How Has The Pharmaceutical Industry Reacted To The Changes In Labeling Rules?

How Has The Pharmaceutical Industry Reacted To The Changes In Labeling Rules?
How Has The Pharmaceutical Industry Reacted To The Changes In Labeling Rules?

Video: How Has The Pharmaceutical Industry Reacted To The Changes In Labeling Rules?

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Video: U.S. FDA Drug Labeling Requirements 2023, February
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Last week, the editorial staff of Business FM broadly covered several times the problem of drug shortages in Russian pharmacies. It is primarily associated with failures in the digital marking system.

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On October 23, we asked a question about this to Dmitry Peskov. A presidential spokesman referred him to the government, saying the Kremlin had no information on the details. On the same day, State Duma deputies from the Liberal Democratic Party asked Deputy Prime Minister Tatyana Golikova to introduce a moratorium on mandatory labeling.

On Saturday, the Ministry of Industry and Trade responded. The head of the department, Denis Manturov, said that the system would be switched to notification mode. What it means: now both manufacturers and distributors and pharmacists are required to enter data on each package into the Honest Mark system and wait for a response from it. But due to problems with answers, I had to wait several days, the data was lost, the system hung. Without registration in the system, it is impossible to ship batches of drugs and sell them in pharmacies, for violation - fines and loss of license. Now there is no need to wait for an answer from "Honest Sign" - you just need to notify.

Will the decision of the Ministry of Industry and Trade help, comments Viktor Dmitriev, General Director of the Association of Pharmaceutical Manufacturers.

Viktor Dmitriev General Director of the Association of Pharmaceutical Manufacturers “Goal-setting is lost, because when this whole system was started, it had to prevent counterfeit drugs from getting into circulation. If there is no such exchange of information with the operator, the goal cannot be achieved. We have to make sure that the operator is able to make the system work. Until we saw it. As they say, in this case I mean the operator, the system now contains no more than 10% of labeled drugs, and it has already collapsed."

The pharmacists were divided. Representatives of large networks maintain a notification order. But they propose to introduce it for a year, so that during this time the operator, the Center for the Development of Advanced Technologies, has time to debug the system. Small market participants support the State Duma's proposal to introduce a moratorium. Their arguments: firstly, failures lead to the fact that it is impossible not only to wait for an answer, but in principle to enter data into the system. This means that the drugs will not go on sale anyway. Secondly, the decree on digital marking is not canceled or frozen.

And although the authorities have promised not to fine the pharmacists, no one knows how they will proceed. The manager of pharmacy 254 Simplex, Alexander Vandyshev, comments.

Alexander Vandyshev Manager of the 254 Simplex pharmacy “In fact, the government's decree is in effect today, according to which the circulation of medicines without the Honest Mark is illegal, it is in effect, no one has canceled it, and, judging by Manturov's statement, it is not going to be canceled. Therefore, if in Moscow we will not be fined immediately, perhaps heavily, then regional officials will invent and do whatever they want. I have no doubts. So it was and so it will be."

The Ministry of Industry and Trade announced that they are changing the principle of operation of "Honest Sign", given the "peak of increased demand." The hype has indeed contributed to the drug shortage. But this is the demand for antibiotics, for antipyretics, for those drugs that doctors prescribe to patients with coronavirus. The problem is that other drugs that have nothing to do with COVID-19 have disappeared from pharmacies. This is what the therapist Lyudmila Lapa says.

Lyudmila Lapa therapist “An elderly woman, we cannot take her temperature away with anything.If we had the same "Metipred", we would have solved this issue very quickly. He was diagnosed and all over the place, but we have not been able to remove the temperature of 39.9 for a week. The same cannot be. There are no hormones, for example. This is generally a disaster. It is also a vital medicine for many, especially for autoimmune patients with rheumatoid arthritis. And they are simply not on sale”.

Another touch that we found in a letter from Kaliningrad. Roszdravnadzor (for some reason, not a local branch, but Nizhny Novgorod) decided that one of the pharmacies was breaking the law by selling drugs over the Internet without permission. But the site in question is, in fact, an aggregator, it only allows you to book drugs so that they can be delivered to the desired pharmacy. And in conditions of shortage, when in search of medicines you have to go around the whole city, this is a way out. Igor Kastusik, the owner of the Kaliningrad pharmacy chain “More than less”.

Igor Kastusik is the owner of the Kaliningrad pharmacy chain “More than less” “The buyer went there and bought the medicine he had booked in one pharmacy. He didn’t have to travel around town looking for a cure. Moreover, you know that there is a deficit now. In one pharmacy one medicine, in another - another. Thus, the buyer went to one pharmacy, bought the medicine and did not infect others, driving around in transport, by taxi, visiting different pharmacies."

There is another problem, which, in addition to labeling and rush demand, also led to a shortage. These are the prices for vital drugs, which are regulated by the state. Manufacturers stop supplying such drugs because the cost is sometimes higher than the prices dictated by the authorities. As a result, drugs, primarily inexpensive, disappear from pharmacies.

True, the FAS and the Ministry of Health and Business have heard and are now developing a document that will allow indexing prices for unprofitable, but vital drugs. The project, as recently reported by anti-monopoly officials, is in the process of being finalized and approved. We'll have to wait for the civil servants to finalize, agree and accept. Whether the new rules of the labeling system will work effectively will be shown in the coming weeks. Goal: to create conditions for billions of packages to pass through the "Honest Sign" without interruptions. Reality: as they say on the market, 10% of the labeled drugs were introduced into the system - and it did not survive.

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