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2017 (12) TMI 1737
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....gs Act is the prior consultation of the Drugs Technical Advisory Board (DTAB) set up under Section 5 of the said Act. It must be stated that the learned single Judge differed from judgments of the Karnataka and Madras High Courts in this regard, wherein two other learned single Judges of two other High Courts have held that such consultation with the DTAB is not mandatory before exercise of such power under Section 26A. Since we are concerned only with this narrow question that has been decided by the learned single Judge of the Delhi High Court, we are not going into any other contentions that have been raised by learned counsel for the parties. 3. The issue regarding the prevalence of many Fixed Dose Combinations (hereinafter referred to "FDCs") that were flooding the Indian market and had not been tested for efficacy or safety was considered by the Parliamentary Standing Committee on Health and Family Welfare in its 59^th Report in May, 2012. The Standing Committee observed that some of the State Licensing Authorities have issued manufacturing licenses for a very large number of FDCs without prior clearance from the Central Drugs Standard Control Organization (CDSCO). Such FD....
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.... safe and effective based on pharmacokinetic and pharmacodynamic interaction, dosage compatibilities of FDCS vis-a-vis that of single ingredients present in the FDC, available literature/evidence, clinical experience and other data available. d. Those FDCs which may be considered as rational, based on present data and knowledge available. However, data in post market scenario is required to be generated within a period of 1 to 2 years to confirm the same. e. All the FDCs falling, under category "b" above would be referred to the respective Expert Committee out of 10 Expert Committees already constituted. Composition of Expert Committee for examining the safety & efficacy of Fixed Dose Combinations (FDCs) is as under: S.No. Name of Expert Name & Address of Institutions Qualification Status in the Committee 1 Prof. Chandrakant Kokate Vice-Chancellor, KLE University, Belgaum, Karnataka & Ex-President of Pharmacy Council of India. M. Pharm, Ph.D. Chairman 2 Dr. C.L. Kaul Former Director, NIPER, 432, Ph.D. Mahatma Society, Koth Road, Pune-38. B. Pharm, Member 3 Prof. Sanjay Singh Deptt. of Pharmaceutics, II....
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....ese FDCs. In category D, 126 FDCs have to be considered for further generation of data by the prospective applicants. It is only after carrying out of this exercise, that by notifications dated 10.3.2016 issued under Section 26A, the Central Government banned manufacture and sale of 344 FDCs. 7. In March 2016, a large number of writ petitions were filed in the Delhi High Court against the aforesaid notifications. The impugned judgment then followed on 1.12.2016 disposing of 454 petitions, followed by an order dated 21.12.2016, in which the Delhi High Court disposed of 51 further writ petitions in terms of the judgment dated 1.12.2016. 8. Letters Patent Appeals were filed before the Delhi High Court. Meanwhile, the Union of India filed transfer petitions in this Court. This is how these matters have been heard by us in civil appeals arising out of SLPs against the judgment of the single Judge dated 1.12.2016 and in transfer cases in which the LPAs pending before the Delhi High Court have been transferred to us. 9. Ms. Pinky Anand, learned Additional Solicitor General, took us through various provisions of the Drugs Act, and emphasized that Section 26A does not expressly ref....
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....ing of persons who are not members of the DTAB, who may consider particular matters, thereby making it clear that the DTAB alone can induct experts who are outside Section 5 and not the Central Government. He further referred to the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the "Drugs Rules"), in particular Rules 21, 68A, 122A, 122D and 122DA, to buttress his submission that a detailed filtration process has to be gone through before a drug can be manufactured and put on the market and that the Central Government cannot ban such drug without consulting the technical expert under the Drugs Act namely, the DTAB, that is set up under Section 5. He also argued that Sections 10A and 26A were introduced by way of an amendment in 1982 and this being so, it is clear that it is assumed by Parliament that Section 5 of the Drugs Act will be read along with both of them so as to make the DTAB a mandatory consultee before action is taken under Section 26A. 11. Shri Vashisht, learned senior counsel appearing for some of the respondents, adverted to Section 5 and stated that it was in two parts, the first being advice to the Central Government on all technical matters arising....
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.... that Sections 29 and 35 thereof make it clear that amendments were made in certain Sections with reference to the DTAB under Section 5 and that, therefore, the omission of any reference to the DTAB in Section 26A is deliberate. She also went on to state that Rule 66 of the Drugs Rules, which deals with cancellation of individual licenses and which requires compliance with natural justice, should be contrasted with Section 26A of the Drugs Act which, according to her, is a legislative power as opposed to an administrative power. 14. Having heard learned counsel for the parties, it is first important to set out some of the provisions of the Drugs Act. "5. The Drugs Technical Advisory Board.- (1) The Central Government shall, as soon as may be, constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act and to carry out the other functions assigned to it by this Act. (2) The Board shall consist of the following members, namely:- (i) the Director General of Health Services, ex officio, who shall be Chairman; ....
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.... to such sub-committees for such periods, not exceeding three years, as it may decide, or temporarily for the consideration of particular matters, persons who are not members of the Board. (6) The functions of the Board may be exercised notwithstanding any vacancy therein. (7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary. 6. The Central Drugs Laboratory.- (1) The Central Government shall, as soon as may be, establish a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to carry out the functions entrusted to it by this Act or any rules made under this Chapter: Provided that, if the Central Government so prescribes, the functions of the Central Drugs Laboratory in respect of any drug or class of drugs or cosmetic or class of cosmetics shall be carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in respect of such drug or class of drugs or such cosmetic or c....
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....10. Prohibition of import of certain drugs or cosmetics.- From such date as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import- (a) any drug or cosmetic which is not of standard quality; (b) any misbranded drug or misbranded or spurious cosmetic; (bb) any adulterated or spurious drug; (c) any drug or cosmetic for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence; (d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true formula or list of active ingredients contained in it together with the quantities thereof; (e) any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed; (ee) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended; (f) any drug or cosmetic the import of which is proh....
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....dard quality, or is misbranded, adulterated or spurious; (ii) any cosmetic which is not of a standard quality or is misbranded, adulterated or spurious; (iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label 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 accompanying 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; and (vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made thereunder; (b) sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder; (c) manufacture for sale or for distribution, or sell, or sto....
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....or testing and analysing drugs or cosmetics; (b) prescribe the qualifications and duties of Government Analysts and the qualifications of Inspectors; (c) prescribe the methods of test or analysis to be employed in determining whether a drug or cosmetic is of standard quality; (d) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation; (dd) prescribe under clause (d) of section 17A the colour or colours which a drug may bear or contain for purposes of colouring; (dda) prescribe under clause (d) of section 17E the colour or colours which a cosmetic may bear or contain for the purpose of colouring; (e) prescribe the forms of licences for the manufacture for sale or for distribution, for the sale and for the distribution of drugs or any specified drug or class of drugs or of cosmetics or any specified cosmetic or class of cosmetics, the form of application for such licences, the conditions subject to which such licences may be issued, the authority empowered to issue the same, the qualifications of such authority and the fees payable therefor; and provide for the cancellation or sus....
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....ne containing such drug; [****] (n) prescribe the powers and duties of Inspectors and the qualifications of the authority to which such Inspectors shall be subordinate and specify the drugs or classes of drugs or cosmetics or classes of cosmetics in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed; (o) prescribe the forms of report to be given by Government Analysts, and the manner of application for test or analysis under section 26 and the fees payable therefor; (p) specify the offences against this Chapter or any rule made thereunder in relation to which an order of confiscation may be made under section 31; (q) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder, of any specified drug or class of drugs or cosmetic or class of cosmetics; and (r) sum which may be specified by the Central Government under section 32-B. 33EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in public interes....
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....er or rules made thereunder is contravened or any of the conditions subject to which they are issued is not complied with; (f) prescribe the conditions to be observed in the packing of Ayurvedic, Siddha and Unani drugs including the use of packing material which comes into direct contact with the drugs, regulate the mode of labelling packed drugs and prescribe the matters which shall or shall not be included in such labels; (g) prescribe the conditions subject to which small quantities of Ayurvedic, Siddha or Unani drugs may be manufactured for the purpose of examination, test or analysis; (gg) prescribe under clause (d) of section 33EE the colour or colours which an Ayurvedic, Siddha or Unani drug may bear or contain for purposes of colouring; (gga) prescribe the standards for Ayurvedic, Siddha or Unani drugs under section 33EEB; (ggb) prescribe the records, registers or other documents to be kept and maintained under section 33 KB; and (h) any other matter which is to be or may be prescribed under this Chapter." 15. Having heard learned counsel for the parties, it is clear that Section 26A has been introduced by an amendmen....
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....ic interest to regulate, restrict or prohibit manufacture, sale or distribution thereof. So long as the Central Government's satisfaction can be said to be based on relevant material, it is not possible to say that not having consulted the DTAB, the power exercised under the said Section would be non est. Take the case of an FDC that is banned in 50 countries of the world owing to the fact that the said FDC involved significant risk to human beings. Assuming that the Central Government is satisfied based on this fact alone, which in turn is based on expert committee reports in various nations which pointed out the deleterious effects of the said drug, can it be said that without consulting the DTAB set up under Section 5, the exercise of the power under Section 26A to prohibit the manufacture or sale or distribution of a drug that is banned in 50 countries would be bad only because the DTAB has not been consulted? The obvious answer is no inasmuch as the Central Government's satisfaction is based upon relevant material, namely, the fact that 50 nations have banned the aforesaid drug, which in turn is based on expert committee reports taken in each of those nations. Take another exa....
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....ad to such a conclusion. Equally, the single Judge's reliance upon a Division Bench judgment contained in E. Merck (supra), where, in holding Section 26A to be constitutional, the Court stated: "Before the Government records its satisfaction to prohibit the manufacture, sale, distribution etc. of a particular drug, opinion of the DTAB and/or Drugs Consultative Committee is obtained." This is an equally stray sentence and what has been stated with respect to Systopic Laboratories (supra), applies equally to this sentence. 20. We have now to consider certain other arguments made on behalf of the respondents. One argument was that Section 5 is in two parts and that the first part necessarily applies to all technical matters that arise out of the administration of the Drugs Act, and that, therefore, the Central Government is bound to take the advice of the DTAB in all such matters. We must first advert to the fact that the DTAB is only an advisory body. No doubt, it would be desirable for the Central Government to take its advice on technical matters arising out of the administration of the Drugs Act, but this does not lead to the conclusion that if such advice is not ta....
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....drugs are completely separately dealt with. Indeed, Section 33A, which must be read with Section 7A, expressly provides that save as provided in this Drugs Act, nothing contained in this Chapter, i.e. Chapter IV, shall apply to Ayurvedic, Siddha or Unani drugs. Chapter IVA consists of a separate and distinct drill to be followed in the case of Ayurvedic, Siddha and Unani drugs. Under Section 33C, there is a separate technical advisory board for Ayurvedic and Unani drugs and a separate consultative committee for Ayurvedic, Siddha and Unani drugs (see Section 33D). When Section 7A says that nothing in section 5 shall apply to Ayurvedic, Siddha or Unani drugs, all that it affirms is that the DTAB set up under Section 5 will apply to all drugs except Ayurvedic, Siddha or Unani medicines. The Latin maxim "expressio unius est exclusio alterius" cannot apply, as has been held in State of Karnataka v Union of India & Ors., (1977) 4 SCC 608 at 662, making it clear that the said maxim should be very carefully applied and when misapplied would turn out to be a "dangerous master" as opposed to a "useful servant". This has also been held in Assistant Collector of Central Excise, Calcutta Divisi....
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....emplated by Section 26A would not be there and the exercise of the power would be struck down on this ground. Further, it is argued that the provision may be read down to make it constitutionally valid, but in so doing, words cannot be added as a matter of constitutional doctrine. 26. In Cellular Operators Association of India and others v. Telecom Regulatory Authority of India and others, (2016) 7 SCC 703 at 740-741, this Court held as under: "50. But it was said that the aforesaid Regulation should be read down to mean that it would apply only when the fault is that of the service provider. We are afraid that such a course is not open to us in law, for it is well settled that the doctrine of reading down would apply only when general words used in a statute or regulation can be confined in a particular manner so as not to infringe a constitutional right. This was best exemplified in one of the earliest judgments dealing with the doctrine of reading down, namely, the judgment of the Federal Court in Hindu Women's Rights to Property Act, 1937, In re [Hindu Women's Rights to Property Act, 1937, In re, AIR 1941 FC 72]. In that judgment, the word "property" in Section 3 of....
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....two interpretations are possible - one rendering it constitutional and the other making it unconstitutional, the former should be preferred. The unconstitutionality may spring from either the incompetence of the legislature to enact the statute or from its violation of any of the provisions of the Constitution. The second situation which summons its aid is where the provisions of the statute are vague and ambiguous and it is possible to gather the intentions of the legislature from the object of the statute, the context in which the provision occurs and the purpose for which it is made. However, when the provision is cast in a definite and unambiguous language and its intention is clear, it is not permissible either to mend or bend it even if such recasting is in accord with good reason and conscience. In such circumstances, it is not possible for the court to remake the statute. Its only duty is to strike it down and leave it to the legislature if it so desires, to amend it. What is further, if the remaking of the statute by the courts is to lead to its distortion that course is to be scrupulously avoided. One of the situations further where the doctrine can never be called into p....
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....ile the advisory role of DTAB is indicated in broad and general terms in Section 5(1), it is indicated in specific terms in Sections 6(2), 7(1), 8(2), second proviso to Section 10, 12(1) and 33(1). Therefore, the absence of any reference to such requirement of consultation in Section 26-A assumes great significance. It is a well settled principle of interpretation of statutes that the Courts are not expected to supply the omission. The Parliament had consciously incorporated the expressions "after consultation with the Board" or "on the recommendation of the Board", in certain provisions of the Act such as Sections 5(1), 6(2), 7(1), 8(2), second proviso to Section 10, 12(1) and 33(1). But it has deliberately omitted to include any of those expressions while inserting Sections 26-A and 26-B. It is a case of casus omisus. Therefore, the argument that the Central Government ought to have taken the consultation of the DTAB before issuing the ban order, can hold good only if I can supply into Section 26-A, what was deliberately left out by the Parliament. This cannot be done by me and hence the first contention has to be rejected." 29. To similar effect is the judgment of a single Ju....
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....o hear submissions from the All India Drugs Action Network. The DTAB/Sub-Committee set up for this purpose will deliberate on the parameters set out in Section 26A of the Drugs Act, as follows. 33. First and foremost in each case, the DTAB/Sub-Committee appointed by it must satisfy itself that the use of the Fixed Dose Combinations (FDC) in question is likely to involve any one of the aforesaid three things: (a) that they are likely to involve any risk to human beings or animals; or (b) that the said FDCs do not have the therapeutic value claimed or purported to be claimed for them; or (c) that such FDCs contain ingredients and in such quantity for which there is no therapeutic justification. 34. The DTAB/Sub-Committee must also apply its mind as to whether it is then necessary or expedient, in the larger public interest, to regulate, restrict or prohibit the manufacture, sale or distribution of such FDCs. In short, the DTAB/Sub-Committee must clearly indicate in its report: (1) as to why, according to it, any one of the three factors indicated above is attracted; (2) post such satisfaction, that in the larger public interest, it i....