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.