3 years later *** turn OTC gates open again

Business News Agency March 4th News Stagnation Nearly three years later, the door to over-the-counter drugs (OTCs) has finally opened again.

The State Food and Drug Administration issued a report on February 25. According to the requirements of the relevant regulations, the State Food and Drug Administration confirmed that in the summer, 54 drugs, including no tablets, were officially converted into non-prescription drugs.

The transfer of prescription drugs to OTCs was suspended from 2008 to 2010 due to changes in the OTC management business of the subcommittee of the Food and Drug Administration and disputes over “double-span” varieties. With the re-opening of the conversion gate, an OTC "feast" again came quietly. However, the problems of conversion standards, or "scale", and the "double-span" problem that has been temporarily suspended are still an obstacle to be surpassed in the use of safe drugs.

Release potential needs

The manufacturers of nine chemicals, 44 proprietary Chinese medicines, and one biological product jointly became the first beneficiaries after the reopening of the OTC gate for prescription drugs.

According to the "Administrative Measures for the Classification of Prescription Drugs and Non-prescription Drugs (Trial)", prescription drugs must be prescribed, purchased, and used only with the prescription of a practicing physician or a licensed assistant doctor. However, once switched to OTC, consumers no longer need to dispense prescriptions, which will undoubtedly release potential demand.

In addition, the above-mentioned 54 kinds of medicines will be able to be advertised in the mass media after being transformed into OTC.

In fact, in recent years, the “double-span” variety has increased year after year, which has always hidden a new mode of business promotion. It will soon be used clinically for many years, and the prescription drugs that are suitable for promotion in the OTC channel will be transformed into “double-span” varieties, and the old varieties will be reappeared through the effective combination of advertising and promotion methods.

“There may be another spring after there are no successful bidders or prescription drugs that have not entered the list of base drugs,” said the sales director of a large pharmaceutical group in North China.

In addition, because of the non-prescription drug pricing power in the provincial price department, the existence of local protectionism, this operation space is undoubtedly good for some local pharmaceutical companies.

Potential risks remain

It is understood that the OTC procedures for prescription drugs are mainly applied by enterprises and the Food and Drug Administration gives approval. An important consideration in the approval and non-approval is whether it can provide adequate drug safety data and materials.

However, it should be noted that the change of prescription drugs to OTC not only means that the promotion model including advertising behavior will change, but the consumer groups will also change. Therefore, it is not only the drug manufacturer's commercial behavior but also the issue of medication safety.

An old expert who is engaged in pharmacopoeia research in Beijing told the reporter that this summer's non-tablet was converted to OTC as an example. The main component of the drug was tuber in summer with a small amount of alkaloids such as tetrahydropalmatine and other alkaloids. Can be used for basal ganglia to produce "ankylosing syncope" phenomenon. The drug was also applied for conversion to OTC several years ago. However, the application has not been approved because of the small amount of toxicity of the drug.

“Toxic issues should be considered first. In addition, after the conversion to OTC, the drug instruction manual should also be revised accordingly. Dosage, treatment, and adverse reactions should be clearly stated,” said the expert.

Shenzhen Science and Technology Chief Scientist Lu Xianping also said that if a drug is to be converted from prescription drugs to OTC, then the safety of this drug should have a very long-term accumulation of data, prove that in the OTC sales model, not There will be safety issues arising from overuse, improper use, and human differences.

Whether the "double span" cancellation is still undecided

The president of the Chinese Non-prescription Medicine Association Bai Huiliang told reporters that the reason why the transition from prescription to non-OTC work was suspended for a period of time was mainly due to the problem of “double-span” drugs (both prescription drugs and OTC). Double-span 'varieties, the current competent authority is studying whether to cancel the 'double span'."

In fact, most domestic drug manufacturers and multinational drug manufacturers in China are reluctant to "double-span." For domestic drug manufacturers, the existence of "double-span" varieties will help them extend the life cycle of prescription drugs and increase revenue. The multinational companies are prescription drugs because they were approved in the early days. Therefore, they also hope to promote some OTC prescription drugs to better layout the Chinese retail market.

According to Professor Zhou Chaofan of China Academy of Chinese Medical Sciences, under the joint promotion of domestic and foreign pharmaceutical manufacturers, as of 2010, China has had more than 2,000 "double-span" drugs. Due to the huge number, if you cancel it, you must also consider the pressure of medical insurance. This is not an easy task.

“The “double-span” variety can be considered as Chinese characteristics, and developed countries in Europe and America are very clear when dealing with the boundaries between OTC and prescription drugs. “Double span” was originally set up, mainly considering that it is convenient for the masses to do self-medication and relieve The people are having difficulty seeing the doctor and expensive medical services. The competent authorities have thus consciously expanded the number of double-cross varieties,” said Zhou Chaofan.

An expert who studies the FDA's drug regulatory system said: "In the strict sense, many drugs, especially preclinical evaluations of Chinese medicines, are inadequate. In the course of clinical research, there will be some kind of objective assessment of safety. Therefore, regardless of the change from 'single-span' varieties to 'double-span' varieties, OTC should be used for prescription drugs, and objective and pre-clinical and clinical safety assessments should be made, and then based on long-term safety data after listing, To decide whether it is suitable for conversion."