Opened in Nor Gyugh community of Kotayk region on October 26, the FDA Lab complex, a medicine supplier and retailer in the Armenian market, operates within the system of Tonus-Les LLC. The founder and president of the company, Levon Hakobyan, tells about the details of the FDA Lab project in an interview with ArmInfo.

Mr.Hakobyan, how the idea of creation of the FDA Lab originated?

The idea originated 3 years ago. It stemmed from the demand, and the construction was launched in September 2010. The thing is that Armenia lacks internationally certified laboratories that can carry out a serious examination of medicaments and food commodities. This means that the documents on test results, issued in Armenia, cannot be recognized abroad. So, the laboratories issuing these documents should undergo the specified certification.

What products can FDA Lab test?

At present the laboratory is ready to test water, tobacco, dairy and other foodstuffs to reveal high-density metals, antibiotic substances, harmful microorganisms, etc. We also conduct the whole spectrum of medicine and clinical testing for bioequivalence of medicaments.

What are the peculiarities of the complex?

When building FDA Lab, Tonus-Les thoroughly thought over the designing, acquisition of equipment, personnel training, and introduction of performance standards. It is a labor-intensive and science-intensive work which requires essential financial costs. We have intentionally chosen the construction site outside Yerevan: the laboratory is built in Nor Gyugh community of Kotayk region, in an environmentally pristine area at the foot of Hatis Mountain. The area of the land plot, whereon the laboratory and the clinic are built, is 3,600 sq m. The laboratory occupies a 5-storey building, with the foundation area being 420 sq m. The storage premises are on the ground floor, the sample receiving room is on the first floor. There is also a security infrastructure, a reception room, a conference hall, a coffee corner and an interior garden. The FDA Lab laboratories for medicine testing and food safety testing, as well as a microbiological laboratory for testing of both medicaments and food products, will occupy three floors of the building.

What are the advantages of FDA Lab?

FDA Lab has nothing uncertified, even the furniture and equipment are certified. 5 types of gases (acetylene, oxygen, argon, helium, and nitrogen) to be applied on the testing facilities are also certified. We tried to acquire these gases in Armenia, but they proved to be uncertified in the country. None of the importers of these gases was able to prove their purity. The gas cylinders, corrosion-resistant pipes and the pipeline, through which the gas will enter the equipment, are also to be certified. They must be solid-drawn. Such pipes are not produced in the post-Soviet area, and we had to acquire them in Austria, and we imported the gases and the connecting fitting of the pipes from other European countries. It was impossible to build such a laboratory by means of reconstruction, modernization or re-equipment; it was necessary to do everything from the very beginning.

We have a doctor of science, 5-6 candidates of science, the personnel has a big experience, and relevant work is being done to retrain the specialists. The imported equipment is installed by the manufacturers’ specialists. The peculiarity of the lab is that the whole testing process is automated and fixed in the computers’ memories, and this makes any fraud impossible and completely rules out the human factor.

The food laboratory also has a lab for tobacco testing. The international standards of these tests demand bringing the cigarettes to the fixed level of humidity by means of special devices. Special equipment equally burns the cigarettes to test the composition of the cigarette smoke. It should be noted that Armenia lacks independent labs to test the compliance of the imported and locally produced cigarettes with international standards. The locally manufactured labs are unable to conduct such testing, as they are concerned parties to the cigarette import.

Why have you chosen FDA Lab as a name? FDA is the contracted name of the US Food and Drug Administration, isn’t it?

The name of our laboratory stands for Food and Drug Analysis Laboratory. Tonus-Les patented this name and the relevant trademark, hoping to make this name more recognizable abroad. In addition, FDA Lab sounds short and clear and embraces the spheres, wherein the laboratory operates.

What goals will the clinic within the complex have?

I’d clarify that the laboratory of medicaments will also test the medicine bioequivalence. Creation of new medicine formulae requires immense investments, and it is a rather long process. Within 20-25 years after patenting the medicaments, the manufacturers make a return on investment, and after the patent expires the medicaments become generic drugs (generic products are available once the patent protections afforded to the original developer have expired). And to receive the right to produce generic drugs, a company should confirm by means of testing that the drugs are completely comparable to the brand drug product in its parameters.

During the testing, a group of volunteers takes the brand drug, and the other group takes the future generic drugs. Later the results of the long-term laboratory analyses are compared, and if the data of both groups coincide, a conclusion on the generic drug bioequivalence is issued. The conclusion is to contain the passport data of the volunteers, their insurance policies, time and order of intake of the brand and generic drugs, as well as the indices after the intake. Only after this procedure the producer has the right to apply for registration of the generic drug in some country.

Certainly, the volunteers should stay at the clinic for some time, and the clinic should meet the standards of the Good Clinic Practice, and the laboratory, where the medicine impact analyses are made, should meet the standards of the Good Laboratory Practice. Armenian producers are still conducting the clinical testing at general clinics, which do not meet the standards of the Good Clinic Practice. The FDA Lab clinic is protected against the infections and other impacts that are possible in other clinics. In addition, our clinic has a SPA center, a refectory, germproof rooms, intensive care unit, rooms for tests, systems of ventilation and surveillance.

What do you expect from implementation of the FDA Lab project?

We'd like the project to be assessed properly. This project cannot be called a business plan, because the return on investment will take much time, and the risks are great. So, FDA Lab is the result of performing a civil mission rather than a business plan. One should mind that FDA Lab will deal with national security in turnover of food commodities. To note, our project required investments worth more than 3 mln USD, with over 2 mln USD of them being loans borrowed from a resident bank. Some part of the equipment was acquired on lease.

In 2011 the Armenian Government's decree provided us with a three-year delay in VAT payment for the imported equipment. By this step the Government acknowledged the importance of the FDA Lab project. For the local producers FDA Lab is an access to the foreign market, because after the food laboratory is certified to meet the ISO 17025 standard, its conclusions will be recognized in the foreign markets. The food producers should mind that their products' compliance with international standards is composed of many factors. For instance, in case of fish products, the following is taken into account: quality of the water bodies, where the fish are bred, fish food, substances for fish processing, and the quality of the end fish product.

When can the FDA Lab receive an ISO/IEC 17025 certificate?

Relevant work is currently being done to introduce this standard. We hope that the PCB program (Germany) will help us. It supports the companies wishing to undergo certification by accredited European companies. We hope to receive the certificate for FDA Lab by late 2013. To certify FDA Lab as complying with ISO/IEC 17025:2005 (the general requirements for the competence to carry out tests and/or calibrations, including sampling), a foreign company will be invited, as there are no competent companies in Armenia to certify FDA Lab.

President of Tonus-Les LLC: FDA Lab to deal with national security in turnover of foodstuffs

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