M/S T.C. HEALTHCARE P. LTD. & ANR. versus UNION OF INDIA & ANR.

Citation: [2019] 14 S.C.R. 618 · Decided: 15-11-2019 · Supreme Court of India · Bench: ARUN MISHRA · Disposal: Dismissed

Judgment (excerpt)

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618
SUPREME COURT REPORTS
[2019] 14 S.C.R.
M/S T.C. HEALTHCARE P. LTD. & ANR.
v.
UNION OF INDIA & ANR.
(Civil Appeal No. 4687 of 2010)
NOVEMBER 15, 2019
[ARUN MISHRA, VINEET SARAN AND
S. RAVINDRA BHAT, JJ.]
Drugs (Price Control) Order, 1995: Paras 3, 7, 8 and 9
Fixation of ceiling price of drug, Scheduled formulations –
Notifications dated 11th July, 2006 and 30th April, 2009 imposing
ceiling prices on a drug formulation, Frusemide, Potassium and
Theophylline – Challenged to, by the drug manufacturers as ultra
vires Para 7 of the DPCO – High Court dismissed the writ petitions
– Interference with – Held: Not called for – Modifications in drug
release are often desirable to increase the stability, safety and
efficacy of the drug, to improve the therapeutic outcome of the drug
treatment and/or to increase patient compliance and convenience
of administration – Use of the term “sustained release” denotes
the systems that maintain the rate of drug release over a sustained
period – Controlled release systems are drug delivery systems in
which the drug is released in a predetermined pattern over a fixed
period of time – Materials on the record show that the DPCO was
aware of the existence of different systems of drug delivery and
of sustained release – Manufacturers ought to have demonstrated
that the systems used by them were unique or different – In absence
thereof, they were obliged to follow the pricing norms and ceiling
prices fixed by the impugned notifications.
Dismissing the appeals, the Court
HELD: 1.1 The High Court, took note of the notification
dated 13th August, 2008, which fixed conversion costs for plain
tablets, coated tablets, dispersible tablets, gelatin coated tablets,
bi layered tablets, sustained release tablets, chewable tablets,
effervescent tablets, inlay tablets, capsules and other drugs. The
appellants had not urged that different conversion costs were
fixed for controlled release system, or the continuous release
systems, anytime. In these circumstances, it was held that the
   [2019] 14 S.C.R. 618
618
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pricing norms were applicable. Note (d) to the notification of 30th
April, 2009, stated that for different packing materials used or
different drug delivery systems or any other special features/forms
claimed, the ceiling prices, as specified in Column 5 shall be
applicable unless the companies approach NPPA for specific price
approvals for its formulations”. In the instant case, the appellants
did not approach NPPA for specific price, or contend before it
that their products contained special features. On the other
hand, the allusion to “sustained release” and drug delivery
systems (in Note (d)) clearly contemplated that unless otherwise
specifically sought– in regard to particular drugs, the price
fixation norms applied to all. [Para 10, 11] [626-C-G]
1.2 According to pharmacopedias and the US Food and
Drug Administration’s definitions, modifications in drug release
are often desirable to increase the stability, safety and efficacy
of the drug, to improve the therapeutic outcome of the drug
treatment and/or to increase patient compliance and convenience
of administration. In that context, the use of the term “sustained
release” denotes the systems that maintain the rate of drug
release over a sustained period. For example, if the release of
the drug from the dosage form is sustained such that the release
takes place throughout the entire gastrointestinal tract, one
could prolong the time interval of drug concentration in the
therapeutic range. This in turn may reduce the frequency of
dosing, for example from three times a day to once a day.
Sustained–release dosage forms achieve this mostly by the use
of suitable polymers, used either to coat granules or tablets
(reservoir systems) or to form a matrix in which the drug is
dissolved or dispersed (matrix systems). Controlled release
systems are drug delivery systems in which the drug is released
in a predetermined pattern over a fixed period of time.
Therefore, the materials on the record show that the DPCO was
aware of the existence of different systems of drug delivery; it
specifically talked of sustained release. If the appellants wished
to say that the systems used by them were unique or different,
it was open for them to have so demonstrated. Their omission
to do so, did not in any way affect their obligation to follow the
pricing norms and ceiling prices fixed by the impugned
notifications. Therefore, there i

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