OREANDA-NEWS.  June 16, 2014. Investigating petitions of “Pharmasisntez” OJSC that the Ministry of Health Care refused to register medicines, FAS established discrepancy between the directions for use of original drugs registered in the Russian Federation and the same drugs circulating on the European market.

For instance, the Ministry of Health Care did not grant state registration of Olitid (Abacavir International Non-Proprietary Name), Regast (Efavirenz International Non-Proprietary Name) and Dizaverox (Zidovudine + Lamivudine International Non-Proprietary Name) based on the conclusions of the “Scientific Centre for Expert Examination of Medical Facilities” of the Ministry of Health Care. According to the conclusions of the Centre, in all cases refusals were substantiated that draft directions for use of the above drugs must be improved in accordance with the “up-to-date information” on clinical use experience. To FAS enquiries, the “Scientific Centre for Expert Examination of Medical Facilities” reported that “up-to-date information” means information received from official sources that are highly trustworthy, for example, the Internet resources of the European Medical Agency (ЕМА).

At the same time, the directions for use of Olitid, Regast and Dizaverox submitted by “Pharmasisntez” OJSC for registration matched the directions for use of the original drugs – Ziangen (Abacavir International Non-Proprietary Name), Stokrin (Efavirenz International Non-Proprietary Name) and Combivir (Zidovudine + Lamivudine International Non-Proprietary Name), registered in the Russian Federation.

Thus, the directions for use of the original drugs – Ziagen, Stokrin and Combivir registered and circulated in the Russian Federation do not match similar instructions approved by ЕМА. For instance,

- The directions for use of Ziagen lacked information, particularly, on by-side effects: hepatomegalia, fatty liver syndrome, opportunistic infections

- The directions for use of Stokrin lacked information, particularly, on by-side effects: lactose deficiency, lactose intolerance, glucose-galactose malabsorption

- The directions for use of Combivir lacked information, particularly, on by-side effects – hepatitis; and special directions for use lacked information on osteonecrosis, mitochondrial dysfunction.

As a result, on the one hand, generic drugs are not allowed to the market, the monopoly of economic entities producing original drugs is preserved; on the other – use of original drugs is not safe. Also, drugs circulating on the market have the same International Non-Proprietary Name, the same form of presentation, dosage, route of administration but with different directions for use.

Since the exposed inconsistencies can decrease safety of drug use, FAS forwarded information to the Federal Service for Supervision of Public Health and Social Development upon a fact of comparing Ziagen, Storkin and Combivir, the directions for medical use of which contain incomplete and incorrect information. At the same time, to prevent violations of competition among comparative drugs and generic drugs, FAS submitted its proposals to the Ministry of Health Care.

The Ministry informed producers of drugs containing as active ingredients Abacavir, Zidovudine + Lamivudine and Efavirenz that changes should be made to the directions for use of registered drugs.

It follows from the letter of the Ministry of Health Care that due to statements (from producers of drugs containing as active ingredients Abacavir, Zidovudine + Lamivudine and Efavirenz) on making changes to the documents in the registration dossier for registered drugs, expert examinations are being carried out at the Centre upon instructions from the Ministry in accordance with the established procedures.

“We expect that upon investigating those cases, the Ministry of Health Care is intensifying the efforts on adjusting directions for use of drugs with the same active ingredient, the same form of presentation and dosage, the same content, moreover that the relevant amendments to the Law on drug circulation, facilitating this efforts are coordinated in a large package of amendments and are submitted to the Government of the Russian Federation”, pointed out the Head of FAS Department for Control over Social Sphere and Trade, Timophei Nizhegorodtsev.