ASU drugs to have capital letter format for date of manufacture & expiry on labels from Aug 1

Ministry of Ayush has indicated a particular format to be followed for a date of manufacture and expiry of products of Ayurveda, Siddha and Unani(ASU). The format needs to be implemented on all labels of the ASU drugs from August 1, 2017.

In a communiqué, the Ministry of Ayush has specified that dates of manufacture and expiry of all Ayurveda, Siddha and Unani products needs to be incorporated on the labels of all packs of the Ayurveda, Siddha and Unani drugs. It needs to be written in month and year format. The month will be printed using the first three alphabets in capital font followed by a full stop and the year as four digits, both separated by a slash.

The provision according to the Ministry of Ayush is effective from August 1,2017 and will not affect the batches of Ayurveda, Siddha and Unani drugs that are already manufactured and available in the market.

The circular has been sent to regulators of all state departments of Ayush and related offices including the National Health Rural Mission.

The Ayush industry points out that the reason to capitalise the date of manufacture and date of expiry is to attract the consumer on the same. Although upper lower case of presentation will enhance ease of readability, yet all capital letters reaffirm the importance of an information that needs to be conveyed.

A key aspect to this is that the Ministry is being cautious to ensure total safety to the patient and consumers. Missing expiry dates is a common and at times the text is difficult to read because of font size or style, insufficient color contrast, or other design elements. Moreover the size of the container label to a great extent persuades the complete container label design, pointed a section of the industry.

It is interesting to read the clarification issued in a letter by Ministry of Ayush regarding the manner of labeling of date of Manufacturing (MFD) and expiry date (EXD) for AYUSH drugs. The clarification letter does not cite the reason for issuing this nor the current problems being faced. The letter gives direction for declaring these two information for Ayush drugs on their labels. However it does not give any clarification. MFD and EXD declarations are also governed by PCRO (packaging commodities regulation order) and Weights and Measures act.

For the consumers, in my opinion, the new directions are as good as current one, stated an expert in Ayush, Food and Drug science and regulations who did not want to be identified.

“The presentation of all capitals with full stops adds to the problems of labelling because of calligraphy. If some company does not include the full stop, some regulatory authority from the department of drugs control department or weights and measures could state it is misbranded and the company could face action. Actually there is no need to change because it is already given in the Drugs & Cosmetics Act & Rules calling to display only month and year. Everybody understands an information displayed in numerical. Therefore people who cannot read English will find it difficult to understand,” he added.

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