24 Jan 2017
Views Sought on Rules for Naming OTC Chinese Medicines
A draft for soliciting opinions of proposed naming rules for generic Chinese medicines recently issued by the China Food and Drug Administration (CFDA) has aroused much concern among industry players. According to the proposed nomenclature principles, the generic names of over-the-counter or non-prescription Chinese medicines must not contain exaggerated claims about the efficacy of such products. Descriptions like “imperial formula” and “secret formula” will also be prohibited. It is expected that more than 10,000 product varieties will be affected.
The proposed principles not only apply to the naming of new Chinese drugs; they also aim to address the unregulated naming of existing OTC Chinese medicines. Some long-used drug names may consequently have to be changed. In this case, formerly-used names of the drugs concerned can be shown on the product during the transition period which should be enforced pursuant to relevant provisions stipulated by the drug supervision and administration department of the State Council.
The draft puts forward four basic naming rules:
- Drug names should be scientific, simple and clear. Avoid duplication of names.
- Relevance and reasonableness.
- Avoid suggestion and exaggeration of efficacy.
- Drug names may reflect traditional cultural features.
First of all, the generic names of OTC Chinese medicines should be scientific, simple and clear, not likely to result in ambiguity and misunderstanding. Difficult or technical terms should be avoided. Generally, a drug name should consist of no more than eight Chinese characters; names of people, places and companies are also forbidden.
More importantly, the proposed naming rules make clear that drug names associated with pharmacology, anatomy, physiology, pathology and therapeutics which may give consumers any implication of efficacy should be avoided. For example, drug names should not contain such claims as “blood sugar-lowering”, “blood pressure-lowering”, “lipid-lowering” and “anti-inflammatory” etc. Exaggerated, self-praising expressions like bao (treasure), ling (panacea), jing (precious essence), qiangli (extra strength) and xuxiao (rapid impact) should not be used. Boastful claims such as “imperial formula” and “secret formula” must also be excluded.
Once adopted, the naming requirements are likely to affect many products, as not only new OTC drugs have to be named properly but the names of existing ones may face changes as well. Just input as search keywords some of the prohibited wordings in the indigenous Chinese medicines database in CFDA’s website and several thousand currently approved drugs will be returned. Among these, some 2,000 contain the Chinese character “ling” which implies panacea in their names.
For details of the opinion-soliciting draft in Chinese, please see: http://www.sda.gov.cn/WS01/CL0778/168461.html