IN THE HIGH COURT OF JUDICATURE AT MADRAS
Mr. Justice Ramaswami
The Proprietrix of Messrs. The Indian Process Chemical Laboratory
Versus
The Drugs Inspector, Madras City
Cr. R.C. Nos. 447 and 448 of 1957.(Cr. R.P. Nos. 437 and 438 of 1977.)
Decided On : 27 January 1958
These are Revision Cases which have been filed against the convictions and sentences by the learned Eighth Presidency Magistrate, G. T., Madras, in C.C. Nos. 13680 and 13747 of 1956.
The facts are: — The complaints in these cases have been filed by the Drugs Inspector, Madras City against Messrs. Indian Process Chemical Laboratory, 283, Linghi Chetty Street, Madras 1, the proprietrix of the said firm Srimati Krishna Bhamini Devi and the Manager of the said firm Sri V. S. Krishnamurthy.
The charge is that this firm has been stocking and exhibiting for sale and distributing drugs manufactured by their principal firm at Bangalore, Indian Process Chemical Laboratory. Tincture Digitalis, B. P. was one of the drugs so stocked and distributed. Samples of the Tincture Digitalis were taken by the Drugs Inspector, Madras and sent for analysis to the Government Analyst, Guindy, and were found to be sub-standard quality. The accused are thus said to have violated the provisions of section 18 (a) (1) of the Drugs Act, 1940, and committed an offence punishable under section 27 of the said Act.
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.
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 digitalis 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.
The defence put forward on behalf of accused 2 in the written statement was as follows: —
"We have not committed any offence.
We are an Indian Firm and we have been taking great care under expert guidance to manufacture drugs which are up to standard. In fact many of our drugs are in no way inferior to those manufactured by foreign firms.
The drug ‘Tincture Digitalis’ is a drug which is subject to rapid deterioration. Eminent Scientists have been at pains to find out the cause for this deterioration of the potency in "Tincture Digitalis" and they have been baffled by this deterioration.
The attention of the Court is invited on the subject of deterioration to the following passages’ contained in: —
1. Page 370 of the United States Dispensatory, 23rd Edition:
Deterioration :— "It has been for many years that preparation of digitails lose their potency. This is "undoubtedly, at least in part due to hydrolysis of the glycosides, as it is well established that the aglycones are much less potent than the glycosides from which they are derived ; this hydrolysis may be brought about by enzymes which are contained in the leaves".
"This rate at which digitalis leaf undergoes a loss of activity may vary front nothing to 50% within 6 months when tested by the frog method. It may be noted parenthetically that the cat method of assay (sen under assay) shows generally much less evidence of loss of potency than the frog method."
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“.
3. Page 1147 of The United States Dispensatory, 23rd edition:
”All 4 samples were assayed both by the frog method of U.S.P. XI and by the quantity required to kill a cat. In every patient in
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