV.

“It’s easier said than done. This program is very complex and it is difficult to implement,” he said.

For example, he said it can be difficult for doctors to reach patients and ensure they have access to the kinds of drugs and programs needed for the therapy to be effective.

A state epidemiologist said in a news report in the Indy Star last year that fewer than half those diagnosed with HIV had been prescribed antiretroviral treatments.

Prior to the outbreak in Austin, there was only one clinic providing health care in the town.

The Indiana team, including the B.C. doctors, plans to use mapping technology to examine risk factors for HIV transmission. Other research will investigate the clustering of HIV transmissions. And scientists will evaluate how to counter the damage of injection-drug use through harm-reduction services.

“The situation in Indiana marks a critical need for implementing best practices in harm reduction and HIV prevention. Treatment-as-prevention is a model for opening up access to early HIV treatment and care, for reducing stigma and for targeted disease elimination,” Dr. Montaner said in a news release.

“Providing sustained, consistent treatment and care ensures that an individual’s viral load decreases, dramatically reducing the likelihood of disease progression and secondarily stopping HIV transmission.”

B.C.’s treatment model has also been widely adopted in other jurisdictions of the world including China, Latin America and Europe.

“The BC Centre for Excellence in HIV/AIDS is recognized internationally for [its] outstanding work in providing access to treatment and care for those affected by or at high risk of HIV in urban and rural areas in British Columbia,” Dr. Janowicz said.