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A major milestone

In light of World Aids Day on Saturday, Thailand celebrates a noteworthy public health milestone as a locally produced antiretroviral drug has passed the World Health Organization's prequalification criteria

Efavirenz, Thailand's first drug to qualify for the World Health Organization's Prequalification (WHO PQ) programme. Tawatchai Kemgumnerd

There are approximately 440,000 Thai adults and children living with the human immunodeficiency virus or HIV, according to statistics from UNAids, equivalent to 0.6% of the entire population. Fortunately, over 70% of all HIV-infected cases have received antiretroviral drugs, which means a lot to their quality of life.

"Thailand's national HIV/Aids strategy is for patients to be given antiretroviral drugs as soon after the diagnosis as possible so that the viral load can be quickly suppressed, allowing patients to live a better life and at the same time lessening chances of virus transmission," said chairman of the board of the Government Pharmaceutical Organisation (GPO) Dr Sopon Mekthon.

Antiretroviral drugs or ARVs are standard medications for HIV/Aids infection. Although the drugs do not kill or cure the virus, they can prevent its proliferation. When the virus is slowed down, so is the disease, which means patients are less vulnerable to other HIV/Aids-related complications. The ARVs allow them to live on instead of dying.

It is, therefore, a celebratory milestone for Thailand when the GPO announced recently that its antiretroviral medication Efavirenz finally passed the World Health Organization's Prequalification (WHO PQ) programme. It is the country's first drug to have passed international-scale criteria and been included in the WHO's list of pre-qualified medications. The WHO Prequalifcation aims to ensure that diagnostics, medicines, vaccines and immunisation-related equipment and devices for high-burden diseases meet global standards for quality, safety and efficacy in order to optimise use of health resources and improve health outcomes.

Drug-manufacturing technologies from Germany have been deployed at the GPO's newly-opened plant in Thanyaburi district, Pathum Thani province. Photos: Tawatchai Kemgumnerd

According to Dr Sopon, the fact that Efavirenz has passed the WHO PQ threshold is one of the most significant chapters in the history of healthcare in Thailand. Not only is it a guarantee of quality for Thai patients, but it can create economic value for the country.

"When international health organisations such as the Global Fund [to Fight Aids, Tuberculosis and Malaria] or Unicef are looking for medications to be used in other countries, they would see if such medications and the factories where they are manufactured are WHO PQ certified. This is an opportunity to bring medicines from Thailand to an international level," added Dr Sopon.

Thailand took a baby step towards sending its medication to the WHO PQ programme in 2001 when the GPO vowed to get Efavirenz certified by 2019. Fast-forward to 2018, the ARV was pre-qualified by the WHO, one year earlier than anticipated.

"This is an important step we take in order to improve the lives of all Thais and to strengthen their confidence in the quality of locally-produced medication," said deputy managing director of the GPO, Mukdavan Prakobvaitayakit.

Kannikar Kijtiwatchakul, former access campaigner for Medecins Sans Frontieres (MSF) Thailand, said the country's HIV/Aids treatment has come a long way since MSF first set foot in Thailand in 1995. Back then, being diagnosed with HIV was synonymous with hopelessness.

"No one spoke about any cure or certain drugs that could help prevent opportunistic infectious symptoms. Back then, no one thought of ARVs," said Kannikar.

In those days, she added, MSF visited HIV/Aids patients across Thailand only to educate them that the virus was not transmitted as easily as people would imagine and that patients should never be stigmatised. Although later, renowned pharmacist Prof Krisana Kraisintu, former director of the Research and Development Institute under the GPO, introduced her locally-formulated antiretroviral drug to Thai people, questions loomed if the medication was up to standard.

To ensure that the medicine was safe to use, MSF sent a team of inspectors to look over a pilot plant located within the GPO's headquarters on Bangkok's Rama VI where the ARV was manufactured. Most of the findings were satisfying except the fact that the plant was situated in a metropolitan area.

"When MSF found that things were up to standard, they decided to purchase the first batch of ARVs from the GPO. The drugs were given to 44 HIV/Aids patients as part of their treatment/research project where they worked alongside district hospitals," recalled Kannikar, adding that MSF can be considered the GPO's first ARV buyer.

The WHO PQ-certified Efavirenz is no longer manufactured at the GPO's Rama VI plant but its production takes place at a newly-opened factory in Thanyaburi district of Pathum Thani province. For the ARV tablets to meet the WHO PQ criteria, the Thanyaburi plant had to be inspected by the WHO officers. The inspection was carried over four days by four inspectors, after which over 100 procedures were queried and adjusted.

Drug-manufacturing technologies from Germany have been deployed at the GPO's newly-opened plant in Thanyaburi district, Pathum Thani province. Photos: Tawatchai Kemgumnerd

"Flaws had been fixed. Over 2,000 pages of questions had been answered. In the end, we passed the WHO PQ in August this year," said Mukdavan, adding that the plant has received a technology transfer and know-how for Efavirenz production from the pharmaceutical company Mylan in India. Locally produced Efavirenz also underwent a bioequivalence study against its model antiretroviral drug Sustiva manufactured by American pharmaceutical firm Bristol-Myers Squibb to ensure that the medicinal properties within the two drugs are identical and that Efavirenz is as effective as its model medicine.

There is also another pilot plant located within the Thanyaburi factory where new drugs are manufactured on a trial phase. Certified by Thailand's Food and Drug Administration (FDA), this pilot plant deploys several technologies from Germany such as airlock access and will soon kick off its production of such medicines as the GPO's AntiOx (turmeric extract) and medicine for bird flu treatments.

The idea of creating sustainability in pharmaceutical manufacturing is a pivotal part of every country's healthcare development because the more drugs a country can produce, the less dependent it becomes towards other nations in terms of pharmaceutical imports. Kannikar believes that drug sustainability should be promoted.

"The ability to manufacture a generic drug is crucial for any country although this ideology is somehow still a subject of debate," said the former MSF officer.

"Especially on a global scale, people question whether it is easier to purchase medicines from India, the pharmacy of the world -- as long as you can afford it -- and then you don't have to bother producing your own. But the GPO is determined to create pharmaceutical manufacturing sustainability and the only way to achieve that is for Thailand to produce its own medicines because we never know what the future has in store for us. Right now, many more countries are thinking about drug sustainability after realising they cannot just rely on India all the time."

Thailand introduced Universal Health Coverage in 2002. And since 2005, ARV drugs have been covered by the healthcare scheme, which means HIV/Aids patients in Thailand are entitled to receive the medication for free. As of now, over 300,000 infected Thais are on ARVs covered by Universal Health Coverage, which means if the country produces its own ARVs, the healthcare burden will be lessened and, more importantly, patients' lives can be prolonged.

"Antiretroviral medication allows HIV patients to live their lives like normal people," said Kannikar. "And when that's the case, patients should no longer be branded by a social stigma because with ARVs they can study, work and live with us. They can be of great help in the society."

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