Indian Drug Manufacturers' Association (IDMA) has suggested that the inclusion of clause xiii in rule 96 sub rule 1 of Drugs and Cosmetics Rules, 1945 and should be made more clear to the manufacturer for its implementation on their products and provide at least 12 months time for adopting the change in label artwork.
With reference to the draft notification, it is proposed to amend rule 96, sub rule 1 by adding a clause (xiii) in D&C Rules, 1945. The clause xiii only states that the conditions of storage with specific temperature range in thick and bold letters, whereas the IDMA has suggested to include the storage condition with specific temperature range wherever applicable as given in schedule P of D&C Rules, 1945, or Indian Pharmacopoeia (IP) or by the manufacturers for implementation in thick and bold letters.
As per IP 2014, official statutory book of drug standards in India, which clearly states, where no specific storage directions or limitations are given in the monograph or by the manufacturer, it is to be understood that the storage conditions include protection from moisture, freezing and excessive heat any temperature above 40 degree celsius. Accordingly, there are numerous drugs and drug products which are not temperature sensitive and hence do not require specific temperature conditions for storage. For example in the Indian Pharmacopoeia monograph, storage conditions are not specified for paracetamol including tablet and suspension, caffine, phenylephrine etc as stores are protected from light and moisture and these ingredients are not temperature sensitive.
Similarly, there are other finished products, which do not require temperature controlled conditions for storage. The Schedule P of D&C Rules, 1945, allows products to be stored under normal room temperature wherever, conditions of storage are not specified under the schedule. Thus, IP as well as Schedule P of D&C Act mandates specific storage temperature requirements 'wherever strictly applicable'.
Further the drugs are sold through the licensed pharmacies, under the supervision of a pharmacist wherein the adequate temperature conditions are maintained.
IDMA has also urged to provide at least 12 months time to the manufacturers for implementing the change in label artworks so that the current inventory of label artwork can be exhausted to make way for and smoothly switchover to new label requirement. This will help in minimising the wastage and losses.
In the representation to K L Sharma, joint secretary of ministry of health and family welfare, IDMA states that the amendments are welcome and it is one step towards the good distribution practices (GDP). It will also ensure availability of quality and safe medicine to consumers and patients.