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TMI Blog2017 (12) TMI 1737X X X X Extracts X X X X X X X X Extracts X X X X ..... such quantity for which there is no therapeutic justification - The power exercised under Section 26A must further be exercised only if it is found necessary or expedient to do so in public interest. When the power is so exercised, it may regulate, restrict or prohibit manufacture, sale or distribution of any drug or cosmetic. Section 26A was brought in by an amendment in 1982. The amendment specifically made changes in Sections 33 and 33N in which it added the words on the recommendation of the Board . From this, it is clear that Parliament in the very Amendment Act which introduced Section 26A made certain changes which involved the DTAB under Section 5 of the said Act. It is clear that the additional power that is given to the Central Government under Section 26A does not refer to and, therefore, mandate any previous consultation with the DTAB. If the power under Section 26A is exercised on the basis of irrelevant material or on the basis of no material, the satisfaction itself that is contemplated by Section 26A would not be there and the exercise of the power would be struck down on this ground. - Also, as a matter of statutory interpretation, words can only be added if ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... DCs can pose significant risks to persons and need to be withdrawn immediately in that human lives can be at risk. The Committee recommended that a clear and transparent policy may be framed for approving FDCs based on scientific principles, and that, at present, Section 26A of the Drugs Act is adequate to deal with the problem of FDCs not cleared by the CDSCO. Pursuant to the aforesaid report, the Ministry of Health in October, 2012 issued directions to States and Union Territories under Section 33P of the Drugs Act not to grant licenses to FDCs falling under the definition of new drugs and not approved by the Drug Controller General of India (DCG(I)). The DCG(I), in turn, had requested all States/Union Territories Drug Controllers to ask concerned manufacturers in their respective States/Union Territories to prove the safety and efficacy of such FDC licenses issued prior to 1.10.2012, without due approval of the DCG(I), within a period of 18 months, failing which such FDCs would be considered for being prohibited, both qua manufacture and marketing in the country. On 5.7.2013, the DCG(I) vide its communication to the State Drug Controllers asked manufacturers to make applicatio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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, IIT, BHU, Varanasi. M. Pharm, Ph.D. Member 4 Dr. C.D. Tripathi Prof. HOD (Pharmacology), Safdarjung Hospital, New Delhi. MD, Pharamacology Member 5 Dr. Bikash Medhi Deptt. of Pharmacology, PGIMER, Chandigarh. MD, Pharmacology Member 6 Dr. Sanjeev Sinha Prof. (Medicine), AIIMS,New Delhi MD, Medicine Member 7 Dr. R.K. Khar Former Dean Head, Jamia Hamdard, 403,Lalleshwari Vatika ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 refer to the DTAB. According to her, a large number of provisions of the Drugs Act expressly refer to the DTAB in various contexts and, therefore, it is not permissible for the Court to read a mandatory requirement of consultation with the DTAB into Section 26A, when such mandatory consultation is present in other provisions, but is conspicuous by its absence in Se ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 22DA, 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 out of the administration of the Drugs Act and the second (and distinct part) being to carry out other functions assigned to it by the Drugs Act. It is clear, therefore, that in all matters which fall within the first part, the advice of the Board would be mandatory before the Central Government were to take action under Section 26A. He also referre ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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; (ii) the Drugs Controller, India, ex officio; (iii) the Director of the Central Drugs Laboratory, Calcutta, ex officio; (iv) the Director of the Central Research Institute, Kasauli, ex officio; (v) the Director of the Indian Veterinary Research Institute, Izatnagar, ex officio; (vi) the Presi ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t 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 class of cosmetics shall be exercised by the Director of that Institute or of that other Laboratory, as the case may be. (2) the Central Government may, after consultation with the Board, make rules prescribing- (a) the functions of the Central Drugs Laboratory; ******** (d) the procedure for the submis ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... etic; (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 prohibited by rule made under this Chapter: Provided that nothing in this section shall apply to the import, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis or for personal use: Provided further that the Central Government may, after consultation with the Board, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 stock or exhibit or offer for sale, or distribute any drug or cosmetic, except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter: Provided that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any dr ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... , 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 suspension of such licences in any case where any provision of this Chapter or the rules made thereunder is contravened or any of the conditions subject to which they are issued is not complied with; (ee) prescribe the records, registers or other documents to be kept and maintained under section 18B; (eea) pre ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 interest.- Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied on the basis of any evidence or other material available before it that the use of any Ayurvedic, Siddha or Unani drug is likely to involve any risk to human beings or animals or that any such drug does not hav ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e 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 amendment in 1982. A bare reading of this provision would show, firstly, that it is without prejudice to any other provision contained in this Chapter (meaning thereby Chapter IV). This expression only means that apart from the Central Government s other powers contained in Chapter IV, Section 26A is an additional power which ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 example. Suppose the Central Government were to ban an FDC on the ground that, in the recent past, it has been apprised of the fact that the FDCs taken over a short period of time would lead to loss of life, which has come to the notice of the Central Government through reports from various distric ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ibution 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 taken power under Section 26A cannot be exercised. Indeed, the Central Government s satisfaction may be based on a number of factors, one of which may be advice tendered to it by the DTAB under Section 5. There is no warrant to read Section 26A to constrict the wide powers grante ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ter 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 Division v. National Tobacco Co. of India Ltd., (1972) 2 SCC 560 at 575 as follows: The High Court's view was based on an application of the rule of construction that where a mode of performing a duty is laid down by law it must be performed in that mode or ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 the Hindu Women s Rights to Property Act was read down so as not to include agricultural land, which would be outside the Central Legislature s powers under the Government of India Act, 1935. This is done because it is presumed that the leg ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... r 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 play is where the statute requires extensive additions and deletions. Not only it is no part of the court s duty to undertake such exercise, but it is beyond its jurisdiction to do so. (emphasis supplied) 52. Applying the afore ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ence 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 Judge of the Karnataka High Court in Lundbeck India Pvt. Ltd. v Union of India, (2014) 5 Kant LJ 440. 30. We approve of these two judgments as having laid down the correct law on the construction of Section 26A of the Dr ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 is necessary or expedient to (i) regulate, (ii) restrict, or (iii) prohibit the manufacture, sale or distribution of such FDCs. 35. The DTAB/Sub-Committee must also indicate in its ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the original petitioners in these cases, stated that these cases have been transferred to this Court from the Madras High Court. A Section 33 ban, which was imposed on 294 FDCs in these cases, has been stayed by the Madras High Court, and the very exercise that we have proposed in the Delhi cases has apparently been carried out in this group of cases. A report of the expert committee of the DTAB to review the rationality and safety of 294 FDCs is taken on record. The report indicates that 42 FDCs reportedly were repeated or duplicate; 44 were already prohibited for manufacture in the country; 83 were considered rational; 56 were considered not rational; 49 required further generation of data; 17 were considered inadequate so far as rationality, safety and efficacy is concerned; and 3 other cases were sent for further examination by an expert committee constituted by the Ministry of Health and Family Welfare. The DTAB after review of the report and deliberations recommended that the FDC Ofloxacin and Prednisolone at serial number 75 under the category of GI in Annexure C does not appear to be rational and should be re-examined. The list of the drugs mentioned in Annexure D are requi ..... X X X X Extracts X X X X X X X X Extracts X X X X
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