The Drugs Technical Advisory Board (DTAB) has dismissed the proposal to mandate the requirements of medicine labels in Hindi or local languages along with English.
The proposal, which was deliberated in its 86th meeting held on April 13, 2021, was dismissed on the grounds of space constraint on the label of the formulations especially on small vials and multi component products.
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The board, based on the deliberations of its committee, also further stated that 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 therefore is not desirable.
The proposal was submitted based on the representation received regarding the requirements of medicine labels in Hindi or local languages along with English as peoples / patients who don’t understand English are facing problems in reading and understanding the text of medicine labels, package inserts and literatures.
Earlier, similar issue for labeling of iron tablets and polio drops distributed to the children under government programmes with name and expiry date in Hindi along with English was deliberated in 77th meeting of DTAB and DTAB in its 78th meeting constituted a sub-committee to examine and give its recommendation to streamline the labeling requirements of drugs.
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The sub-committee had submitted its recommendations that names of medicines shall be printed both in English and Hindi for open market, whereas government agencies during procurement of medicines are at liberty to ask for regional language on the label of drug products along with English.
However, DTAB in its 82nd meeting held on April 2, 2019 while deliberating the recommendations of the sub-committee did not agree for making it mandatory to include drug name and expiry date in Hindi/regional language along with English.
In the 86th meeting on April 13, the board deliberated its earlier recommendation of 82nd meeting and recalled the reasons for not mandating the requirements of medicine labels in Hindi or local languages along with English.
The reasons include space constraint on the label of the formulations especially on small vials and multi component products and 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 whole country. Further, it will add cost and logistic burden which may be passed on to the patients and the same is not desirable.
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