Pharmabiz
 

Impact of prefix-suffix notification on herbal industry

Prof. Dr. K. SreedharWednesday, January 28, 2015, 08:00 Hrs  [IST]

The last year notification of Ayush banning  - “prefix and suffix for 3(a) drugs as well as preventing resemblance and mimicking names for 3(h) formulations” will be major set-back to the efforts of both government as well as industry in the promotion of herbal industry in India. The 5th amendment in its present form it will adversely affect thousands of formulations directly or indirectly under both 3(a) as well as 3(h) category. As per the Drugs & Cosmetics Act 1940, the drugs in traditional medicine covering Ayurveda, Siddha and Unani systems are licensed either under 3(a) category [when the formulations are made as per the text] or under 3(h) category [when the formulations are essentially made using the ingredients of formulae from the schedule texts].

How does this amendment impact the ASU industry?
The original drafting of the Act in 1961 was done after proper understanding about the intricacies in the nomenclature of the ASU medicines. The contemporary scholars have drafted the Act with a fore-sight by providing sufficient scope for nomenclature of the formulations under 3(a) as well as 3(h).

The 3(a) drugs (ASU drugs) made as per books of first schedule obviously carry the name from the classical texts where ever possible. Under this category a scope is also provided for the nomenclature of several formulations which have no textual names viz., Nishamalaki; Rasanasaptaka kvatha etc. Some of the formulations have been promoted by traditional Vaids/Hakims on the basis of one of the ingredients of the formulation e. g. Hingwashtaka churna; Triphaladi churna, etc.

In case of 3(h) drugs (P&P medicines) which are formulated by using the ingredients of the formulae from the schedule books, the name is decided by the manufacturer. Under this category, the exact formulation(s) from the texts is not allowed. Therefore, whenever a formulation is modified from that mentioned in the Schedule books, the name is given either by using a “prefix-suffix” or by using a name “resembling-mimicking” the original name e.g. Sona-chandi Chyavanprash for prefix and Chyavanprash special for suffix.

The amendment on “resembling” and “mimicking” brings in a vague practice in the industry and adversely affects century old formulations. For example, Amritanjana which is the name of a classical formulation from schedule texts may cause threat to a century old formulation. The other examples for resemblance may include Lakshmivilas Avaleh; Navaratan tel; Raktashodhak; Shatavarikalpa etc while the examples for mimicking may include Pamari; Charmasanjivani: Dahashamaka malam; Shodhana taila; Karnabindu; Amavatari kashayam, etc.

Another important observation is that many 3(a) formulations under the same name have several variants e.g. 7 variants of Chandraprabhavati, 15 variants of Chyawanprash avaleha, 5 types of Gokshuradi churna etc. In spite, of this there is no confusion because the physicians who prescribe the formulation are aware of the differences. Since the label contents are declared on the label, the consumers will get the information about the ingredients in the variants as well.

Whether Ayurveda provide scope for variants in classical formulations?
Charaka Samhita (a schedule book) provided wide scope for the variants of the original formulae in the texts (C.S. Su.4.). Ashtanga Sangraha (a schedule book) quoted that – “a new dosage form must be considered when the patient is fed up with taste, smell etc due to long term administration or when the patient develops dislike on a particular dosage form of a formulation” - (A. S. Su. 23.). Sarangdhara in his work (Schedule book) quoted that – “any ingredient from a formulation may be changed in case that ingredient has no place for the selected indication. Similarly, a new ingredient though it is not mentioned under the given yoga may be added if needed” - (Sa.Sa. Pu.Kh.1).

Conclusion
These references definitely indicate that the said notification is an insult to the wisdom of Seers and Sages like Charaka who promoted adoption of new ideas as well as technologies. It is essential to note that the original texts of Ayurveda never attached importance to the name of a drug or a disease. One would fail to appreciate, how one formulation having multiple variants (between 10-40 variants with one name) under 3(a) category is not confusing the consumer but confusing the consumers when licensed with a differentiator is under 3(h) category?

It is important to recognize the need of using the prefix and/or suffix as well as resemblance and/or mimicking as per the necessity on a case to case basis. For more than 50 years, prefix and suffix were used successfully by the industry as a good practice. Several technical committees comprising ayurvedic scholars have agreed to this practice. The above facts stand as proof for the genuine industrial practice which does not give scope for cheating the consumer (either by using prefix-suffix or by using resemblance-mimicking). In fact the nomenclature of the industry is more transparent than that of the schedule texts.

The present amendment is not providing any frontiers for resembling-mimicking. In the absence of specific definitions, different licensing authorities may have different interpretations making life miserable for the industry. Finally, it will be beneficial to note that the current practice is in vogue for more than 50 years (1961-2013) and never resulted in confusion or malpractice. Therefore, there is a need to rework at the amendment which is going to adversely affect more than 5000 formulations both under 3(a) as well as 3(h) categories.

(Author is with Dept of Shalya,  Ayurvedic College, Jammu)

 
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