Case: UNION OF INDIA AND ANR Vs. PFIZER LIMITED AND ORS

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 courts duty to undertake such exercise, but it is beyond its jurisdiction to do so."(emphasis supplied)52. Applying the aforesaid test to the impugned Regulation, it is clear that the language of the Regulation is definite and unambiguous - every service provider has to credit the account of the calling consumer by one rupee for every single call drop which occurs within its network. The Explanatory Memorandum to the aforesaid Regulation further makes it clear, in Para 19 thereof, that the Authority has come to the conclusion that call drops are instances of deficiency in service delivery on the part of the service provider. It is thus unambiguously clear that the impugned Regulation is based on the fact that the service provider is alone at fault and must pay for that fault. In these circumstances, to read a proviso into the Regulation that it will not apply to consumers who are at fault themselves is not to restrict general words to a particular meaning, but to add something to the provision which does not exist, which would be nothing short of the court itself legislating.For this reason, it is not possible to accept the learned Attorney Generals contention that the impugned Regulation be read down in the manner suggested by him."27. Also, as a matter of statutory interpretation, words can only be added if the literal interpretation of the Section leads to an absurd result. As has been stated by us, the construction of Section 26A on a literal reading thereof does not lead to any such result. Dr. Singhvis argument to read in words to save Section 26A must, therefore, be rejected.28. We may also mention that the Madras High Court in its judgment in Macleods Pharmaceuticals Limited v. Union of India & Ors., Writ Petition Nos.21933 and 25442 of 2011, specifically held as under:"38. Thus, the Act gives in every Chapter, an indication of the functions to be exercised by the DTAB. In other words, the territory within which the DTAB is to operate and exercise its functions, is clearly demarcated in various provisions of the Act such as 5(1), 6(2), 7(1), 8(2), second proviso to Section 10, 12(1) and 33(1). But Section 26-A is completely silent about any consultation with DTAB. It is so even with Section 26-B.39. While 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 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 Drugs Act.31. Though arguments have been made as to whether Section 26A is legislative in nature and therefore excludes natural justice, we do not propose to go into the same inasmuch as since the learned single Judges judgment is being set aside on one point and one point alone. In this view of the matter, we are of the opinion that the impugned judgment dated 1.12.2016 deserves to be set aside.32. On the facts of these cases, a suggested course of action was stated by learned counsel appearing on behalf of the petitioners/appellants. This course is that instead of now remitting the matter back to the Delhi High Court for an adjudication on the other points raised in the writ petitions, the case of 344 FDCs that have been banned, plus another FDCs that have been banned, which comes to 349 FDCs, (barring 15 FDCs that are pre 1988 and 17 FDCs which have DCG(I) approval) pursuant to the Kokate Committee report, by notifications of the Central Government under Section 26A of the Drugs Act, should be sent to the DTAB, constituted under Section 5 of the Drugs Act, so that it can examine each of these cases and ultimately send a report to the Central Government. We reiterate that only on the peculiar facts of these cases, we think that such a course commends itself to us, which would obviate further litigation and finally set at rest all other contentions raised by the petitioners. We say so because we find that the Kokate Committee did deliberate on the 344 FDCs plus 5 FDCs and did come to a conclusion that the aforesaid FDCs be banned, but we are not clear as to what exactly the reasons for such conclusions are, and whether it was necessary in the public interest to take the extreme step of prohibiting such FDCs, instead of restricting or regulating their manufacture and supply.

Decision (1 = appeal accepted, 0 = rejected): 1

Explanation:
1[ds]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 Governments other powers contained in Chapter IV, Section 26A is an additional power which must be governed by its own terms. Under Section 26A, the Central Government must be "satisfied" that any drug or cosmetic is likely to involve(i) any risk to human beings or families; or(ii) that any drug does not have the therapeutic value claimed or purported to be claimed for it; or(iii) contains ingredients in such quantity for which there is no therapeutic justification. Obviously, the Central Government has to apply its mind to any or all of these three factors which has to be based upon its "satisfaction" as to the existence of any or all of these factors. 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.16. Undoubtedly, Section 26A has to be read with the rest of the Drugs Act. So read, it is clear that unlike Section 6(2), Section 8(2), second proviso to Section 10, proviso to Section 12(1), Section 16(2), proviso to Section 18(2), Section 33 and Section 33N, there is no explicit requirement to consult the DTAB set up under Section 5 of the Drugsobvious answer is no inasmuch as the Central Governments 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 toe, which has come to the notice of the Central Government through reports from various district authorities, in let us say, a majority of districts in which the said FDC has beenobvious answer again is yes for the reason that the Central Government has been satisfied on relevant material that it is necessary in public interest to ban such drug. Examples of this nature can be multiplied to show that the width of the power granted under Section 26A cannot be cut down by artificially cutting down the language of Section 26A.It is clear that a stray sentence in a judgment without a focused argument cannot be considered as the ratio of such a judgment. Also, on a careful reading of the second sentence in paragraph 19, it is clear that all that is stated by this Court is that, while exercising its power under Section 26A of the Drugs Act, the basis of the Central Governments decision must be "expert advice". The sentence then goes on to add that the Drugs Act makes provision for obtaining such advice through the Board and the DCC. According to us, there was no focused argument on whether such advice is or is not mandatory before powers under Section 26A of the Drugs Act can be exercised, and merely reading a stray sentence in this judgment does not lead to such amust 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 Governments 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 granted to the Central Government by aharmonious construction of the statute. Another argument made is that Section 5 makes it clear that the DTAB alone can constitutewhich may have persons who are not members of the Board on them. We are afraid that this again does not lead us very far. It is clear that the reason for Section 5(5) is completely different.may be appointed for such periods not exceeding three years or temporarily for the consideration of particular matters. Suchmay be set up in the wisdom of the DTAB for short periods of time or temporarily to consider certain matters and make reports which the DTAB may then utilize. This is a power of the DTAB which can be exercised when the DTAB deems it desirable. From this power, it cannot be inferred, as a matter of logic, that since Section 5(5) permits persons who are not members of the board to sit onthe Central Government may not, under Section 26A, refer to any persons other than those who are board members. This argument, therefore, is alsohave already pointed out how the very amendment Act of 1982 also amended Sections 33 and 33N by referring to the DTAB and that, therefore, it is obvious that the omission of any reference to the DTAB under Sections 10A and 26A cannot but be said to be deliberate. This argument also need not detain us further.22. A negative argument was made stating that Section 7A of the Drugs Act makes it clear that Section 5 will not apply to Ayurvedic, Siddha or Unani drugs and that, therefore, it will apply to all other drugs. The reason for Section 7A is again something very different from what has beenmust first be pointed out that under Chapter IVA, which is a separate Chapter introduced by Act 13 of 1964, Ayurvedic, Siddha and Unani 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 Division v. National Tobaccoia Ltd., (1972) 2 SCC 560     at 575 asHigh Courts 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 not at all. This rule flows from the maxim: "Expressio unius ast exclusio alterius". But, as was pointed out by Wills, J., in Colguoboun v. Brooks [(1888) 21 QBD 52, 62] this maxim "is often a valuable servant, but a dangerous master....". The rule is subservient to the basic principle that Courts must endeavour to ascertain the legislative intent and purpose, and then adopt a rule of construction which effectuates rather than one that may defeat these. "This argument, therefore, also need not detainour construction of Section 26A, it is clear that no such non obstante clause was necessary in that the width of the expression "is satisfied" contained in Section 26A cannot be cut down by reference to Section 5. As has been stated by us hereinabove, the expression "without prejudice" makes it clear that Section 26A is an additional power given to the Central Government which must be exercised on its ownour opinion, there are sufficient indicators in the Section to eschew any ground of arbitrariness. The power can only be exercised based on satisfaction of material that is relevant to form an opinion that the drug in question falls within any of the three categories outlined by the Section and that, further, it is necessary or expedient to either regulate, restrict or prohibit manufacture, sale or distribution of the said drug in public interest. Indeed, this is made explicit in Section 33 EED of the Drugs Act, wherein a similar power is given to the Central Government qua Ayurvedic, Siddha or Unani drugs, where the Section states: "... the Central Government is satisfied on the basis of any evidence or other material available before it that ..."25. 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. 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.Also, as a matter of statutory interpretation, words can only be added if the literal interpretation of the Section leads to an absurd result. As has been stated by us, the construction of Section 26A on a literal reading thereof does not lead to any such result. Dr. Singhvis argument to read in words to save Section 26A must, therefore, be rejected.28. We may also mention that the Madras High Court in its judgment in Macleods Pharmaceuticals Limited v. Union of India & Ors., Writ Petition Nos.21933 and 25442 of 2011, specifically held asThus, the Act gives in every Chapter, an indication of the functions to be exercised by the DTAB. In other words, the territory within which the DTAB is to operate and exercise its functions, is clearly demarcated in various provisions of the Act such as 5(1), 6(2), 7(1), 8(2), second proviso to Section 10, 12(1) and 33(1). But SectionWhile 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 Sectionassumes 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 SectionsB. 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 Sectionwhat was deliberately left out by the Parliament. This cannot be done by me and hence the first contention has to be rejected.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 Drugs Act.31. Though arguments have been made as to whether Section 26A is legislative in nature and therefore excludes natural justice, we do not propose to go into the same inasmuch as since the learned single Judges judgment is being set aside on one point and one point alone. In this view of the matter, we are of the opinion that the impugned judgment dated 1.12.2016 deserves to be set aside.32. On the facts of these cases, a suggested course of action was stated by learned counsel appearing on behalf of the petitioners/appellants. This course is that instead of now remitting the matter back to the Delhi High Court for an adjudication on the other points raised in the writ petitions, the case of 344 FDCs that have been banned, plus another FDCs that have been banned, which comes to 349 FDCs, (barring 15 FDCs that are pre 1988 and 17 FDCs which have DCG(I) approval) pursuant to the Kokate Committee report, by notifications of the Central Government under Section 26A of the Drugs Act, should be sent to the DTAB, constituted under Section 5 of the Drugs Act, so that it can examine each of these cases and ultimately send a report to the Central Government. We reiterate that only on the peculiar facts of these cases, we think that such a course commends itself to us, which would obviate further litigation and finally set at rest all other contentions raised by the petitioners. We say so because we find that the Kokate Committee did deliberate on the 344 FDCs plus 5 FDCs and did come to a conclusion that the aforesaid FDCs be banned, but we are not clear as to what exactly the reasons for such conclusions are, and whether it was necessary in the public interest to take the extreme step of prohibiting such FDCs, instead of restricting or regulating their manufacture and supply.Insofar as the list of cases handed over by Shri Sibal, in which DCG(I) approvals have allegedly been granted, we are of the view that since the Parliamentary Standing Committee itself refers to DCG(I) approvals and the manner in which they were granted, we do not accede to Mr. Sibals request that these cases be kept outside the purview of the fresh look that has to be given by thein these cases.39. Insofar as the status quo, obtaining as on today, is concerned, that will continue in all cases (including the 5 FDCs which are not the subject matter of stay orders already made) until the Central Government issues fresh notifications in this behalf.