Bombay High Court
Pfizer Ltd. And Another vs Union Of India And 2 Others on 4 September, 2018
Bench: B. R. Gavai, M. S. Karnik
(905)-WP-2519-18.doc
BDPSPS
IN THE HIGH COURT OF JUDICATURE AT BOMBAY
Bharat
Digitally
signed by
Bharat
Dasharath
ORDINARY ORIGINAL CIVIL JURISDICTION
Dasharath Pandit
Pandit Date:
2018.09.10
11:07:09
+0530
WRIT PETITION NO.2519 OF 2018
Pfizer Limited and another ..Petitioners
Versus
Union of India and others ..Respondents
Mr. Navroz Seervai, Senior Counsel a/w Ms. Aarti Raghavan, Mrs.
Shruti Katakey I/by M/s. AAT Legal & Co., Advocate for the
Petitioners.
Mr. Anil Singh, Additional Solicitor General a/w Mr. Aditya Thakkar,
Mr. A. M. Sethna, Mr. D. P. Singh & Carina Xavier, Advocate for the
Respondents.
CORAM: B. R. GAVAI &
M. S. KARNIK, JJ.
DATE: 4th SEPTEMBER, 2018 P.C.:-
1] Issue notice to Respondents, returnable on 03/10/2018.
2] Mr. Singh, learned Additional Solicitor General with learned Counsel Mr. Thakkar, waives service of notice on behalf of the Respondents.
3] Mr. Singh, learned Additional Solicitor General, opposed the grant of ad-interim order. However, Mr. Seervai, learned Senior 1/9 (905)-WP-2519-18.doc Counsel appearing on behalf of the Petitioners, insisted on grant of ad-
interim protection. He submitted that the matter is adjourned at the request of the Respondents right from 31/07/2018 on the pretext that they want to file reply.
4] We have heard the submissions made by Mr. Seervai, learned Senior Counsel appearing on behalf of the Petitioners and Mr. Singh, learned Additional Solicitor General appearing on behalf of the Respondents.
5] Mr. Seervai, learned Counsel appearing on behalf of the Petitioners, submitted that it is the contention of the Petitioners that Prednisolone Tablet which is a Dispersible Tablet is not covered by the Notification dated 10/03/2016 vide which the Drugs (Price Control) Amendment Order, 2016 has been promulgated (hereinafter referred to as "the said Order"). The learned Senior Counsel submitted that clause (2) of the Explanation to the Schedule of the said Order would reveal that any innovation in medicine and formulation developed through incremental innovation or novel drug delivery systems like lipid/liposomal formulations, sustained release/controlled release etc., are to be considered as included only if specified in the list against any medicine. He submitted that such different formulations can be considered differently for purposes such as procurement policy, pricing etc. The learned Senior Counsel submitted that the communication 2/9 (905)-WP-2519-18.doc addressed by Respondent No.3 dated 01/08/2016 in response to the representation made by the Petitioners dated 27/06/2016 is totally in conflict with Clause (2) of the Explanation to the Schedule of the said Order and therefore not sustainable. He therefore submitted that the action which is sought to be taken against the Petitioners by the impugned show cause notice is not permissible in law. The learned Senior Counsel also relied upon the Judgment of Delhi High Court in the case of Modi-Mundipharma Pvt. Ltd. vs. Union of India & Ors dated 17.07.2018 passed in W.P. (C ) 11802/2016.
6] Mr Singh, learned Additional Solicitor General, per contra submitted that Clause (2) of the Explanation to the Schedule of the said Order cannot be read in isolation. He submitted that Clause (2) has to be read with Clause (1), which provides that any dosage form of a medicine, other than the dosage form included in this Schedule, but is of the same strength then though it is not included in the schedule, the same shall be considered to be included in the schedule. He submitted that from the averments made in the Petition itself, it would reveal that the drug which is sought to be excluded from the Price Control Order is not innovative but has been used by the Petitioners for a long period. He therefore submitted that the prayer for ad-interim order deserves to be rejected.
7] Undisputedly, the product "Prednisolone"is covered by the 3/9 (905)-WP-2519-18.doc said Order. However, the question that falls for consideration is as to whether the Dispersible Tablet would be covered by the said Order or not?
8] It will be relevant to refer to Clause (1) of the Explanation to the Schedule of the said Order, which reads thus :-
"(1) Any dosage form of a medicine, other than the dosage form included in this Schedule, but in same strength and route of administration, which does not have significant difference in terms of pharmacokinetics or pharmacodynamics or efficacy-safety profile over the dosage form mentioned in the list shall be considered as included. To elaborate, if a tablet is included, other dosage forms like conventional tablets and capsules are considered as included. However, such different dosage forms should be considered differently for purposes such as procurement policy, pricing, etc. This principle also applies to all other dosage forms e.g. oral liquid dosage forms, injectables, topical dosage forms, etc."
Perusal of Clause (1) would reveal that it provides that any dosage form of medicine, other than the dosage form included in the Schedule but in the same strength and route of administration, which does not have significant difference in terms of pharmacokinetics or pharmacodynamics or efficacy-safety profile over the dosage form 4/9 (905)-WP-2519-18.doc mentioned in the list shall be considered as included in the said list. An illustration is given that if a tablet is included, other dosage forms like conventional tablets and capsules are considered as included. It further provides that such different dosage forms should be considered differently for purposes such as procurement policy, pricing, etc. It further provides that this principle also applies to all other dosage forms e.g. oral liquid dosage forms, injectables, topical dosage forms, etc. 9] It could thus be seen that, what Clause (1) provides is that if same medicine which is covered in the list to the Schedule of the said Order which does not have significant difference in terms of pharmacokinetics or pharmacodynamics is manufactured in different dosage, the same shall be deemed to be included in the schedule. To give an example, in the case of the Petitioners' product "Prednisolone", the Tablet of 5 mg / 10 mg / 20 mg is mentioned in the schedule. If in addition to Tablet of 5 mg / 10 mg / 20 mg, the Petitioners also manufacture capsule of 5 mg / 10 mg / 20 mg, the same would also be covered by the said Order.
10] However, it has to be noted that the effect of Clause (2) of Explanation to the Schedule of the said Order is totally different. Clause (2) reads as under:-
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(905)-WP-2519-18.doc "(2) Innovation in medicine must be encouraged. The formulations developed through incremental innovation or novel drug delivery systems like lipid/liposomal formulations, sustained release/controlled release etc. should be considered as included only if specified in the list against any medicine.
Such different formulations should be considered differently for purposes such as procurement policy, pricing etc."
The said order provides for excluding formulations, medicines which are developed through incremental innovations or novel drug delivery systems. Instances given in the said Clause (2) of the Explanation, like lipid/liposomal formulations, sustained release/controlled release are followed by the word "etc." It could thus be seen that instances are not exhaustive but illustrative in nature. It could further be seen that such of the formulations which are developed through incremental innovations or novel drug delivery systems are to be considered as included only if specified in the list against any medicine. It could thus be seen that, the legislative intent is clear. If formulations which are developed through incremental innovations or novel drug delivery systems, the same shall not be considered to be covered by the said Order, unless the same are specifically included in the list against such medicine.
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(905)-WP-2519-18.doc 11] No doubt that the Petitioners are claiming exemption in respect of the drug "Prednisolone". However, exemption which is sought is not in respect of ordinary tablet but only in respect of Dispersible Tablet. It is a specific contention of the Petitioners that Dispersible Tablets are innovated so as to enable the person who has difficulty in swallowing the medicine, to consume the same. We find that legislative intent as manifested in Clause (2) of the Explanation to the Schedule of the said Order is also given effect to in the said Schedule itself. It will be relevant to refer to Clause 3.7 of the said Schedule, which refers to the product of the Petitioners.
3.7 Prednisolone P,S,T Tablet 5 mg Tablet 10 mg Tablet 20 mg Oral liquid 5 mg/5ml Oral liquid 15 mg/5 ml Per contra, it is also relevant to refer to Clauses 6.4.3.1.3, 6.4.3.1.5 and Clause 6.4.3.2.2 of the said Schedule.
6.4.3.1.3 Lamivudine (A) + S,T Dispersible Tablet 30 mg
Nevirapine (B) + (A) + 50 mg (B) +
Stavudine (C) 6mg(C)
Tablet 150 mg (A) + 200
mg (B) + 30 mg (C)
6.4.3.1.5 Stavudine (A) + S,T Dispersible Tablet 6
Lamivudine (B) mg(A) + 30 mg (B)
Tablet 30 mg (A) + 150
mg (B)
6.4.3.2.2 Nevirapine S,T Dispersible Tablet 50 mg
Tablet 200 mg
Oral liquid 50 mg/5 ml
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(905)-WP-2519-18.doc
The perusal of the above clauses would reveal, that insofar as drugs covered under clauses 6.4.3.1.3, 6.4.3.1.5 and 6.4.3.2.2 are concerned, the Schedule specifies the Dispersible Tablet in addition to ordinary Tablet. Per contra, insofar as product of the Petitioners is concerned, what is mentioned is only ordinary Tablet and not Dispersible Tablet.
12] Similar view has been taken by the learned Single Judge of the Delhi High Court in the case of Modi-Mundipharma Pvt. Ltd. vs. Union of India & Ors dated 17.07.2018 passed in W.P. (C ) 11802/2016. No doubt that the view taken by the Delhi High Court is not binding on us and it will only have persuasive value. However, we have ourselves independently, by applying the first principle of interpretation, come to the prima facie conclusion that insofar as innovative formulations are concerned, unless they are specifically mentioned in the Schedule against the name of the medicine, the same will not be covered by the said Order. It is not necessary to mention that the Order issued by exercising powers under Section 3 of the Essential Commodities Act, is quasi legislative piece of legislation. The administrative instructions which are in conflict with quasi legislative piece of legislation, cannot be permitted to supersede the same.
13] We are therefore of the considered view, that the impugned 8/9 (905)-WP-2519-18.doc coercive action which is sought to be taken against the Petitioners is not permissible in view of the interpretation as placed by us hereinabove on Clause (2) of the Explanation to the Schedule of the said Order.
14] In that view of the matter,there shall be ad-interim relief in terms of prayer clause (d).
(M. S. KARNIK, J.) (B. R. GAVAI, J.)
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