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4. The complaint in C.C. No. 13680 of 1956 related to samples of Tincture Digitalis B. P. seized on 19th July, 1955, samples bearing batch No. 53412, while C.C. No. 13747 of 1956 related to samples of the same drug seized on 22nd August, 1955, samples bearing batch Nos. 53047 and 53097.

5. The certificates of analysis by the Government Analyst as well as the Protocols of Biological Assay of the sample of Tincture Digitalis taken in both the cases have been filed as exhibits in both the cases. The Analyst has reported that in respect of Tincture Digitalis, B.P. batch No. 53412, the sample did not have specific activity of digitals experimented on frogs and that the chemical test showed that there was practically no digitalis glycosides in the sample and that in respect of batch No. 53057 the analysis showed only an average potency of 42.8 per cent, of the 1953 B. P. standard and that the analysis of batch No. 53097 showed an average potency of 6.5 per cent, of the 1953 B. P. standard.

This rate at which digitalis leaf undergoes a loss of activity may vary from nothing to 50% within 6 months when tested by the frog method. It may be noted parenthetically that the cat method of a say (see under assay) shows generally much leas evidence of loss of potency than the frog metod.

2. Page 372 of The United States Dispensatory, 23rd edition:

Preparation of Digitalis vary so much in their potency, and the condition in which it is used so frequently demand the full actions of the drug that the therapeutist should be guided in his dosage only by the degree of effect.

4. Page 1148 of The United States Dispensatory, 23rd edition:

It is well established that Tincture of 'Digitalis' is more liable to deteriorate than the properly preserved leaves. The rapidity with which various samples of tincture lose their potency is subject to the most inexplicable variation; of two, tinctures made by the same method and preserved under the same condition, one may show an apparent loss of 20% of its potency within 6 months and the other none. Neither hydrogenation concentration, nor proportion of alcohol, nor temperature at which it is stored will explain these variations (see Emig. J.A. Ph. A., 1932, 1273; and Rowe and Scoville, J.A. Ph. A., 1933, 22, 1087). The observation of Macht and Krantz (Proe. S. Ex. B., 1926, 23, 340) suggest that the action of the ultraviolet rays may have some connection with the loss of potency.

25. To sum up, having regard to the nature of the duty, the person upon whom it is imposed and the person by whom it would in ordinary cases be performed and the person on whom the penalty is imposed and the words used, there cannot be the slightest doubt that the Act creates an absolute liability and rules out mens rea as a constituent part of the crime. Point 1 fails.

26. Point 2. - The learned Public Prosecutor rightly concedes that there are several extenuating features in this case which call for a mitigation of punishment. This Chemical firm is fruitfully carrying on a nascent Indian industry. It is stated to have a well-equipped Laboratory and competent scientific advisers. The leaves were purchased only from the Cinchona Factory in the Nilgiris. The prepared stuff was sent to Madras after being tested and under warranty. It is not disputed that even preparations of standard potency deteriorate inexplicably and for reasons which are baffling. The firm has always been anxious to carry out the instructions of the Drugs Inspector and in fact it is prepared to submit samples of any batch of the preparation for analysis at Guindy at its expense before that batch is sold. It is also willing to bottle the preparation in small quantities in amber coloured bottles and keep them in a cool place as now instructed. It is capable of manufacturing preparations of standard potency is evident from its submitting subsequently samples of another batch prepared, which was found to be of full potency. In fact after these proceedings were taken they have stopped preparing Tincture Digitalis and which is a pity because we want our nascent industries to grow and prosper and serve our public fully. Otherwise, we would be at the mercy of foreign preparations which on account of exchange restrictions might not be even available. I, therefore, consider that the fines inflicted may be set aside and the firm might be admonished and I admonish accordingly through their learned advocate to give no room for a complaint of this kind in future in regard to this or any other preparation that might be put into the market. The fine amounts, if collected, will be refunded.