What is the business scope of medical herbal therapy preparations

From the perspective of the current domestic drug supervision and market supervision rules and the compliance boundaries of actual operations, the business scope of legal medical herbal therapy preparations core covers the following directions: herbal preparations with registered mechanical brands, herbal preparations prepared in-hospital by regular medical institutions, and non-medicinal external disinfection herbal preparations, which can basically meet the routine business needs of ordinary physical therapy centers, traditional Chinese medicine clinics, and pharmaceutical retail stores.

When I helped a community TCM clinic I knew well to add qualifications two years ago, I checked with the staff at the city supervisory window. Products that are registered as medical devices, such as mugwort warm moxibustion patches, herbal cold compress gels, and herbal medicated bath packs that are most commonly seen every day, are the most common categories that can be operated. As long as the supplier can provide complete registration certificates and quality inspection reports, they can be sold normally without applying for additional special qualifications.

However, there is also a controversial boundary in the industry now, that is, whether herbal ointments and substitute teas of food brands can be included in this business scope. Regulatory authorities in some places believe that such products are ordinary foods and cannot be promoted as "medical", nor can they be included in this category. However, the regulatory standards in some areas are relatively loose. As long as businesses do not publicize their therapeutic effects, they are allowed to be sold as supplementary health care products. There is currently no unified national implementation standard on this point, and it is ultimately subject to the requirements of local regulatory authorities.

If you want to sell homemade herbal preparations from medical institutions, such as the herbal eczema ointment and bone trauma external application powder self-developed by other tertiary traditional Chinese medicine hospitals, you cannot just buy the goods and sell them. You must obtain the approval document for the preparation and use in advance. Last year, we had a private clinic here that secretly sold homemade herbal hemorrhoid ointment from the provincial traditional Chinese medicine practitioner. It did not go through the dispensing and approval procedures, and was directly fined more than 30,000 yuan, and its annual practice points were deducted. Many people who are new to the industry are prone to fall into this trap.

In addition to the sale of finished products, if you add related technical services when applying for qualifications, you can also undertake business such as formula research and development of medical herbal preparations and compliance processing consulting. However, this must be tied to a GMP-qualified OEM. You must not accept processing orders for homemade preparations privately. That is a red line that cannot be touched.

To be honest, there are indeed differences in the tightness of supervision in this area in various places. If you really plan to enter this business, don't just follow the online strategies. Make a list of the categories you plan to do first, and go to the local drug supervision and market supervision window to ask for clarification. It is safer than anything else.