If the new order on pharmacy manufacturing rules comes into force, the entire industry will collapse
Back in the fall, everyone rejoiced at the adoption of a new law on the revival of manufacturing pharmacies, which are so necessary for patients with rare diseases, so 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 injection, 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 in the whole country – These are expert estimates, no one has 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 appeared «On the approval of the rules for the manufacture and distribution of medicines for medical use by pharmacy organizations licensed for pharmaceutical activities», which, as experts are sure, will lead to the fact that the remaining single pharmacies will simply close.
< p>The new document did not cancel outdated requirements, retaining the approaches to pharmaceutical manufacturing from 1968; did not introduce modern ones.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 be 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» order (the absence of the necessary punctuation marks in a number of places does not count, although this also indicates the quality of the 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, the 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 for quality control, conduct research and tests based on stability studies. A direct ban on the manufacture of medicines from sterile registered medicines has been established. A ban is also introduced on the packaging of registered concentrated solutions, which is widespread 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 for storing medicines is not generally described. In addition, different parts of the document use different terms and definitions, 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 allow to achieve the economic profitability of pharmacy manufacturing. As told "MK" Elena Gladkova, general director of a pharmacy chain that has a production pharmacy, now industrial pharmacies simply will not have the opportunity to manufacture injectable dosage forms: “This will lead to further closure of hospital industrial pharmacies that were able to prepare these forms. These drugs are in high demand, they are much cheaper than factory-made ones and can be supplied to hospital departments in case of urgent need. For example, it 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 injection from the Far East, where it is industrially produced, so these dosage forms have always been manufactured by industrial pharmacies. An analysis for apyrogenicity (absence of microorganisms) of injection solutions is done up to 10 days, and the deadlines 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 draw up such documents do not even delve into the essence of the issue!"
"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 provision of medicines to the population, especially children. 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,» Victoria Presnyakova notes.
…Meanwhile a group of State Duma deputies have already sent a review to the draft new order, which, in their opinion, «will not contribute to the revival of pharmacy production.»