The World Health Organization (WHO) has certified the Government Pharmaceutical Organization's (GPO) facility in Pathum Thani under the WHO Prequalification Programme (WHO PQ) for manufacturing the antiretroviral drug Efavirenz.
GPO director Mingkwan Suphanpong said certification of the facility, the first in Thailand and the Asean region to have received WHO PQ certification, means Efavirenz tablets manufactured by the GPO remain on the WHO Prequalified List.
In 2018, the WHO approved GPO's request to register the drug on its list after the GPO submitted an application in 2016.
Efavirenz is prescribed to all HIV-infected people when they are diagnosed with the virus and it is often prescribed in combination with tenofovir/emtricitabine in adults, adolescents and children.
Efavirenz is also used in combination with other antiretroviral agents as part of an expanded post-exposure prophylaxis regimen to reduce the risk of HIV infection in people exposed to a significant risk.
Dr Mingkwan said the certification reflects GPO's commitment to quality and safety, ensuring Thais have access to medicines that are as effective as the original version. The drug also can be registered in other countries, enhancing export opportunities.
Dr Mingkwan said certification follows a third inspection conducted on Aug 12–16 last year as part of the WHO PQ to ensure compliance with WHO requirements.
The inspection covered manufacturing process, production support systems, laboratory, and quality management among others. It is valid for three years.
Dr Mingkwan said GPO's research, development, and production of Efavirenz serve as a key example of its success in producing generic drugs, especially essential medicines, which are crucial for the healthcare system.
Generic drugs provide Thais with access to effective treatments comparable to original drugs at lower costs and they have also earned GPO international credibility, she said.
The GPO must continue with research and development of generic drugs so that, once original drug patents expire, patients can immediately benefit from affordable alternatives, she said.
The GPO's recent success also helps affirm the possibility for HIV patients to live a normal life as non-HIV individuals.
WHO's policy on the role of HIV viral suppression says people living with HIV who have an undetectable viral load, using any WHO-prequalified combination of medications and testing platforms, pose zero threat in transmitting HIV to others.
Mingkwan: Attests to quality, safety
Jarunee Siriphan, director of the Foundation for Action on Inclusion Rights (Fair) and founder of the People's Movement to Eliminate Discrimination (MovED) said undetectable means untransmittable.
She cited the undetectable equals untransmittable (U=U) campaign, a public health intervention to tackle HIV that benefits from advances in public health science to ensure a healthy life for people living with HIV (PLHIV).
"U=U is an important tool to empower PLHIV to unlock themselves from being internalised as tarnished and sinful.
"It helps them to see they could pursue their dream and live their life with their full potential because aside from being healthy, they would no longer transmit the virus," she added.
Ms Jarunee said the U=U approach is important for PLHIV, especially when it comes to employment because they are allowed to describe themselves as healthy and impossible to infect others.
"While WHO has made it clear, the Public Health Ministry must come and certify the U=U approach, and integrate the concept in the public sector, some elements of which have refused to employ PLHIVs based on their blood status," she added.
However, she said employers must not exploit this approach by demanding PLHIV candidates show proof of their virus suppression during recruitment, as that would violate people's rights.
"Regardless of suppression level, employers have no right to exclude them from employment. The state must be a role model for every employer and everyone in society in tackling discrimination against PLHIVs," she added.
Jarunee: Hails U=U campaign
