Drug production in pharmacies is under threat of extinction

If the new order on the rules of pharmacy manufacturing comes into force, the entire industry will collapse

Back in autumn, everyone rejoiced at the adoption of a new law on the revival of industrial pharmacies, which are so needed by patients with rare diseases, those who need a non-standard dosage of pharmaceuticals, children, as well as patients for whom it is unprofitable to produce medicines for large companies today. In addition, industrial pharmacies also fulfill orders from large hospitals – for example, they provide them with water for injections, infusion solutions, and more.

However, just the other day, the Ministry of Justice registered a draft new order on the rules of pharmacy manufacturing, which should come into force on September 1. Industry experts say that this document will immediately bury the entire pharmacy industry.

In recent years, industrial pharmacies in Russia survived with great difficulty. There are about 450 of them left for the whole country – these are expert estimates, no one counted for sure. And it seems that they decided to revive them. The project for a full-scale revival of industrial pharmacies involved the development of a whole package of documents to regulate their activities. After the adoption of the law, a working group was created, where pharmacists sent their proposals. But in the end, an order “On Approval of the Rules for the Manufacture and Dispensing of Medicinal Products for Medical Use by Pharmacy Organizations Licensed for Pharmaceutical Activities” appeared, which, as experts are sure, will lead to the fact that the remaining individual pharmacies will simply close.

The new document did not cancel outdated requirements, retaining the approaches to pharmaceutical manufacturing from 1968; did not introduce modern ones. As experts say, work with him will not only become more difficult – it will become completely impossible. The development of a high-tech pharmacy infrastructure that meets the modern requirements of the pharmaceutical industry should be completely forgotten.

SRO Association of Independent Pharmacies on behalf of the Alliance of Pharmaceutical Associations (unites pharmacies from Sakhalin to Kaliningrad) sent an official letter to the State Duma of the Russian Federation, which lists the main “blunders” of the order (the absence of the necessary punctuation marks in a number of places does not count, although this also indicates the quality document). The pharmacy community indicates that all the proposals that the professionals formed were ignored.

For example, as the head of the Alliance of Pharmaceutical Associations, director of the SRO of the Association of Independent Pharmacies Viktoria Presnyakova says, some paragraphs of the order contain restrictions with direct indications of a specific manufacturing technology or the need to use specific equipment, which do not correspond to modern methods of pharmaceutical manufacturing of medicines. “Most of the provisions of the document do not allow the introduction of automation processes. The draft order does not allow pharmacy organizations to independently develop technologies and methods of quality control, conduct research and tests based on stability studies. A direct ban on the manufacture of medicines from sterile registered medicines has been introduced. on the packaging of registered concentrated solutions, which is widely used in the manufacture, as well as in the implementation of dilution (recovery) of drugs.There are no requirements for labeling containers in which pharmaceutical substances, excipients and other raw materials are stored, and the system as a whole In addition, in different parts of the document, different terms and definitions are used, the concepts of which are not established either in the text of the order itself or in the law in general, “says Presnyakova.

But the main stumbling block is that the document establishes the requirements for continuous quality control (which are higher than for pharmaceutical manufacturers of finished forms), which will not make it possible to achieve economic profitability of pharmacy production. As Elena Gladkova, general director of the pharmacy chain, which has a production pharmacy, told MK, now production pharmacies simply will not have the opportunity to manufacture injectable dosage forms: “This will lead to further closure of hospital production pharmacies that had the opportunity to prepare these forms. These drugs are in high demand, are much cheaper than factory-made ones and can be supplied to hospital departments in case of urgent need.For example, this is saline, glucose, water for injection.Some of the drugs are not produced by factories at all or are not produced in the dosages and quantities that are required.Sometimes with them there is a severe defect – and then industrial pharmacies close this niche. For example, it is unprofitable to transport saline, water for injections from the Far East, where it is industrially produced, so these dosage forms have always been manufactured by industrial pharmacies. 10 days, and the deadline for their storage, according to the new order – 2 days. If we are preparing an injection solution today, the department will receive it tomorrow morning, and by night it will be considered expired, in many cases it will simply be impossible to use it in time. The people who write these documents don’t even get to the heart of the matter!”

“From September 1, we will face the fact that industrial pharmacies will not be able to work within the legal framework. This means that another part of the pharmacies will close (suspend their activities), which will negatively affect the drug supply of the population, especially babies. Today we are constantly in touch with industrial pharmacies from Sakhalin to Kaliningrad, colleagues ask the same question: “How are we going to work further and why was all this necessary?” It was necessary to systematize the work, structure it and make it easier and more convenient, but it turned out exactly the opposite,” notes Victoria Presnyakova.

…Meanwhile, a group of State Duma deputies have already sent a response to the draft new order, which, in their opinion, “will not contribute to the revival of pharmacy production.”