QCIL spearheading production of new generation ARVs, antimalarials

Quality Chemicals Industrial Limited (QCIL) in partnership with the Cipla Ltd, an Indian multinational pharmaceutical, is currently producing new generation antiretrovirals (ARVs) and anti-malarial drugs. These drugs are here to address the challenge of drug resistance which is caused primarily due to non-adherence to drugs sometimes perpetuated by drug shortage.

For malaria treatment, QCIL has embarked on the production of artemisinin based combination therapy (ACT) under the brand name, Lumartem. It is a first line treatment against uncomplicated malaria as recommended by the World Health Organization (WHO).

This follows the population’s resistance to conventional medicines such as Chloroquine.

Lumartem contains artemisinin and lumefantrine, two active anti-malarial ingredients and is significantly cheaper than its sister brand-Coartem. 

Samuel Opio (R) showing President Paul Kagame a sample of Lumartem

“We are also in the process of producing another ACT; a combination of Artesunet and Amodiaquine which is recommended by WHO as the first line treatment for uncomplicated malaria in many of the franco-phone countries,” said Samuel Opio, QCIL’s head pharmacist.

QCIL also recently introduced the first Tenofovir-based combination, a newer generation of ARVs with better safety pro- file and greater efficacy under the brand name-Duomune. It is a fixed dose combination of tenofovir, disoproxil fumarate and lamivudine.

The recommended dose of Duomune is one tablet, taken orally, once daily.

Opio says Duomune reduces pill burden as it is taken once a day and has been found to significantly reduce the transmission of HIV.

With currently installed capacity of 75 million tablets per month, QCIL is positioning itself to supply the region with life saving medicine. 

Samuel Opio, QCIL (R) during a tour with President Yoweri Museveni (C)

WHY FOCUS ON MALARIA AND HI

Despite remarkable progress in combating the disease burden in Uganda, progress in meeting MDG six of combating HIV/Aids and malaria is still dampened by high prevalence and incidence of the two diseases. Today, there are some 630,000 Ugandans in need of ARVs to manage the HIV/Aids. Yet only 350,000 are receiving it leaving nearly a half of the population without treatment.

Deaths due to malaria in Uganda number 312 daily and over 100,000 annually. Because malaria covers a continuum that extends from asymptomatic infection to acute infections and death, many survivors bear the toll of non lethal effects such as anaemia, low birth weight and hypoglycaemia without attributing it to malaria.

According to Uganda’s 2011 Demographic and Health Survey, malaria is the significant cause of death to 99 out of every 1,000 children under five years. This is way above the MDG goal of having only 58 deaths per 1000 children. This is worsened by the fact that more than three quarters of Ugandans live in highly endemic areas.

Owing to the fact that Uganda is among the most highly malaria-endemic countries in Africa, Gross Domestic Product loss from the disease is estimated at $23.4 m (Shs 58 b) which translates to seven per cent of the health budget. The health sector was allocated Shs 825b in the 2013/14 national budget.

At household level, malaria episodes result in reduced productivity because of the inability to work. Conversely, malaria, said Opio, increases HIV replication in one’s cells. 

REGIONAL MARKET THE DRUGS

QCIL is the only facility in East and Central Africa licensed and prequalified by WHO to produce generic drugs. Generic drugs are comparable to the brand-name drug but are sold at a significantly lower price than the branded ones.

It’s sister company, Cipla, one of the world’s largest producers of generic drugs and is offering advanced technology, technical assistance and staff training to QCIL.

With this boost, the local pharmaceutical supplies ACTs and ARVS to Kenya, Tanzania, Rwanda and Burundi.

“In the recent past, our installed capacity was 60 million tablets because we initially sought to meet the local demand of 50 million tablets. With a boost of another 25 million tablets, we are able to supply the region,” said Opio during an interview. 

CHALLENGES

The biggest challenge is market access. There are huge multinational companies which import medicines from production plants some which do not meet the WHO recommendations and sale them at highly subsidized prices. This limits access for the drugs produced by QCIL.

There is also a challenge of limited skilled labour.

“Many graduates have the knowledge but lack the practical skills. But with current technological transfers with CIPLA, we are bridging this gap,” Opio said.

QCIL currently has 250 employees and 70 per cent of these have science backgrounds including pharmacists, bio chemists, chemists, mechanical engineers.

There is also a challenge of donor dumping which comes in the form of aid. 

FUTURE PROSPECTS

In the next five to 10 years, QCIL is aims at increasing its production capacity.

Plans are also underway to establish an Active Pharmaceutical Ingredient (API) Plant which will provide the region with a source of affordable and quality pharmaceutical raw materials for example artemether which is grown in the western part of the country.

 This will reduce costs of importing the raw material from India, china and Vietnam. However at present, Quality Chemicals does not have extraction technology required to produce artemisinin at 100 per cent purity.

“Artemether will be exported to India where they will purify the plant and extract its medicinal component which will then be imported by Uganda. But we believe that the purification process can be done here,” Opio explained. 

QCIL is also considering transitioning fully to the production of Tenofovir based combinations and paediatric formulations in form of dispersable tablets dissolvable in water. Realisation of these formulations is expected within the next two years.

With the deadline extension of the World Trade Organization’s (WTO) Trade Related Aspects of Intellectual Property (TRIPS) to 2021, Opio says QCIL together with Cipla are considering production of newer molecules that can be availed even after TRIPS has ended. The original deadline was 2016.

According to the TRIPS agreement, least developed countries (LDCs) are supposed to enforce patents on all medicines by 2021. This would mean the end of all generic drugs. Patents guarantee the right to exclude others from making, using, offering for sale or selling the invention 20 years from the date on which the application for the patent was filed.

“We welcome the extension but we still need a further extension until we have developed enough capacity. The only capacity we are talking about right now is QCIL which is the regional capacity. We also need to build on research,” said Opio.

WAY FOWARD

As part of overall sustainability, treatment for malaria, Opio said it is important to invest in the future by developing a strong research and development centre that can tap into the potential of local medicines.

“As QCIL, we believe we are ready for this but we need partners to be able to scale up,” he said.

Cancer to hit 24m Cases annually in 20 years

One the eve of World Cancer day, a report released on from the International Agency for Research on Cancer (IARC) shows some disappointing figures for the global fight against cancer. By 2030, cancers are expected to jump from 14 million in 2012 to 21.6 million a year, and overall deaths are expected to increase from 8.2 million to 13 million annually.

 Lung cancer is the biggest killer, and the report criticizes tobacco companies' push into poorer countries. It said a smoking “epidemic” is “potentially impeding human development by consuming scarce resources, increasing pressures on already weak health-care systems, and inhibiting national productivity.”

The world is facing a "tidal wave" of cancer, and restrictions on alcohol and sugar need to be considered, say World Health Organization scientists.

It predicts the number of cancer cases will reach 24 million a year by 2035, but half could be prevented.

In Uganda, some 3000 new people afflicted with various cancers will have presented themselves at the Uganda Cancer institute (UCI), the only cancer referral facility in the country for treatment by the end of 2014. 

This is because of the increase in infections malaria, HIV, Hepatitis B, Human Papilloma Virus (HPV) and typhoid. Infection-related cancers include Burkitt’s lymphoma, associated with malaria and affects children between four and seven years, Kaposi's sarcoma caused by the Human Herpes Virus 8 (HHV8) whose risk increases dramatically in people with HIV infection and Hepatocellular Carcinoma (cancer of the liver) caused by the Hepatitis B Virus (HBV).

The UCI director, Dr. Jackson Orem says HIV has accelerated the burden of cancer in the country so much so that 60 percent of cancers in adults at UCI are related to HIV.

“Thirty percent of cancers in developing countries are related to infection. Most cancer patients in Uganda are young and in their prime as opposed to elderly population in the developed world,” he said in an interview with the Observer.

Dr. Orem adds that institute is seeing an influx of children afflicted with Burkett’s lymphoma, a potentially fatal and disfiguring cancer that often develops in the jaw or abdomen caused by the Epstein-Barr virus that is as a result of frequent and ill-treated malaria.

Other infection related cancers include; blood, cervical, bladder and stomach cancers.

Worldwide, cancer kills more people than AIDS, tuberculosis, and malaria combined and has become a leading cause of death in the world. (WHO) estimates that by 2030 more than 12 million people could die from cancer related diseases. About 80 per cent of these deaths are likely to occur in low-income and middle-income countries such as Uganda.

Currently, according to information from the Non-communicable disease unit of the health ministry, 300 people per every 100,000 are estimated to have cancers

Last year, UCI recorded a total of 2800 patients with infection related cancers last year accounting for more than 50 per cent of the cancer burden in the country.

“If the infections are not reduced sooner than later, cancer is going to be the next big epidemic in the country,” Dr Fred Okuku, a senior oncologist at UCI warns.

The WHO said there was now a "real need" to focus on cancer prevention by tackling smoking, obesity and drinking.

The World Cancer Research Fund said there was an "alarming" level of naivety about diet's role in cancer.

Fourteen million people a year are diagnosed with cancer, but that is predicted to increase to 19 million by 2025, 22 million by 2030 and 24 million by 2035.

The developing world will bear the brunt of the extra cases.

Dr Chris Wild, the director of the WHO's International Agency for Research on Cancer, told the BBC: "The global cancer burden is increasing and quite markedly, due predominately to the ageing of the populations and population growth.

“If we look at the cost of treatment of cancers, it is spiralling out of control, even for the high-income countries. Prevention is absolutely critical and it's been somewhat neglected.”

The WHO's World Cancer Report 2014 said the major sources of preventable cancer included:

·         Smoking

·         Infections

·         Alcohol

·         Obesity and inactivity

·         Radiation, both from the sun and medical scans

·         Air pollution and other environmental factors

·         Delayed parenthood, having fewer children and not breastfeeding

For most countries, breast cancer is the most common cancer in women. However, cervical cancer dominates in large parts of Africa.

The human papillomavirus (HPV) is a major cause. It is thought wider use of the HPV and other vaccines could prevent hundreds of thousands of cancers.

One of the report's editors, Dr Bernard Stewart from the University of New South Wales in Australia, said prevention had a "crucial role in combating the tidal wave of cancer which we see coming across the world".

Dr Stewart said human behavior was behind many cancers such as the sunbathe "until you're cooked evenly on both sides" approach in his native Australia.

He said it was not the role of the International Agency for Research on Cancer to dictate what should be done.

But he added: "In relation to alcohol, for example, we're all aware of the acute effects, whether it's car accidents or assaults, but there's a burden of disease that's not talked about because it's simply not recognised, specifically involving cancer.

“The extent to which we modify the availability of alcohol, the labelling of alcohol, the promotion of alcohol and the price of alcohol - those things should be on the agenda.”

He said there was a similar argument to be had with sugar fuelling obesity, which in turn affected cancer risk.

Meanwhile, UCI has been chosen by the International Atomic Energy Agency (IAEA) to host the Virtual University for Cancer Control (VUCCnet)- a regional centre for excellence for Cancer training in East Africa.

Currently, the modern Lymphoma Treatment Centre is nearing completion and it is expected to accommodate 100 patients at any one time.

Starving for attention; kids under five wasting away

BY RACHEAL NINSIIMA

For the first time in my life, I saw a severe acute malnourished child. I will never forget his appearance. I met this toddler at Bubukwanga Health Centre III in Bundibugyo District where I had gone to report on the Congolese refugees’ influx.

He was one and half years old. His face was swollen, lips chapped, legs highlighted with open sores and was severely lethargic. He rested comfortably in his father’s bosom as if clinging onto him for life support. His little feet hang midway between his father’s calf and the floor and I noticed that they too were swollen, a visible sign of oedema. Oedema is severe wasting of the body swelling from excessive accumulation of watery fluid in cells, tissues or cavities. 

Father and son at Bubukwanga Health Centre III where the toddler was being treated for malaria. He is also acutely malnourished

“My son occasionally gets sick and a year after he was born, we tested him for HIV and found out that he had it,” he told me.

The two had spent five days in the health facility where his son had been admitted with severe malaria. When I met him, he told me that they have only one meal a day and the situation is not different at home where there are four more children.

In this region of Uganda, families mainly grow cocoa, a cash crop and live off its sale as a means of living. Majority of the households survive on less than $2 (Shs 5000) per day and are battling with malnutrition. In a report released early this year titled, ‘Food Security Eludes Households in the Ruwenzori region’ indicates that over 650 children in Bundibugyo are stunted (low height for age). Stunting is associated with higher mortality and lower cognitive development

This trend is however consistent throughout the country especially in rural areas where poverty is rife. According the 2011, Uganda Demographic Health Survey (UDHS), an estimated 2.4 million children (about 33 percent) aged less than five are stunted and about 110,220 children have died in the last five years due to malnutrition.

 By far, Karamoja, West Nile and the southern western region are leading with the highest stunted and wasted (low weight for height) children.

 The situation is worse for those afflicted with HIV.

“Children living with HIV are five times more likely to die from malnutrition before their second birth day compared to non infected children and worse, stunting is irreversible after 24 months of age,” Michele Sibide, the Executive Director of UNAIDS said.

This was during the international conference on maternal, newborn and child health in Africa that was held in South Africa between 1^st and 3^rd August.

In Uganda, more than 40% of the acutely malnourished children are HIV positive.

In fact Uganda loses 1.8 trillion shillings every year to averting malnutrition and treating its opportunistic infections according to a study, ‘Cost of Hunger’ conducted by the office of the prime minister this year. It costs the country about $120 (Shs 300,000) to treat a person affected with malnutrition and its opportunistic infections.

“Most health interventions in the country are done by development partners and yet Uganda needs only 15b from government to intervene in nutrition programs,” Florence Mutyabule, the chairperson of the Uganda Parliamentary forum for children said in an interview.

She added that consumption of mostly staple foods without a good balance of vege­tables, fruit, beans, and animal-source foods can lead to nutrient deficiencies and poor growth in children. 

Many Ugandan children like these are dying before their fifth birthday because of malnutrition

Situation across the continent;

Despite global progress in the fight against hunger and under nutrition, 165 million children globally were stunted as of 2011. This, according to report from the African Union on nutrition, new born and child health was as a result of inadequate vitamin and minerals in their food. In eastern Africa 42% under fiver five were affected as of 2011.  

In Zambia, 45% of children are stunted.

Ethiopia has over the past two years reduced acute malnutrition from 13.4% to 9.5% especially in the southern Tigre and northern Shao regions. This follows a partnership to end famine between the Ethiopian government and Food and Agricultural Organization (FAO) which supported women with agricultural income generating activities such as poultry farming and vegetable growing.

Ghana and Mauritania have also reduced hunger by 50% since 2001 thus reducing incidences of malnutrition.

In Uganda, Vitamin A deficiency has doubled among children under five over the last 10 years between 2001 and 2011 from 19% to 38%. This is according to the 2011 UDHS.

With the growing impetus to end under and malnutrition, Hon. Sarah Opendi, the state minister for primary health care advises mothers to exclusively breastfeed their children.

“A non breastfed child is 14 times more likely to die of malnutrition and related illnesses such as anaemia in the first six months of life than an exclusively breastfed child,” Hon Opendi said in an interview.  

Using therapeutic foods as drugs;

At the government run hospital of Bundibugyo, RECO industries ltd is providing malnourished children with ready to use therapeutic foods commonly known as RUFTs. RUFTs are high energy foods fortified with macro and micro nutrients such as vitamins and minerals. It is a combination of locally grown foods such as maize, rice, cassava.

While one of the most renowned international nutritional products for malnourished children is Plumpy Nut for children and Plumpy Sup for adults, these are not always available.

Reco Industries together with United Nations Children’s Fund (UNICEF) is currently using RUFTs to treat 20,000 children against severe acute malnutrition. Since the beginning of the year, they have reached over 17,000 children and adults in 103 health facilities across the 62 districts with RUFTs.  

“Our target is to integrate nutrition in agriculture and livelihood and our aim is to train 150,000 small holder farmers on what crops to plant, post harvest handling among others,” Brian Rwabogo, Reco Industries’ chief of party said. This was during the recent launch of the production for improved nutrition project that is working to provide therapeutic and supplementary foods to treat malnutrition.  The project is funded by the United States Agency for International Development (USAID) and is being implemented by RECO industries.

RUFTs are now on the World Health Organization (WHO) essential drug list.

However, challenges still remain. Agnes Baku Chandia, the head, nutrition unit in the health ministry says most foods used are prone to afflatoxins (naturally occurring poison) produced by a fungus. There are also inadequate storage facilities and limited community involvement in adopting and distributing this product country wide.

To avert these challenges, there is need for wide spread awareness.

“As leaders, we owe our communities knowledge. To educate them that they need to cultivate food because therapeutic is a drug and not everyday food,” Hon Janet Museveni, minister for Karamoja affairs said during the launch. 

Hon Janet Museveni signs the production for improved nutrition paper during the program launch last week

Momentum builds country-wide to end malnutrition

In April this year, the Uganda Action for nutrition (UGAN) launched a tow year campaign dubbed, ‘Commit to scale up nutrition, Food for all.’ Its aim is to increase awareness of the importance and how to achieve proper nutrition among schools across the country.

Earlier in 2011, the government adopted the Uganda Nutrition Action Plan (UNAP) as the framework for scaling up nutrition in Uganda between2011–2016.

The goal of this plan is to improve the nutrition status of all Ugandans, with emphasis on women of reproductive age, young children, and infants. The plan is intended to reduce the magnitude of malnutrition in Uganda and its impact on the individual, the household, the community, and the nation at large.

“The strategic challenge at hand calls for increased financial and human resource investment in all relevant sectors for nutrition and food security; adequate institutional structures to scale up nutrition, reporting and supervision,” Hon Amama Mbabazi, Uganda’s prime minister said during the launch of the cost of hunger report on June 18 at Imperial Royale Hotel.

He also called for wide social movement to rally support for nutrition services among the public and stakeholders a robust monitoring and evaluation framework, and an enabling legal and policy framework for nutrition and strengthened coordination among stakeholders.

With Africa’s population projected to reach 2 billion by 2050, the unprecedented challenge of feeding the continent’s children looms large. Nutrition interventions are among the best investments that African countries can undertake.