Union of India v. M/S. Ranbaxy Laboratories Ltd. and Others

[2008] 8 S.C.R. 315 -~ ...I. A B ~ ## UNION OF INDIA _v._ M/S. RANBAXY LABORATORIES LTD. AND OTHERS (Civil Appeal No. 3497 of 2008) MAY 12, 2008 [S.B. SINHA AND V.S. SIRPURKAR, JJ.] ~ _Drugs (Price Control) Order, 1995:_ ---~ ' )\ ,, .... - - _Paragraphs 8(6), 23 and 25 Scheduled bulk drug Exemption from operation of Order_ - _Notification dated_ c _29. 8. 1995_ - _HELD: By reason of Notification the drug which was manufactured by company has been exempted and area of exemption is operation of price control_ - _They have a direct nexus and are co- related with each other_ - _If the Company was entitled to benefit of notification ti/131.1.1979, some time_ D _would be necessary for it to market the same_ - _Essential Commodifies Act, 1955_ - _s. 3_ - _Interpretation of Statutes_ - _Purposive construction._ Respondent no. 1, a pharmaceutical company was E engaged in manufacture of bulk drug including Pentazocine in the formulation of Pentazocine injection. Sale and marketing of the said drug was controlled by the Drugs (Price Control) Order, 1995 issued by the Central Government in exercise of its powers u/s 3 of the Essential Commodities Act, 1955. By Notification dated 29.8.1995 the[F ] drug in question was exempted from operation of the price control stipulated in the 1995 Order. The exemption granted in favour of respondent no. 1 expired on 31.10.1999. Respondent no. 1, by notice dated 29.4.2002 was required to deposit Rs. 2,59,76,070/- with 15% interG est. The writ petition filed by respondent no. 1 was dismissed by Single Judge, but its Letters Patent Appeal was allowed by the Division Bench of the High Court. 315 H SUPREME COURT REPORTS [2008] 8 S.C.R. 316 > ~ - A In the instant appeal filed by the Union of India, it was contended for the appellant that the High Court failed to take into consideration that the 1995 Order was concerned with distribution and not manufacture and as a manufacturer, respondent no. 1 could sell its products since exemption B[was in regard to sale only and not to manufacture; and that ] after 31.10.1999 respondent no. 1 was at liberty to sell the drug at any price and not at the stipulated one. A .,.. The question for consideration before the Court was: whether the exemption Notification dated 29.8.1995 would c apply in respect of drugs which were manufactured upto 31st October, 1999 or manufactured and sold upto the said date. Dismissing the appeal, the Court D D HELD: 1.1 The principle of purposive construction may be applied so as to give full effect to the exemption notification. The exemption notification must be construed to be a workable one. The Court while construing an exemption notification cannot lose sight of the ground reE[alities including the process ][of ][marketing and sale. ][In ] view of Clause (6) of Paragraph 8 of the Drugs (Price Control) Order, 1995 what is prohibited is market of a new pack without obtaining prior approval of its price from the Government. The exemption Notification dated 29th August, F[1995 is clear and unambiguous. By reason thereof what ] has been exempted is the drug which was manufactured by the company and the area of exemption is from the operation of the price control. They have a direct nexus. They are co-related with each other. [para 16,25 and 27] G[[327-D, ][325-E,F, ][322-C,D,E] ] )( _i_ • ,. _New India Assurance_ Co. _Ltd.. vs. Nusli Neville Wadia and another_ 2007 (14) SCALE 556; _Oriental Insurance_ Co. _Ltd. vs Brij Mohan and others_ 2007 (7) Scale 753 - relied on. 1.2 It is true that 1995 Order was to control the price H ' 317 - _.J._ " _)4_ ## UNION OF INDIAV. M/S. RANBAXY LABORATORIES LTD. AND OTHERS ;( \" .it .. _-+_ and not the manufacture. But there cannot be any doubt A that the price is that of a manufactured drug. Process of marketing the drug as also the maximum price which can be charged have direct relation with manufacture and also the date thereof. The wrapper/foil/containers in which the drug is marketed contains several informations for the B general public, one of them being the date of manufacture and the retail price. Not only in terms of the Essential Commodities Act, 1955 but also under various other statutes applicable several informations are required to be furnished. If it is held that the first respondent was bound c not only to manufacture but also to sell at a price upto 31s[1 ] October, 1999, the same would lead to an absurdity. Such an anomaly and absurdity must be avoided. [para 23 and 26] (325-B-C, 326.D] 1.3 While construing an exemption notification not D only a pragmatic view is requ!red to be taken but also the practical aspect of it. A manufacturer would not know as to when the drug would be sold. It has no control over it. Its control over the drug would end when it is despatched to the distributor. All statutes have to be considered in E the light of the object and purport of the Act. If the first respondent was entitled to avail the benefit of the exempti on notification till the midnight of 31st October, 1999, sometime would be necessary for it to market the same. There must be some time lag between the period the drug F is manufactured and the actual sale by a retail dealer to the customer. Applying the principle of doctrine of purposive construction, meaningful purpose could be achieved only if such construction of the notification is adopted and no other. [para 23-25] 325,G; 326,A; 325,D; E F G _Union of India_ vs. _Cynamide India Ltd._ (1987) 2 SCC 720; _Prag Ince_ & _Oil Mills_ vs. _Union of India_ (1978) 3 SCC 459 ;and _Sree Meenakshi Mills vs. Union of India_ (1973) 1 - sec 129 held inapplicable. H SUPREME COURT REPORTS 318 [2008] 8 S.C.R. A Aharon Barak, _Purposive Interpretation in Law,_ (2007) at pg. 87) CIVILAPPELLATE JURISDICTION: Civil Appeal No. 3497 of 2008 B From the final Judgment and Order dated 19.12.2005 of the High Court of Delhi at New Delhi in LP.A. No. 675 of 2004 D. Mohta, D.S. Mahra and V.K. Verma for the Appellant. S. Ganesh, Ashu~osh Khaitan, Tania Sharma, Umesh c Kumar Khaitan, U.A. Rana and Abhishek Rao (for M/s. Gagrat & Co.) for the Respondents. The Judgment ot the Court was delivered by S.B. SINHA, J. 1. Leave granted. D 2. First respondent is a pharmaceutical company and is engaged in the manufacture, inter 2!ia, of the bulk drug Pentazocine in the formulation of Pentazocine injection with the brand name 'Fortwin'. Sale and marketing of the said drug is controlled by the Drugs (Price Control) Order, 1995 ( 1995 Order). E The said order has been made by the Central Government in exercise of its powers under Section 3 of the Essential Commodities Act, 1955 (1955 Act). We may notice some interpretation clauses in the 1955Act, which are as under:- F G "2.(a) "bulk drug" means any pharmaceutical, chemical, biological or plant product including its salts, esters, stereoisomers and derivatives, conforming to pharmacopoeia! or other standards specified in the Second Schedule to the Drugs and Cosmetics Act, 1940 (23 of 1940), and which is used as such or as an ingredient in any formulation; 2.(c) "ceiling price" means a price fixed by the Government for scheduled formulation in accordance with the provisions of para. 9. 2(f) "drug" includes- H UNION OF INDIA V. M/S. RANBAXY LABORATORIES LTD. AND OTHERS [S.B. SINHA, J.] 319 ... A ·- ~ _... (i) (ii) (iii) bulk drugs and formulations; .. 2(1) "manufacture" in relation to any drug, includes any process or part of a process for making, altering, finishing, B packing, labelling, breaking or otherwise treating or adapting any drugs with a view to its sale and distribution, but does not include the compounding or dispensing of any drug or the packing of any drug in the ordinary course of retail business, and "to manufacture" shall be construed accordingly; c c 2(r) "price list" means a price list referred to in paragraphs 14 and 15 and includes a supplementary price list; ,JI 2(s) "retail price" means the retail price of a drug arrived at or fixed in accordance with the provisions of this Order D and includes a ceiling price;" 3. The drug in question is one of the scheduled bulk drugs being at SI. No.43 in the First Schedule. ., ... ~ 4. The Central Government in exercise of its powers conE ferred upon it by paragraph 23 of the 1995 Order issued guidelines for the purpose of grant of exemption in terms of paragraph 25 specifying that a manufacturer who had been given a price exemption for bulk drug should submit an application in prescribed forms for fixation of price of suck bulk drug and forF mulation four months before the expiry of the period of the exemption. It was furthermore stipulated :- "However, if there is an existing notified price for bulk drug or ceiling price for formulations, the manufacturer shall follow the same on the expiry of the exemption and obtain[G ] price approval for non-ceiling packs of formulation (s) based on that bulk drug." 5. A similar provision has been made for grant of exemptiqns in respect of New Delivery System, in terms whereof a H SUPREME COURT REPORTS 320 [2008] 8 S.C.R. ... A manufacturer is required, where there is an existing notified price, to follow the same on the expiry of the exemption. "'" 6. The exemption granted in favour of the first respondent had expired on 31 •[1 ] October, 1999. B First respondent was asked to show cause as to why an amount of Rs.2,59,76,070/- should not be recovered from it and why action should not be taken under paragraphs 21 and 24 of 1995 Order read with Section 10 of the 1955 Act by a notice dated 29[1] h April, 2002. In respQnse thereto the first respondent c[inter alia contended that it had not overcharged price from any ] customer and no amount towards any alleged over charge was payable by it. It was furt~ermore contended that the company had furnished all the informations, as and when asked for by the prescribed authorities of the appellant. D 7. As the said reply was found to be unsatisfactory, the first respondent was asked to depcsit the alleged over charged amount with interest@ 15% per annum as provided under Section 7 A of the 1955 Act. 8. A writ petition was filed thereagainst by the first respondent before the Delhi High Court. The said writ petition was dismissed by a learned Single Judge of the said High Court by an order dated 20[1] h May, 2004. E 9. A Letters Patent Appeal was filed thereagainst which F has been allowed by a Division Bench of the said Court by reason of the impugned judgment and order dated 19[1] h December, 2005. The High Court opined that the exemption Notification dated 29[1] h August, 1995 clearly show that the same related to G drugs manufactured by 31•[1 ] October, 1999 and thus the same would apply even if the drugs have been sold after the said date. 10. Mr. Gopal Subramaniam, learned Additional Solicitor General of India appering on behalf of the appellant, would submit :- H .,. > )( - .. ,l .. .. 321 UNION OF INDIA V. M/S. RANBAXY LABORATORIES LTD. AND OTHERS [S.B. SINHA, J.] _, G - i) That the High Court committed a serious error A in passing the impugned judgment in so far as it failed to take into consideration that 1995 Order is concerned with distribution and hot manufacture. Aj " . ""' _).;_ - ii) An exemption Notification must be strictly[B ] construed and so construed, it must be held that no benefit could be claimed by the first respondent beyond the period of 31[51 ] October, 1999 as by reason of the said exemption Notification it could sell the drug at any price c and not at the stipulated one and thus, as soon as the period of exemption expired, the price provided for under the 1999 Order was required to be charged. - iii) As a manufacturer the first respondent could[D ] sell its products but the exemption was in regard to sale only and not to manufacturer, the impugned judgment cannot be sustained. > 11. Mr. S. Ganesh, learned Senior Counsel, appearing on E behalf of the first respondent, on the other hand, would submit that exemption Notification must be given a purposive meaning and so construed, the impugned judgment is wholly unassailable F 12. Admittedly the drug in question is an essential commodity within the meaning of the provisions of 1955 Act. 13. Section 3(2)(c) of 1955Act empowers the Central Government to make an order providing for controlling the price at which the essential commodity may be bought or sold. -· .. 14. Exemption clause contained in paragraph 25 of the 1995 Order vis-a-vis Notification dated 29th August, 1995 must be construed having regard to the object and purport, which 1995 Order seeks to achieve. A scheduled drug contains details not only of the maximum retail price but also the date of H SUPREME COURT REPORTS [2008] 8 S.C.R. 322 A manufacture. The price fixed in terms of paragraph 9 of the 1995 Order shall be the ceiling price. Paragraph 3(1) empowers fixing of the maximum sale price at which the same can be sold. The factors which were required to be considered therefore, however, are not required to be noticed. B 15. In terms of clause 3 of paragraph 3 of 1995 Order, a statutory prohibition had been created in terms whereof nobody could sell the bulk price exceeding the maximum sale price fixed under paragraph 1. Clause 2 of paragraph 8 empowers the authority fix retail price of scheduled formulations in terms whereof C revision in the price is permissible. 16. Clause 6 of paragraph 8 of 1995 Order reads as under:- (6) No manufacturer or importer shall market a new pack, D if not covered under sub-paragraph 3 of para 9, or a new formulation or a new dosage form of his existing scheduled formulation without obtaining the prior approval of its price from the Government. Thus, what is prohibited is market of a new pack without E obtaining the prior approval of its price from the Government. Paragraph 9 empowers the authority to fix ceiling price of scheduled formulations. Paragraph 23 provides for the power of the Central GovF ernment to issue guidelines and directions. Such guidelines and directions, however, must be consistent with the provisions of the Order. 17. What is, thus, necessary to be taken into considerG ation is the power for exempting and the Notification issued therefore by the Central Government. The power of exemption is contained In clause 25 of he Order, which reads as under :- "25. Pqwerto exempt.-(1) Government may, having regard to tl}e factors mentioned in sub-paragraph (2) and subject to such conditions as it may specify by an order in the H ·- .. 323 UNION OF INDIA V. M/S. RANBAXY LABORATORIES LTD. AND OTHERS [S.B. SINHA, J.] -' ""' Official Gazette, exempt any manufacturer from the A operation of all or any of the provisions of this Order. (2) While granting exemption under sub-paragraph (1 ), the Government shall have regard to all or any of the following factors,- B - (a) number of workers employed: _.. - (b) amount of capital invested; - (c) range/group and type of products manufactured; - a) sales turnover; c - b) < " )< - c) production of a new drug which has not been produced elsewhere, if developed through indigenous research and development." D 18. The exemptionNotification dated 29th August, 1995, reads thus:- "ORDER .i. _.j_ S.O. No./ 7153 (E), in exercise of the powers conferred by sub-paragraph (1) of Paragraph 25 of the Dugs (Price Control) Order, 1995, the Central Government having regard to the factors specified in the clause(e) of subparagraph (2) of paragraph 25 of the said order and also having been satisfied for the need to do so in the public interest hereby exempts the bulk drug and formulations based thereupon specified in column 2 of the Table bellow which is manufactured by the company specified in the corresponding entry in column 3 from the operation of price control stipulated in sub-paragraph (1) of paragraph 3, sub paragraph (1) of paragraph 8 and sub-paragraph (1) of paragraph 9 of the said order, upto the period as indicated in column 4 thereof. E F G TABLE H 324 SUPREME COURT REPORTS [2008) 8 S.C.R. |S.No.|Nameofthe<br>Product|Nameofthe<br>Company|Perioduptowhich<br>theexemptionis<br>granted| |---|---|---|---| |1|2|3|4| |1|Pentazocine<br>anditsformu-<br>lations|M/s.<br>Ranbaxy<br>Labo<br>ratoriesLtd.|31-10-1999| c Sd/- (K. MULALIDHARAN) ## DESK OFFICER " 19. For issuance of an exemption Notification the Central D Government is required to apply its mind. The factors which are relevant, must be taken into consideration as provided for under paragraph 2 of clause 25 of the Order. _JI._ < , 20. The relevant considerations inter alia are the sales turnE[over ][as ][also ][production ][of a ][new ][drug ][which ][was ][not ][produced ] elsewhere, if developed through indigenous research and development. 21. Pentazocine is used for a patient suffering from traumatic pain. The Central Government must be held to have apF plied its mind before issuing the exemption notification. 22. What must have been taken into consideration for that purpose is that respondent No.1 fulfilled the requisite criteria. The area of exemption is from the operation of the price conG[trol. ][Such ][exemption ][admittedly ][had ][been ][granted ][upto ][31 ][•][1 ][Oc-] tober, 1999. Indisputably the Central Government had the power to extend the period of exemption. It could have granted further exemption subject to any condition. • I> "· 23. The short question which arises for our consideration H[is ] as[to ] whether the exemption Notification would apply[in ] re- UNION OF INDIA V. MIS. RANBAXY LABORATORIES LTD. AND OTHERS [S.B. SINHA, J.] 325 ..., _.A_ spect of drugs which were manufactured upto 31st October, 1999 A or manufactured and sold upto the said date. The exemption granted is in respect of what. It is in respect of a drug manufactured by a company. What is marketed for sale is the drug manufactured. Manufacture of a drug is controlled by a different statute, namely the Drugs and Cosmetics Act, 1940. Process of B marketing the drug as also the maximum price which can be charged have direct relation with manufacture and also the date thereof. The wrapper/foil/containers in which the drug is marketed contains several informations for the general public; or.e of them being the date of manufacture and the retail price. Vari- c ous other informations are also required to be furnished. 24. The contention of learned Additional Solicitor General that the drug could be manufactured upto 31st October, 1999 but on and from 1st November, 1999 it could be sold only at the )i price specified in the order, in our opinion, cannot be accepted. D "' If the first respondent was entitled to avail the benefit of the exemption notification till the midnight of 31st October, 1979, sometime would be necessary for it to market the same. There must be some time lag between the period the drug is manufactured and the actual sale by a retail dealer to the customer. E E .., .... _.>_ 25. The Court while construing an exemption notification cannot lose sight of the ground realities inclduing the process of marketing and sale. The exemption order dated 29[1] h August, 1995 is clear and unambiguous. By reason thereof what has been exempted is the drug which was manufactured by the comF pany and the area of exemption is from the operation of the price control. They have a direct nexus. They are co related with each other. While construing an exemption notification not only a pragmatic view is required to be taken but also the practical aspect of it. A manufacturer would not know as to when the drug G would be sold. It has no control over it. Its control over the drug would end when it is despatched to the distributor. The distributor may despatch it to the whole seller. A few others may deal with the same before it reaches the hands of the retailer. The manufacturer cannot supeNise or oversee as to how others H SUPREME COURT REPORTS [2008] 8 S.C.R. 326 ... A would be dealing with its product. All statutes have to be considered in light of the object and purport of the Act. Thus, the decision relied upon by the learned Additional Solicitor General in _Union of India vs. Cynamide India Ltd._ : (1987) 2 SCC 720; _Prag Ince_ & _Oil Mills vs. Union of India:_ (1978) 3 SCC B[459 and ] _[Sree Meenakshi Mills ][vs. ][Union ][of ][India ]_[: ( ][1973) 1 ] sec 129 will have no applicability. 26. It is true that 1995 Order was to control the price and not the manufacture. But there cannot be any doubt that the price is that of a manufactured drug. ... c Not only in terms of the Essential Commodities Act, 1955 but also under various others, for example Customs and Central Excise Act and Weights and Measures Act (if applicable) several informations are required to be furnished. If the submisD[sion ][of ][Mr. ][Gopal Subramaniam that the first respondent was ] bound not only to manufacture but also to sell at a price upto 31•[1 ] October, 1999 is correct, the same in our opinion lead to an absurdity. Such an anomaly and absurdity must be avoided. > )( ., 27. Learned counsel wants us to apply the principle of purE[posive construction. It may be applied so as to give full effect to ] the exemption notification. The exemption notification must be construed to be a workable one. F G H In _New India Assurance_ Co. _Ltd .. vs. Nusli Neville Wadia and another:_ 2007 (14) SCALE 556 this Court opined :- "51. Barak in his exhaustive work on 'Purposive Construction' explains various meanings attributed to the term "purpose". It would be in the fitness of discussion to refer to _Purposive Construction_ in Barak's words: "Hart and Sachs also appear to treat "purpose" as a subjective concept. I say "appear" because, although Hart and Sachs claim that the interpreter should imagine himself or herself in the legislator's shoes, they introduce two elements of objectivity: _First,_ the interpreter .... "" ..... UNION OF INDIA V. MIS. RANBAXY LABORATORIES LTD. AND OTHERS [S.S. SINHA, J.] 327 ... c E -'I > should assume that the legislature is composed A of reasonable people seeking to achieve reasonable goals in a reasonable manner; and _second,_ the interpreter should accept the nonrebuttable presumption that members of the legislative body sought to fulfill their B constitutional duties in good faith. This formulation allows the interpreter to inquire not into the subjective intent of the author, but rather the intent the author would have had, had he or she acted reasonably." (Aharon Barak, _Purposive Interpretation in Law,_ (2007) at pg. 87) ~ ll While referring to its decision in _Oriental Insurance_ Co. _Ltd. vs. Brij Mohan and others_ : 2007 (7) Scale 753 it applied D the doctrine of purposive construction. Applying the principle of doctrine of purposive construc·iiOn, we are of the opinion that meaningful purpose could be achieved only if the construction of the notification as indicated hereinbefore is adopted and no other. 28. There is no merit in this appeal which fails and is accordingly dismissed with costs. Counsel's fee assessed at Rs.50,000/- "" ,., R.P. Appeal dismissed. ' , . ,_. "' . _:;f"'· •" . ~ I .,,..,._ ~-" " ... - , .. ~ _:._