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The Proprietrix of the Indian Process Chemical Laboratory and anr. Vs. the Drugs Inspector - Court Judgment

LegalCrystal Citation
SubjectCriminal
CourtChennai High Court
Decided On
Reported in(1958)2MLJ308
AppellantThe Proprietrix of the Indian Process Chemical Laboratory and anr.
RespondentThe Drugs Inspector
Cases Referred and Bred v. British Drugs Houses Ltd.
Excerpt:
- - 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. this is undoubtedly, at least in part due to hydrolysis of the glycosides, as it is well established that the glycones are much less potent than the glycosides from, which they are derived; it is well established that tincture of 'digitalis' is more liable to deteriorate than the properly preserved leaves. another point of interest brought out by this investigation is that 20 out of 60 tinctures submitted to us for biological assay were absolutely inactive and had to be condemned as being unfit for there-apeutic use. all these tinctures were prepared by.....orderramaswami, j.1. 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 1956.2. 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.3. 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.....
Judgment:
ORDER

Ramaswami, J.

1. 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.

2. 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.

3. 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.

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.

6. 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 thos6 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 glycones 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 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.

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 whom two preparations were employed the clinical effects produced more nearly followed the dosage of a cat assay than of the frog. The present Pharmacopeia has followed the lead of several of the European Pharmacopoeia and adopted a cat assay in the place of the frog method which had been officially recognised for 25 years. But we do not believe that either method affords any accurate measure of clinical dosage.

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.

5. Page 1273 of The Journal of American Pharmaceutical Association, Vol. XXI:

Definition. - One of the most important preparations appearing in the United States Pharmacopeia is Tincture Digitalis. When this drug is prescribed a definite action upon the heart is expected. Often this characteristic digitalis action-slowing of the rat', decrease in conductivity, increase in irretibility, lengthening in disastole and more effective systole, is not obtained, or is only weekly exhibited by old preparation. Although such tinctures at the time of manufacture assay full strength, at the end of the period of storage biological tests show that they have undergone a loss of all or part of their potency.

6. Pages 1275 and 1276 of The Journal of American Pharmaceutical Association, Vol. XXI:

By the addition of H.C.I. various Phranges from 5.6 to 4.1 were obtained The tincture showed a decrease in potency from 30% to 50% in comparison to a normal tincture. The tincture, after one year of storage displayed a further decrease of from 12% to 50%. Nevertheless those preparations having the greatest decrease after manufacture now show the smallest drop, while those with the lower percentage decrease originally, now show a greater substandard condition. Due to this counter balancing the product at the end of the time period showed about the same potency, a decrease of 65% to 100% from the normal tincture regardless of the condition of storage.

The two tinctures having the Ph. values of 5.1 and 54 and kept in sealed and unsealed bottles at room temperature showed at the end of one year a decrease of 33.3% and 50% respectively, or a 100% when compared with the normal.

On the alkali side of the scale the potency is lowered more than when acids are added. In the original assay the decrease was proportional to the alkalinity. With a Ph. of 6.4 there is a fall of 50%; and with a Ph. of 8.1 a loss of 83.3% when compared with the normal. At the end of the year a second assay showed further decrease of 27.3% to 44.4% for those kept at room temperature. The ultimate potency of all these tinctures was approximately the same. Nevertheless compared with the normal all the K.O.H. tinctures displayed a decrease of 115.7%. Those kept in the refrigerators had a loss of 9.1% to 33.3% from the original value. When compared with the normal tincture the decrease was 100%.

7. Page 313 of the Indian Medical Gazette:

Light is another important factor. Macht has shown that not only sun light but even moon light may produce deterioration of glucosides, and unless this is rigidly excluded the leaf rapidly loses its potency.

Another point of interest brought out by this investigation is that 20 out of 60 tinctures submitted to us for biological assay were absolutely inactive and had to be condemned as being unfit for there-apeutic use. All these tinctures were prepared by reputable firms who employ a well-trained and experienced staff. They also obtained the best quality of the leaf and took all possible precautions as regards storage in a cool, dry and dark place in tin-lined boxes.

8. Page 314 of 21fe Indian Medical Gazette:

One third of the total specimens of tinctures prepared from all kinds of leaf for the Market which was sent to us for assay were found to be absolutely inactive and had to be condemned and discarded. These were prepared-by reliable firms and under most favourable condition the dangers of using un-standardised preparation.

9. Page 97, Indian Medical Gazette:

1. Clinical observations as well as biological and chemical assay of tincture of digitalis show that it undergoes deterioration rapidly in a tropical climate such as that of India.

2. This deterioration cannot be accurately determined by any single method in the laboratory such as Hatchers 'cat method', the 'frog method' or Kundson and Dreschachi Chemical Method.

3. Clinical tests give the most r-liable information. The average dose of 15 c.c. (or 4 1/2 drachms) of the tincture per 100 pounds of body weight required to get the patient under digitalis effect in 36 to 48 hours is considerably increased after the tincture has been in the tropics even for a short time.

4. Deterioration is due to some change in the digitalis glucosides, the nature of which has not yet been determined.

10. Page 383 of Thorpe's Dictionary of Applied Chemists, IV Edition, Vol. II.

11. Page 1147 of United States Dispensatory, 23rd edition.

12. The opinion of Dr. A. Stoll an internationally acknowledged authority on the subject and who had been invited by the Government of India as a honourable guest during the Science Congress - Ref: 'The Cardiac Glycosides' by Dr. A. Stoll - Page 71.

Tables (xi) and (xii) indicates the various possibilities for more or less extensive decomposition of genuine glucosides during the manufacture of the galenical preparation by the usual method. To what extent such decomposition actually occurs can be gathered from the following observation: An infusion of digitalis lanate from the powdered leaf was prepared in accordance with the directions of this Pharmacopeia Helvetica IV and analysed immediately. Only about one-half of the amount of the genuine glycosides originally present could be detected. When such admittedly unstable infusions are stored the decomposition will probably proceed further. It is connion knowledge anung physicians that the digitalis infusions must always be prepared freshly.

13.Page 484 of The Extra Pharmacopeia - Martindale, Vol. I, 22nd Edition.

Experiments extending over 3 years indicate that the addition of glacial acetic acid and sodium acetate to a tincture prepared from the defatted drug yields a stable preparation.

In tropical climate such as that of India Tincture of Digitalis undergoes deterioration in a short time. Tinctures become darkish in colour on dilution and are evidently considerably weaker in therapeutic efficacy. Dosage used in India far too small.

In cold countries the average quantity of tincture of digitalis required to cause toxic effects varies 4 to 7 dr. but in Calcutta the smallest dose required was 9 dr. The highest 29 dr. while the average was well over 14 dr. due to loss of potency of tincture and increased decomposition in the alimentary track and liver. Toxic effects with B.P. tincture in 15 m. doses thrice daily very rare in India. To obtain prompt results in grave cases 2 to 3 dr. per day for 5 days should be given.

14.The Indian Medical Gazette - Page 94 - Table 1. From this table it will be evident that within 3 months potency has reduced to nearly 30% from 100% when material has been kept in the ideal condition of laboratory of Government and by one of the topmost men of science of India.

To the best of our knowledge and belief British Pharmacopoeia does not state specifically as to how and under what conditions this drug should be kept or stored. It is only in September, 1956 (after this prosecution) the Indian Pharmacopoeia has indicated the storage conditions.

After we were informed by the Drug Authorities that the samples drawn from our Madras Depot had deteriorated we decided to stop further manufacture of this drug for the purpose of supply and sale. We, however, prepared this drug in a small quantity for experimental purpose and sent the same to the Government Analyst, Guindy (P.W. 2) for assay. Even though it was found to be of standard quality we did not wish to run the risk of the inexplicable deterioration in the potency of the drug 'Tincture -Digitalis' and therefore we stopped manufacture of this drug altogether.

It is also submitted that the digitalis leaves were purchased from the Government Cinchona Factory at Nilgiris for manufacture of 'Tincture Digitalis'.

7. Accused 3 in his statement relied on the vagaries of Digitalis in the matter of deterioration and alleged that it was a feature for which he could not be held responsible and that at the time of manufacture the drug had full potency and that he had a warranty to that effect from his principal.

8. The learned Magistrate who enquired into these cases in the first instance came to the conclusion that no case had been made out against the accused and discharged them. On revisions being preferred by the State my learned brother Sornasundaram, J., set aside the orders of discharge and directed further enquiry. The learned Magistrate who made the further enquiry came to the conclusion that accused 2 and 3 were guilty of an offence under Section 18(a)(i) read with Section 27 of the Drugs Act, 1940, and fined each, of them Rs. 200 in each case. Hence these Revisions by accused 2 and 3.

9. The three points which arise for determination are whether for committing an offence under Section i8(a)(i) read with Section 27 of the Indian Drugs Act, 1940, the appropriate guilty intention to do the guilty act which is made penal by the statute is required; secondly, whether in the circumstances of this case what will be appropriate punishment to be awarded; and thirdly, whether certain additions for the more efficient administration of the Drugs Act, 1940, are required.

10. Before entering into a discussion of these points, we must bear in mind the relevant sections of the said Act as they stand.

11. Section 18(a)(0) states:

From such date as may be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself nor by any other person on his behalf-

(a) manufacture for sale or sell or stock or exhibit for sale or distribute-

(i) any drug which is not of a standard quality; * * *

12. Section 27 states:

Whoever himself or by any other person on his behalf manufactures for sale, sells, stocks or exhibits for sale or distributes any drug in contravention of any of the provisions of this Chapter or any rule made thereunder, shall be punishable with imprisonment which may extend to one year or with fine which may extend to Rs. 500 or both.

13. The fundamental principle of English Criminal Jurisprudence to use a maxim which has been familiar to English lawyers for nearly 800 years is actus nonfacit reum nisi mens sit rea. An act does not make a man guilty without a guilty intention to do the guilty act which is made penal by the statute or Common Law: Allard v. Serfridge & Co. Ltd L.R. (1925) 1 K.B. 129. But there is generally no room for the application of this doctrine in the Indian Penal Statutes as their terms are precise and contain within themselves the precise and particular elements that go to make up the offences referred to in those statutes. The Indian Penal Code is one of the most exhaustive Codes of Penal Laws and devotes a ml chapter towards this interpretation clause, while an equally large part of it is devoted for the general exceptions which withdrew acts which would otherwise be an offence from that category. Its elaborate paraphernalia has been designed, it is said, to prevent captious Judges from wilfully misunderstanding the Code and cunning criminals from escaping its provisions. So, in Indian Penal Statutes where the doctrine of mens rea is intended to come into operation and a guilty mindis deemed essential for the proof of an offence, the Statute itself uses words like 'knowingly', 'willingly', 'fraudulently', 'negligently' and so on.

14. But there are now a large class of penal Acts created under the State as well as Central Acts, which are really not criminal but which are prohibited by the levy of a penalty in the interests of the public. To such a category belong offences against Revenue, Adulteration Acts, Forest Laws, etc., penalties directed against public nuisances, and cases in which though the proceedings are criminal in form, they are only summary modes of enforcing civil rights. In such cases, the prosecution need only prove the prohibited act and the defendant must then bring himself within a statutory defence. The position is the same in (a) England (b) America and (c) India.

ENGLAND.

15. Halsbury's Laws of England (Simonds Edition, I955), Vol. III at page 273, paragraph 508 has the following to say:

A statutory crime may or may not contain an express definition of the necessary state of mind. A statute may require a specific intention, malice, knowledge, wilfulness, or recklessness. On the other hand, it may be silent as to any requirement of mens rea, and in such a case in order to determine whether or not mens rea is an essential element of the offence, it is necessary to look at the objects and terms of the statute. In some cases, the Courts have concluded that despite the absence of express language the intention of the Legislature was that mens rea was a necessary ingredient of the offence. In others, the statute has been interpreted as creating a strict liability irrespective of mens rea. Instances of this strict liability have arisen on the legislation concerning food and drugs, liquor licensing arid many other matters.' R. v. Wheat L.R. (1921) 85 J.P. 203, Horton v. Gwymme L.R (1921) 2 K.B. 661, Cotterell v. Penn L.R. (1936) 1 K.B. 53, R. v. Leinster L.R. (1924) 1 K.B. 311, Harding v. Price L.R. (1948) 1 K.B. 695 , Reynold's Case (1951) 1 All E.R. 606, Qualities Diaries (York) Ltd. v. Pedley L.R. (1952) 1 K.B. 275, Lamlis Cases (1951) 1 All E.R. 923 , Watson v. Coupland (1945) 1 All E.R. 217 Tayor's Case (1951) 2 T.L.R. 284.

16. Archbold's Criminal Pleadings Evidence and Practice in Criminal Cases, 33rd Edition, 1954, at pages 23 to 24:

It has always been a principle of, the Common Law that mens rea is an essential element in the commission of any criminal offence against the Common Law. Chisholm v. Doulton (1889) L.R. 22 Q.B.D. 736, R. v. Twose 14 Cox. 327, Reynolds v. Austin (G.H.) & Sons L.R. (1951) 2 K.B. 135...In the case of statutory offences it depends on the effect of the statute; Cundy v. Lecocq L.R. 13 Q.B.D. 207. There is a presumption that mens rea is an essential ingredient in a statutory offence, but this presumption is liable to be displaced either by the words of the statute creating the offence or by the subject-matter with which it deals; Sherras v. De Ruszen L.R. (1895) 1 Q.B. 918 , Wright, J. Unless a statute clearly or by implication rules out mens rea, a man should not be convicted unless he has a guilty mind. Brend v. Wood (1946) 175 L.T. 306. In finding whether mens rea is excluded the Court should consider whether the offence consists in doing a prohibited act or in failing to perform a duty which only arises if a particular state of affairs exists. Harding v. Price L.R. (1948) 1 K.B. 695 at 701.

17. When there is an absolute prohibition against the doing of an act, scienter forms no part of the offence and absence of it afford no defence to the accused person, the doing of the act itself supplies the mens rea; see Kat v. Kiment L.R. (1951) 1 K.B. 24....

AMERICA.

18. American Jurisprudence, pages 784-785 (Section 24) has the following to say:

An evil intention or guilty knowledge, which is an essential part of crimes at Common Law, is in some cases, but not in others, held to be an element of crimes created by statute or ordinance. The view is taken in some cases that a criminal intent is not a necessary element of offences which are merely malum prohibitum, or of prohibitive statutes which cover misdemeanours in aid of the police power, where no provision is made as to intention. This is especially important in that if a criminal intent is not an essential element of a statutory crime, it need not be proved in order to justify a conviction. In other words, it is immaterial that the defendant acted in good faith or did not know that he was violating the law. In some cases it is said that where a statute denounces the doing of an act as criminal, the law imputes criminal intent from the doing of the act.

19. Corpus Juris at pages 76-77 (Section 42):

As a general rule where an act is prohibited and made punishable by statute only, the statute is to be construed in the light of the Common Law and the existence of a criminal intent is to be regarded as essential, even when not in terms required. The Legislature, however, may forbid the doing of an act and make its commission criminal without regard to the intent or knowledge of the doer and if such legislative intention appears the Courts must give it effect, although the intent of the doer may have been innocent. This rule has been generally, although not quite universally, applied in the enforcement of statutes passed in aid of the police power of the State, where the word 'knowingly' or other apt words are not employed to indicate that knowledge is an essential element of the crimes charged. The doing of the inhibited act constitutes the crime, and the moral turpitude or purity of the motive by which it was prompted, and knowledge or ignorance of its criminal character, are immaterial circumstances on the question of guilt. Whether or not in a given case a statute is to be so construed is to be determined by the Court by considering the subject-matter of the prohibition as well as the language of the statute, and thus ascertaining the intention of the Legislature...' See United States v. Belint 258 U.S. 250 : 66 L. Ed. 604, Shevlin Carpenter Co. v. Minnesota 218 U.S. 557, Armour Packing Co. v. U.S. U.S. 153 Fed. 1, Peo v. Roby 52 Mich 577 : 50 Am. Rep. 270, India Peo v. Werner 174 Ny. 132, Peo v. West 106 Ny. 293 : 60 Am. Rep. 452 extracted in footnotes.

20. Dr. Sir Hari Singh Gour's The Penal Law of India, 6th Edition (1955), edited by Ex-Chief Justice Verma of Allahabad, Volume 1, page 207 (Section 81, Indian Penal Code)..There are, however, a limited and exceptional class of offences which can foe held to be committed without a guilty mind, but they are usually of a comparatively minor character. Apart from isolated and extreme cases, the principal classes of exceptions may perhaps be reduced to three, and these three are: One is a class of acts which are not criminal in any real sense, but are acts which in the public interests are prohibited under a penalty. The second class is all public nuisance, and the third case in which, although the proceeding is criminal in form, it is really a summary mode of enforcing a civil right.

So far as the Indian Penal Code is concerned, every offence under it virtually imports the idea of criminal intent or metis rea. Intent denotes all those states of mind which the statute creating the offence in question regards as necessary that an accused must have in order to fix the guilt in him. But no question of mens rea arises where the Legislature has omitted to prescribe a particular mental condition as an ingredient of an offence, because the presumption is that the omission is intentional.

21. Srinivasa Mall Bairota v. Emperor (1947) M.L.J. 328 : I.L.R. Pat. 460 : A.I.R. 1947 P.C. 135, Isak Solomon v. Emperor I.L.R. (1948) Bom. 329 : A.I.R. 1948 Bom. 364, Legal Remembrancer v. Ambikacharan I.L.R. (1946) 2 Cal. 137, Ismail v. Emperor A.I.R. 1947 Lah. 220, Emperor v. Ramchandra : AIR1938Bom87 , Ravula Hariprasad Rao v. The State : 1951CriLJ768 and State v. Sheo Prasade : AIR1956All610 ; see also V.B. Raju, I.C.S., Penal Code (1957), page 249 and Appendix (A.).

22. I have discussed at length the scope of mens rea in statutory offences with special reference to certain provisions of the Indian Motor Vehicles Act in Ramamurthy v. The State (1957) M.W.N. (Crl.) 1., wherein I have referred to the considerable literature which has now grown around this topic of day to day importance.

23. Bearing these principles in mind, if we examine these relevant provisions, there cannot be the slightest doubt that they create an absolute liability. It clearly rules out mens rea as a constituent part of the crime. The object of the statute in creating such absolute liability is the imperative necessity to safeguard the lives of the citizens. If a tube of Tincture Digitalis is purchased for a patient suffering from heart attack, it would be practically murdering that patient if the tube supplied contained Tincture Digitalis not of the required B.P. standard quality which is the prescribed standard in such cases. Where the Pharmacopoeia does not prescribe any standard the drug must confirm to the commercial standard and evidence is admissible to show that it is of commercial standard or not; Dickins v. Randerson L.R. (1901) 1 K.B. 437, Boots Cash Dispensing Chemicals Ltd. v. Cowling (1903) 67 J.P. 195, Hudson v. Bridge (1903) 67 J.P. 195, and Bred v. British Drugs Houses Ltd. (1947) 2 All E.R. 613; see 88th Edition of Stone's Justices Manual (1956), Volume I, page 906 and following (food and drugs). The nature of the duty imposed upon the supplier of the Tincture Digitalis is an imperative one of supplying the standard quality, which would meet the requirements of the case.

24. The liability of the person from whom that supply of standard quality drug is required can admit of no qualifications and he must take all precautions to see that what he supplies is the standard quality preparation. In this very case the Drugs Inspector has suggested several precautions like bottling this medicine in amber coloured bottles and in small qualities and keeping them in cool places and have every batch supplied before use tested in the local laboratory and assure himself that what is supplied is of the standard quality. But even if after these precautions are taken, it turns out that sub-standard quality drug is supplied, it would make no difference to the criminal liability prescribed by the Act. It would only affect the question of punishment.

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.

27. Point 3. - On hearing the careful submission of the learned advocate Mr. B.T. Sundarajan, the learned Public Prosecutor and the Drugs Inspector, I have come to the conclusion that it is my duty to bring to the notice of the authorities concerned three things on their submissions which have impressed me. Firstly, the staff of Drugs Inspectors seems to be hopelessly undermanned. Two Drugs Inspectors are in charge of several firms in this city. Their inspections must necessarily be few and far between. In this case by the mercy of Providence these sub-standard preparations were detected in time and withdrawn from circulation. Otherwise, many avoidable deaths of cardic sufferers might have happened. Early strengthening of the staff and more frequent check of these stockist firms are indicated. Secondly, directives must be issued by the Central Government agency to the Drugs Inspectors to look upon themselves more as guide, philosophers and friends of these nascent industries and not as prosecutors. The work of the agency must be educative and not punitive. Only in cases where the firms have proved unresponsive and recalcitrant and are by the poverty of their resources unable to fulfil their obligations, should prosecutions be undertaken in the last resort. This is already the role assumed by Factory Inspectors and Sales-tax and Shops Establishment Inspectors in the State as impressed in the decisions of this Court. Thirdly, rules may be so suitably modified that it will be open to stockists of these dangerous drugs liable to deterioration for unknown causes and inexplicably, to have a sample of each batch before making them available to the public tested by the Guindy Institute or if it is overworked by other reputable laboratories through the agency of the Drugs Inspector and at the expense of the concerned firm and for which course this firm and others are only too willing. It has to be borne in mind that the firms want to safeguard their repute and their monetary returns are dependent upon the confidence which they inspire in the reliability of their drugs in the public mind. Therefore, it will be an exception rather than the rule for a firm not to co-operate with the Drugs Inspectorate staff. Of course I am excluding from this purview deliberate traffickers in inferior or adulterated drugs out for making quick and large profits. It is be hoped that these suggestions will commend themselves to the powers that be and bear early fruition.


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