Detailed scrutiny of characteristics of different probable options revealed, that the option of dye encapsulated in a temperature sensitive membrane with precursor coated on the outer surface of the membrane, holds maximum promise and is likely to meet the requirements of drug industry. Promising options found suitable are:
For injectables and life saving drugs – Japanese Patent Nos.63, 112, 684; 63, 165, 479 and 63, 165, 480.
For vitamins and formulation – Japanese Patent No.62, 263, 176.
All the above promising options have not yet reached production stage.
The patentees of the above promising options, have claimed, that their patents are suitable for application on items of mass consumption. However, none of them, have provided application related parameters, as such detailed technical analysis on suitability of promising options taking all aspects into consideration is not feasible.
Further Investigations Required
A detailed evaluation is considered necessary to assess the suitability of each of the promising options indicated above. It will be preferable, to carry out the evaluation, firstly, at a control laboratory and subsequently on a pilot plant scale, under actual packaging conditions of a drug factory. Parameters which require further evaluation are:
Reliability of operation in controlled environment at normal packaging speeds.
Life cycle tests under different environments prevalent in Indian sub-continent.
Fixing methods of sensitive levels at normal operating speeds of labelling machines.
Immunity of labels against commonly available solvents and other items.
Acceptability of these labels by drug manufacturers, retailers and customers.
Actions Necessary for Induction of Promising Options
For induction of temperature sensitive labels on drug phile, the following actions are considered necessary:
Statutory Incorporation of Labels on Drug Philes: For statutory incorporation, Drug Controller relies on recommendations outlined in the Indian Pharmacopoeia. No pharmacopoeia in the world has till date given any guidelines on the subject. Nor statutory induction of temperature sensitive labels on drug philes, recommendations / guidelines has to be incorporated in the Indian Pharmacopoeia.
Indigenous Availability of Temperature Sensitive Labels at Reasonable Cost: Towards this indigenous production of temperature sensitive labels is essential.
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