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State Of Gujarat v. M/S. Alpin Industries, New Delhi And Others

Gujarat High Court
Apr 12, 2002
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Structured Summary of the Opinion

Factual and Procedural Background

The State of Gujarat, on behalf of the original complainant Bharatkumar Hariprasad Trivedi (Drug Inspector, Commissioner of Food & Drugs Control Administration, Mehsana), appealed against an order of discharge recorded by the learned Judicial Magistrate (First Class), Kalol in Criminal Case No. 1679 of 1996 dated 30-6-1999. The respondents were prosecuted under section 27 of the Drugs & Cosmetics Act, 1940, for alleged violation of Section 18(A)(i) of the Act.

Facts as recorded: on 27-3-1995 a sample of Fymacetine Skin Cream (Batch No. 2590; manufacturing date September 1994; expiry date August 1996) was drawn from the medical stores at Kalol. The sample was sent to the Government Analyst, Vadodara, who reported it to be sub-standard, and complaint followed. The accused were provided with the Government Analyst's report on 12-7-1996.

The accused, by letter dated 5-8-1996 (within 28 days of receipt), informed the Drug Inspector that they did not admit the analyst's report and reserved the right to adduce evidence in controversion. The Magistrate's first returnable date for hearing was 6-9-1996; on that date the accused applied for the sample to be sent to the Central Laboratory (C.L.) for re-analysis, but the learned Magistrate did not direct re-analysis because the sample had expired. The learned Magistrate discharged the accused on 30-6-1999; the State filed the present revision challenging that discharge.

Legal Issues Presented

  1. Whether the learned Magistrate's order discharging the respondents-accused was legally sustainable in view of the statutory scheme of Section 25 of the Drugs & Cosmetics Act, 1940 (particularly subsections (3) and (4)).
  2. Whether the accused extinguished their right to challenge the Government Analyst's report by failing to have the sample re-analysed at the Central Laboratory within time, or whether the steps (or omissions) of the complainant deprived the accused of that right.
  3. Whether, on the facts, it was proper to continue the prosecution when the accused's opportunity to get the sample re-analysed had been effectively lost due to the returnable date and expiry of the sample.

Arguments of the Parties

Appellant / State (learned A.P.P. Mr. Desai)

  • Contended that the accused failed to send the sample to the Central Laboratory within time despite being informed of the Government Analyst's report.
  • Relied on precedents (State of Haryana v. Brij Lal Mittal; Amery/Amety Pharmaceuticals v. State of Rajasthan) but, as recorded, fairly accepted that the learned Magistrate's finding is legal.

Respondents-Accused (learned Counsel Mr. Ravani)

  • Submitted that this was not a situation where a sample was handed over to the accused at the time it was drawn, so the accused could not themselves send the sample to the Central Laboratory before the sample's expiry.
  • Argued that the complainant remained silent on timing/returnable dates and thereby caused serious prejudice to the accused; mandatory statutory provisions were violated.
  • Relied on State Of Punjab v. National Organic Chemical Industries Ltd. (Insecticides Act precedent) to show the legislative intent and procedural safeguards are similar and protective of accused's rights to re-analysis.

Table of Precedents Cited

Precedent Rule or Principle Cited For Application by the Court
State of Haryana v. Brij Lal Mittal and Ors., AIR 1998 SC 2327 The opinion records that learned A.P.P. referred to the ratio of this Apex Court decision (no detailed principle from that decision is reproduced in the provided text). The A.P.P.'s reliance on this decision was noted; the A.P.P. accepted that the learned Magistrate's finding was legal. The Court recorded no additional specific doctrinal application from this citation in the text provided.
Amery/Amety Pharmaceuticals and Anr. v. State of Rajasthan, AIR 2001 SC 1303 Explains interpretation of Section 25(3) and (4) of the Drugs & Cosmetics Act: a person who receives a copy of the Government Analyst's report must notify within 28 days to controvert; a manufacturer not supplied a copy still has remedies (including requesting Central Laboratory re-analysis under s.25(4)); the Court has discretion on late requests; once C.L. report produced its conclusiveness is incontrovertible. The court relied on these principles to interpret s.25(3) and (4) in the present context and to conclude that accused who had reserved their right within 28 days were entitled to the remedial procedures, and that the complainant's failure to secure timely re-analysis effectively violated the accused's important right.
State Of Punjab v. National Organic Chemical Industries Ltd., JT 1996 (10) SC 480 The decision under the Insecticides Act explaining sample division, delivery of a portion to the manufacturer/person from whom the sample was taken, the report sequence, and the two options available to an accused to dislodge conclusiveness: (a) request and obtain the sample portion and have it tested at Central Insecticide Laboratory; or (b) request the court to send the sample lodged in court to the Central Insecticide Laboratory for testing. The court used this reasoning by analogy to show that the legislative intent and procedural scheme under the Drugs & Cosmetics Act are similar, supporting the conclusion that accused must be afforded an opportunity for re-analysis and that failure of the complainant to facilitate that possibility can lead to prejudice and justify discharge.

Court's Reasoning and Analysis

The Court examined the statutory framework and the factual chronology as recorded in the case papers and the learned Magistrate's order. The key analytical steps in the Court's reasoning were:

  1. Establishment of timeline: the Government Analyst's report was provided to the accused on 12-7-1996; the accused responded within 28 days by letter dated 5-8-1996 indicating non-admission of the report and reserving the right to adduce evidence in controversion (i.e., they notified their intention within the statutory period under Section 25(3) of the Act).
  2. Identification of the practical consequence of dates: the first court date fixed by the Magistrate was 6-9-1996. By that time the sample's expiry date had passed (expiry August 1996), making a second analysis by the Central Laboratory useless.
  3. Assessment of parties' duties and omissions: the Court observed that the complainant could and should have taken steps—specifically, to ensure a returnable date prior to sample expiry or to move the court (or otherwise) to have the sample sent promptly to the Central Laboratory—once the accused had made the request within 28 days. The complainant failed to take those steps.
  4. Application of precedent and statutory interpretation: relying on the principles set out in Amery/Amety Pharmaceuticals (interpreting s.25(3) and (4)) and the analogous Insecticides Act decision (State of Punjab v. National Organic Chemical Industries Ltd.), the Court emphasised that the statutory scheme contemplates remedies for accused to controvert analyst reports (including C.L. testing) and that courts have discretion regarding late requests; however, where the complainant's conduct prevents effective exercise of those remedies, the accused suffers prejudice.
  5. Conclusion on legal effect: because the accused had reserved their right within the mandatory 28-day period and because the complainant's inaction resulted in the effective loss of the opportunity for meaningful re-analysis (due to sample expiry), the learned Magistrate correctly concluded that the accused's right to re-analysis was violated and therefore could not properly be charged; continuing prosecution would be fruitless and a waste of court time.

The Court expressly agreed with learned Counsel for the respondents and the learned Magistrate's factual appreciation and legal conclusion; the learned A.P.P. also did not press an opposite conclusion after referring to the cited Supreme Court decisions.

Holding and Implications

Holding:

Criminal Revision dismissed; the impugned order dated 30-6-1999 discharging the respondents-accused from the offences punishable under Section 27 of the Drugs & Cosmetics Act, 1940, is confirmed.

Implications:

  • The immediate legal consequence is that the respondents-accused remain discharged from the charges under Section 27 of the Act as recorded by the learned Judicial Magistrate (F.C.), Kalol.
  • The Court found that in the particular factual matrix—where an accused validly reserves the right to controvert the Government Analyst's report within 28 days but, through the complainant's failure to act, is deprived of a meaningful opportunity to obtain re-analysis—the appropriate remedy is discharge rather than continuation of a prosecution that cannot fairly proceed.
  • The opinion does not purport to lay down a new general precedent beyond applying existing Supreme Court principles; the decision is tied to the facts and the statutory interpretation of Sections 25(3)–(4) of the Drugs & Cosmetics Act as already expounded in the cited authorities.

Rule discharged. Directions to the concerned Court were given as recorded in the opinion.

Show all summary ...

1. Heard learned A.P.P. Mr. Desai for the State and learned Counsel Mr. Ravani for the respondents-accused.

2. This appeal is preferred by the State of Gujarat on behalf of Bharatkumar Hariprasad Trivedi - original complainant - Drug Inspector of the Commissioner of Food & Drugs Control Administration, Mehsana, against the order of discharge recorded by learned Judicial Magistrate (First Class), Kalol in Criminal Case No. 1679 of 1996 on 30-6-1999.

3. Respondents-accused were prosecuted for the offence punishable under section 27 of the drugs & cosmetics act, 1940 (hereinafter referred to as 'the act') for violating the provisions of Section 18(A)(i) of the Act. According to complainant, he had drawn sample of Fymacetine Skin Cream, having Batch No. 2590 on 27-3-1995 from the Medical Stores of D/1, Kamdar Rajya Vima Yojna, Kalol, having manufacturing date September 1994 and expiry date August 1996. The Central Medical Stores of Ahmedabad had supplied this medicine to the Medical Stores at Kalol and the said stock was purchased in the month of October, 1994. As per prosecution, cream from which sample was taken, was manufactured by original accused No. 1-M/s. Alpine Industries, New Delhi. The sample was sent for analysis to Government Analyst, Vadodara. Report of Analyst revealed that sample was found sub-standard, and therefore, complaint was filed.

4. On careful consideration of the facts reflected from the record and order passed by the learned Magistrate, this Court is of the view that the order passed by the learned Magistrate discharging the respondents accused, is absolutely in accordance with law and is passed after appreciating the facts in correct perspective.

5. It is on record that on 12-7-1996, report of Government Analyst, Vadodara was provided to the accused by Drug Inspector and acknowledgment was also received by the Drug Inspector. In view of the provisions of Section 25 of the Act, within 28 days from the date of receipt of report, the accused were supposed to disclose before the Drug Inspector whether they admit the document i.e. report of analyst or not. The accused, vide their letter dated 5-8-1996 had informed the Drug Inspector about not admitting the document reserving their right to adduce evidence in controversion of the report, within the mandatory period of 28 days as stipulated under Section 25(3) of the Act.

6. On 13-8-1996, Drug Inspector acknowledging receipt of the letter from respondents accused, informed them about filing of complaint in the court of learned Judicial Magistrate (F.C.), Kalol, being Criminal Complaint No. 1679 of 1996 and further informed them that first date of hearing is 6-9-1996. On very first day, i.e. 6-9-1996, respondents accused appeared before the Court without receiving summons from the process serving agency and moved an application requesting the Court to send sample for analysis by Central Laboratory (C.L. for short). First application dated 6-9-1996 clearly indicates this aspect. However, learned Magistrate did not send the sample for second analysis by C.L. as the period of sample had already expired and it was of no use to send the sample for second analysis.

7. According to learned A.P.P. Mr. Desai, accused have failed in sending the sample to C.L. well within the time as they were already informed by the complainant about the report of first analysis made by the Government Analyst. Learned A.P.P. Mr. Desai, after referring the ratio of the decision of the Apex Court in the case of State of Haryana v. Brij Lal Mittal and Ors., reported in AIR 1998 SC 2327 and principles propounded by the Apex Court in another decision in the case of Amery Pharmaceuticals and Anr. v. State of Rajasthan, reported in AIR 2001 SC 1303, has fairly accepted that the finding of the learned Magistrate is legal. This is not a case of extinguishment of the right on the part of the accused. In case of Amety Pharmaceuticals (supra), the Supreme Court has said that :-

25. In our view, the Court should lean to an interpretation as would avert the consequences of depriving an accused of any remedy against such evidence. He must have the right to disprove or controvert the facts stated in such a document at least at the first tier. It is possible to interpret the provisions in such a way as to make a remedy available to him. When so interpreted the position is thus : The conclusiveness meant in Section 25(3) of the Act need be read in juxtaposition with the persons referred to in the sub-section. In other words, if any of the persons who receives a copy of the report of the Government Analyst fails to notify his intention to adduce evidence in controversion of the facts stated in the report within a period of 28 days of the receipt of the report, then such report of the Government Analyst could become conclusive evidence regarding the facts stated therein as against such persons. But as for an accused, like the manufacturer in the present case, who is not entitled to be supplied with a copy of the report of the Government Analyst, he must have the liberty to challenge the correctness of the facts stated in the report by resorting to any other modes by which such facts can be disproved. He can also avail himself of the remedy indicated in Sub-section (4) of Section 25 of the Act by requesting the Court to send the other portion of the sample remaining in the Court to be tested at the Central Drugs Laboratory. Of course, no Court is under compulsion to cause the said sample to be so tested if the request is made after a long delay. It is for that purpose that a discretion has been conferred on the Court to decide whether such sample should be sent to the Central Drugs Laboratory on the strength of such request. However, once the sample is tested at the Central Drugs Laboratory and a report as envisaged in Section 25(4) of the Act is produced in the Court the conclusiveness mentioned in that subsection would become incontrovertible.

8. In the present case, accused have already informed the complainant within mandatory period of 28 days reserving their right to adduce evidence in contravention of earlier report. It was possible for the complainant to pray before the learned Magistrate to see that returnable date of summons issued by the learned Magistrate 'is at least prior to 31-8-1996. Complainant was aware that accused had demanded, impliedly, to get the sample analysed by C.L. by the spirit reflected in the letter dated 5-8-1996. It was possible for the complainant to submit before the learned Magistrate that sample be sent immediately to C.L. for analysis as returnable date fixed by the learned Magistrate is after the expiry date of the sample cream. In absence of entitlement to have a sample as per the scheme of the Statute, the second mode provided under Sub-section (4) of Section 25 of the Act is available to the manufacturer. The complainant had failed in taking proper steps, and therefore, it is rightly held by learned Magistrate that important right of the accused to get sample reanalysed by C.L. has been violated. In these set of facts, it was not possible for learned Magistrate to even frame charge against the accused, and therefore, learned Magistrate has rightly discharged the accused from the offences under the Act. There is no need to continue fruitless prosecution involving wastage of time of the Court.

9. Mr. Ravani, learned Counsel appearing for the respondents-accused has rightly submitted that this is not a case of handing over of a sample to the accused at the time when sample was drawn, it was not possible for the accused to send the sample directly to the C.L. for analysis before the self-expiry date. That complainant has deliberately kept silence on this aspect and this has also resulted in to serious prejudice to the accused. That mandatory provisions has also been violated, and therefore, order passed by learned Magistrate is absolutely legal. It would be beneficial to refer the decision in the case of State Of Punjab v. National Organic Chemical Industries Ltd.., reported in JT 1996 (10) SC 480. The Apex Court was dealing with a case under Insecticides Act, 1968. In reference to Section 24 and the Scheme of Sub-sections (3), (4) & (5) of Section 22 of the said Act, the Court observed that :-

Thus, it would be clear that after inspection and seizure of the insecticide, the Insecticide Inspector shall divide the insecticide into three portions, as contemplated and in the manner prescribed and deliver one such sample to the manufacturer, or person from whom insecticide was taken. One should be sent to the Insecticide Analyst. After the receipt of the report, the accused would be notified of the result of the report. Thereafter, the complaint is required to be lodged in the Court. At that stage, two options are open to the accused. The accused is entitled to have one copy of the sample entrusted to him to have it notified to the Court for proving to the contrary to the conclusive evidence of the report of the analyst; after such a notification having been given to the Court, he is entitled to have it tested by Central Insecticide Laboratory and adduce evidence of the report so given. That such certificate by the Director of C.I.L. has a proof of his defence to dislodge the conclusiveness attached to the report of the Insecticide Analyst under sub-section (3) of section 24. The other option is, after the complaint is laid in the Court, the copy of the sample that is lodged with the Court by the Insecticides Inspector, would be requested to be sent by the Court to C.I.L. and the report thus given by the Director of C.I.L. shall be conclusive evidence as to the quality, consent and facts stated therein.

Legislative intent is very similar to the Drugs & Cosmetics Act.

10. On perusal of the papers, this Court is in full agreement with the submission of learned Counsel Mr. Ravani that no error has been committed by the learned Magistrate.

11. For the reasons aforesaid, there is no merits in this Criminal Revision Application and the same is hereby dismissed. Impugned order dated 30-6-1999 passed by learned Judicial Magistrate (F.C.), Kalol in Criminal Case No. 1679 of 1996 discharging the respondents-accused from the offences punishable under Section 27 of the Act, is hereby confirmed. Rule discharged. Yadi to concerned Court.