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2015 (7) TMI 1421 - HC - Indian LawsFfixation of ceiling price under the provisions of the Drugs (Prices Control) Order, 2013 - male contraceptives (condoms) - the fixation of price is in conformity with the powers vested under the Essential Commodities Act, 1955 read with the Drugs and Cosmetics Act, 1940 or not - HELD THAT:- A product would not cease to be a medicine merely on the ground that its dosage and strength have not been specified. However, it is not clear as to how Paragraph 4 of DPCO-2013 can be made applicable to those formulations for which the dosage and strength have not been specified. A perusal of Paragraph 4 of DPCO-2013 shows that the same provides for fixation of ceiling price of only a scheduled formulation of specified strength and dosage as specified under the First Schedule. Para 2(1)(d) defines “ceiling price‟ as a price fixed by the Government for “scheduled formulations‟ in accordance with the provisions of DPCO-2013 - It is evident from the First Schedule that it contains the formulations of which strength and dosage have been specified as well as the formulations of which strength and dosage have not been specified. Para 2(1)(zb) defines scheduled formulations as formulation included in the First Schedule whether referred to by generic versions or brand name. Thus, it is clear that all formulations that are included in the First Schedule, irrespective of specification of strength and dosages, are “scheduled formulations‟. In other words, scheduled formulations include non-scheduled formulations. On a combined reading of Para 4, Para 2(1)(d) and Para 2(1)(zb), it appears that the specification of dosage and strength in the First Schedule has a specific bearing with regard to fixation of ceiling price under DPCO-2013. The words in the definition of “ceiling price‟ under Para 2(1)(d) i.e. “in accordance with the provisions of this order‟ make the intention of the Legislature abundantly clear and that the same shall be given due weight while implementing the provisions of DPCO-2013 - It is pertinent to note that DPCO-2013 contains a different method of regulation so far as “non-scheduled formulations‟ are concerned. Para 20 of DPCO-2013 provides for monitoring the “maximum retail prices‟ of the non-scheduled formulation and Para 25 mandates display of prices of non-scheduled formulation and price list thereof. The question that arises for consideration is whether ceiling price can be fixed by the NPPA for all the formulations/medicines included in the First Schedule to DPCO-2013 ignoring the legislative intention that the said power be not extended to some of the formulations. Considering an identical issue, the Supreme Court in SECRETARY, MINISTRY OF CHEMICALS AND FERTILIZERS, GOVT. OF INDIA VERSUS M/S. CIPLA LTD. AND OTHERS [2003 (8) TMI 541 - SUPREME COURT] held that the contents of the policy documents cannot be read and interpreted as statutory provisions and that too much of legalism cannot be imported in understanding the scope and meaning of the clauses contained in policy formulations. It was also added that the Government exercising its delegated legislative power should make a real and earnest attempt to apply the criteria laid down by itself as a policy maker and that the delegated legislation that follows the policy formulation should be broadly and substantially in conformity with that policy, otherwise it would be vulnerable to attack on the ground of arbitrariness resulting in violation of Article 14. The NPPA exceeded the powers conferred by Paras 4, 6 & 14 of DPCO-2013 while fixing the ceiling price for condoms. The language of Para 4 is unambiguous and makes clear the legislative intent that the ceiling price can be fixed only for scheduled formulations of specified strengths and dosages as specified under the First Schedule. Therefore, according to us, the provisions of Para 4 cannot be made applicable to “condoms‟ the dosage and strength of which have admittedly not been specified under the First Schedule. Since the impugned action of fixation of ceiling price is held to be bad on the ground that the NPPA exceeded the powers conferred by Para 4, 6 and 14 of DPCO-2013 and the policy decision under NPPP-2012 has not been interfered in any manner, it is also not necessary to refer to the various decisions cited by the learned counsel for both the parties with regard to the scope of judicial review vis-à-vis policy decision. The Orders of NPPA dated 05.11.2013 and 10.07.2014 are illegal and unsustainable - Petition disposed off.
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