The Union health ministry will soon amend the Rule 96 of the Drugs and Cosmetics Rules, 1945 for making a provision for labelling of drugs with the storage conditions.

A decision to this effect was taken by the Drugs Technical Advisory Board (DTAB) at its 68th meeting held on February 16 this year. In the meeting, the DTAB members were briefed that Rule 96 related to manner of labelling does not make it mandatory for the manufacturers to provide storage conditions in the label of the drug with specific temperature range at which the drugs should be stored. In view of this, some manufacturers indicate storage conditions on their own while majority of drugs formulations do not provide such information.

The Drugs Controller General of India (DCGI) Dr GN Singh, who is the member secretary of the DTAB, informed the members that representations were received that it should be made mandatory to mention the storage conditions because of high variations in the temperatures prevailing at any time in the country. Drugs pass through various channels viz distributors, retailers, and transporters till it reaches the consumer.

In order to ensure that drugs do not lose their efficacy because of improper storage, the Rule 96 is needed to be amended to provide that the label of the drug provides this information so that the drugs are kept under proper conditions during storage and transportation.

The DCGI proposed to insert a new clause under sub-rule (1) of rule 96 as under: "Drugs and their preparations shall bear on their labels in a conspicuous manner the conditions of storage with specific temperature range."

The DTAB, which is the highest authority under the Union health ministry on technical matters, after deliberations agreed to the proposed amendment.