written on 12.08.2015

Interview: Kevin Moodaley – Head of Operations, Hetero Drugs South Africa

Kevin Moodaley - Hetero Drugs (2)The head of operations of Hetero South Africa talks about the need for a more efficient regulatory system with a fast track process for essential molecules, and how Hetero is playing a key role in tackling  HIV by supporting local players from an API and a technology transfer perspective.

Would you please introduce yourself and Hetero South Africa to our readers?

I began my career working at Aspen. In 2008 I was approached by Hetero to open up an office in South Africa, establishing a first presence in the country. The main focus at that time, because of the South African HIV pandemic, was for Hetero to assist in tackling this burden of disease and support the local players. Local players do not have formulation plants and R&D facilities to manufacture Active Pharmaceutical Ingredients (APIs), which is where Hetero can offer assistance. We support companies from an API and a technology transfer perspective, equipping them to manufacture locally. For me business is all about developing strategic relationships. I have a passion for pharmaceuticals and making a difference in people’s lives. When I opened the Hetero South Africa office, I was on my own but as the business grew, I employed pharmacists, marketing and logistics personnel, API specialists and regulatory scientists. Today, we have a formidable team to ensure smooth operations. Since 2008 we have had a 140 percent growth rate. ARV’s have been the cornerstone of our business, but we also focus on other niche molecules

Today Hetero has a product portfolio of over 200 products and is leader in specialized therapeutic areas including oncology and anti-retroviral drugs. Where are the growth spots for the company in South Africa?

We have a strong footprint in a number of niche areas including Biosimilars, and TB, being the first company in South Africa to launch the genericanti TB drug, Linezolid. From a Hetero perspective, and being a new player in Africa, we have achieved a lot in eight years. As a research driven pharmaceutical company, Hetero is committed to the development, manufacturing and marketing of APIs, intermediates and finished dosages and hence we have a growing footprint in many therapeutic classes. We continue our commitment and dedication to save millions of lives across the world with South Africa being one of the key focus areas.

As on today, about 4.5 million HIV/AIDS patients are on ARV formulations manufactured by Hetero nearly one third of total 11.5 million HIV/AIDS patients. Minister Motsoaledi was telling of us his vision of producing a generation of under 20s who are HIV-free. What role can Hetero play in tackling the high burden of disease in South Africa?

The main issue in South Africa is one of supply. The demand is increasing and Hetero can play a key role given our API and finished formulation capacities. We are one of the leading companies in terms of our large manufacturing capacities. The government, and our objective is to make the prices of medicines more affordable. We are a vertically integrated company, from our APIs to our finished formulations. Previously, we use to distribute single molecules but today we have a wide range of fixed dose combinations. We have a number of molecules in our pipeline. We are looking to reduce the number of pills required for treatments; instead of taking three pills a day for HIV, you will be able to take just one. We are continuously working towards broadening our fixed dose combinations portfolio to meet Minister Motsoaledi’s need for making more fixed dose combinations available to patients across the country.

Minister Motsoaledi was telling us how South Africa being the country which carries the biggest burden of HIV and AIDS, accounting for about 5.4 million out 33 million globally, must have the greatest expertise in dealing with such issues. Do you believe South Africa can become a regional hub of expertise in the area of HIV and AIDS?

I believe so, I believe we can do it. The challenges that the local manufacturers and multinationals have is in registering our products. The Medical Control Council is doing a good job, but we need a more efficient fast track process. If the focus of government is to reduce the mortality rate, you need to find a way to fast track essential molecules. Another issue, is that the local players have to import APIs. From an economical perspective, and from an exchange rate perspective, this presents a challenge. At Hetero, we never compromise on quality and we always strive to give our partners the the best price. We strive for supply and price sustainability but quality is our main priority.

Why do companies choose to partner with Hetero, what is it that makes you the partner of choice?

A large number of international company’s choose Hetero as a partner of choice, due to our high quality standards. Most of our facilities are USFDA and WHO Pre Qualified approved and being located in India, we are also cost efficient. We recently received an approval from Gilead to launch a generic for the treatment of Hepatitis C. Hetero is most certainly on the map and a force to be reckoned with. Globally we have a turnover of 1.2 billion dollars, as well as being a top 10 pharmaceutical company in India. In South Africa, the government is trying to close the gap in pricing between the private sector and the public sector. Hetero does contract manufacturing for local players, marked out of India, where the price is 50 percent less than it would be locally.

How important is collaboration for Hetero, with the government and with other key stakeholders?

Our role, going forward, is for Hetero to partner with stakeholders in both the private and public sectors. We are already collaborating with many players in the market. We are working with them from an API and contract manufacturing perspective. With all our hard work, we have been able to build the Hetero brand in South Africa. Going forward, collaboration is the key. We need to have a good relationship with the Department of Health, the government and all the other players in the market, helping to reduce the pandemics we have in the country, in particular in HIV/AIDS and TB. By continuing to bring our products and molecules to South Africa, and registering them with the MCC, in a country where there is a dire need for these type of molecules, we can make a real difference.

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