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  • Sections 17(a), 18(a)(i) and Rule 78(m) read with Section 27(d) of the Drugs and Cosmetics Act (in brief the Act)
  • sub-sections (1), (2) and (3) of Section 319 of the Cr. P.C 1973 (2 of 1974),
  • provisions of Sections 23(4)(iii) and 25(2) and (4) of Act
  • Section 23(4)(iii) and Section 25(4).
  • Cosmetics Act, 1940 and the Rules
  • provisions of Section 25(4),
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Citation Codes
Equivalent Citations
citation codes
Case Number
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Acts
  • Sections 17(a), 18(a)(i) and Rule 78(m) read with Section 27(d) of the Drugs and Cosmetics Act (in brief the Act)
  • sub-sections (1), (2) and (3) of Section 319 of the Cr. P.C 1973 (2 of 1974),
  • provisions of Sections 23(4)(iii) and 25(2) and (4) of Act
  • Section 23(4)(iii) and Section 25(4).
  • Cosmetics Act, 1940 and the Rules
  • provisions of Section 25(4),
Smart Summary

Factual and Procedural Background

P.W.1 (an Inspector) purchased ten bottles of sodium chloride and dextrose injections from M/s Nidubrolu Medical Agencies, Nidubrolu (in the presence of P.W.2, the proprietor). The product was stated to have been manufactured on 13-2-1989 by M/s Vezey Parenteral Products (A-1). Two bottles were sent to the Government Analyst, Drugs Control Laboratory, Hyderabad (Form No. 18 dated 28-6-1989), whose report (Ex. P-3) stated the sealed solution contained many particles and a fungus-like mass and concluded the sample was not of standard quality under the Drugs and Cosmetics Act, 1940 and rules thereunder.

P.W.1 sent a copy of Ex. P-3 by registered post to M/s Nidubrolu Medical Agencies requesting the source of supply. P.W.2 stated they had purchased the drug from M/s Amruta Medical Agencies, Narsaraopet (invoice 9-5-1990). P.W.1 then wrote to M/s Amrutha, and P.W.3 (a partner there) stated the drug was supplied by A-1 (invoice 8-5-1989) and confirmed the sale to Nidubrolu Medical Agencies.

A prosecution was launched against A-1 and the revision petitioner (the sole proprietor of A-1) in C.C. No. 78/90 before the Judicial First Class Magistrate, Ponnur. The Magistrate acquitted A-1 but convicted the revision petitioner under Sections 17(a), 18(a)(i) and Rule 78(m) read with Section 27(d) of the Drugs and Cosmetics Act, sentencing him to one year rigorous imprisonment and a fine of Rs. 500 (one month R.I. in default). The petitioner appealed (Criminal Appeal No. 119 of 1991) to the Sessions Judge, Guntur, which appeal was dismissed. The present revision petition to the High Court followed.

Legal Issues Presented

  1. Whether the statutory requirements for division and supply of samples and analyst's reports (in particular Section 23(4)(iii) and Section 25(2) and (4) of the Drugs and Cosmetics Act) were complied with and, if not, whether non-compliance precludes conviction and entitles the accused to acquittal.
  2. Whether the manufacturer (revision petitioner) was entitled to receive a portion of the sample and a copy of the analyst's report as a person whose name and address were disclosed under Section 18-A, and thereby to have the sample tested in the Central Drug Laboratory.
  3. Whether the analyst's report (Ex. P-3), which recorded particles and a fungus-like mass, is sufficient for conviction when those particles/mass were not separately analyzed (considering the principles in Prem Pharmaceuticals v. State of M.P.).
  4. Whether Section 32-A of the Act (power of the Court to implead the manufacturer during trial) or authorities considering impleading under Section 32-A can justify non-supply of the sample or report to the manufacturer impleaded under Section 18-A.

Arguments of the Parties

Revision Petitioner / Defence (as argued by Sri Padmanabha Reddy)

  • Under Section 23(4)(iii) read with Section 18-A, the revision petitioner (manufacturer) was entitled to a portion/one container of the sample.
  • Under Section 25(2) the petitioner was entitled to a copy of the Government Analyst's report (Ex. P-3); because the sample and report were not supplied, he was precluded from exercising his statutory right under Section 25(4) to have the sample tested at the Central Drug Laboratory.
  • The statutory provisions (Sections 23(4)(iii), 18-A and 25(2)) are mandatory; non-compliance is fatal to prosecution and entitles the accused to acquittal.
  • The analyst did not separately analyze the particles and the fungus-like mass recorded in Ex. P-3; relying on Prem Pharmaceuticals v. State of M.P., the absence of analysis of these particulars undermines the conclusion that the substance was extraneous and that the drug was sub-standard.

Prosecution (as argued by Sri Narsimha Reddy, Assistant Public Prosecutor)

  • A-1 was informed about the contents of Ex. P-3 on 6-3-1990 (Ex. P-10) and a copy was received on behalf of the revision petitioner (acknowledgment Ex. P-11); thus the petitioner was aware of Ex. P-3 and, if he wished, could have sought the sample for testing.
  • Because the petitioner did not request the sample or notify the Inspector/Court within the statutory period, he cannot now complain that the copy of Ex. P-3 or the sample was not supplied.
  • Section 32-A authorizes the Court to implead a manufacturer during trial; when the manufacturer is impleaded in that manner, service of the analyst's report or supply of the sample to the manufacturer is not required in the same way (prosecutor relied on Section 32-A and an authority, Manager, Medico Pharmaceutical Processors v. State of A.P.).
  • The prosecution contended that informing A-1 by Ex. P-10 constituted communication of the analyst's findings, and the further right to have the sample tested was not frustrated by the steps actually taken.

Table of Precedents Cited

Precedent Rule or Principle Cited For Application by the Court
Drugs Inspector, C.D.S.C.O (South) Zone, Madras v. Modern Drugs, 1982 (2) Cr. L.J. 2285 Section 25 of the Act is mandatory; strict observance is imperative; accused has a valuable right to a copy of the analyst's report and to seek contradiction within 28 days; denial of this right precludes conviction. The Court treated this authority as categorical support for the mandatory nature of Section 25 and for the proposition that non-supply of the report/sample can prejudice the accused.
A.M. & G. Stores v. State, AIR 1973 MP 225 Supports the proposition that provisions like Section 25 are mandatory and must be complied with. The Court cited it as being to the same effect as Modern Drugs, corroborating the mandatory character of Section 25.
Manager, Medico Pharmaceutical Processors v. State of A.P., (1983 Cr. L.J. 67) Held (as relied upon by the prosecution) that non-supply of the analyst's report/sample did not necessarily cause prejudice to the accused where the manufacturer was impleaded under Section 32-A. The Court distinguished this authority: it was in the context of impleading under Section 32-A (not under Section 18-A). The Court held the decision inapplicable to a case where impleading is under Section 18-A and the statutory rights under Sections 23(4)(iii) and 25 apply.
Prem Pharmaceuticals v. State of M.P., 1989 Cr. L.J. 2048 Where particles found in an intravenous fluid were not separately analyzed, the Court observed that without analysis it cannot be established that they were extraneous matter; absent allegation of awareness of intermixture, presence of particles alone does not make the drug sub-standard. The Court relied on this reasoning to note that in the present case the particles and the fungus-like mass in Ex. P-3 were not analyzed, and therefore Ex. P-3 did not conclusively establish that the drug was sub-standard without further proof or allegation of awareness.

Court's Reasoning and Analysis

The Court proceeded by examining the statutory scheme and the facts proven on record.

First, the Court interpreted Section 23(4)(iii) in context: where a sample is divided, the Inspector must return one portion to the person from whom the sample was taken, send one portion to the Government Analyst, produce one portion before the court if proceedings are instituted, and send the other portion to the person whose name and particulars have been disclosed under Section 18-A. In the present case the retail seller (P.W.2) disclosed that the supplier was M/s Amruta and that Amruta had obtained the drug from A-1. On that basis the Court held that the revision petitioner (being the manufacturer A-1) fell within the class of persons entitled to receive the portion referred to in Section 23(4)(iii).

Second, the Court emphasized that forwarding a sample to the manufacturer is not a mere formality: Section 25(4) grants the manufacturer the right to have the sample tested or analysed in the Central Drug Laboratory to obtain a second opinion on the Government Analyst's report received under Section 25(1). The Court treated Section 25 as mandatory, relying on the Modern Drugs decision and A.M. & G. Stores, which hold that strict observance of Section 25 is imperative and that denial of the accused's right to the report/sample can defeat the prosecution.

Third, the Court addressed the prosecution's reliance on Ex. P-10 and its acknowledgment (Ex. P-11) to argue that the revision petitioner was informed of Ex. P-3. The Court found that mere communication of the contents (as in Ex. P-10) was not equivalent to the statutory modes of supply contemplated by Sections 23 and 25; compliance required the specific statutory steps so the manufacturer could exercise the right to have a sample tested at the Central Drug Laboratory.

Fourth, the Court considered the prosecution's reliance on Section 32-A and the Medico Pharmaceutical Processors decision. It drew a distinction: Section 32-A applies where a manufacturer is impleaded by the Court during trial (under circumstances described in that section), and the rights of a manufacturer impleaded in that manner are not governed by Section 32-A. However, where a manufacturer is a party by virtue of Section 18-A, his statutory rights are specifically set out in Sections 23(4)(iii) and 25(2)/(4). Therefore the Medico Pharmaceutical Processors authority (involving impleading under Section 32-A) was inapplicable.

Fifth, on the evidential point, the Court relied on Prem Pharmaceuticals to observe that particles and masses noted by an analyst, if not separately analysed, cannot automatically be treated as extraneous or as rendering the drug sub-standard; without analysis or an allegation of awareness of intermixture, the presence of such particles does not necessarily support the charge. The Court recorded that in the present case the mass and particles were not analysed by the analyst.

Putting these strands together, the Court concluded that the revision petitioner was prejudiced by non-compliance with the mandatory provisions (Sections 23(4)(iii) and 25(2) and (4)) and by lack of analysis of the particles/mass recorded in Ex. P-3; these defects undermined the prosecution case and vitiated the conviction.

Holding and Implications

Holding: The revision petition is allowed and the conviction recorded by the Judicial First Class Magistrate, Ponnur, is set aside.

Consequences and implications:

  • The revision petitioner is entitled to an acquittal under the circumstances of this case (i.e., prejudice resulting from non-compliance with statutory sample/report provisions and absence of analysis of the particles/mass).
  • The fine amount, if any was paid, may be refunded to the revision petitioner (as directed by the Court).
  • The Court treated the statutory provisions (Sections 23(4)(iii), 25(2) and 25(4)) as mandatory and emphasized the practical effect that denial of those statutory safeguards can prejudice the accused; the Court distinguished authorities concerning impleading under Section 32-A where different considerations arise.
  • No broader novel legal principle was pronounced beyond applying existing authorities (as cited) to the facts: the decision effects the direct relief of acquittal and refund for the petitioner in this case.

    Vetcha Venkata Raju v. State Of Andhra Pradesh .

    Iyyapu Panduranga Rao, J.:— P.W.I inspected M/s Nidubrolu Medical Agencies, Nidubrolu, a licensed sales premises, and purchased ten bottles of Sodium Chloride and dextrose injections manufactured under date 13-2-1989 to be used within 18 months there from said to be manufactured by M/s Vezey Parenteral Products, F-7, Industrial Estate, Kakinada (hereinafter referred to as A-1). The samples were taken, after observing necessary formalities, in the presence of P.W 2, the proprietor of M/s Nidubrolu Medical Agencies, etc. Two such bottles were sent to the Government Analyst Drugs Control Laboratory Hyderabad in form no. 18 under date 28-6-1989 after observing necessary formalities and the report of the analyst states that the said sample is not of standard quality as defined in the Drugs and Cosmetics Act, 1940 and the Rules made thereunder as the solution in the sealed bottles contains plenty of particles and fungs like mass. This report is marked as Ex. P-3. P.W.I sent a copy of Ex. P-3 by registered post to M/s Nidubrolu Medical Agencies, Nidubrolu with a direction to disclose source of supply from whom they acquired the said product in view of that, P.W 2, representing M/s Nidubrolu Medical Agencies, Nidubrolu informed P.W.I that the said product was purchased from M/s Amruta Medical Agencies, Narsaraopet vide invoice no. 12/100 dated 9th May, 1990 and produced the xerox copy of the purchase bill. As such P.W.I addressed a letter dated 16-2-1990 to M/s. Amrutha Medical Agencies, Narsaraopet about the contents of Ex. P-3 and about the factum of P.W 2 informing P.W.I that P.W 2 purchased the same from M/s Amrutha Medical Agencies Narsarapoet. Thereupon, P.W 3, a partner of the M/s Amrutha Medical Agencies informed P.W.I that the drug in question was supplied by A-1 vide invoice No. 7/89 dated 8-5-1989. In the said communication, P.W 3 confirmed to have sold the drug in question to M/s Nidubrolu Medical Agences, Nidobrolu from whom P.W.I took the sample. Later, P.W.I laid prosecution against A-1 and the revision petitioner, who is no other than sole proprietor of A-1 in C.C No. 78/90 on the file of the Judicial First Class Magistrate, Ponnur. The learned Magistrate having tried the case held that A-1 is not guilty of any offence and the revision petitioner is guilty of offences under Sections 17(a), 18(a)(i) and Rule 78(m) read with Section 27(d) of the Drugs and Cosmetics Act (in brief ‘the Act’) and the rules framed thereunder and convicted the revision petitioner to suffer R.I for a period of one year and also sentenced to pay a fine of Rs. 500/- in default to undergo R.I for one month. Aggrieved by the same the revision petition filed Criminal Appeal No. 119 of 1991 on the file of the learned Sessions Judge, Guntur. The learned Sessions Judge having considered the matter dismissed the appeal. Aggrieved by the same present revision case is filed.

    2. Sri Padmanabha Reddy, the learned counsel appearing for the petitioner submits that under Section 23(4)(iii) read with Section 18(A) of the Act, the revision petitioner is entitled to a portion of the sample; as per the provisions of Section 25(2) of the Act, his client is also entitled to a copy of Ex. P-3 and since the sample or copy of Ex. P-3 were not supplied, his client is precluded from exercising a valuable right to get the sample examined by the Central Drug Laboratory, as provided under Section 25(4) of the Act. He further contends that the above provisions are mandatory and consequently the accused is entitled for an acquittal. To appreciate the above contentions, Sections 23(4)(iii) 18(A) and 25(2) of the Act are extracted below:

    Section 23(4)(iii):

    “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 dispose of the same as follows—

    (iii) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have been disclosed under Section 18-A”

    Section 18(A):

    “From such date as may be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf—

    (a) Manufacture for sale or distribution, or sell, or stock or exhibit or offer for sale:

    (i) any drug which is not of a standard quality or is misbranded, adulterated or spurious;

    (ii) any cosmetic which is not of a standard quality or is misbranded or spurious;

    (iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the lable or container thereof the true formula or list of active ingredients contained in it together with the quantities thereof;

    (iv) any drug which by means of any statement, design or device accompany it or by any other means, purports or claims (to prevent, cure or mitigate) any such disease or ailment, or to have any such other effect as may be prescribed;

    (v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;

    (vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made thereunder:

    Section 25(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.”

    3. Section 23 of the Act shows that where a sample of drug or cosmetic was taken for the purpose of analysis, after observing necessary formalities, the Inspector shall restore one portion of the sample so divided to the person from whom he takes the sample, one portion of the sample be sent to the Government Analyst for test or anlaysis, another portion shall be produced before the Court before which proceedings, if any, are instituted in respect of the drug or cosmetic and the other portion be sent to person, if any whose name and address and other particulars have been disclosed under Section 18-A. It is to be seen that when P.W 1 asked P.W 2 as to where the drug in question was purchased, P.W 2 informed that the drug was purchased from M/s Amruta Medical Agencies, Narsaraopet and P.W.I was also informed that M/s Amruta Medical Agencies purchased the drug in question from A-1. Thus, as per the provisions of Section 18-A of the Act read with Sction 23(4)(iii), the revision petitioner who is the sole proprietor of A-1 is entitled to the same. It is further to be seen that sending a sample to a person situated similar to the Revision petitioner, who is the manufacturer, is not a mere formality. In the event of such a sample being sent to the manufacturer, as could be seen from the provisions of Section 25(4), the manufacturer is entitled to get the same tested or analysed in the Central Drug Laboratory, to have a second opinion regarding the contents of the report of the Government Analyst, received under Section 25(1) of the Act. The learned counsel for the revision petitioner relied upon a decision reported in Drugs Inspector, C.D.S.C.O (South) Zone, Madras v. Modern Drugs, 1982 (2) Cr. L.J 2285 wherein it is observed as follows:

    “Section 25 is mandatory and it should be complied with. Strict observance of the provision is imperative. As the Analyst's report is conclusive evidence of its contents, it is absolutely necessary to observe corresponding security and safeguards. The right is a every valuable right for, within twenty-eight days of the receipt of the copy of the report, accused can notify in writing to the Inspector or to the Court that he intends to adduce evidence in controversion of the report. The prosecution cannot deny the right oy not serving a copy of the Analyst's report on the accused. Where there is a denial of the right, prosecution is not entitled to secure the conviction of the accused.”

    4. This decision categorically lays down that Section 25 of the Act is mandatory and it should be complied with. It is further observed that the provisions of Section 25 are imperative and should be followed and that the right is a very valuable right whereunder the petitioner is entitled to get the sample tested or analysed in the Central Drugs Laboratory. To the same effect is the decision reported in A.M & G. Stores v. State. (AIR 1973 MP 225).

    5. Sri Narsimha Reddy, the learned Assistant Public Prosecutor submits that on 6-3-1990 A-1 was informed about the contents of Ex. P-3, the relevant communciation was marked as Ex. P-10 and a copy of the same was received by the revision petitioner on behalf of A-1 as could be seen from Ex. P-11, the acknowledgment. Thus, the revision petitioner was duly informed about the contents of Ex. P-3 and in the event of the revision petitioner seeking to get the sample examined by Central Drug Laboratory, he would have informed P.W.I about the same. Thus the learned Public prosecutor submits that it is clear from the above, that the revision petitioner is fully aware of the contents of Ex. P-3 and having not asked P.W.I for a copy of Ex. P-3 or the sample of the product, he is precluded now from contending that a copy of Ex. P-3 was not supplied or that the sample of the product was not given to him. Though Ex. P-10 shows that the sample was not of standard quality, a copy of Ex. P-3 was not supplied, enabling the revision petitioner to know the contents of Ex. P-3. Apart from that supplying a copy of Ex. P-3 and further supplying sample is not a mere formality. Under the statute, the revision petitioner is entitled to get the sample tested in the Central Drug Laboratory, to know as to whether Ex. P-3 is correct or otherwise and by virtue of the fact that the revision petitioner was not supplied with the sample, the revision petitioner was deprived of his valuable right to get the sample analysed in the Central Drugs Laboratory, a right given to him under Section 25(4) of the Act. Thus, the fact that the complainant informed A-1 about the contents of Ex. P-3 under Ex. P-10 is not sufficient compliance of the provisions of the Act.

    6. The learned Public Prosecutor relied upon Section 32-A of the Act and submits that when the manufacturer was impleaded as a party in a pending criminal case, he need not be served with a copy of the report of the Analyst or receive the sample. Section 32-A of the Act reads as follows:

    “Power of Court to implead the manufacturer, etc.—Where at any time during the trial of any offence under this Chapter alleged to have been committed by any person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, the Court is satisfied, on the evidence adduced before it that such manufacturer or agent is also concerned in that offence, then, the Court may notwithstanding anything contained in sub-sections (1), (2) and (3) of Section 319 of the Cr. P.C 1973 (2 of 1974), proceed against him as though a prosecution had been instituted against him under Section 32.”

    7. Section 32-A covers a case where in the course of the proceedings, the manufacturer was impleaded as a party. The rights which the manufacturer can exercise by virtue of his being impleaded as a party are not governed by Section 32-A of the Act. But, in a case where the manufacturer was sought to be impleaded as a party by virtue of provisions of Section 18(A) of the Act, his rights are categorically given in Section 23(4)(iii) and Section 25(4). Consequently, the fact that Section 32-A of the Act is silent about the rights of the manufacturer, is not a circumstance to show that revision petitioner is entitled to invoke the provisions of Section 25(4)(iii) and Section 25(4) of the Act

    8. The learned Public Prosecutor relied upon a decision reported in Manager, Medico Pharmaceutical Processors v. State of A.P, (1983 Cr. LJ. 67) to show that no prejudice is caused to the accused by non-supply of Ex. P-3 and the sample. This is a case where the manufacturer was sought to be impleaded under Section 32-A of the Act and not under Section 18(A) of the Act and in the event of the manufacturer being impleaded as a party invoking the provisions of Section 18(A) of the Act, his rights are governed by the provisionsof Section 23(4)(iii) and Section 25(2) & (4) of the Act. As such, this decision has no application.

    9. The learned counsel for the petitioner next submits that the particles and mass said to have been present in the sample, as evidenced by Ex. P-3, was not analysed by the Analyst and consequently, Ex. P-3 is not helpful to the prosecution to show that the sample is not of standard quality. Elaborating his submission, the learned counsel for the petitioner submits that under Section 19 of the Act, the pleas which the accused is entitled to raise are mentioned, in Ex. P-3, it was mentioned that the sample contained certain particles and fungus like mass and that neither the particles nor the mass were analysed and consequently no credence be given to Ex. P-3. To substantiate his contention, the learned counsel for the petitioner relied upon Prem Pharmaceuticals v. State of M.P, (1989 Cr. L.J 2048) That was a case where the pharamaceutical firm was prosecuted under Section 18(a)(i) read with Section 27 of the Act on the ground that on analysis of intravenous fluid sodium chloride injection (the same drug as in this case) manufactured by the firm, which was reported to be sub-standard, it was found to contain particles of foreign matter. The Madhya Pradesh High Court observed as follows:

    “On a careful consideration of the arguments and the relevant provisions of the Act, I am of the view that the contention that in the absence of analysis of the particulars found in the medicine it cannot be held that they were of extraneous substance and not particulate matter of the contents of the medicine coming into existence during storage subsequent to its manufacture must be accepted. Further in view of the provision in Section 19(2)(b) of the Act, even on the assumption that the particles were of extraneous matter the drug cannot, in the absence of allegation of awareness of the intermixture, be said to be sub-standard merely on the ground of their presence therein. Absence of such allegation knocks the bottom out of the prosecution case.”

    10. In this case also, the mass as well as the particles were not analysed by the analyst.

    11. In the circumstances, this is case where the revision petitioner was prejudiced by non-compliance of mandatory provisions of Sections 23(4)(iii) and 25(2) and (4) of Act and consequently the revision petition is entitled to an acquittal. In the result, the revision petition is allowed setting aside the conviction recorded by the learned Judicial First Class Magistrate, Ponnur. The fine amount, if any paid, may be refunded to him.

    12. Petition allowed.

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    Vetcha Venkata Raju v. State Of Andhra Pradesh .
    (Dec 24, 1992)