Research › Browse › Judgment

Himachal Pradesh High Court · body

1990 DIGILAW 28 (HP)

KIRAN DEV SINGH v. STATE OF HIMACHAL PRADESH

1990-05-24

BHAWANI SINGH, V.K.MEHROTRA

body1990
JUDGMENT V. K. Mehrotra, J.—M/s. Rose Chem is a manufacturer of drugs in the Industrial Area, Chandigarh. Kiran Dev Singh is its proprietor. A complaint dated December 15,1988 filed under the signatures of the Drug Inspector, Mandi, is pending trial in the court of the Chief Judicial Magistrate, Mandi. 2. The complaint says that a sample of Furalin suspension (Batch No. RFD) manufactured by Rose Chem, having a license under the provisions of Drugs and Cosmetics Act, 1940 (briefly the Act) was found to be of non-standard quality in the report dated September 28, 1988, by the Government Analyst, Punjab. The sample said to have been drawn from the supply of Furalin suspension, a drug for Diarrhoea, made by Kiran Dev Singh to the Sub-Centre Stores, Public Health, Mandi, on the basis of an order which had been secured by M/s. Easter Pharmaceuticals Laboratory, Parwanoo, from the Chief Medical Officer, Mandi. 3. The allegation in the complaint further is that the sample having been found to be of a drug which was not of standard quality, the Incharge of the Sub-Centre Stores was intimated about the fact by the Drug Inspector vide letter dated October 4, 1983. The Incharge was required to disclose the name of the person from whom he had received the drug. The Incharge disclosed the name of Easter Pharmaceuticals Laboratory, Parwanoo through his letter of October 6, 1988 and supplied the purchase invoice. In this purchase invoice no batch number of the drug was found mentioned. 4. A copy of the report of analysis of the drug sample was furnished to M/s. Easter Pharmaceuticals Laboratory, Parwanoo. A part of the sample, which had been collected by the Drug Inspector on January 21, 1988, at the Sub-Centre Stores, Mandi, was also supplied to M/s. Easter Pharmaceuticals Laboratory, Parwanoo. No such copy of the report of the Analyst or part of the sample was, however, supplied to Kiran Dev Singh, who learnt about the case on receiving of the process from the court of the Chief Judicial Magistrate, Mandi. 5. On December 14, 1989, Kiran Dev Singh filed a petition under section 482 of the Code of Criminal Procedure in this Court for quashing the proceedings initiated against him by the complaint dated December 15,1988. 5. On December 14, 1989, Kiran Dev Singh filed a petition under section 482 of the Code of Criminal Procedure in this Court for quashing the proceedings initiated against him by the complaint dated December 15,1988. He urged that it was incumbent upon the Drug Inspector to supply a copy of the report of the Analyst and a part of the sample as well to enable him to get the sample analysed by the Director, Central Drugs Laboratory, with a view to find out whether the report of the Analyst was correct or not. Since the mandatory provisions in this regard had not been followed in the case, the proceedings against him were totally without jurisdiction and, therefore, liable to be quashed. 6. The case came up before one us (V.K. Mehrotra J.) The stand which was taken on behalf of tne State of Himachal Pradesh was that having regard to the requirements of section 18-A of the Act, Kiran Dev Singh was not entitled to be supplied with a part or a copy of the report of the Analyst nor would the failure to do so result in rendering his prosecution invalid in any manner. In support of this plea reliance was placed on behalf of the State upon the decision of this Court by V. D. Misra, C. J. in Manager Medical Pharmaceutical Processors, Amritsar v- State of H. P and others, 1983 Cr LJ 67. Another submission made on behalf of the State, with which we are not concerned at present, was that objection in this regard can well be taken before the Chief Judicial Magistrate at the trial and the benefit, if any, of the plea can be claimed by Kiran Dev Singh in that court. 7. In Manager, Medical Pharmaceutical Processors, the view taken by Chief Justice V D> Misra was that if the name of the manufacturer was not disclosed under section 18-A, it would not be necessary for the Drug Inspector to forward either a part of the sample of the drug or a copy of the report to him. The failure to do so would not adversely affect the proceedings against the manufacturer. The failure to do so would not adversely affect the proceedings against the manufacturer. Since one of us (V K. Mehrotra, J) felt that this did not represent a correct view of law, the papers were directed to be placed before the Chief Justice, for getting the question decided by a larger Bench, by an order of March 30, 1990, for the reasons contained therein. The matter has been placed before this Bench thereafter. 8. The basic question which arises for determination is whether there is an obligation upon the Drug Inspector, under the provisions of the Act, to furnish a part of the sample and a copy of the report of the Analyst to a manufacturer of the drug in question or not. Some provisions of the Act merit a look in this connection. 9. Chapter IV deals with manufacture, sale and distribution of drugs. Section 16 provides for standards of quality. Section 17 deals with mis-branded drugs. Section 18 contains a prohibition of manufacture and sale of certain drugs except in accordance with the conditions of a licence issued for the purpose. Section 18-A says that:— "18-A. Disclosure of the name of the Manufacturer, etc.—Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the drug or cosmetic." In the event of a breach of the provisions of section 18, a prosecution is contemplated under the Act. In such a prosecution there are certain pleas which are open to a person accused of an offence. Some defences are barred. This is to be found under section 19. Sub-section (3) of section 19 says that: "(3) A person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall not be liable for a contravention of section 18 if he proves— (a) that he acquired the drug or cosmetic from a duly licensed manufacturer, distributor or dealer thereof. (b) that he did not know and could not, with reasonable diligence, have ascertained that the drug or cosmetic in any way contravened the provisions of that section ; and (c) that the drug or cosmetic, while in his possession, was properly stored and remained in the same state as when he acquired it." 10. (b) that he did not know and could not, with reasonable diligence, have ascertained that the drug or cosmetic in any way contravened the provisions of that section ; and (c) that the drug or cosmetic, while in his possession, was properly stored and remained in the same state as when he acquired it." 10. Inspectors are to be appointed by the Central or the State Government for the purposes of the Act in exercise of power under section 21. Section 22 outlines the powers of these Inspectors. Section 23, which provides for the procedure to be followed by the Inspectors, in its material part is in the following terms:.— "23. Procedure of Inspectors — (1) Where an Inspector takes any sample of a drug or cosmetic under this Chapter he shall tender the fair price thereof and may require a written acknowledgment therefor. (2) * * * * * ? (3) Where an Inspector takes a sample of a drug or cosmetic for the purpose of test or analysis, he shall intimate su;h purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person, unless he wilfully absents himself, shall divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of the portions so sealed and marked ; Provided that where the sample is taken from premises whereon the drug or cosmetic is being manufactured, it shall be necessary to divide the sample into three portions only: Provided further that where the drug or cosmetic is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug or cosmetic be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them. (4) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same as follows :— (i) one portion or container he shall forthwith send to the Government Analyst for test or analysis ; (ii) the second he shall produce to the Court before which proceedings, if any, are instituted in respect of the drug ; and (iii) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have beet* disclosed ender section 18-A.” 11. Section 25 contemplates that a Government Analyst, to whom a sample of any drug has been submitted for test or analysis under sub-section (4) of section 23, shall deliver to the Inspector submitting it, a signed report in triplicate in the prescribed form. Sub-section (2) says that:— "(2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken and another copy to the person, if any, whose name, address and other particulars have been disclosed under section 18-A, and shall retain the third copy for use in any prosecution in respect of the sample." Sub-section (3), which deals with the conclusive nature of the report, subject to the claim of the accused person to adduce evidence in controversion of the report, provides that :— "(3) Any document purporting to- be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken or the person whose name, address and other particulars have been disclosed under section 18-A, has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report." Thereafter, under sub-section (4), the report of analysis made by the Director, Central Drugs Laboratory, who may analyse the sample, inter alia, at the instance of a person who, as an accused, exercises option to adduce evidence in controversion of the report of the Government Analyst, is held to be conclusive evidence of the facts stated therein* 12. The provisions noticed above make one thing amply clear. And, it is that where the manufacturer of a drug, which is found to be lacking in the requisite standard of quality, can be traced, he is ultimately to be held responsible for the supply of such a drug and, thus, liable for prosecution. Where, as in a case covered by section 19, the plea of warranty put forward by a person from whose possession the Inspector takes the sample or by a person who supplies the drug to such a person, is coming forward as an acceptable plea of defence, the ultimate liability for breach of the provisions of section 18 rests upon the manufacturer. If the intendment of the Act is to get hold of the manufacturer of a drug, which is lacking in necessary standards of quality, it is absolutely clear that such a manufacturer should have effective opportunity for a defence to the effect that the drug manufactured by him, out of which was drawn the sample, is not lacking in the necessary standards of quality. If such a defence is available to the manufacturer, it is obvious, that he should have access to a part of the sample drawn from his product, as well as to the report describing it as lacking in standards of quality, within a reasonable period to enable him to exercise the right ot adducing evidence in controversion of the report of the Analyst which describes his product as lacking in necessary standards of quality. 13. There is intrinsic indication in the Act itself which leads to this conclusion, The indication is contained in sub-section (3) of section 23 read earlier. The first proviso to that sub-section says that where the sample is taken from the premises wherein the drug is being manufactured, it shall be necessary to divide the sample into three portions only and the earlier part of this section says that the Inspector shall divide the sample into four portions. This discloses the legislative intent of a sample being necessarily made available to a manufacturer of the drug in question in unmistakable terms* A look at sub-section (4) of section 23 reinforces this conclusion. This discloses the legislative intent of a sample being necessarily made available to a manufacturer of the drug in question in unmistakable terms* A look at sub-section (4) of section 23 reinforces this conclusion. It provides that apart from the person from whom the sample is taken, one portion is to be sent to the Government Analyst for analysis, the other shall be produced before the court before which the proceedings are instituted in respect of the drug and the third is to be sent to the person, if any, whose identity is disclosed under section 18-A. 14. In case the sample is drawn from the store of the manufacturer, he gets a part thereof. Where it is drawn from a place other than a manufacturers store, the fourth part of the sample is meant for a person whose identity is disclosed under section 18-A. 15. Under section 18-A, disclosure of identity is to be by a person from whom the sample is drawn by the Inspector. If it is the manufacturer of the drug or his agent for distribution, there is no necessity or requirement of such a disclosure. The disclosure is contemplated in other cases alone. Such a provision, as contained in section 18-A, also suggests that the identity of the manufacturer of the drug is being aimed at by the legislature for the purpose of ensuring compliance with the provisions of the Act in regard to the standard of quality. 16. True it is that a literal reading of the provisions may lead to the conclusion that the obligation cast upon the Inspector under section 24 (4) would stand discharged where he forwards a part of the sample to the person whose identity is disclosed under section 18-A and that In case the person whose identity is so disclosed is different from the manufacturer, it would not be necessary for the Inspector to forward a part of the sample (or a copy of the report as envisaged by section 25 (3)) to the manufacturer yet Laving regard to the scheme of the Act discussed above, it would be incumbent upon the Inspector to make a part of the sample, as also a copy of the report of the analyst, available to the manufacturer. 17. 17. A perusal of the judgment in Manager, Medical Pharmaceutical Processors, 1983 Cr LJ 67, would show that the learned Chief Justice was of opinion that a manufacturer cannot claim any right which is not given to him under the aforesaid provisions of the Act. With utmost respect to the learned Chief Justice, the view taken by him proceeds on literal reading of the provisions without having regard to the scheme of the Act and the basic principle of law that person who is likely to be affected adversely by initiation of criminal proceedings against him for the breach of the provisions of the Act must legitimately have an effective opportunity for his defence within the four-corners of the Act. The prosecution of a manufacturer in respect of a drug, of which sample is drawn by the Inspector, is likely to result in the penalties envisaged by the Act. in case it is found that the drug manufactured by him was lacking in the requisite standards of quality contemplated under the Act. The object of the Act clearly being to get at tbe manufacturer of the drug, which is found lacking in the necessary standards of quality, for ensuring the availability of drugs of standard quality to the actual consumer, it is consistent with the concept of justice that such a manufacturer, whose drug is found by the Analyst to be lacking in the necessary standards of quality, should know about it and have an opportunity of getting the sample rechecked by analysis by the Director, Central Drugs Laboratory and thus put forward his defence, if any, effectively. This can only be ensured by reading the provisions of the Act in a manner that would lead to the conclusion that it is incumbent upon the Inspector to make available a copy of the report of the Analyst and a part of the sample to the manufacturer, where his identity becomes known before he is actually proceeded against from the initial stages by being made a party to the complaint filed by the Inspector. 18. There may be occasions where identity of the manufacturer becomes known later, during the pendency of the trial. 18. There may be occasions where identity of the manufacturer becomes known later, during the pendency of the trial. In that situation, he can only be brought before the Court in exercise of power under section 32-A. In such a case, it may not be necessary that the report of the Analyst or any part of the sample of the drug in question be made available to him. The report would be read against him as well. Law in this respect has been clearly laid down by the Supreme Court in V. N. Kamdar and another v. Municipal Corporation Delhi, AIR 1973 SC 2246 and M/s. Bhagwan Dass Jagdish Chander v. Delhi Administration and another, AIR 1975 SC 1309, while dealing with an identical provision contained in section 20-A of the Prevention of Food Adulteration Act, 1954. In a case, however, where the manufacturer is before the Court from the inception of the proceedings, there seems no legitimate ground to take the view that he should not be provided with a copy of the report of the Analyst or a part of the sample to enable him to defend himself by seeking the examination afresh of the sample by the Director, Central Drugs Laboratory. 19. It was also urged on behalf of the State that in the present case, the identity of the manufacturer, that is, M/s. Rose Chem was not disclosed under Sec. 18-A at all The identity of the manufacturer was known from the label of the drug and is also mentioned in the details filled in by the Drug Inspector in the prescribed form XVII. If that be so, as it seems, the claim of the manufacturer to be furnished with a copy of the report of the Analyst and a part of the same would stand on firmer ground. There is no doubt, in such a situation, of the source from which the drug in question has emanated. The manufacturer is brought before the court for trial on that account. For an effective defence, therefore, the manufacturer would, in these circumstances, have a right to supplied with a copy of the report of the Analyst and a part of the sample of the drug in question. Apart from anything else, such a claim would be well founded on the principles of natural justice. 20. For an effective defence, therefore, the manufacturer would, in these circumstances, have a right to supplied with a copy of the report of the Analyst and a part of the sample of the drug in question. Apart from anything else, such a claim would be well founded on the principles of natural justice. 20. Under the provisions of the Prevention of Food Adulteration Act, a right is given under section 13 (2) to the vendor to have the sample given to him analysed by the Director, Central Food Laboratory. This right has been described as a valuable one by the Supreme Court in Municipal Corporation of Delhi v. Ghisa Ram, AIR 1967 SC 970, wherein it has been held that where on account of the deliberate conduct of the prosecution, the vendor is deprived of the right to get the sample analysed by the Director of the Central Food Laboratory, he is so seriously prejudiced in his trial as to lead to his conviction, founded on the report of the Public Analyst, being set aside. 21. The dictum of the Supreme Court has been relied upon by a learned single Judge of the Punjab and Haryana High Court in Cyanamid India Limited v. The State of Haryana and another, 1989 CC Cases 60 (HC) for his view that a manufacturer of insecticides can claim to be furnished with a copy of the report of the Analyst even though there is no specific provision entitling him to do so under the Insecticides Act, 1968. The learned Judge also sought support from the decision in the case of Mr. H. Lange v. The State of Punjab and others, 1986 (1) PLR 262. 22. In view of what we have stated above, it appears clear that the decision in Manager, Medical Pharmaceutical Processors, Amritsar v. State of H. P. and others, 1983 Cr LJ 67 does not lay down the correct law. The provisions of the Act, when read in the light of the scheme thereof, lead to the unmistakable conclusion that it is incumbent upon the Drug Inspector to make, a copy of the report of the Analyst as also a part of the sample, available to the manufacturer where his identity becomes known before he is actually proceeded against from the initial stages by being made a party to the complaint filed by the Inspector. This is the mandate of law lest the manufacturer is deprived of an effective opportunity for a defence to the effect that the drug manufactured by him, out of which the sample was drawn, is not lacking in necessary standard of quality. The manufacturer should have access to the report and a part of the sample drawn from his product within a reasonable period to enable him to exercise the right of adducing evidence in controversion of the report of the analyst which describes his product as lacking in necessary standards of quality. 23. With this opinion the case may now be listed before the learned single Judge for final disposal. Order accordingly.