The Union health ministry will consult the Indian Pharmacopoeia Commission (IPC) on the proposal to bring in changes to the Drugs and Cosmetics (D&C) Rules to specify storage conditions including the temperature range on the labels of the drugs for the better understanding to the consumers.

This was decided after a proposal in this regard came up before the Drugs Consultative Committee (DCC) which recommended review of the same by the IPC as storage conditions are prescribed in the Indian Pharmacopoeia, as well as the Schedule P.

Though the conditions of the storage of a drug is of vital importance for preserving the potency of the drug throughout its storage conditions, there is no enabling provision in the D&C Rules 1945, prescribing the manner of labelling of the drug with storage conditions indicating the specific temperature/range of temperature for the drugs not listed in Schedule P.

It was pointed out at the meeting that different manufacturers were labelling the same drug in different ways as “store below 25 degree C”, “store in cool place”, “store under normal room temperature”, etc. Further, these conditions are not conspicuously printed on the label so as to clearly visible to the consumer/dealer who wants to comply the storage conditions at their end.

It was also cited that in many times and in many places the temperature is above 25 degree C. The terms like “normal room temperature”, “general conditions” are not defined. The normal room temperature varies from place to place, season to season and there is a lot of variation in temperatures.

According to the Rule 96(1)(vii), the drugs specified in Schedule P and their preparations including combinations with other drugs shall bear on their labels, the date of manufacture and the date of expiry of potency and the period between the date of manufacture and the date of expiry shall not exceed that laid down in the said schedule under the conditions of storages specified therein. Schedule P of the D&C Rules 1945 prescribed the storage conditions for certain drugs only in terms of cool place (between 10 and 25 degree C), cold place (not exceeding 8 degree C) and at normal room temperature.

The Indian Pharmacopoeia mentioned storage conditions in some monographs only. But the manner of mentioning of storage conditions with specific temperature/range on the label of the drugs is not prescribed.

The proposal was to amend the Rule 96 for directing the manufacturer to print the storage conditions on the label with specific temperature/ range in bold red letters to enable the consumer to understand the storage conditions properly. The general terms like “normal room temperature”, “general conditions”, “cool” and “cold” are to be avoided on the label. The Schedule P may be amended accordingly in a more specific manner.

The DCC in principle agreed to the proposals, but suggested that the matter should be examined by the IPC for tits recommendations and views, before making the amendment.