Objective

The expiry periods of pharmaceutical products have a meaning only if the products are stored under conditions prescribed on the labels. Otherwise, essential and life saving drugs are likely to loose their potency before they reach the consumer. A retail pharmacist is a vital link in the distribution chain for pharmaceutical products. It is not uncommon to find that the period spent by products during distribution is quite long in the wholesale and retail outlets. It is, therefore, very important to maintain proper storage conditions in these units. The purpose of this document is to provide guidance on good storage practices for community pharmacists

Scope

The document covers the storage conditions labelled currently on the pharmaceutical products in India. It also takes into account prevalent storage conditions in community pharmacies

General principles

A survey was recently conducted by the DELHI PHARMACEUTICAL TRUST (DPT) in Delhi to determine the nature of storage conditions prescribed on the labels of pharmaceutical products in the country and the kind of storage conditions available with the retail outlets. The purpose was to assess the gap between the two. A lot of shortcomings were found. Details of the findings are published elsewhere.1 Based on the observations, it was thought fit to bring out this document so as to help the community pharmacists in the country to understand the storage requirements and to suggest how these can be easily fulfilled in a simple manner

Storage conditions labelled currently on the pharmaceutical products in India

It has been found that industry labels a wide variety of storage conditions on the medicines. Some of these are given below:
1. Keep in a cool dry place
2. Keep in a cool dark place
3. Protect from heat & light
4. Store below 250°C
5. Store at +20 to 25°C
6. Store below 20°C
7. Store between 150 to 25°C
8. Store in dark at 2° to 8°C
9. Store away from sunlight
10. Do not store above 25°C
11. Store at room temperature
12. Store in a dry place at 2-8°C
13. Store below +4°C (do not freeze)
14. Store below 30°C. Do not freeze
15. Keep in a cool place (do not freeze)
16. Store at a temperature between 2-10°C
17. Store at controlled temperature 15-30°C
18. Keep in a dry place, not exceeding 30°C
19. Keep in a cool dry place protected from light
20. Store below 30°C protected from moisture
21. Store at controlled room temperature 20-25°C
22. Store in a cool place protected from frost
23. To be preserved at temperature less than 22°C & sheltered from the light As evident from the list, there are quite a few storage instructions given on labels that are neither friendly to the pharmacist nor to the consumer. The DPT has already taken up this matter with the Indian Drug Manufacturers' Association (IDMA), the Organisation of Pharmaceutical Producers of India (OPPI), the Indian Pharmaceutical Alliance and the Drugs Controller General (India) with a view to minimising the number of storage conditions on the labels of marketed products and making them more exact and practical.

Prevalent storage facilities in community pharmacies

The storage facilities currently available in the retail drug outlets and pharmacies include:

1. A refrigerator, mostly of 165-litre size w Freezer compartment of the same refrigerator
   Open shelves (storage at the ambient temperature and light of the outlet)
2. Covered cupboards/drawers that do provide protection from light at the ambient temperature of     the outlet
3. Air-conditioning, providing an environment of less than 300C, at about 10% of the outlets only.

According to the Drugs and Cosmetics Rules, 1945, a refrigerator is one of the mandatory requirements to operate a retail pharmacy outlet. Therefore, a dilemma remains on how to meet the storage conditions prescribed on the labels of drug products as mentioned under paragraph 2 above