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  • Section 5, Subsection 2 of the 1983 Income Tax Act
  • The Drugs and Cosmetics Act, 1940
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Citation Codes
Equivalent Citations
citation codes
Case Number
Disposition
Advocates
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  • Section 5, Subsection 2 of the 1983 Income Tax Act
  • The Drugs and Cosmetics Act, 1940
Smart Summary

Factual and Procedural Background

The appellant, Medimpex, obtained a manufacturing licence in 1969 under the Drugs and Cosmetics Act, 1940 and the accompanying Rules for nine drugs. On 25 January 1975 six additional drugs were endorsed on that licence; one of the six was described as “Santonin and Calomel tablets or any brand name.” The appellant asserts that, by an earlier application dated 15 April 1974, it had sought substitution of “Santopar” tablets for the Santonin/Calomel formulation, but the official endorsement actually granted on 25 January 1975 did not mention Santopar.

In 1982 Respondent 2, Naya Dawakhana, obtained a licence to manufacture Santopar tablets. The appellant filed CWJC No. 2747 of 1983 in the Patna High Court challenging that grant. Because the authenticity of the appellant’s alleged renewal certificate (purporting to include Santopar) was disputed, the High Court directed the Drug Controller to hold an evidentiary inquiry.

By order dated 22 December 1984 the Drug Controller found (i) that the photocopy of the renewal certificate produced by the appellant bore no authenticating signature, (ii) that the attached list of 23 items including Santopar was fabricated, and (iii) that the appellant had manufactured Santopar without a licence, whereas Respondent 2 held a valid licence of 11 June 1982.

The appellant withdrew a writ petition against that finding and, instead, filed an appeal before the State Health Minister, who on 15 October 1985 allowed the appeal and cancelled Respondent 2’s licence. Acting on that direction, the Drug Controller on 11 November 1985 ordered Respondent 2 to stop manufacturing Santopar. Respondent 2 challenged those two orders in CWJC No. 5943 of 1985. Meanwhile, the Drug Controller seized the appellant’s stock of Santopar tablets on 6–7 May 1986, prompting the appellant to file CWJC No. 4788 of 1986 seeking, inter alia, a direction to issue a licence in its favour.

On 17 February 1989 the Patna High Court allowed Respondent 2’s writ (CWJC 5943 of 1985) and dismissed the appellant’s writ (CWJC 4788 of 1986). The present appeals were filed in the Supreme Court by special leave.

Legal Issues Presented

  1. Whether the appellant possessed a valid licence to manufacture “Santopar” tablets.
  2. Whether the Drug Controller’s factual findings of forgery and absence of licence, recorded on 22 December 1984, were sustainable.
  3. Whether an appeal lay to the State Government under Rule 84-A of the Drugs and Cosmetics Rules against an order that merely recorded findings of fact and did not refuse grant or renewal of a licence.
  4. Consequently, whether the Health Minister’s order dated 15 October 1985 and the Drug Controller’s follow-up order of 11 November 1985 were void for want of jurisdiction.

Arguments of the Parties

Appellant’s Arguments

  • Relied on a certificate dated 20 January 1984 (Annexure A to I.A. No. 2 of 1989) allegedly signed by Shri Y.K. Sinha, claiming it authenticated the disputed renewal certificate and attached list that included Santopar.
  • Contended that its application of 15 April 1974 itself satisfied the requirement for endorsement of Santopar, and that the endorsement should be deemed granted even if no express order issued.
  • Asserted that the High Court erred in holding the appeal to the Health Minister incompetent.

The opinion does not contain a detailed account of Respondent 2’s legal arguments.

Table of Precedents Cited

No precedents were cited in the provided opinion.

Court’s Reasoning and Analysis

The Supreme Court first noted the Patna High Court’s finding, based on official records, that no application was made by the appellant for endorsement to manufacture Santopar at the time of licence renewal for 1975-76. The Court emphasised that the appellant could not point to any material demonstrating that the Drug Controller’s findings were perverse.

Regarding the certificate of Shri Y.K. Sinha produced for the first time in the Supreme Court, the Court refused to consider it because:

  • The certificate was neither produced before the Drug Controller during inquiry nor filed in the High Court.
  • No affidavit from Shri Y.K. Sinha attesting to its authenticity was on record.

On the alternative argument that an unacted-upon application should be deemed accepted, the Court held that an endorsement adding a drug to a licence requires a conscious, formal order; mere filing of an application cannot create a deemed licence.

Interpreting Rule 84-A, the Court agreed with the High Court that an appeal to the State Government lies only against refusal to grant or renew a licence. The Drug Controller’s order of 22 December 1984 did neither; it merely recorded factual conclusions pursuant to the High Court’s directive. Hence, the Health Minister lacked jurisdiction to entertain the appellant’s appeal, rendering the orders of 15 October 1985 and 11 November 1985 void.

Holding and Implications

DISMISSED – The Supreme Court dismissed the appeals and affirmed the Patna High Court’s judgment. No order as to costs.

Implications: Respondent 2’s licence to manufacture Santopar stands restored, the appellant remains without a licence for that drug, and the seizure of its stock remains undisturbed. The Court did not lay down new precedent; it applied existing statutory provisions to the facts. It clarified, however, that the appellant may rely on the contested certificate, if duly proved, in any ongoing criminal prosecution regarding unlicensed manufacture.

    M/S Medimpex (India) (P) Ltd. v. Drug Controller-Cum-Chief Licensing Authority And Others

    N.D Ojha, J.— Special leave granted.

    2. These appeals by special leave have been preferred against the judgment of the Patna High Court dated 17-2-1989 in CWJC No. 5943 of 1985 and CWJC No. 4788 of 1986. The appellant was granted a licence in 1969 under the Drugs and Cosmetics Act, 1940 (the Act) and the Drugs and Cosmetics Rules (the Rules) to manufacture nine drugs. The said licence was renewed from time to time. On an application being made in this behalf by the appellant six more drugs were included in the licence by order of the Licensing Authority dated 25-1-1975. One such item was Santonin and Calomel tablets or any brand name. According to the appellant before the order dated 25-1-1975 was passed by the Licensing Authority another application was made on 15-4-1974 by the appellant stating that it had decided to manufacture Santopar brand name instead of Santonin and Calomel tablets and that the said product may be considered as one of the items of manufacture. It, however, appears from the list enclosed to the order dated 25-1-1975 that the request made in the said application was not granted and the item added was Santonin and Calomel tablets or any brand name as initially applied for. Subsequently, the appellant made an application for the renewal of the licence for the period between 1-1-1975 and 31-12-1976. However, along with this application no application for inclusion of any additional item as contemplated by Rule 69(5) of the Rules was made. This fact as is apparent from the judgment appealed against was not disputed by the appellant. In the year 1982 Naya Dawakhana, Respondent 2 applied for and was granted licence for manufacture of the drug Santopar. This grant of licence to Respondent 2 was challenged by the appellant before the High Court in CWJC No. 2747 of 1983. The said writ petition was opposed by Respondent 2 and one of the questions arose as to whether the appellant had ever been granted licence to manufacture Santopar on account of which the grant of licence to Respondent 2 could be held to be illegal. Reliance on behalf of the appellant seems to have been placed on a list attached to a certificate dated 9-6-1976 containing Santopar tablets also. This certificate, according to the appellant, was issued to it along with a letter dated 10-6-1976 granting renewal of its licence for the period between 1-1-1975 and 31-12-1976. For Respondent 2 it was contended that the said certificate was forged. The High Court took the view that since disputed questions of fact were involved a thorough probe was needed in the matter. On this view the writ petition was disposed of on 2-8-1984 by issuing a direction to the Drug Controller to hold an inquiry after giving reasonable opportunity to the parties to adduce evidence in support of their respective claims and to pass final orders in the matter after hearing them. The Drug Controller held an inquiry as directed by the High Court and inter alia found that the photostat copy of the renewal certificate relied on by the appellant did not bear any impression of the signature of the Chief Licensing Authority and that the list of 23 items including Santopar appeared to be fabricated and forged document. In this connection he pointed out that no duplicate copy of the said list was available in the relevant file which was serially numbered. He also held that the appellant had been manufacturing the drug Santopar with effect from 15-4-1974 without any licence and thereby contravened the provisions of the Act and the Rules. He further held that Naya Dawakhana, Respondent 2 was legally manufacturing the drug Santopar under a valid licence dated 11-6-1982.

    3. Aggrieved by the aforesaid order the appellant filed CWJC No. 169 of 1985 in the High Court. The said writ petition was, however, by order dated 25-2-1985 permitted to be withdrawn with liberty to take recourse to any other remedy which may be available to the appellant. Subsequently, an appeal was preferred by the appellant before the Health Minister against the aforesaid order dated 22-12-1984. This appeal was allowed on 15-10-1985 in pursuance whereof the Drug Controller passed an order on 11-11-1985 whereby Respondent 2 was informed that its licence to manufacture Santopar stood cancelled. Respondent 2 was also directed to stop manufacturing the said drug. CWJC No. 5943 of 1985 which is one of the writ petitions decided by the judgment appealed against, was filed by Naya Dawakhana, Respondent 2 challenging the aforesaid orders dated 15-10-1985 and 11-11-1985.

    4. By subsequent orders dated 6-5-1986 and 7-5-1986 issued by the Drug Controller the entire stock of Santopar tablets produced by the appellant was seized. Aggrieved by this seizure the appellant filed CWJC No. 4788 of 1986 namely the other writ petition decided by the judgment appealed against with a prayer to quash the aforesaid orders and also to direct the Drug Controller to issue licence to the petitioner in pursuance of the order passed by the Health Minister and to restrain Respondent 2 from manufacturing and selling Santopar tablets. CWJC No. 5943 of 1985 filed by Respondent 2 has been allowed whereas CWJC No. 4788 of 1986 filed by the appellant has been dismissed by the High Court. As already stated above, these appeals have been preferred by the appellant against the said order of the High Court.

    5. Before we deal with the submissions made by Shri Bimal Chandra Sandhya, the Managing Director of the appellant company who has appeared in person we may point out that the High Court has held:

    “Upon perusal of the records of the case, as also the records maintained in the office of the Drug Controller produced by the learned Advocate before us, we do not find any application having been filed by Medimpex in this regard for manufacturing the Drug “Santopar” along with its renewal for the year 1975-76.”

    6. It has also held that nothing was pointed out by counsel for the appellant to indicate that the findings of the Drug Controller were perverse or unsustainable. It has further been held by the High Court that the findings of the Drug Controller in his order dated 22-12-1984 that no such licence as claimed by the appellant for manufacture of Santopar was granted in its favour, could not obviously be treated as an order whereby either the licence of the appellant had been cancelled or its renewal had been refused. That being so, the appeal filed by the appellant before the Health Minister against the order of the Drug Controller dated 22-12-1984 was not maintainable inasmuch as Rule 84-A of the Rules which contained the necessary provision for appeal to the State Government contemplated an appeal only against an order of the Licensing Authority refusing to grant or renew a licence. It was held that since right to file an appeal was a creature of statute and no appeal had been provided for against an order such as the order dated 22-12-1984 passed by the Drug Controller in the inquiry held in pursuance of a direction of the High Court that no licence at all had been granted to the appellant to manufacture Santopar tablets, the order passed by the Health Minister was obviously without jurisdiction and consequently the order of the Health Minister dated 15-10-1985 and the subsequent order dated 11-11-1985 were liable to be quashed and as a necessary corollary the writ petition filed by the appellant deserved to be dismissed.

    7. It has been urged by Shri Sandhya that the order of the Drug Controller dated 22-12-1984 was, on the face of it, erroneous and the High Court committed an error in upholding it. In support of this submission reliance was placed on a document filed as Annexure A to I.A No. 2 of 1989 made in the special leave petitions purporting to be a true copy of a certificate said to have been issued on 20-1-1984 by Shri Y.K Sinha to the effect that the certificate of renewal and the list attached thereto as Annexure issued along with letter dated 10-6-1976 relating to the issue of licence for manufacture of non-biological drugs to the appellant bore his signature and the same were signed 9-6-1976. According to Shri Sandhya in view of this certificate the finding of the Drug Controller that the photostat copy of the renewal certificate and the list attached thereto were forged and fabricated was patently erroneous. Suffice it to say, so far as this submission is concerned, that the said certificate does not appear to have been produced during the course of inquiry before the Drug Controller. The order of the Drug Controller is completely silent about it and nothing has been brought to our notice to indicate that the said certificate was indeed produced before the Drug Controller. So far as the writ petition filed by the appellant which has been decided by the judgment appealed against is concerned, on a specific question being put by us to him Shri Sandhya stated that the said certificate was not produced in the said writ petition. This being the position we are not inclined to take into consideration the said certificate particularly in the absence of any affidavit by Shri Y.K Sinha vouchsafing the genuineness of the said certificate. On merits we find no justification to interfere with the finding recorded in this behalf by the Drug Controller and affirmed by the High Court, the same being essentially a finding of fact based on material placed before them.

    8. It was then urged by Shri Sandhya in the alternative that since an application had been made on behalf of the appellant on 15-4-1974 already referred to above containing information that the appellant had decided to manufacture Santopar brand name instead of Santonin and Calomel tablets or any brand name with a prayer that the said product may be considered on the appellant's manufacturing item it fulfilled the requirement of making an application for endorsement and even if no order was passed thereon it should be deemed that endorsement as prayed for had been granted. We find it difficult to agree with this submission either. The question as to whether an endorsement of making an addition in the licence should or should not be granted apparently requires an application of mind and an order making such endorsement is needed. Even in the case of the appellant the Licensing Authority had passed an order on 25-1-1975 specifically granting the appellant's application made for adding six more drugs in its licence, after considering the merits of the application.

    9. We also do not find any substance in the submission made by Shri Sandhya that the High Court committed an error in holding that no appeal lay to the State Government against the order passed by the Drug Controller on 22-12-1984. The finding by the Drug Controller that no licence had ever been granted to the appellant to manufacture Santopar tablets recorded in the order dated 22-12-1984 passed by him in the inquiry made in compliance with the direction of the High Court could not obviously be treated as an order either refusing to grant licence or to renew it. Since an appeal lay to the State Government only against an order either refusing to grant a licence or to renew it the High Court, in our opinion, cannot be said to have committed any mistake in taking the view that the appeal filed by the appellant against the said order of the Drug Controller dated 22-12-1984 was not maintainable. On the writ petition filed by Respondent 2 being allowed by the High Court the reliefs prayed for by the appellant in its writ petition could not obviously be granted.

    10. In view of the foregoing discussion, we find no substance in these appeals and they are liable to be dismissed.

    11. Before parting with the case, however, we may point out that it has been brought to our notice by Shri Sandhya that a prosecution is pending against the appellant in connection with the manufacture of Santopar tablets without a licence. In order to ensure that the defence of the appellant is not prejudiced we wish to make it clear that since we have not taken into consideration the certificate said to have been issued by Shri Y.K Sinha referred to above, it would be open to the appellant to rely on the said certificate in proceedings for prosecution after proving the same in accordance with law.

    12. In the result, these appeals fail and are dismissed but there shall be no order as to costs.

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    Comments

    M/S Medimpex (India) (P) Ltd. v. Drug Controller-Cum-Chief Licensing Authority And Others
    (Dec 5, 1989)