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1980 DIGILAW 362 (MAD)

State by Public Prosecutor v. Rajamani, Proprietor-cum-Vaidyar, M/s. Shanmuga Pharmacy, Erullappapuram, Nagercoil

1980-09-18

S.SURYAMURTHY

body1980
Judgment : This is an appeal against the judgment of the learned Chief Judicial Magistrate, Kanyakumari at Nagercoil, acquitting the respondent against whom a complaint was filed by the appellant for offences under sections 18 (c), 18 (a) (ii) and 18-A of the Drugs and Cosmetics Act (hereinafter referred to as the Act), and the Rules framed there under punishable under sections 27 (a) (ii), 27 (b) and 28 of the Act. 2. The complainant, who is the Drugs Inspector, Kanyakumari at Nagercoil, visited on 20th February, 1975, the Shanmugha Pharmacy, Erulappapuram, Nagercoil, belonging to accused/respondent took three bottle of Sandhanasavam manufactured by the said Shanmugha Pharmacy for analysis. The three bottles were sealed with the official seal of the complainant in the presence of the accused to whom a copy of the intimation in Form No. 17 was given together with the sealed bottle. The cost of the three bottles was paid. One sealed bottle with an intimation under Form No. 18 was sent the Government Analyst, Drugs, King Institute, Guindy, for analysis. The Government Analyst reported that the sample was misbranded as it contained 1.6 mgm. of morphine per 100 ml. of the sample. According to the complainant, an Ayurvedic preparation cannot contain morphine. Ayurvedic preparation should be manufactured exclusively in accordance with the formula described in the authoritative boofes of Ayurveda specified in Schedule I to the Act. As the preparation contained morphine it was contended by the complainant that it was not an Ayurvedic preparation within the meaning of section 3 (a) of the Act, but a preparation within the meaning of the word ‘drug’ as defined in section 3 (b) of the Act. 3. This case of the prosecution was spoken to by P.W.1, the Drugs Inspector, who took the sample, and P.W. 2 who was the Government Analyst at the King Institute in Guindy, and who analysed the sample in question and issued the certificate, Exhibit P-4, stating that it contained 1.6 mg. of morphine in 100 ml. of the sample. 4. 3. This case of the prosecution was spoken to by P.W.1, the Drugs Inspector, who took the sample, and P.W. 2 who was the Government Analyst at the King Institute in Guindy, and who analysed the sample in question and issued the certificate, Exhibit P-4, stating that it contained 1.6 mg. of morphine in 100 ml. of the sample. 4. The accused filed C.M.P. No. 392 of 1975 for sending the sample bottle given to him for analysis by the Central Drugs Laboratory, Calcutta, in the said petition, he did not ask the Director of the Central Drugs Laboratory Calcutta, to analyse the contents of the sample bottle sent to him and report regarding the ingredients thereof, but very cleverly wanted the opinion of the Director as to whether the Sandhanasavam is an Ayurvedic preparation or not, and. therefore, the Director of the Central Drugs Laboratory, Calcutta, reported that as no analytical standards in respect of the Ayurvedic Drugs had been prescribed yet under the Drugs Act and the Rules framed there under, the Central Drugs Laboratory is not in a position to analyese the simple and give any Opinion as to whether it is an Ayurvedic preparation or not. He, therefore, referred the matter to the Adviser, Indigenous System of Medicine, Ministry of Health, Government of India, Nirman Bhavan, New Delhi, for his opinion. The Counsel, for theaccusedthereafterfiled,another petition requesting that the sample may be sent to the Adviser, Indigenous System of Medicine, Ministry of Health, Government of India, Nirman Bhavan, New Delhi, for his opinion as to whether the samples are Ayurvedic preparation or not. The sample sent to the Adviser, Indigenous system of Medicine, would appear to have been sent to Caapt. Srinivasamurthi Research Institute. Adyar, Madras, for analysis, where it was analysed by D.W. 1 who submitted the reports, Exhibits D-2 and D-3. According to Exhibits D-2 and D-3, there was no morphine, hut only chloral hydrate. Though the learned Magistrate was aware that Capt. Srinivasamurthi Research Institute at Adyar is not a statutorily recognised institution, nevertheless he relied on the evidence of D.W. 1 and his reports to come to the conclusion that there was no morphine in the sample, and, therefore, found the accused not guilty. 5. Though the learned Magistrate was aware that Capt. Srinivasamurthi Research Institute at Adyar is not a statutorily recognised institution, nevertheless he relied on the evidence of D.W. 1 and his reports to come to the conclusion that there was no morphine in the sample, and, therefore, found the accused not guilty. 5. It is contended by the learned Counsel for the respondent now that Chapter IV of the Act had not been extended to the territory of Tamil Nadu and has not come into force in this State prior to 1st June, 1977, that the standards for Ayurvedic, Unani and Siddha have not been prescribed for this State, that a Government Analyst in relation to Ayurvedic, including Siddha and Unani Drugs within the meaning of section 3 (c) (i) of the Act has not been appointed by the Central Government or by the State Government under section 33-F of the Act and it at therefore, there is and was nobody competent to pronounce an Opinion regarding the quality and standard of the sample, namely, Sandhanasavam prepared by the accused. 6. Taking up the later argument first, I may staightway say that the question is not whether the Sandhanasavam prepared and marketed by the accused, samples of which were taken by P.W-1 conform to the Ayurvedic standards or not. if that question is to be determined, no doubt only an Analyst appointed by the Central Government or a State Government under section 33-F of the Act as contemplated by section 3 (a) (i) of the Act can give an opinion after analysis. The question ill the instant case is whether what was sold by the accused as Sandhanasavam was mis-branded in the sense that it contained morphine. 7. The question ill the instant case is whether what was sold by the accused as Sandhanasavam was mis-branded in the sense that it contained morphine. 7. Section 3 (a) of the Act defines “Ayurvedic or Unani Drugs” as including: “all medicine intended for internal or external use for or in the diagnosis, treatment mitigation Or prevention of desease in human beings, mentioned in and processed and manufactured exclusively in accordance with the formulae prescribed in the authoritative boots of Ayurvedic system of medicine, specified in the First Schedule.” By reason of section 3 (b), “drug’ includes- (i) all medicines for internal or external use of human beings or animals arid all substances intended to be used for or (in the diagnosis, treatment) mitigation or prevention of disease in human beings or animals, and (ii) such substances (Other than food) intended to effect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette”. It would be seen from this that the definition of “drug’ is a comprehensive definition excluding only medicines and substances which are exclusively used or prepared for use exclusively in the Ayurvedic or Unani system. It has been held by the Supreme Court in Ishwar Singh Bindra v. State of U.P.1. "The scheme of clause (1) of section 3 (b) is to take in all medicines or substances with the exception of such medicines or substances which are exclusively used or prepared for use in accordance with the Ayurvedic or unani system of medicine. The exception made in the case of latter class of medicines or substances was essentially meant to cover only such medicines or substances which were used in the Ayurvedic or Unani system or were prepared for use in accordance with these systems." Morphine is an official preparation in the Indian Pharmacopoeia, and is not therefore a drug exclusively used in accordance with the formulae described in any authoritative Ayurvedic text. 8. The allegation of the prosecution is that the accused has no licence to manufacture a drug containing morphine. The accused has not produced the manufacturing license issued to him to show that he has a right to use morphine in any Ayurvedic preparation. 8. The allegation of the prosecution is that the accused has no licence to manufacture a drug containing morphine. The accused has not produced the manufacturing license issued to him to show that he has a right to use morphine in any Ayurvedic preparation. In fact, I granted time to produce the licence, but the licence has not been produced. Therefore, I find that by lusing morphine, which is not a drug exclusively used in Ayurvedic or Unani preparation, and that too without a valid licence, the accused has contravened the provisions of section 18 (c) and section 18 (a)(ii) of the Act, reas with reules 17 (e) and 96 of the rules framed under Act. 9. It is, however, contended by the learned Counsel for the accused/respondent that the accused has been deprived of his valuable right of getting an opinion from a great expert by sending the sample of the drug under section 25 (4) of the Act to the Central Drugs Laboratory; This argument is without any substance. In fact, an application has been filed by the Counsel for the accused in the lower Court under section 25 (4) of the Act for sending the sample kept in the Court to the Central Drugs Laboratory for analysis and report, and, therefore, the sample was sent to the said Laboratory But, in the memo, dated 2nd September 1975 filed m the Court of the Chief Judicial Magistrate the Counsel for the accused has stated that, "the samples of Sandhariasavam which are to be sent to the Central Drug Laboratory are Ayurvedic preparation and so the opinion required is, as to whether the samples of Sandhanasavam are Ayurvedic preparations or not“. He has further submitted that, ”Opinion is to be called for, as to whether the samples of Sandhanasayam are Ayurvedic preparations or not.“ Thus, the Counsel for the accused has deliberately drawn a red-herring across the line, and the learned Chief Judicial Magistrate was misled and allowed himself to be misled into thinking that the drug had to be analysed at the Central Drugs Laboratory in Calcutta by the expert to ascertain whether it is an Ayurvedic preparation. Thereafter, the Central Drugs laboratory had replied by letter, dated 17th September, 1975, as follows: ”As no analytic standards in respect of Ayurvedic drugs has yet been prescribed under the Drugs Act and Rules there under we regret we are not in a position to analyse these samples and give any opinion whether it is an ayurvedic preparation or not. The case may peihaps be referred to the adviser, Indigenous System of Medicine’s, Ministry of Health, Government of India, Nirman Bhavan, New Delhi-11 for his Opinion. However, if there is any suspicion by the Drug Control autnorities as to the presence of any allopathic ingredient, (which must be specified by name), this laboratory could perhaps try to detect the presence of such ingredient in such samples under reference“. At least, after receiving this letter, the Chief Judicial Magistrate should have applied his mind to the facts of the case and should have asked the Director, Central Drugs Laboratory, Calcutta, to state whether the samples sent contained morphine. However the Chief Judicial Magistrate failed in his duty to ask for an opinion relevant to the case and has allowed himself to be misled as aforesaid by the accused. 10. Again, the accused has filed a petition before the Chief Judicial Magistrate, on 25th September, 1975, for sending the samples to the Adviser, Indigenous System of Medicine, Ministry of Health, Government of India, Nirman Bhavan, New Delhi’ for his Opinion as to whether these samples are Ayurvedic preparations or not. He has stated in this petition: ”In the interests of justice it is absolutely necessary that the sarnple should be analysed by the Adviser, Indigenous. System of Medicine to find out whether it is an Ayurvedic preparation or not.“ Earlier, in this petition he has stated that, ”The point for consideration is whether it is an Ayurvedic preparation or not.“ This again, was a misleading petition, and the learned Chief Judicial MagisUate ened in thinking that the sample had to be analysed to ascertain whether it was an Ayurvedic preparation in nor. What had to be ascertained was whether it contained morphine, a drug of India Pharmacopoeia. The Adviser replied by letter, dated 6th December, 1975, that : ”The Central Government has not so far established any Drug Testing Laboratory for Ayurveda, Siddha or Unani Drugs“. 11. What had to be ascertained was whether it contained morphine, a drug of India Pharmacopoeia. The Adviser replied by letter, dated 6th December, 1975, that : ”The Central Government has not so far established any Drug Testing Laboratory for Ayurveda, Siddha or Unani Drugs“. 11. Subsequently, the Deputy Adviser, Ministry of Health and Family Planning, Government of India, New Delhi, sent the sample of the drug to Captain Srinivasamurthy Research Institute, Adyar, Madras, ”for necessary analysis“. The said Institute has sent Exhibits D-2 and D-3 to the Chief Judicial Magistrate, Kanyakumari District expressing the Opinion that: ”The sample does not conform to the preliminary standards for Chandanasavam (prepared according to the formula given in Bhaisajya Ratnavalli. Sukra-mehadhikara, Sloka 34-38, which corresponds to the formula given in Sahasrayoga) in that the total solid and alcohol contents are in excess of the limits.“ 12. By letter dated 25th March, 1976(marked as Exhibit D-1) the Adviser in Indgienous Systems of Medicines has informed the learned Chief Judicial Magistrate that: ”The fact that the samples do not conform to the preliminary standards for Sandhanasavam (Prepared according to the formula given in Bhaisajya Ratnavalli Sukrarael. aadhikara Sloka 34-38 which corresponds to the formula given in Sahasra. yogam) received with your letter No. 6163/75-HC, dated 21st December, 1975, in respect of total solid and alcohol content, which are in excess of the limit, will not make this medicine non ayurvedic, since the "standards have not been notified by the Government of India". However, the presence of Chloral hydrate, in even negligible quantity, which is not mentioned in the formula will make this medicine Non-Ayurvedic." In the face of Exhibit-D-1, it is preposterous to contend, as the learned Counsel for the accused does, that the Sandanasavarm manufactured by the accused, a sample of which was taken by the Drugs Inspector, is an Ayurvedic prepatation. In any event, after asking the Director, Central Drugs Laboratory, Calcutta, to state whether the samples of Sandhanasavam sent are Ayurvedic preparation or not, instead of asking him to analyse the sample and find out whether it contains morphine it is not open to the accused to turn round and wail now that he has been denied an opportunity to have the drug analysed by the Director of Central Drugs Laboratory, Calcutta, to find out whether it contains morphine. I may add that there was no purpose in sending the sample to the Director of Captain Srinivasamurthy Research Institute, Adyar Madras, for analysis, because the said Director has not been appointed by notification in the Official Gazette to be a Government Analyst as laid down in section 33-F of the Act. 13. Incidentally, I may add that when the concerned Chief Judicial Magistrate was called upon to" explain under what circumstances he sought for the opinion of the Director, Central Drugs Laboratory, Calcutta, as to whether the preparation is an Ayurvedic preparation or not instead of asking his opinion whether it contained morphine or not, he has sent an irrelevant reply without understanding the reason for which the explanation was sought and has contended that- "If for any reason the High Curt construes that the action of mine (as Chief Judicial Magistrate, Kanyakuttari at Nagercoil) is not in compliance with the abovesaid provision of law, the question would amount to one of error of judgment in construing the abovesaid provision of law and in all principles governing administrative tribunals and departments, no error of judgment can be the subject-matter of any kind of action whatsoever". The explanation was sought, because the learned Counsel for the accused endeavoured to throw the blame on the learned Chief Judicial Magistrate for asking the opinion whether the sample seized was Ayurvedic drug or not, instead of seeking an opinion as to whether it contained morphine or not, and not for taking any action against the learned Magistrate. This Court does not need to be told by the learned Magistrate, when action can be taken and when it cannot be taken. 14. As the preparation called Sardhara. savam the sample of which was taken by the Drugs Inspector in the instant case, is proved to have contaired normal. it is not an Ayurvedic preparation. It is therefore, a misbianded drug 15. The learned Chief Judicial Magistrate, has however, observed that- "when it is the case and the contention and the evidence is also such that in an Ayurvedic preparation, morphine has been added, it would be a case of adultering Ayurvedic medicine and hence it is highly doubtful as to whether the provisions of section 18 (c) and section 18 (a)(ii) of the Drugs and Cosmetics Act would apply." The learned Magistrate has not understood the prosecution case. Subsequently, he observed that- "In this case a peculiar situation has arisen in which the presence of morphine itself has become a matter of doubt." The learned Magistrate seems to be assailed by such a doubt, because the "accused sent the sample given to him to the Central Drug Laboratory, Calcutta, for analysing it as to whether it is an ayurvedic preparation or not The learned Magistrate was obviously unable to understand the difference between asking for an Opinion as to whether the drug contained morphine and an opinion as to whether it is an Ayurvedic drug. The judgment of the learned Magistrate is lacking in rectitude in induction and consistency in deduction. 16. The learned Magistrate has relied on the evidence of D.W. 1 the expert wloana. lysed the samples sent to Captain Srinivasaraurthy Research Institute, Adyar, Madras, and Exhibits D-2 arid D-3 to corns to the conclusion that "the presence of morphine as per Exhibit P-4 and the evidence of P.W. 2 would become doubtful". In view if the provisions of section 33-F of the Act, the learned Magistrate, ought not to have relied on the opinion of D.W. 1. The learned Magistrate, however, observes that- "D.W. 2 would say that he also tested to find out whether there was morphine or not; but found no morphine and found out only Chloral Hydrate. Therefore, the presence of morphine having been not found by D.W. 2 although he specially tested the same purpose it has become a highly doubtful matter as to whether morphine was really present or not." Only one witness has been examined by the accused and he is D.W. 1 (Dr. Bhima Rao) attached to Captain Sinivasamurthy Research Institute, Adyar, Madras, whose opinion, as already stated cannot be relied on as he is not a Government Analyst appointed by notification in the Official Gazette by the Central Government or the State Government as laid down in section 33-F of the Act. It appears from the judgment of the learned Magistrate that the learned Assistant Public Prosecutor brought to the notice of the learned Magistrate the provisions of section 33-F of the Act, and contended that- "Captain Srinivasamurthy Research Institute, Adyar, maintained by the Government of Indiaa under the Ministry of Health and Family Planning and intended for. Indian Medicine like. It appears from the judgment of the learned Magistrate that the learned Assistant Public Prosecutor brought to the notice of the learned Magistrate the provisions of section 33-F of the Act, and contended that- "Captain Srinivasamurthy Research Institute, Adyar, maintained by the Government of Indiaa under the Ministry of Health and Family Planning and intended for. Indian Medicine like. Ayurveda, Unani and Siddha and Homeopathy is not a recognised Institute unaer the Drugs and Cosmetics Act and therefore, any certificate issued by that Institute has no legal basis and has to be excluded." The learned Magistrate has got over this argument by observing that- "Although Captain Srinivasamurtly Research Institute at Adyar is not a recognised one under the Drugs and Cosmetics Act arid therefore it has no statutory recognition, inasmuch as the Institute and D.W.2 are Experts in Indigenous Medicine and are competent to analyse Ayurvedic preparations, certainly it has evidentiary value. No statutory character can be attached. But evidentiary value cannot be lost sight of ". Here again, the learned Magistrate has fallen into an error by equating the analysis to ascertain whether a formulation contains morphine with competency to analyse and state whether the pieparation is Ayurvedic or not. The learned Magistrate has lost sight of the difference between the two purposes. It is impossible to find out what the learned Magistrate means by saying that "no statutory character car be atiached". The observation of the learned Magistrate that the evidentiary value cannot be lost sight of, has no meaning, because in the face of section 33-F of the Act and the further fact that the expert in Ayurvedic Medicine attached to Captain Srinivasamurthy Research Institute was asked to state whether the sample seized is an Ayurvedic preparation or not, and has stated that it is not an Ayurvedic preparation, there is no evidence of any value, the sight of which the learned Magistrate refuses to lose. 17. The learned Magistrate considers D.W. 1 to be "an Expert of mustarding qualification" because he is "an M.A. in Chemistry and M.Sc., in Organic Chemistry and Ph. D. in Organic Chemistry besides a Ph. D. Degree holder of Madras University". Later on, he observes that D.W. 1. 17. The learned Magistrate considers D.W. 1 to be "an Expert of mustarding qualification" because he is "an M.A. in Chemistry and M.Sc., in Organic Chemistry and Ph. D. in Organic Chemistry besides a Ph. D. Degree holder of Madras University". Later on, he observes that D.W. 1. "being an Expert in the Field and he having found no morphine certainly a serious doubt has arisen with regard to the evidence of P.W. 2 and Exhibit P-4 and the benefit of the same has to be given to the accused who has been contending throughout that he never added morphine. I have already pointed out that even Exhibit P-8 he has so contended. When he has been putting forward the straight contention from the beginning and the Expert/D.W. 1, has found no morphine, certainly a serious doubt has arisen and the benefit of the same has to be given, and if so done the very basis of the prosecution is lost." The qualifications of D.W. 1 do not detract from the effect of section 33-F of the Act and his opinion cannot be relied on. 18. The learned Magistrate appears to have been impressed by what he calls the "straight contention" of the accused "from the beginning" that the formulation contains no morphine. The opinion of P.W. 2 expressed in Exhibit P-4 that the sample of Sandhanasavam contains morphirie has become final after the attempt of the accused to side track the issue by asking the Opinion of the expert in the Central Drugs Laboratory, Calcutta, to state whether or not it is an Ayurvedic preparation. No accused can be expected to admit his guilt, and the mere fact that the accused disputes the case of the prosecution "throughout" does not take away the effect of the evidence adduced by the prosecution. Accepting the evidence of P.Ws. 1 and 2 and the opinion of p.W- 2 in Exhibit P-4 that the sample of Sandhanasavam contains morphine, I find that the accused is guilty of the offences punishable under section 18 (c) read with section 27 (a) of be Act and section 18 (a) (ii) read with sections 17 (e) and 27 (b) of the Act. At the request of the learned Counsel for the accused, this case is adjourned to 4th August, 1980, for hearing the accused On the question of sentence. 19. At the request of the learned Counsel for the accused, this case is adjourned to 4th August, 1980, for hearing the accused On the question of sentence. 19. I have heard the accused and the learned Counsel for the accused on the question of sentence. The accused feels highly repentant and says that he was not aware that morphine should not be added to the preparation called "Sandhanasavam". The Ayurvedic medicine called "Sandhanasavam" prepared by the accused was not for internal consumption, but only for external application, and only a very small percentage of morphine was found. As the preparation was not intended for internal consumption. I am of the Opinion that a severe sentence of imprisonment is not called for. The accused appears to be weak in health and also old I am satisfied with bis assurance that hereafter he will take care to see that no drug of the Indian Pharmacopoeia is added to any of his preparations. In these circumstances, on the first count of charge framed under section 18 (e) read with section 27 (a) of the Act, the accused is convicted arid sentenced to imprisonment till the rising of the Court, and to a fine of Rs. 500 and in default to suffer simple imprisonment for three months. On the second count of charge framed tinder section 18 (a) (ii) read with sections 17 (e) and 27 (b) of the Act, the accused is convicted and sentenced to imprisonment till the rising of the Court and’ to a fine of Rs. 500 and in default to suffer simple imprisonment for three months. Time for payment of fine — one month from the date of receipt of this order in the lower Court. Accused convicted and sentenced.