[2010(5) ADJ 401 (DB)]
ALLAHABAD HIGH COURT
BEFORE : ASHOK BHUSHAN AND RAM AUTAR SINGH, JJ.
M/s. TC HEALTHCARE PVT. LTD. AND ANOTHER .......Petitioners
Versus
UNION OF INDIA AND ANOTHER ......Respondents
(Civil Misc. Writ Petition Nos. 33753 and 7400 of 2009,
decided on 20th April, 2010)
(B) Drug (Price Control) Order, 1995—Paragraphs 7, 8, 9 and 11—Notification dated 2nd March, 1992 issued under Paragraph 7—Applies to Small Scale Industries and exempts them from operation of Paragraph 8—But even Small Scale Industries are liable to be controlled by price control notification issued under Paragraphs 9 and 11. [Para 20]
(C) Drug (Price Control) Order, 1995—Paragraphs 9 and 11—Notification dated 11th July, 2006—Issued under Paragraphs 9 and 11 on price control—Applicability—It applies to drugs manufactured from control release technology—Mere fact that a different method is adopted by manufactures—Does not bring it beyond purview of applicability because in the end it comes under control release system. [Paras 22 and 23]
(D) Drug (Price Control) Order, 1995—Paragraphs 9, 11 and 7—Notifications dated 30th April, 2009 and 11th July, 2006—Issued under Paragraphs 9 and 11—Fixing ceiling prices of Frusemide formulation drugs and Formulation Unicontin Theophythine drugs—Found to have been issued in accordance with Paragraph 7, keeping in view cost or efficiency—As such, not ultra vires—Exercise of power under Paragraph is a legislative activity and in the nature of subordinate legislation in which rules of natural justice are not attracted—Both the notifications are valid and issued in accordance with law. [Paras 26, 28, 32 to 34, 36, 37 and 58]
(E) Drug (Price Control) Order, 1995—Paragraphs 13 to 16—Scheme contained therein, regarding recovery of overcharged amount—Manufacturer is liable to pay overcharge amount, if drug manufactured by it is sold at price fixed, i.e., ceiling price. [Paras 39, 40, 42, 43, 44, 46, 47 and 58]
(F) Drug (Price Control) Order, 1995—Paragraphs 19, 13, 11 and 9—Trade margin of 16%—Permitted to be given to manufacturers while fixation of retail price of drugs—Has to be deducted while calculating overcharge amount. [Paras 48 to 50 and 58]
(G) Essential Commodities Act, 1955—Section 7-A(1)—Drug (Price Control) Order, 1995—Paragraph 13—Liability to pay interest, as contemplated by Section 7-A(1)—Arises when default is committed in payment—Interest, therefore, cannot be charged for period prior to demand of overcharge. [Paras 53, 55 and 58]
(H) Drug (Price Control) Order, 1995—Paragraphs 9, 11 and 22—Constitution of India, 1950—Article 226—Notification issued under Paragraphs 9 and 11—Fixing ceiling price of certain drugs—High Court permitted petitioners (manufactures) to avail remedy of review available under Paragraph 22 to them. [Paras 56 and 58]
Result; Order Accordingly.
Hon’ble Ashok Bhushan, J.—These two writ petitions challenge two different notifications issued under paragraphs 9 and 11 of the Drug (Prices (Control) Order, 1995 fixing ceiling prices of two drug formulations. In the second writ petition in addition to prayer for quashing the notifications fixing ceiling price, challenge has also been made to the orders directing the petitioners to deposit the overcharge amount realised in excess of the ceiling price. Some of the issues in both the writ petitions being common, both the writ petitions have been heard together and are being disposed of by this common judgment with the consent of learned counsel for the parties.
2. Sri Udai Lalit, Senior Advocate, assisted by Sri Ashutosh Khaitan, Sri Pranay Agarwala and Sri Rahul Chaudhary have been heard for the petitioners and Dr. A.K. Nigam, learned Additional Solicitor General of India, assisted by Sri Ajay Bhanot have been heard for the respondents.
3. In both the writ petitions pleadings are complete. For deciding the issues raised in these two writ petitions, it is necessary to note the facts of both the cases separately.
4. The facts of Writ Petition No. 33753 of 2009 (hereinafter referred to as the first writ petition) are; Petitioner No. 1 is a company registered under the provisions of the Companies Act, 1956 and is engaged, inter alia, in the manufacture, production, distribution and sale of drugs and formulations including Diucontin K, 20 mg and 40 mg prepared from the bulk drug Frusemide. The manufacturing plant of petitioner No. 1 is situate in Modinagar, district Ghaziabad. The petitioner No. 1 has been granted drug licence by Drug Controller Uttar Pradesh. The petitioner No. 2 is a company registered under the Companies Act, 1956. The petitioner No. 2 markets the above mentioned formulation. The petitioner No. 2 is authorised to market the said formulations under the licence granted by Licensing Authority, Meerut. Both the petitioners are registered small scale industrial units with District Industries Centre, Ghazaibad and District Industries Centre, Meerut respectively. The petitioners’ case is that the Frusemide formulation manufactured and marketed by them is by a method known as ‘’continus drug delivery system’ to achieve a controlled release of the formulation in the human body. It is claimed that the technology used by the petitioners in its formulation is based on diffusion as well as dissolution technology. The petitioners claimed to be major manufacturer of Fursemide formulation. In exercise of the power under Section 3 of the Essential Commodities Act, 1955, the Government issued an Order, namely, Drug (Price Control) Order, 1995 (hereinafter referred to as DPCO 1995). In exercise of power under Paragraphs 9 and 11 of the DPCO 1995 a notification has been issued on 30th April, 2009 fixing the ceiling price of Frusemide formulation in control release system. The petitioners by means of this writ petition have challenge the fixation of ceiling price for the formulation Frusemide+Potassium Chloride tablet (20 mg and 40 mg) as fixed by the notification dated 30th April, 2009. The petitioners case further is that after issue of notification fixing a unreasonably low ceiling price, the petitioners were left with no option but to stop the manufacturing and marketing their formulation from 14th May, 2009. the petitioners have prayed for quashing the notification dated 30th April, 2009 and further for a mandamus directing the respondents to fix the ceiling price of the Frusemide formulation manufactured and marketed by the petitioners in accordance with the procedure as laid down in paragraphs 7, 9 and 11 of DPCO 1995 in a time bound manner.
5. Facts of Writ Petition No. 7400 of 2009 (hereinafter referred to as the second writ petition), are; the petitioners claim to manufacture a drug formulation Unicontin (400 mg and 600 mg) from the bulk drug Theophylline by the dual mechanism, i.e., diffusion and dissolution tec
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