- You automatized the manufacturing process and even use robots for individual operations. Is there a risk they will replace people?
- This is a question from the area of futuristics and projections. But today, a completely automatic warehouse complex is in operation; at the time it was opened in 2008, it was the first project on this scale in Eastern Europe.
It consists of 12 levels for 10,000 pallets. All the operations in the product storage area is performed by robots.
The warehouse is operated almost without human involvement, controlled by a computer system, and is connected to the other areas by conveyor and elevator network. This organism has a "memory" and knows everything about each unit of raw materials, materials, or finish products: from the composition and quantity to the production site and expire date. - Pharma is dominating in terms of investment intensity: 19 kopiika of capital investment falls per every hryvnia of value added costs in this industry. How much do you invest in? What exactly do you spend money on?
- We invest in R&D (research and development works —
ed.) and CAPEX (capital investment) about 10 % of the income. This is a standard for the industry.
Over the past 10 years, the Zagorys (owners of the Darnitsa company —
ed.) has invested more than 200 million euros in the manufacturability of the entire manufacture and compliance with GMP requirements.
It's not only about modernization. We have automatized both standard business processes and sales planning, logistics and production operations starting from planning the requirements for raw materials. Today we are in the phase of creating a digital company: we are digitalizing the document flow and lifecycle of the medicines.
When it comes to the large investments, installation of a modern infusion production line worth more than half a billion hryvnia can be attributed to the large projects, in addition to the automatic warehouse.
- How long is the payback period for such equipment?
- This process is still going on. In general, the payback period is about 7 years. - What exactly do your investments in R&D involve?
- An important area is clinical trials, confirmation of bioequivalence.
Generics are authorized copies of original medicines. Such medicines have a "complete profile" with proven efficacy, safety and quality. In addition, they are much cheaper than the originals.
The generic must satisfy certain criteria, and its effectiveness should be equivalent to the original medicines. For this purpose, clinical trials of bioequivalence are conducted. Historically, few to no clinical trials were conducted in Ukraine.
Today, Darnitsa is the leader of the Ukrainian market (both among national and international companies working here) in terms of the number of clinical trials of bioequivalence. This year alone, we have obtained certificates for six medicines. - How was bioequivalence confirmed earlier? Why weren't bioequivalence investigations conducted?
- It is enough for an international company to merely provide confirmation that clinical trials of bioequivalence were conducted whatsoever, and such documents are valid in Ukraine. At the same time, it is difficult to verify the validity of these trials; also, how and in what conditions they were conducted are questionable.
The issue is typical not only for our country. In 2015, a big scandal unfolded due to such practise: one of the Indian companies was providing false documents for their medicines sold on the EU market. The European Medicines Agency (EMA) banned 700 Indian medicines considered as substandard
, as a result of the inspection.
By the way, a very interesting book has recently been published, Bottle of Lies by the American investigative journalist Katherine Eban, in which the quality of Indian pharmaceutical products is contemplated. I recommend reading it. Many interesting things about Ukraine are said there.