In a decision that will give a sigh of relief to hundreds of Ayurveda, Siddha and Unani (ASU) manufacturers in the country, the Ayush department has made amendments in its earlier order and allowed the use of prefixes and suffixes with the classical ASU formulation name in the ASU classical Patent and Proprietary drugs if the product has been in the market for more than 30 years. The new order will save several established brands in the market which they have built over several decades, spending hundreds of crores of rupees.

The Ayush department early this year had banned the use of prefixes and suffixes with the classical ASU formulation names which threatened the continuation of many big brand names including the famous Chyavanpras. It had asked the state licensing authorities to immediately ban such brands which are prefixing or suffixing the classical ASU formulation name but are not manufactured as per the 54 books mentioned in the First Schedule of Drugs and Cosmetics Act, 1940.

The Ayush department's earlier action was prompted by the information that there are many ASU products in the market as patent and proprietary drugs with some prefix or suffix with the classical name being marketed under a brand name which is misleading and improper use of a classical ASU drug name.

Amending the order, the Ayush department said, "If a classical ASU product is registered as a proprietary ASU drug by the state licensing authority with classical names with some prefixes like Brihat, Maha, Laghu, Cheriya, etc for more than 30 years, i.e., before the publication of Ayurveda/Unani Formulary of India, that product can continue to be registered as a proprietary ASU drug in the same form as registered initially".

In case a company wants to now register a classical product (as per the Ayurveda/Unani Formulary of India and various classical texts mentioned in schedule-1 of the Drugs & Cosmetics Act, 1940 and Rules, 1945) as a branded Proprietary ASU product, the same may be allowed by the state licensing authorities provided the formula is as per the classical texts or the Ayurveda/Unani Formulary of India and the classical name is not distorted in any manner. In case there is any variation in the formula or the dosage form, expert opinion of the Ayurveda/Siddha/Unani Pharmacopoeia Committee shall be obtained through the department of Ayush before any such license is granted, the Ayush department's new order said.

Meanwhile, the Ayurvedic Drug Manufacturers Association (ADMA) had asked the department to give a 10-year change-over period to the ASU drug manufacturers to comply with the ministry's recent order on suffix and prefix.