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.

All for the love of a king Thousands race through weekend downpour with no clue what fistula is

Time check is 5:30am and it is Sunday April 6.

I am nestled deep in the warmth of my bed listening to the rain’s music on the iron roof above me. It had only been a few hours since drowsiness had overwhelmed me, the heaviness of my head bringing me down to rest upon the soft mattress.

No sooner had I put my head back down than a thought rushed through my mind like a gushing wind: I was supposed to be running 21 km in the next 90 minutes.

Not from my home, but from Lubiri, Mengo where thousands of people had registered to run to raise money for women suffering from fistula, as a commemoration of the Kabaka’s (king of Buganda Kingdom) 59^th birthday.

A fistula is a tear between the birth passage and the bladder or rectum, caused by obstructed and prolonged labour.  During this time, the soft tissues of the pelvis are compressed between the baby’s head and the mother’s pelvic bones.

The lack of blood flow causes tissue to die, creating a hole between the mother’s vagina and bladder, or between the vagina and rectum, or both, resulting in leakage.

The race’s main sponsor was Airtel together with Buganda kingdom and others.

I swiftly rose from my comfort and drew my coarse green curtains apart. Darkness was lingering in the sky and the downpour seemed to be getting heavier with each passing minute.

I thought, “Was anyone going to risk their lives and run in this rain and cold?” But I answered myself immediately: “Oh yes… Ninsiima. You are joking with the Baganda and their Kabaka. Because of him, they will do anything.”

I fixed a quick breakfast, called my regular boda boda taxi and jolted off to Lubiri at 6:40am.

In the unrelenting rain, I set my feet on the now gullied ground at 7.05am. And lo! A huge crowd was already gathered.

Each runner wore a red t-shirt with the words, ‘Kabaka’s birthday race 2014: Fight against fistula.’ Their sneakers in different colours lit up the soaked grounds. 

Then King Ronald Muwenda Mutebi II pulled into the grounds, wearing a maroon shirt, light brown trousers and a grey coat. He was accompanied by his prime minister, Charles Peter Mayiga who donned a dark blue tracksuit, red t-shirt and black boots.

The Kabaka’s arrival was met with so much noise, the splash of muddy water as excited feet stomped the soaked grounds, cheering and whistling.

Guarded from the rain with a huge umbrella, Mutebi stood in the runners’ path holding a flag.

Although the race which was supposed to have begun at 7am, it was delayed by about 30 minutes, yet none of the runners – going for five, 10 and 21 kilometres – seemed bothered as the rain hammered them. 

To my left, a group of young ladies wiped the rain water from their faces and to my right two children, about 10 and seven years old, pulled their soaked cardigans closer for warmth.

At the rise and fall of the flag in the king’s hands, the runners, like a herd of elephants, took off. 

As I panted along, my eyes caught a glimpse of MPs, John Ken Lukyamuzi, Lulume Bayigga and Joseph Sewungu Gonzaga.

As we whizzed through Nakulabye, I wondered whether all the runners had any idea what fistula was. I asked and the answers were very disappointing.

One lady running proudly along told me: “It is a swelling in the stomach”.

And  another: “It is the remaining parts of a foetus in the uterus after one has had an abortion”, and yet another: “The side effects of a C-Section.” Hmm. Well, at least they were running the marathon having paid Shs 10,000 each; their education could wait another day.

I realised majority of the participants in the race were running just because the Kabaka had asked them to!

My curiosity turned to the men. There was this old man, with grey locked hair, racing along in a white kanzu and chanting: ‘yogaayoga ai ssabassajja! (oh hail the king!)’

I joined him in chorusing the phrase. After establishing rapport, I asked, “By the way, what is fistula?”

And his answer: “Nze ebyo tebinkwatako… tuddukira kabaka waffe (those things do not concern me…we are running for our king.”

Some runners were so committed to their king’s cause, they came up with ‘better’ costumes; one woman ran the race in Buganda’s traditional dress, the busuuti.

At least after unbelievable rounds of wrong answers, one gentleman managed to tell me what a fistula, in its correctness, was.

After advancing through a few familiar places such as Wandegeya and Kampala road, paralysing traffic, I felt excellent. I knew I had run for at least three kilometres. But as we huffed and puffed the rest of the journey away, my legs felt heavy and I felt a stitch in my sides.

I resorted to walking just like many who had started off with vigour. I later spotted musician and dancer, Sarah Short, Uganda Police publicist, Judith Nabakooba, Makindye division boss Dr Ian Clark and the marathon’s chief runner, Mutebi’s younger brother Prince David Kintu Wassajja, who was drenched to the bone.

That man would possibly look fine wearing sack cloth! 

Prince Wasajja (in maroon) runs towards the finishing point

The intensity of the rain made the ground slippery and hard for people to maintain a firm grip against the surface. But two hours later, the winner of the 21km stretch, Gonzaga Ssebuuma made it back to the sodden Lubiri grounds.

Those that had run or walked the five and 10km stretches had arrived earlier and were being sensitized on what fistula was.

My group made it to the grounds at 10:45am, to the sight of vendors, food sellers and bodies moving to the rhythm of local music.

Some of the lyrics gave me the giggles: “I am like Ssemakookiro (Kabaka’s youngest son). I even have ebiwawatiro (wings) and land in miles.’

We then lined up on either side at the finishing point to wait for the chief runner. To keep our spirits alive, we were treated to bouts of comedy from the emcees and more music.

Then behold, the prince in a maroon t-shirt, black shorts and green cardigan looped around his waist run his way into the grounds at exactly 11:10am.

His sneakers and legs spluttered with mud, Prince Wassajja acknowledged the deafening ululation by imitating sprinter Ussain Bolt’s trademark pointing celebration after winning a race. 

That drew even louder cheers.

Then the last runner, Vision Group’s CEO, Robert Kabushenga, showed up about 30 minutes after Wassajja, a bunch of yellow bananas in hand.

Like the bananas, the day’s events ripened with the katikkiro Mayiga urging participants to continue supporting women living with challenges of fistula.

He also reminded them to support Kabaka’s main birthday celebrations on April 13, to be held with students of Gombe Secondary School.

Although it was already a few minutes after midday, the events of the day seemed to have consumed the participants, cloaking them in dance, food and drink.

After all, the rain made the day both chilling and thrilling.