W.P.(C)/9978/2018 of M/S MICRO LABS LIMITED Vs DRUGS CONTROLLER GENERAL OF INDIA AND ANR.

IN THE HIGH COURT OF DELHI AT NEW DELHI

%Judgment delivered on: 13.02.2019+W.P.(C)9978/2018andCMAPPL.38873/2018&38874/2018

M/S MICRO LABS LIMITED

versus

..... Petitioner

DRUGS CONTROLLER GENERAL OF INDIAAND ANR.

..... Respondents

WITH

+W.P.(C)10757/2018andCMAPPL.41978/201841979/2018

INTAS PHARMACEUTICALS LIMITED

..... Petitioner

versus

DRUGS CONTROLLER GENERAL OF INDIA

& ANR

..... RespondentsWITH

+W.P.(C)10936/2018andCMAPPL.42605/2018&44745/2018

LUPIN LIMITED & ANRUNION OF INDIA & ANR

..... Petitioners

versus

..... Respondents

AND

+W.P.(C)11278/2018andCMAPPL.43787/2018&43788/2018

ERIS LIFESCIENCES LIMITED

..... Petitioner

versus

UNION OF INDIA AND ANR.

..... Respondents

Advocates who appeared in this case:

For the Petitioners:MsArchanaSahadevainW.P.(C)9978/2018.Ms Bitika Sharma, Ms Namrita Kochhar andMs Vrinda Pathak in W.P.(C) 10757/2018.Mr Gopal Jain, Senior Advocate with MrAjay Bhargava, Mr Aseem Chaturvedi andMr Karan Gupta in W.P.(C) 10936/2018.Mr R. Jawahar Lal, Mr Siddharth Bawa andMr Shyamal Anand in W.P.(C) 11278/2018.

For the Respondents:

MsManinderAcharya,ASGwithMrKirtiman Singh, CGSC and Mr Ripu DamanBhardwaj, CGSC with Mr Waize Ali Noor,GP,MrRishikantSingh,MrPrateekDhanda, Mr Parth Semwal, Ms Shruti Dutt,Mr Viplav Acharya, Mr Harshul Chowdharyand Mr Sahil Sood, Advocates in W.P.(C)9978/2018.

Mrs Suparna Srivastava and Ms Sanjna Dua,AdvocatesforR-1&2inW.P.(C)10757/2018.Mr Ripu Daman Bhardwaj, CGSC with MrT.P. Singh, Advocate for UOI.Ms Tanya Agarwal, Advocate for Impleaderin W.P. (C) 10936/2018.None in W.P. (C )11278/2018.

CORAMHON’BLE MR JUSTICE VIBHU BAKHRU

JUDGMENT

VIBHU BAKHRU, J

1.The petitioners have filed the present petitions impugning thenotifications–nos.S.O.4471(E)and S.O.4472(E)–issuedbyrespondent no.2 (the Central Government) under Section 26A of theDrugs and Cosmetics Act, 1940 (hereafter ‘the Act’).

2.The petitioners in W.P.(C) Nos. 9978/2018; 10757/2018; and10936/2018impugnthenotificationno.S.O.4471(E)dated07.09.2018,wherebythemanufactureandsaleFixedDrugCombinations (FDCs) of the formulations “Glimepiride 1mg/ 2mg/3mg + Pioglitazone 15mg/ 15mg/ 15mg+ Metformin 1000 mg/ 1000mg/ 1000 mg” has been proscribed.

3.The petitioners in W.P.(C) 11278/2018 impugn the notificationno. S.O. 4472(E) dated 07.09.2018, whereby the FDC of theformulation “Glimepiride 1 mg/ 2 mg + Pioglitazone 15 mg/ 15 mg +Metformin 850mg/ 850mg” has been proscribed.

4.The Central Government has proscribed the manufacture, saleand distribution of the aforesaid FDCs on account of inclusion of theformulation Metformin in the said FDCs. The Sub-Committeeconstituted to examine the matter of proscribing/restricting the saidFDCs had, inter alia, found that there are safety concerns, as there is

no safety data available pertaining to the said FDCs. Accordingly, thesub-committee had recommended the prohibition of the said FDCs.Since, the principal issue involved is common, the said petitions wereheard together.

5.Thepetitionershereinhavechallengedtheaforesaidnotifications, essentially, on the following grounds:

(i) That the Drug Technical Advisory Board (DTAB) was not inexistence at the material time when sub-committee was constituted forexamining the matter regarding the FDCs in question, and therefore,the constitution of the sub-committee was void.

(ii) That the that the impugned notifications are based on therecommendations of the sub-committee of Drug Technical AdvisoryBoard (DTAB), which has been made without application of mind.

(iii) That the finding of the sub-committee, that there are safetyconcerns regarding Metformin, is incorrect and contrary to thematerial on record.

(iv) that the said FDCs have sound therapeutic justification and poseno risk to human beings.

(v) That the impugned notification has been passed without followingthe directives issued by the Supreme Court in Union of India v. PfizerLimited and Ors. : 2018 (2) SCC 39.

6.Therespondentscounteredtheaforesaidgrounds.Itiscontended on their behalf that the Sub-Committee has acted inconformity with the directions issued by the Supreme Court in PfizerLimited (supra). It was contended that the recommendations by theSub-Committee were made after due application of mind and forcogent reasons, thus, the impugned notifications, which are based onthe recommendations of the Sub-Committee of the DTAB, cannot befaulted. It is also contended that the impugned notifications have beenissued in exercise of legislative powers and the principles of naturaljustice are not required to be followed in such exercise.

Factual Background

7.The petitioners state that the FDCs in question are used for thetreatment of Type-2 Diabetes Mellitus when diet, exercise and theusage of dual therapy do not result in adequate glycemic control.

8.In the year 2013, pursuant to the directions of the DrugController General of India (DCGI), the manufacturers of variousFDCs were called upon to prove the safety and efficacy of the FDCswhich were issued prior to 01.10.2012, without the required approvalof DCGI.

9.Thereafter, an Expert Committee of ten experts was constitutedby the Central Drugs Standard Control Organisation (CDSCO) forexamining the applications received from various manufacturerspursuant to the aforesaid directions of the DCGI.

10.The Central Drugs Standard Control Organization (CDSCO)had constituted an Expert Committee of comprising of ten experts forexamining the efficacy of the FDCs in question.The ExpertCommittee so constituted did not recommend the FDCs in question, asit was of the view that the studies provided were not sufficient tojustify 15 mg dose of Pioglitazone in the FDCs. Thereafter, anothercommittee was constituted under the Chairmanship of Professor C.K.Kokate, Vice-Chancellor of KLE University of Belgaum, Karnataka toexamine the same (the Kokate Committee). The Kokate Committeerecommended the prohibition of the FDCs in question, inter alia,observing that “the Pioglitazone has safety concerns”. The KokateCommittee also recommended banning several other FDC drugs.

11.In view of the recommendations of the Kokate Committee, on10.03.2016, the Central Government issued notifications (threehundred and forty four in number) proscribing the manufacture, saleand distribution of 344 FDCs with immediate effect. Two of the saidnotifications – being S.O. 806(E) and S.O. 807(E) – prohibited themanufacture, sale and distribution of the FDCs of Glimepiride1mg/2mg/3mg, Metformin 1000mg and Pioglitazone 15 mg, andGlimepiride of 1mg/2mg, Metformin 850 mg and Pioglitazone 15 mg,respectively (the FDCs in question, which are banned in terms of theimpugned notifications).

12.Aggrieved, the petitioners herein preferred writ petitions beforethis Court challenging the aforesaid notifications [S.O. 806(E) andS.O. 807(E)], inter alia, on the ground that the same had been issued

without consultation with DTAB. According to the petitioners, suchconsultation was mandatory and the failure on the part of the CentralGovernment to do so had rendered the said notifications invalid.

13.The said petitions were considered alongwith batch ofpetitions impugning the other notifications, which were disposed of bya common judgment dated 01.12.2016, whereby all the 344 impugnednotifications therein, including S.O. 806(E), were set aside whileholding that it was mandatory for the Central Government to seekconsultation of DTAB.

14.Aggrieved by the said decision, the respondents preferredappeals and transfer petitions before the Supreme Court.The saidpetitions were disposed of by the common judgment dated 15.12.2017in Pfizer Ltd. (supra). The Supreme Court did not accept the viewexpressed by this Court that consultation with DTAB was mandatoryfor issuing notifications under Section 26A of the Act. However, inthepeculiarfactsofthecasesandconsideringthattherecommendations made by the Kokate Committee were not clear, theSupreme Court remanded the matter to DTAB/Sub-Committee todeliberate the matter, keeping in view the parameters as set out inSection 26A of the Act. The relevant extract of the said decision is setout below:-

“31. On the facts of these cases, suggested courseof action was stated by the learned counsel appearingon behalf of the appellant-petitioners. This course isthat instead of now remitting the matter back to the

Delhi High Court for an adjudication on the otherpoints raised in the writ petitions, the case of 344FDCs that have been banned, plus another 5 FDCsthat have been banned, which comes to 349 FDCs[barring 15 FDCs that are pre-1988 and 17 FDCswhich have DCG(I) approval) pursuant to the KokateCommittee report, by notifications of the CentralGovernment under Section 26-A of the Drugs Act,should be sent to the DTAB, constituted underSection 5 of the Drugs Act, so that it can examineeach of these cases and ultimately send report tothe Central Government.We reiterate that only on thepeculiar facts of these cases, we think that such acourse commends itself to us, which would obviatefurther litigation and finally set at rest all othercontentions raised by the petitioners. We say sobecause we find that the Kokate Committee diddeliberate on the 344 FDCs plus 5 FDCs and didcome to conclusion that the aforesaid FDCs bebanned, but we are not clear as to what exactly thereasons for such conclusions are, and whether it wasnecessary in the public interest to take the extremestep of prohibiting such FDCs, instead of restrictingor regulating their manufacture and supply. In orderthat an analysis be made in greater depth, we,therefore, feel that these cases should go to theDTAB and/or sub-committee formed by the DTABfor the purpose of having relook into these cases. Itis important, however, that the DTAB/sub-committeeappointed for this purpose will not only hear thepetitioners-appellants before us, but that they alsohear submissions from the All-India Drugs ActionNetwork. The DTAB/sub-committee set up for this

purpose will deliberate on the parameters set out inSection 26-A of the Drugs Act, as follows.

32. First and foremost in each case, the DTAB/Sub-Committee appointed by it must satisfy itself that theuse of the Fixed Dose Combinations (FDC) inquestion is likely to involve any one of the aforesaidthree things:

(a) that they are likely to involve any riskto human beings or animals; or

(b) that the said FDCs do not have thetherapeutic value claimed or purported tobe claimed for them; or

(c) that such FDCs contain ingredients andin such quantity for which there is notherapeutic justification.

33. The DTAB/Sub-Committee must also apply itsmind as to whether it is then necessary or expedient,in the larger public interest, to regulate, restrict orprohibit the manufacture, sale or distribution of suchFDCs. In short, the DTAB/Sub-Committee mustclearly indicate in its report:

(1) as to why, according to it, any one ofthethreefactorsindicatedaboveisattracted;

(2) post such satisfaction, that in the largerpublic interest, it is necessary or expedientto (i) regulate, (ii) restrict, or (iii) prohibitthe manufacture, sale or distribution ofsuch FDCs.

34. The DTAB/Sub-Committee must also indicate inits report as to why, in case it prohibits particularFDC, restriction or Regulation is not sufficient tocontrol the manufacture and use of the FDC. We

request the DTAB/Sub-Committee to be set up forthis purpose to afford the necessary hearing to allconcerned, and thereafter submit consolidatedreport, insofar as these FDCs are concerned, to theCentral Government within period of six monthsfrom the date on which this judgment is received bythe DTAB. We may also indicate that the CentralGovernment, thereafter, must have due regard to thereport of the DTAB and to any other relevantinformation, and ultimately apply its mind to theparameters contained in Section 26A of the DrugsActand,accordingly,eithermaintainthenotifications already issued, or modify/substitutethem or withdraw them.”

15.In compliance with the aforesaid directions, DTAB in itsmeeting dated 12.02.2018, recommended the constitution of Sub-Committee under the Chairmanship of Dr Nilima Kshirsagar to reviewthe matter pertaining to 344 + 5 FDCs that were the subject matter ofthe petitions before the Supreme Court.In view of the aforesaidrecommendations, the Sub-Committee was constituted by an OfficeMemorandum dated 19.02.2018. Thereafter, on 12.03.2018, noticeswere issued requesting the drug manufacturers and other concernedagencies to submit information in the prescribed format by 07.04.2018for further consideration. Thereafter, the Sub-Committee also heardthe concerned parties and, subsequently, made the recommendations.

16.It is stated that the Sub-committee also provided an opportunityto All India Drug Action Network (AIDAN) to make its submissions.

17.Thereafter, the Sub-committee reviewed the FDCs in questionand submitted its report. The sub-committee, in relation to the FDC

Glimepiride 1mg/2mg/3mg, Metformin 1000mg and Pioglitazone15mg, made the following observations:

“1. As per gazette notification under No. 520(E) dated31.07.2013, safety concerns regarding Pioglitazonehave been addressed and its suspension revoked withcertain conditions.

2. As per the standard treatment guidelines for type2diabetes followed. In India, patients not responding todiet, exercise, monotherapy (Metformin) or dualtherapy (Sulfonylurea/Biguanide) are treated withtripledrug therapy.

3. There is sufficiently large population of patientsnotrespondingtodiet,exercisealongwithmonotherapyanddualtherapy,tripledrugcombinationis appropriate for patient compliance inthis chronic disease.

4. The DCGI has approved FDC of Glimepiride(1mg/2mg) + Pioglitazone (15mg) + Metformin (500 mgER) uncoated tablet for indication: “As 3rd linetreatment of Type II diabetes mellitus when diet,exercise and the single agents and second line therapywith two drugs do not resultin adequate glycemiccontrol” on 16.08.2005 with certain precautions toaddress Pioglitazone’s safety concerns.

5.TheFDCGlimepiride1mg/2mg/3mg+Pioglitazone HCI IP eq. to Pioglitazone 15mg/15mg/15mg+MetforminHCIIP(ImmediateRelease/SustainedRelease/ExtendedRelease)1000mg/1000mg/1000mgtabletscontainsrecommended and approved therapeutic dosage ofeach ingredient.

6. The subcommittee concluded that the FDC hastherapeutic value and has the potential to address the

need of patients with type II diabetes hot respondingto diet, exercise,mono or dual therapy when the doseof individual drugs has been determined/stabilizedwith single ingredient tablets.

7.However,theFDCcanleadtoriskofhypoglycemia. There is no safety data pertaining tothis FDC.”

18.In view of the aforesaid observations, the Sub-Committeerecommended prohibition on the manufacture, sale and distributionof the FDC Glimepiride 1mg/2mg/3mg, Metformin 1000mg andPioglitazone 15 mg. The recommendations made by the Sub-Committee are set out below:-

“The FDC may involve risk to human beings.

Hence in the larger public interest, it is necessary toprohibit the manufacture, sale or distribution of thisFDC under section 26A of the Drugs and CosmeticsAct, 1940.

In view of the above, any kind of regulation orrestriction to allow for any use in patients is notjustifiable. Therefore, only prohibition under section26A is recommended.”

19.The Sub-committeealso recommended the prohibition of theFDC Glimepiride of 1mg/2mg, Metformin 850 mg and Pioglitazone15 mg based on the following observations:

“1. There are sufficient therapeutic options alreadyavailable.

2. The increments in dose of Metformin are made insteps of 500 mg as per treatment guidelines.

3. Availability of multiple strengths can lead tomedicationerror(prescribing,dispensing,administration) with risk of overdosing or under-dosing.

There is no convincing scientific/clinical evidence/justification for the FDC.”

20.The recommendations to ban the said FDC based on theaforesaid observations are set out below:

“There is no therapeutic justification for this FDC.The FDC may involve risk to human beings.

2. Hence in the larger public interest, it is necessaryto prohibit the manufacture, sale or distribution ofthis FDC under section 26A of the Drugs andCosmetics Act, 1940.

In view of the above, any kind of regulation orrestriction to allow for any use in patients is notjustifiable. Therefore, only prohibition under section26A is recommended.”

21.The said report was accepted and the Central Governmentissued the impugned notifications banning the FDCs in question.Aggrieved by the same, the petitioners have preferred the presentpetition.

Reasons and Conclusion

22.Ms Acharya, learned ASG contended that the present petitioncannot be viewed with the prism of Article 19(1)(g) of theConstitution of India. She submitted that the petitioner had nofundamental right to carry on the manufacture of drugs, and it was

merely statutory privilege granted to them. She referred to Article 47of the Constitution of India and submitted that no person has afundamental right to carry on trade in alcohol and drugs which areharmful.

23.The aforesaid contention is plainly unsustainable. Undoubtedly,no person has the fundamental right to carry on business in trade inalcohol and noxious substances, however, the principles of res extracommercium do not apply in case of life saving drugs and othermedicinal products. The fact that certain drugs may have serious sideeffects would, of course, have to be considered while considering thereasonableness of restrictions in terms of Article 19(6) of theConstitution of India.

24.The aforesaid contention is not relevant to the controversy athand as, concededly, the Central Government is empowered underSection 26A of the Act to proscribe any drug if the grounds, asstipulated therein, are established. In view of the above, this Courtmust confine its examination as to whether the impugned notificationscan be sustained on the ground as stated in Section 26A of the Act,and whether the directions issued by the Supreme Court in PfizerLimited and Ors (supra) have been duly complied with.

25.It was contended on behalf of the petitioners that theconstitution of the sub-committee is invalid, as it was constituted afterthe expiry of the term of DTAB. It is stated that the DTAB isreconstituted every three years, and last time it was constituted on

29.12.2014, hence, its term expired on 28.12.2017. The petitionerssubmit that the DTAB was reconstituted on 15.05.2018 and, thus,there was not validly constituted body during the period of 28.12.2017to 15.05.2018. It is stated that the Sub-Committee of DTAB wasconstituted on 12.02.2018 which, according to the petitioners, wasinvalid, as it was constituted after the expiry of the term of DTAB.

26.The aforesaid issue has been examined by this Court in UnisonPharmaceuticals Pvt. Ltd. and other connected matters v. Union ofIndia &Anr.: 10403/2018, decided on 08.01.2019, wherein the Courtobserved that the notification dated 29.12.2014, notifying theconstitution of the DTAB, did not specify the term of the DTAB. ThisCourt further observed that in terms of Section 5 of the Act, (i) theterm of the elected and nominated members of the DTAB is for threeyears and after the expiry of their term, they would be eligible fornomination and re-election, (ii) the ex-officio members wouldcontinue to hold office as per their tenure, and (iii) the functions of theBoard may be exercised notwithstanding any vacancy therein. In thisview, the Court held that notwithstanding the vacancy caused due toexpiry of the term of some of the members, the DTAB would continueto function and there was no flaw in constitution of the Sub-Committee.

27.Next, it was contended by the respondents that the powersexercised by the Central Government under Section 26A of the Actare legislative powers and, therefore, the principles of natural justiceare not applicable. Accordingly, it is contended that the Sub-

committee or the Central Government was not required necessarily togive any reason for banning the said FDC. It was further contendedthat the Sub-committee was constituted by experts in the given subjectand the decision of the said committee is not amenable to judicialreview.

28.The said issue has been examined by this Court in WockhardtLimited and Anr. v. Union of India and Anr.: W.P.(C) 9739/2018decided on 07.01.2019. Further, in BGP Products Operations GMBH& Anr. v. Union of India and Ors.: W.P.(C) 6084/2018 and otherconnected matters,decided on 14.12.2018, the Division Bench of thisCourt also considered the scope of judicial review in the context ofSection 26A of the Act and held as under:

91.TheUnionhadcontended,withsomeemphasis, that notification under Section 26A ispursuant to exercise of legislative power and thecourts should therefore, exercise restraint whileinterfering with it. This court is of opinion thatthere is no per se bar to reviewing regulatoryprovisions, even if they are made in the exerciseof subordinate legislative power. Such rules orregulations do not per se carry threshold ofimmunity greater than what any other instrument,either statutory or non-statutory would. Therelevant public law standards applicable would beno different, to adjudge their validity…..”

XXXXXXXXXXXX

94. In view of the above discussion and given thenature of the authorities, it is held that the Union’s

argument that the impugned notification, as it isthe product of subordinate legislative exercise,carries greater immunity than executive policy iswithout merit. The threshold of immunity in thecase of both: executive policy or norms andstatutory regulations is the same. The submissionis therefore, rejected.”

Section 26A of the Act reads as under:

“26A.PowerofCentralGovernmenttoprohibitmanufacture,etc.,ofdrugandcosmetic in public interest.— Without prejudiceto any other provision contained in this Chapter, ifthe Central Government is satisfied, that the use ofany drug or cosmetic is likely to involve any riskto human beings or animals or that any drug doesnothavethetherapeuticvalueclaimedorpurportedtobeclaimedforitorcontainsingredients and in such quantity for which there isno therapeutic justification and that in the publicinterest it is necessary or expedient so to do, then,that Government may, by notification in theOfficial Gazette, prohibit the manufacture, sale ordistribution of such drug or cosmetic.]”

29.It is clear from the above that the notifications issued inexercise of powers under Section 26A of the Act are of generalapplication, and the power exercised by the Central Government underSection 26A of the Act is legislative in nature. However, such powerscan be exercised only if the Central Government is satisfied that it isnecessary to exercise the same in larger public interest. Plainly, theCentral Government’s satisfaction would be required to be based on

the relevant considerations; cogent material; and by excludingirrelevant considerations.

30.Thus, the limited question that falls for consideration of thisCourt is whether the Central Government’s decision to ban themanufacture, sale and distribution of the FDCs in question is based onrelevant material, and whether the impugned notification has beenissued by due compliance of the directions of the Supreme Court inPfizer (supra).

31.At the outset, it is relevant to note that the Sub Committee hasapproved an FDC comprising of Glimepiride 1/2mg + Pioglitazone 15mg + Metformin 500 mg by S.O. No. 4711(E) dated 07.09.2018. Itis, thus, apparent that the only objection in respect of the FDCsproscribed in terms of S.O. No. 4471(E) and S.O. 4472(E) relate to theincreased dosage of Metformin: 1000mg in FDCs proscribed by S.O.4471(E)and 850 mg in FDCs proscribed by S.O. 4472(E).

32.First six paragraph of the reasons indicated by the Sub-Committee do not indicate any reason for proscribing the FDC. On thecontrary, paragraph 3 of the said reasoning indicates that there is asufficiently large population of patients that requires triple drugcombination for addressing the chronic disease. It is also noted inparagraph 4 of the said reasons that DCGI has approved the FDC ofGlimepiride (1mg/2mg) + Pioglitazone (15mg) + Metformin (500 mgER) uncoated tablet for indication as the third line treatment of TypeII diabetes mellitus in cases where diet, exercise and single agents and

second line therapy with two drugs, do not result in adequate glycemiccontrol.

33.It is important to note that in paragraph 5 of its report, the SubCommittee expressly noticed that the FDCs in question contain“recommended”and“approved”therapeuticdosageofeachingredient. Thus, there is no dispute that the FDC in question have atherapeutic justification and are prescribed for certain patients. This isalso the conclusion drawn by the Sub-Committee, as is apparent fromparagraph 6 of their observations quoted above. It is expressly statedthat the said FDC has therapeutic value and has the potential toaddress the need of patients with Type II Diabetes, who are notresponding to mono or dual therapy.

34.The only reason provided by the Sub-Committee for proscribingthe said FDC is that it can lead to risk of hypoglycemia and there is nosafety data pertaining to this FDC. Once it is accepted that theformulations in the dosages, as included in the said FDC, isrecommended and approved therapeutic dosages for treatment of TypeII Diabetes in certain cases, it is difficult to understand the reason forproscribing the said FDCs on ground of lack of safety data.

35.Insofar as the observation that the said FDC can lead to risk ofhypoglycemia is concerned, the petitioners have produced material onrecord, which indicates that the risk of hypoglycemia in Metformin isminimum. However, this is not an area of controversy which isrequired to be examined by this Court. The question whether

particular drug has any adverse effects is required to be examined bytheexperts,andtheobservationthattheFDCcanleadtohypoglycemia, must be accepted. However, it is difficult to understandthe rationale to proscribe the said FDC on this count, considering thatit is accepted that the formulations in that dosage included in the FDCisrecommendedandapproved.Admittedly,thesaidFDChastherapeutic value in certain cases.

36.The Supreme Court, in the case of Pfizer Limited (supra), hadremanded the matter to DTAB/Sub-Committee for the reason that thereasons given by the Kokate Committee were cryptic. Plainly, thedecision of Central Government founded on such reasons could not besustained. This malady continues to subsist with the observationsmade by the Sub-Committee, as it provides little clarity for sustainingan action under Section 26A of the Act.

37.It is also conceded that the Central Government had notexaminedanyothermaterialotherthantheobservations/recommendations of the Sub-Committee for issuing the impugnednotification. In absence of clear and cogent reasons, such decisionwould be manifestly arbitrary and not sustainable.

38.It is also relevant to note that in Pfizer Limited (supra), theSupreme Court had expressly directed that in case where DTAB/Sub-Committee prohibits particular FDC, it must also indicate in itsreport as to why restrictions or regulations are not sufficient to controlthe manufacture and use of the FDC. The recommendations of the

Sub-Committee, read in conjunction with the risks indicated,do notindicate why regulations or restrictions are insufficient in controllingthe use of the FDC.

39.In view of the above, the notification S.O. No. 4471(E) is notsustainable. Insofar as S.O. No. 4472 (E) is concerned, the sameproscribesanFDCcomprisingofGlimepiride1mg/2mg+Pioglitazone 15mg/15mg + Metformin 850mg/850. As observedabove, it is obvious that the said FDC has been proscribed on accountof an incremental dosage of Metformin 850mg, considering that theFDC comprising of Glimepiride 1mg/2mg + Pioglitazone 15mg andMetformin 500 mg is approved. The observations made by the Sub-Committee for proscribing this FDC are, essentially,three fold. First,that there is sufficient therapeutic option; second, that increments inthe dosage of Metformin are in steps of 500mg as per treatmentguidelines; and third, that availability of multiple strengths can lead tomedication error of overdosing or under-dosing.

40.Clearly, the reason that there are therapeutic options available isnot ground for prohibiting drug under Section 26A of the Act.Adrug can be proscribed under Section 26A, (i) if it involves any risk tohuman being or animals; (ii) the drug does not have any therapeuticvalue purported to be claimed; and (iii) that the drug containsingredients in such quantity for which there is no therapeuticjustification.

41.The fact that there are other alternatives available cannot be aground for proscribing the FDC in question.

42.The second reason – that the increments in the dosage ofMetformin are in steps of 500mg and, therefore, the FDC whichcontain the formulation in the strength of 850 mg ought to beproscribed – is also unsustainable. This is so because it is concededbefore this Court that Metformin 850mg is an also approved drug. Thepetitioner has also produced material to indicate that Metformin in thedosage of 850mg is prescribed in certain patients. Plainly, ifMetformin 850mg is an approved dosage, the question of proscribingthe FDC on the ground that the strength of Metformin is not multipleof 500mg is not sustainable.

43.It is also relevant to note that the Central Government had alsoissued notification under Section 26A of the Act proscribing FDCscomprising of: Metformin 1000 mg + Pioglitazone 7.5 mg +Glimepiride 1 mg; and, Metformin 1000 mg + Pioglitazone 7.5 mg +Glimepiride 2 mg. The said notification – S.O 4467(E) – was subjectmatter of challenge in Unison Pharmaceuticals Pvt. Ltd (supra). It isrelevant to note that the said FDCs were proscribed for the reason thatPioglitazone 7.5 mg was not an approved dose; there was no issuewith regard to inclusion of Metformin 1000 mg in the said FDCs.

44.The third reason, namely, that availability of multiple strengthscan lead to medication error, is also cryptic in the sense that drugscomprising of the FDC are available in multiple strengths.

45.It was contended on behalf of the respondents that if the FDC inquestion is over prescribed or under prescribed, it would entail aserious risk to the patient. In this regard, it is relevant to observe thatthe rationale for making FDC is for the convenience of patient,who is prescribed several drugs (comprising the FDC). There is acompelling argument that an FDC is expedient in cases where apatient is required to take multiple medicines. The risk of overprescription or under prescription is common in all FDCs. The reasonsindicated by the Sub-Committee do provide any clarity as to why thisreason is relevant for the FDCs in question.

46.In view of the above, the recommendation of the Sub-Committee that there is no therapeutic justification, is difficult toaccept. This is also considering that it is not disputed that the contentsof the FDC, in the dosage as included, are prescribed to patients toaddress Type II Diabetes.

47.In view of the above, the impugned notifications are set aside.The matter is remanded to DTAB/Sub-Committee constituted with thedirection to examine the issue regarding the FDCs in question inaccordance with the directions issued in Pfizer Limited and Ors(supra).

48.The DTAB Sub-Committee shall submit report to the CentralGovernment clearly providing an explanation for its recommendationsalong with the material in support thereof. The Central Government is

required take an informed decision after examining the report ofDTAB/Sub-Committee and the material provided along with it.

49.The petitions are disposed of in the aforesaid terms. All pendingapplications stand disposed of.

VIBHU BAKHRU, J

FEBRUARY 13, 2019MK