DTAB rejects proposal to mandate printing drug labels in Hindi, regional languages

This came during its 86th meeting held in April this year where the board was apprised that a representation was received regarding the requirements of drug labels in Hindi or local languages along with English.

It was stated that people/patients who do not understand English have difficulty reading and comprehending the text of medicine labels, package inserts, and literature.

Further, it was submitted that the labels, package inserts and literature should be in Hindi or local languages along with English for the ease of understanding for common people and hence to decrease the breach between the consumer and medical company.

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Earlier, a similar issue for labelling of iron tablets and polio drops distributed to children under Government programmes with name and expiry date in Hindi along with English was deliberated in the 77th meeting of the Drugs Technical Advisory Board (DTAB) and the Board in its 78th meeting constituted a sub-committee to examine and give its recommendation to streamline the labelling requirements of drugs

The sub-committee had submitted its recommendations that names of medicines shall be printed both in English and Hindi for the open market, whereas government agencies during procurement of medicines are at liberty to ask for regional language on the labels of drug products along with English.

However, DTAB in its 82nd meeting had held on 02.04.2019 while deliberating the recommendation of the sub-committee, did not agree to make it mandatory to include drug name and expiry date in Hindi/ Regional language along with English. However, details for reasons in this regard were not captured in the minutes of the meeting of the DTAB.

In the most recent DTAB meeting, the board discussed an earlier recommendation from the 82nd DTAB meeting and recalled the following reasons for not mandating the requirements of medicine labels in Hindi or local languages in addition to English:

• Space constraint on the label of the formulations especially on small vials and multi-component products.

• It is impractical to print labels in Hindi/regional languages since drug products will be manufactured in one State and the same will be distributed for sale in the whole country. Further, it will add cost and logistic burden which may be passed on to the patients and the same is not desirable.