By Umesh K, Vice President and Business Unit Head, Global Anti-Virals, Aurobindo Pharma.
Aurobindo Pharma, which was earlier a well-known bulk drugs manufacturer, forayed into the antiretroviral (ARV) formulation segment in the year 2002 with an aim to make the HIV medication affordable and accessible to global markets. It was during this time that the US government launched the PEPFAR program and Aurobindo pharma rendered support to the program since its inception by filing HIV drugs through the US Food and Drug Administration (USFDA) PEPFAR route for tentative approval to supply to low- and middle-income countries (LMIC) which were supported by PEPFAR. Through the PEPFAR program, Aurobindo could reach out to people living with HIV (PLHIV) and could deliver the drugs at more affordable prices. Aurobindo got excellent support from USFDA through their mentoring which helped in fine tuning the Good Manufacturing Practice (GMP) of our facilities to meet the quality requirements.
Further, we have scaled up the production with the aims to achieve the goals of wider access to HIV treatment, care and support, halting the spread of HIV and contributing to ending AIDS by 2030, as per the Sustainable Development Goals (SDGs).
To ensure that treatment is available in developing countries, Aurobindo Pharma ensured the expansion of its global footprint in providing quality medicines at affordable prices. With continuous quality improvement efforts and integrated API manufacturing facilities, we reduced the cost of treatment through constant optimization of manufacturing processes of both active pharmaceutical ingredients (APIs) and finished dosage forms (FDF). Aurobindo has vast experience and knowledge in chemical R&D and FDF in both adult and pediatric antiretrovirals product development due to the highly qualified and dedicated- scientists working with us.
Through our constant endeavors, we have been able to continuously develop several new molecules through licensing from the innovators and deliver the most advanced treatment available to patients in LMICs. The Medicines Patent Pool’s contribution in the licensing of cutting edge products to global generic companies is significant and praiseworthy and we were the first manufacturer to take a license from the MPP in 2011. Today, we have licences on 8 ARVs and one hepatitis C medicine from the MPP in addition to an MOU on dolutegravir.
This tremendous increase in Aurobindo’s contribution over the years is the result of an active work to acclimatize and improve patient reach in many countries, as well as incorporating feedback from many different stakeholders.
In the next few years, the number of people on treatment is expected to grow to 30 million, which is a big challenge to the entire HIV care community. The new regimens, including for first line, namely dolutegravir-based combinations while giving the boon of latest newer drugs to the needy patients, also pose a major challenge in terms of scaling up and uptake in countries as well as supply chain issues.
Aurobindo was the first generic company to develop dolutegravir and has also developed the combination with tenofovir and lamivudine (“TLD”) and launched the USDFDA approved product in LMICs. Today, Aurobindo has scaled up its capacities significantly and is able to supply treatment for 3-4 million patients globally.
Over the years, Aurobindo has actively worked to adapt and improve our reach out initiatives, incorporating feedback from many different stakeholders, and we continue to closely monitor our efforts with the motto of being committed to healthier life and of reaching as many patients as possible, still there are miles to go!
BECAUSE WE BELIEVE
No child should be born with HIV
No child should be an orphan because of HIV
No one should die due to lack of access to treatment!
Aurobindo Pharma is a global leading generic company and among the largest ‘Vertically Integrated’ pharmaceutical companies in India. Aurobindo has robust product portfolio spread over major product areas encompassing CVS, CNS, Anti-Retroviral, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic with approved manufacturing facilities by US Food and Drug Administration (USFDA), the UK Medicines and Healthcare Products Regulatory Agency (UKMHPRA), the World Health Organization (WHO), the Medicines Control Council in South Africa (MCC) and the National Sanitary Surveillance Agency (ANVISA)-Brazil for both Active Pharmaceutical Ingredients (APIs) & Formulations.