Rationalisation of storage conditions for medicines in India

In view of the fact that the storage conditions included in section 2 above are vague, imprecise and confusing, it is necessary to rationalise the storage conditions for medicines. It is therefore proposed that storage conditions of pharmaceutical products stated on the label by the manufacturer should be restricted to the following:

On the label	Meaning
Do not store over 8°C	To be stored in refrigerator (from +2°C to + 80C)
Do not store over 30°C	To be stored at room temperature (from +2°C to + 30°C)
Do not freeze	To be kept in refrigerator (from +2°Cto + 8°C but not in the freezer chamber)
Protect from moisture	To be stored in normal humidity at room temperature (RH less than 60%); to be provided by the manufacturer in a moisture-resistant container
Protect from light	To be stored in a light-resistant cupboard/drawer; to be provided by the manufacturer in a light-resistant container.

The DPT has suggested that corresponding changes should also be made in the Indian Pharmacopoeia and Schedule P of the Drugs and Cosmetics Rules.

Important points with respect to storage of medicines in community pharmacies

a) The retail outlet in hot areas and in summers should be air-conditioned. This may be kept in mind while designing the outlet. Similarly, in areas of extreme cold, the premises would require heating, especially in winters. The placement of air-conditioner and heating devices should be such that products are not directly exposed to the chill or heating.

b) Due consideration should be given to storage requirements of formulations while designing the shelves and cupboards in the retail outlet. As far as possible, the shelves should be covered with glass panels, which not only protect from dust but also prevent rapid fluctuations in temperature.

c) Arrangements should be made to store products based on the labelled storage conditions. Within these categories, provisions can be made for fast movingand slow moving products and more serious storage considerations should be given to the slow moving products.

d) The retail outlet must be designed in a manner that there is minimal direct sunlight falling on the products. Particular consideration should be given to premises facing the sun.

e) The arrangement of lighting in the interior of the premises should also be in a manner that the lights are not focussed on the products. It has been shown that light causes not only chemical damage but also can catalyse physical changes like moisture uptake by the products. Care should be taken to ensure that only diffused light falls on the products.

f) As far as possible, provision should be made for a temperature and humidity indicator device in a pharmacy. These devices are now easily available.

g) Stability studies of products packed in blisters have revealed that if these are exposed to light, the products tend to absorb moisture. It is therefore necessary for pharmacists to store such products in suitable cartons so that the blisters do not get exposed to light. Pharmacists should do so even if the manufacturer has not provided such cartons.

h) In case stability and storage problems are seen with the formulations, they should be reported immediately to the representative of the manufacturer and such products should be taken out of circulation till the stability problems are attended to satisfactorily. The pharmacist easily sees such stability problems when products show change in appearance, colour, odour, settling of the product contents, breaking of emulsions, melting of creams, oozing of contents from the containers, and such physical changes

i) The light- and temperature-sensitive products should not be stored in counters, where the light is intense or direct and there is no protection from temperature and humidity.

Special storage requirements in certain cases

For formulations requiring critical storage, the pharmacist should seek advice from the manufacturer. The manufacturer can even be asked to provide the facility for storing sensitive formulations.
Improvement in refrigeration technology has provided frost-free refrigerators. Pharmacists should prefer such frost-free refrigerators as they are easy to maintain and protect printed packaging materials. Refrigerators also provide separate and large compartments for the freezer portion and the main storage area with separate doors so that opening one of the doors does not disturb the storage temperature in the other compartment. Pharmacists also need to plan for adequate number of such units to store the entire stocks requiring such refrigerated storage. For storage of relatively large stocks of medicines at temperatures below 30°C, the retail outlet should ideally be air-conditioned.