Russian government will support drug compounding

| By | Drug Compounding, Drug Manufacturing, Drug Registration

Russian government will give its backing to a drug compounding. Senators and experts discussed this matter in the press centre of “Parliamentary Gazette” – the official gazette established by Russia’s Federation Council.

Compounding or extemporaneous preparation is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.

“As many as 25 amendments have been already introduced to the Federal Law “On Circulation of Medicines” and the experts expect more,” said Maria Shkolnikova, the Director of Science at Yu. E. Veltishchev Research Clinical Institute of Pediatrics. “Above all, we need to address three issues. First, Russia allows to use the medicinal products that have not been registered in this country but, nevertheless, proved their efficacy in the countries of manufacture. Due to the lengthy logistics chains, we can ensure their supplies in a long-term but are unable to provide the required drugs on a short notice. We need to simplify this process, for example, through centralized procurement,” said the expert.

Secondly, the treatment of children involves the use of drugs that have been registered in Russia but did not yet pass the clinical trials in the pediatric sector. To prescribe such treatment, a doctor needs to convene the medical commission. Finally, today many effective medicines have no forms for children (for example, digoxin). “As a result, the doctors and parents are compelled to break these tablets into several parts in order to reduce the dose for children,” said Nikolai Volodin, the President of the Russian Association of Perinatal Medicine. “However, the effects of such treatment are not yet fully studied. Many problems could be resolved by creating the medicines in liquid form, as they are easier to measure out in doses.”

“Extemporaneous preparation will be supported by the government in one form or another,” said Tatiana Kusayko, a member of the Council of the Federation Committee on Social Policy.