Caplet India (P) Ltd. v. State of West Bengal — 1998 DIGILAW 539 (CAL)

JUDGMENT N.K. Mitra, J. In short, the case as made out by the writ petitioners in the writ application, inter alia, is that the petitioner No. 1 is a Company registered under the Companies Act and the petitioner No. 2 is a Director of the said Company. The petitioner No. 1 is engaged in manufacturing and sale of different kinds of allopathy medicines in the nature of tablets, capsules, liquids and powders. The medicines of the petitioner No. 1 are mainly supplied in the State of West Bengal, Bihar, Assam and other North Eastern States. The medicines manufactured by the petitioner No. 1 are also supplied to different governmental and semi-governmental institutions wholly owned by the State of West Bengal as well as the Union of India. The writ petitioner No. 1 is manufacturing a tablet under the genetic name of "PARACETAMOL I.P. 500 mg." tablets and the same are supplied to various Governmental institutions under the said name. The said tablets are also supplied in the open market under the brand name of "CEPAL". 2. On or about 23rd October, 1992, the respondent No. 6 had taken sample of the said Paracetamol tablets in four containers, each containing 500 tablets from the District Reserved Store, Chief Medical Officer of Health, Burdwan. While taking the said samples, no representative of the petitioner No. 1 was informed about the taking of such sample. One part of the said sample so collected, was forwarded to the Government Analyst for test and analysis not immediately but after a lapse of about 11 days, but no part of the sample was sent to the petitioner No. 1. 3. The respondent No. 7 had supposedly conducted a test on such sample taken by the respondent No. 1 and submitted his report to the concerned Drug Inspector on or about 13th January, 1993 with a copy to the Director of Drugs Control and the Central Drug Standard Control Organisation. An attested copy of the said test report was served upon the petitioner No. 1 by the respondent No. 6 vide his letter dated 25th July, 1996, i.e. after a lapse of more than 3 years 6 months, as would appear from Annexure 'A', to the writ application. 4. It was stated in the said report, that the said tablets of the writ petitioner No. 1 Company had been found to be spurious, adulterated and misbranded. 4. It was stated in the said report, that the said tablets of the writ petitioner No. 1 Company had been found to be spurious, adulterated and misbranded. Meanwhile, the Inspector of Central Drugs Standard Control Organisation conducted an inspection in the factory of the petitioner No. 1 on or about 14th July, 1996 and made enquiries in respect of the manufacturing process of the said paracetamol tablets and also asked for relevant records and registers maintained by the petitioners in connection with the manufacture and sale of the said paracetamol tablets which were duly supplied by the representatives of the petitioner No. 1 Company. The petitioners through their learned Advocate wrote a letter to the respondents on or about August 11, 1996 pointing out the irregularities and illegalities committed by the respondent-authorities in the matter of taking the sample as aforesaid, and also the subsequent actions taken in respect thereof, as would appear from the copy of the said letter being Annexure 'B' to the writ application. When the writ petitioners received a copy of the test report from the Government Analyst, after a lapse of 3 years 6 months as stated above, by that time the scheduled batch of the said product had expired its potentiality as the same expired in the month of February, 1995. 5. On or about 13th September, 1996, the Director of Drugs Control, Government of West Bengal issued a Show Cause Notice to the writ petitioner No. 1 Company asking it to show cause why its licence for manufacturing drugs should not be suspended and why legal action as per section 18 of the Drugs and Cosmetics Act, 1940 read with section 27 of the said Act should not be taken against the Company. The said Director of Drugs Control further issued a Circular on or about 17th September, 1996 being Annexure 'D' to the writ application, inter alia, mentioning therein that information had received from the Drugs Inspector, Bankura Office and from the Drugs Inspector of Burdwan Office that the Drugs as mentioned in the said Circular had been declared as spurious etc. and the same also included the Paracetamol tablets manufactured by the writ petitioner No. 1 Company and advised the Superintendents of all hospitals to take suitable precautions in placement of Government orders regarding purchase of Drugs. and the same also included the Paracetamol tablets manufactured by the writ petitioner No. 1 Company and advised the Superintendents of all hospitals to take suitable precautions in placement of Government orders regarding purchase of Drugs. According the writ petitioners, the Chief Medical Officer of Health, Bankura on or about 27th September, 1996 also cancelled the order placed with the petitioner No. 1 Company for supply of 1,00,000 Paracetamol tablets. 6. Being aggrieved, inter alia, by the aforesaid Show Cause Notice as well as the aforesaid test report as given by the Government Analyst as referred to above, the writ petitioners have moved the present writ application. On this application an interim order was passed on 9th October, 1996 by the Hon'ble Justice Ruma Pal, inter alia, to the effect that the proceeding initiated by the Show Cause Notice might proceed but must be completed within a period of 10 weeks from the date of the said order unless the time was extended by mutual consent and the final order which might be passed in the proceeding, should not be communicated to the petitioners or given effect to in any fashion whatsoever, without the leave of this Court and the impugned Circular being Annexure 'D' to the writ application should not be construed as meaning a direction for cancellation of the petitioners' contracts. The respondent Nos. 1 to 6 filed a Joint Affidavit-in-Opposition denying and disputing the allegations made in the writ application. In paragraph 4 (c) to the said affidavit-in-opposition, the respondents No. 1 to 6, had stated that in accordance with the prescribed practice, the samples drawn by the respondent No. 6 were each divided into four equal parts, packed and sealed in presence of the Deputy C.M.O.H., Burdwan and were signed by him as the person from whom the samples were taken in accordance with the procedure laid down by section 23 of the Drugs and Cosmetics Act, 1940 and one part of the said samples was made over to the Deputy C.M.O.H., District Reserve Stores, Burdwan and one part of the sample No. SND/Oct (1) was sent to the Central Drugs Laboratory, Calcutta for testing and analysis. In subparagraph (d) of said paragraph 4, the respondent Nos. In subparagraph (d) of said paragraph 4, the respondent Nos. 1 to 6 also stated that on or about 16th July, 1996, the Central Drugs Laboratory, Calcutta forwarded the test report to the respondent No. 7 which was received on 19th July, 1996 and thereafter the respondent No. 6 served a copy of the said report upon the writ petitioners. The respondents, however, in the said affidavit-in-opposition admitted that no portion of the said sample had been forwarded to the writ petitioners, but stated, that a similar packed, sealed and signed portion of the sample was still available with the respondent No. 6 and the writ petitioners, if they so desired, might obtain the same, but the writ petitioners did not make any demand for such samples and that non-furnishing of a portion of the sample to the writ petitioners had not vitiated the test report or obliterated the petitioners culpability. The said respondents further denied in their affidavit-in-opposition that the delay in receiving copy of the test report had deprived the petitioners of their right to challenge the same. 7. Mr. Ghosh, learned Senior Counsel for the petitioners submits that when admittedly, the Inspector of Drugs being the respondent No. 6 had taken samples of Paracetamol Tablets from the District Reserved Store, Chief Medical Officer of Health, Burdwan alleged to have been manufactured by the writ petitioners, in four containers, he should have sent one portion of the said sample to the writ petitioners as per the provisions of sub-section (4) of section 23 of the Drugs and Cosmetics Act, 1940 and that having not been done, had rendered the entire enquiry proceeding as illegal and hence the same is liable to be set aside. 8. Secondly, Mr. Ghosh submits that since there was inordinate delay of more than 3 years and 6 months in sending an attested copy of the result of the analysis of the Government Analyst to the writ petitioners, it had vitiated the entire enquiry proceeding and hence the same should be quashed. 9. Thirdly, Mr. 8. Secondly, Mr. Ghosh submits that since there was inordinate delay of more than 3 years and 6 months in sending an attested copy of the result of the analysis of the Government Analyst to the writ petitioners, it had vitiated the entire enquiry proceeding and hence the same should be quashed. 9. Thirdly, Mr. Ghosh submits that from the Government Analyst's report being Annexure 'A' to the writ application, which was sent by the Inspector of Drugs to the writ petitioners by Registered Post with Acknowledgement Due, vide the Memo dated 25th July, 1996, it would appear that the test report was to the effect that the sample so taken by the Drugs Inspector was spurious, adulterated and was considered misbranded under section 17(B)(d) of Drugs and Cosmetics Act, 1940 and the Rules framed thereunder. 10. According to Mr. Ghosh, in order to declare a drug as misbranded, spurious and adulterated, the conditions as laid down, in sections 17, 17-A and 17B of the aforesaid Act have to be present, but in the present case, those conditions are not present so far as the disputed samples taken by the Inspector of Drugs are concerned. In support of his contentions, Mr. Ghosh has referred to several decisions viz. AIR 1967 SC 970 , 1973 Madhya Pradesh 255, 1975 Cr.L.J. 332 and 1979 Cr. L.J. 530. 11. The learned Counsel for the respondents, however, referred to the affidavit-in-opposition affirmed on behalf of the respondent Nos. 1 to 6 and submits that admittedly one portion of the sample was not sent to the writ petitioners, but, that had not vitiated the proceeding in any way and a similar packed, sealed and signed portion of the said sample was still available with the respondent No. 6 and the petitioners if they had so chosen, might obtain the same. 12. Secondly, the said learned Advocate further submits that though there was some delay in sending a copy of the Analysis Report of the Government Analyst to the writ petitioners by the Inspector of Drugs, but in the affidavit-in-opposition the delay has been sufficiently explained. 12. Secondly, the said learned Advocate further submits that though there was some delay in sending a copy of the Analysis Report of the Government Analyst to the writ petitioners by the Inspector of Drugs, but in the affidavit-in-opposition the delay has been sufficiently explained. The learned Advocate further submits that the final order in the enquiry proceeding had been passed by the authority but because of the interim order passed by this Court, the same has not been communicated to the petitioners, nor any effect has been given to the same and produces a copy of the said order in sealed envelope before the Court. 13. The learned Advocate lastly submits that the provisions of section 23 of the Drugs and Cosmetics Act, 1940 were duly followed in taking out the samples and sending them to the authorities concerned. 14. Considering the submissions of the learned Counsels for the parties as well as the facts and circumstances of the case, I am, however, of the view, that there is much substance in the contentions of Mr. Ghosh. So far as the delay in sending a portion of the sample to the Government Analyst for test or analysis, by the Drugs Inspector is concerned, the explanation given by the respondent Nos. 1 to 6 in their affidavit-in-opposition does not appear to be cogent, inasmuch as, never there were continuous holidays for about eleven days for the Sate Government during Kalipuja and as such the explanation appears to be an after-thought. 15. Secondly, sub-section (4) of section 23 of the Drugs and Cosmetics Act, 1940 speaks of the modes in which the four portions of the sample taken by a Drug Inspector of a drug under sub-section (3) of section 23 of the said Act, are to be disposed of, and clause (iii) of the said sub-section (4) says that the Drug Inspector, should send the third portion of the sample taken by him to the person, if any, whose name, address and other particulars have been disclosed to him under section 18A of the said Act. Admittedly, no portion of the said sample was sent to the petitioners. Admittedly, no portion of the said sample was sent to the petitioners. Further, nothing has been said in the affidavit-in-opposition that the name, address and other particulars of the manufacturer of the drug, whose sample was taken by the Drugs Inspector was not disclosed to him by the person or office from whom the sample was taken. Therefore, there is a clear violation of the statutory provisions of law by the respondent Nos. 1 to 6 in the present case. 16. So far as the judgment of the Supreme Court in the case of Municipal Corporation of Delhi vs. Ghisa Ram, AIR 1967 SC 970 , is concerned, that was a case under the Prevention of Food Adulteration Act (1954), section 13(2) of the said Act confers a right upon the accused-vendor to have the sample, given to him, examined by the Director, Central Food Laboratory and to obtain a certificate from him on the basis of the analysis of that sample. The Supreme Court observed in the aforesaid case, that when a valuable right is conferred by section 13(2) of the Act on the vendor to have the sample given to him analysed by the Director, Central Food Laboratory, it is expected that the prosecution will proceed in such a manner that that right will not be denied to him, as the right is a valuable one. In a case where there is a denial of this right on account of deliberate conduct of the prosecution, the vendor, in his trial, is so seriously prejudiced that it would not be proper to uphold his conviction on the basis of the report of the public analyst. 17. In a case where there is a denial of this right on account of deliberate conduct of the prosecution, the vendor, in his trial, is so seriously prejudiced that it would not be proper to uphold his conviction on the basis of the report of the public analyst. 17. In the present case also, a valuable right is conferred upon the writ petitioner No. 1 Company, i.e., the alleged manufacturer of the drug, under section 23(4)(iii) of the Drugs and Cosmetics Act, 1940 that the writ petitioner No. 1 was to get the third portion of the sample taken by the Drugs Inspector in respect of the disputed Drug allegedly manufactured by the writ petitioner No. 1 Company, more so when the name, address and other particulars of the writ petitioner No. 1 Company were known to the Drugs Inspector, otherwise, he would not have sent the copy of the report of the public analyst to the writ petitioner No. 1 Company in respect of the portion of the sample taken by him and sent to the Government Analyst for analysis and/or test, being annexure 'A' to the writ application. The said fact would also be apparent from the annexures 'C' and 'D' to the writ application. However, the said valuable right was denied by the Drugs Inspector to the writ petitioner No. 1 Company namely, the manufacturer in the present case, and therefore, that has vitiated the entire enquiry proceeding and the manufacturer must be deemed to have been seriously prejudiced by such act and as such, it would not be proper to uphold the enquiry proceeding and the final order passed therein for such non-compliance of the aforesaid statutory provisions by the Drugs Inspector. 18. The respondent Nos. 18. The respondent Nos. 1 to 6, however, in their affidavit-in-opposition have stated inter alia, that still a sample of the said drug is lying with the Drugs Inspector and the writ petitioners, if they so like, can get it, but that will be a futile exercise of the right conferred upon the writ petitioner No. 1 Company under clause (iii) of-sub-section (4) of section 23 of the Drugs and Cosmetics Act, 1940 at this stage i.e. more than 6 years after the date when the sample was taken by the Drugs Inspector from the District Reserved Store, Chief Medical Officer of Health, Burdwan, more so, when the potency of the drug has already expired. 19. Another Bench decision of the Madhya Pradesh High Court in the case of M/s. Agarwal Medical and General Stores vs. The State of Madhya Pradesh and Others, AIR 1973 Madhya Pradesh 255, has also held in clear terms that as required by sub-section (4)(iii) of section 23 read with section 18A of the Drugs and Cosmetics Act, 1940 it is the duty of the Drugs Inspector to supply to the manufacturer the third portion of the sample. 20. Another Bench decision of the Karnataka High Court in the case of The State of Karnataka vs. M/s. Vikram Chemical Laboratories, Bangalore and Another, 1975 Cr.L.J. 332, has also observed inter alia, that when samples of Drugs are taken from a premises where they are not being manufactured, provisions of section 23(4) and section 18A of the Drugs and Cosmetics Act, 1940 come into play. 21. It is also well-settled that where powers, rights or immunities are granted with direction that certain regulations, formalities or conditions shall be complied with, it is neither unjust nor inconvenient to exact a rigorous observance of them as essential to the acquisition of the right or authority conferred. If a statute directs a thing to be done in a certain way, that thing shall not, even if there be no negative words, be done in any other way. The statute shall be deemed to have prohibited the doing of that thing in any other way. If a statute directs a thing to be done in a certain way, that thing shall not, even if there be no negative words, be done in any other way. The statute shall be deemed to have prohibited the doing of that thing in any other way. In the present case also, sub-section (4) of section 23 of the Drugs and Cosmetics Act, 1940 directs the Drugs Inspector the manner in which he is to dispose of the portions of the sample of drugs or cosmetics taken by him and clause (iii) of sub-section (4) of section 23 of the Act in specific terms directs that the Drugs Inspector is to send the third portion of the sample to the manufacturer and when the statute has directed that the portions of the sample are to be disposed of in a particular way, the Drugs Inspector has to follow the said directions and cannot act in a different manner. Therefore, the Drugs Inspector in not sending a portion of the sample to the manufacturer, i.e., the writ petitioner No. 1 Company has clearly violated the statutory provisions of law as stated in clause (iii) of sub-section (4) of section 23 of the Drugs and Cosmetics Act, 1940 and it has vitiated the enquiry proceeding. 22. Secondly, from the certificate of the test or analysis given by the Government Analyst under section 25(1) of the Drugs and Cosmetics Act, 1940 a copy of which, was sent to the writ petitioner No. 1 Company by the Drugs Inspector being annexure 'A' to the writ application, it would appear that it was merely stated therein by the Government Analyst that the sample did not conform to paracetamol I.P. and the sample was spurious, adulterated and was considered misbranded under section 17(B)(d) of the Drugs and Cosmetics Act and Rules made thereunder. 23. On a plain reading of the section 17, it would, however, appear that a drug would be levelled as 'mis-branded' if any of the three conditions as mentioned therein is present, but so far as the present case is concerned, none of the said conditions is present. 23. On a plain reading of the section 17, it would, however, appear that a drug would be levelled as 'mis-branded' if any of the three conditions as mentioned therein is present, but so far as the present case is concerned, none of the said conditions is present. Section 17A speaks of 'adulterated drugs' and under that section, a drug shall be deemed to be 'adulterated' only when it comes under any of the conditions laid down therein namely, conditions (a) to (f), but from the impugned test report, it would appear that none of the said conditions is also present in this case. Section 17B speaks of 'spurious drugs' and a drug shall be deemed to be 'spurious' if it comes under any of the conditions laid down therein being conditions (a) to (e). The test report being annexure 'A' to the writ application is also silent about any of such conditions. 24. Accordingly, it cannot be said that the sample of the drug alleged to have been manufactured by the writ petitioner No. 1 Company as taken by the Drugs Inspector, contained either 'mis-branded drug' or 'adulterated drug' or 'spurious drug', inasmuch as, the test report merely shows that the analyst was of the view that the sample did not contain any paracetamol, but the test report is absolutely silent about the actual ingredients of the said sample. 25. Because such irregularities and/or illegalities as referred to above and also because of the admitted non-compliance of the provisions of clause (iii) of sub-section (4) of section 23 of the Drugs and Cosmetics Act, 1940 which are mandatory in nature, in my view, the impugned proceeding is wholly vitiated and as such, cannot be sustained in law and therefore, stands quashed and so also all consequential orders passed in the said enquiry proceeding including the final order passed therein, if there be any, as well as the decision dated 12th of December, 1996 declared by the Director of the Drugs Control, State of West Bengal and Secretary, Licensing Authority, State of West Bengal, in respect of the impugned enquiry proceeding, which also stands set aside. 26. The writ application accordingly succeeds and is allowed without any order as to costs. 27. All parties are to act as per the signed copy of the operative part of this order on the usual undertaking. Writ petition allowed.