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Allahabad High Court · body

2010 DIGILAW 1261 (ALL)

TC HEALTHCARE PVT. LTD. v. UNION OF INDIA

2010-04-20

ASHOK BHUSHAN, RAM AUTAR SINGH

body2010
JUDGMENT 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’ 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 technology. By notification dated 11th July, 2006 issued in exercise of power conferred by paragraphs 9 and 11 of DPCO 1995 ceiling prices have been fixed for the formulation Theophylline tablets (400 mg and 600 mg). The petitioner No. 1 filed a suit in the Court of Civil Judge (Senior Division), Ghaziabad being Suit No. 1823 of 2006 praying for a decree of permanent prohibitory injunction restraining the defendants from interfering in the sale of controlled release Theophylline tablets (400 mg and 600 mg) at the present maximum retail price of plaintiff+applicable taxes. The petitioner No. 1 filed a suit in the Court of Civil Judge (Senior Division), Ghaziabad being Suit No. 1823 of 2006 praying for a decree of permanent prohibitory injunction restraining the defendants from interfering in the sale of controlled release Theophylline tablets (400 mg and 600 mg) at the present maximum retail price of plaintiff+applicable taxes. A temporary injunction was granted by the trial Court vide order dated 22nd November, 2006. The petitioners started manufacturing and marketing of their drug after the temporary injunction. The petitioners claim to have stopped their manufacturing and marketing with effect from September, 2007. The suit filed by the plaintiff was dismissed in default on 9th September, 2008. A notice dated 15th April, 2008 was issued by respondent No. 2 to show cause as to why action be not taken to recover the overcharge amount alongwith interest since the petitioners had not furnished details of production and sale from the date of notification dated 11th July, 2006. Both the petitioners submitted their reply dated 3rd May, 2008 and 2nd May, 2008 respectively, which was received by respondent No. 2 on 5th May, 2008. An order dated 12th September, 2008 was issued to the petitioners directing them to deposit an amount of Rs. 35,14,44,049/- which is the overcharge amount in respect of the formulation Unicontin (400 mg) for the period 17th July, 2006 to 18th December, 2006 and 23rd December, 2006 to 7th September, 2007. Another order dated 24th October, 2008 was issued with regard to Unicontin (600 mg) for the period 25th July, 2006 to 9th February, 2007 and 10th February, 2007 to 6th September, 2007 directing the petitioners to deposit an amount of Rs. 6,05,52,034/- as overcharge amount in respect of notification dated 11th July, 2007. The petitioner No. 2 also filed a suit in the Court of Civil Judge (Senior Division), Meerut for permanent injunction restraining the defendants from enforcing the demand notices dated 12th September, 2008, 24th October, 2008 and the notification dated 11th July, 2006. In the said suit the defendants have appeared and no injunction order was passed. The petitioners’ case further is that they were advised that appropriate remedy to seek declaration in respect of the notification and demand notice is by way of writ petition, hence applications have been moved in both the suits for withdrawal, which were allowed. In the said suit the defendants have appeared and no injunction order was passed. The petitioners’ case further is that they were advised that appropriate remedy to seek declaration in respect of the notification and demand notice is by way of writ petition, hence applications have been moved in both the suits for withdrawal, which were allowed. In pursuance of the order dated 12th September, 2008 and 24th October, 2008 recovery certificate dated 28th November, 2008 was issued for recovery of the aforesaid amount from the petitioners. The petitioners by this writ petition have prayed for following relief : “(i) issue an appropriate writ order or direction declaring that the impugned Notification dated 11.7.2006 (Annexure 2) bearing SO No. 1080 (E) has no application to the Formulation Unicontin 400 mg and 600 mg manufactured and marketed by the petitioners; (ii) issue a writ in the nature of certiorari quashing the communications dated September 12, 2008 (Annexure 3) and October 24, 2008 (Annexure 4); (iii) issue writ, order or direction in the nature of certiorari quashing the recovery certificates dated 28.11.2008 issued by the respondent No. 2 (Annexures 24 and 25) as also the citation (Annexure 23 & 26) issued by the respondent No. 3. (iv) issue an appropriate writ order or direction in the nature of mandamus, restraining the Respondents from, in any manner recovering the amount in question including by coercive process, from Petitioners, their assigns, agents, representatives.” 6. Sri Udai Lalit learned counsel for the petitioners in support of the writ petition submitted that notification dated 30th April, 2009 has been issued without keeping in view the cost and efficiency of the major manufacturer of the formulation. The petitioners being major manufacturer of the formulation, were required to be asked to submit necessary information regarding cost and efficiency from the petitioners there being no material available with the Government. The respondents having failed to call for necessary information from the petitioners and having failed to take into consideration the cost and efficiency of the petitioners, the notification dated 30th April, 2009 is liable to be struck down. The respondents having failed to call for necessary information from the petitioners and having failed to take into consideration the cost and efficiency of the petitioners, the notification dated 30th April, 2009 is liable to be struck down. It is further submitted that ceiling price has to be fixed in accordance with formula laid down in paragraph 7 of the DPCO 1995 and no notification has been issued under paragraph 7 fixing conversion cost, packaging charges and process loss of materials with regard to formulation based on controlled release system. The impugned notification is ultra vires to the provisions of paragraph 9 of the DPCO 1995. The norms notified under paragraph 7, in the present case, were the norms for formulation based on sustained release drug delivery system, which norms were not applicable in the case of the petitioners. The petitioners being small scale industries registered with Directorate of Industries, State of U.P., were exempted from operation of paragraph 8 of the DPCO 1995 by virtue of notification dated 2nd March, 1995 issued by the Central Government in exercise of power under paragraph 25 of the DPCO 1995. The petitioners being exempted from operation of paragraph 8 of the DPCO 1995 and there being no detail of petitioners’ cost and efficiency with the Government of India, exercise under paragraph 9 of the DPCO 1995 is vitiated under law. The petitioners are only manufacturer of formulation Frusemide+Potassium Chloride, hence taking into consideration their cost and efficiency was must. The information in Form VI, as required to be submitted under paragraph 20 of the DPCO 1995, cannot enable the respondents to study the cost incurred by the petitioners towards manufacture of the said formulation since information to be supplied therein relates to the cash flow and profit and loss statement of a drug manufacturer for an accounting year and does not oblige the manufacturer to delineate therein the cost incurred by it in relation to manufacture of a specific drug. Thus non submission of Form VI was not material. The petitioners in collaboration with M/s. Mundipharma AG Switzerland acquired by way of technology transfer the “Continus Dual Mechanism” drug delivery system which entails substantially higher cost. The petitioners have also to pay royalty to M/s. Mundipharma AG Switzerland which constitutes an important and essential component of the drug. 7. Thus non submission of Form VI was not material. The petitioners in collaboration with M/s. Mundipharma AG Switzerland acquired by way of technology transfer the “Continus Dual Mechanism” drug delivery system which entails substantially higher cost. The petitioners have also to pay royalty to M/s. Mundipharma AG Switzerland which constitutes an important and essential component of the drug. 7. In support of the second writ petition (Writ Petition No. 7400 of 2009), the petitioners challenging the notification dated 11th July, 2006 fixing ceiling price for the drug Theophylline tablets (400 mg and 600 mg) have repeated the above submissions. It is further submitted that the preparation of Uncontin formulation by petitioner No. 1 from the bulk drug Theophylline is a dual mechanism formulation (continus release) and no price has been fixed by the respondents to the dual mechanism formulation of the bulk drug. After issue of the notification dated 11th July, 2006 the petitioners have stopped manufacturing of the drug and they started the manufacturing only after grant of interim injunction by the Civil Court, Ghaziabad on 22nd November, 2006. The manufacturing and marketing by the petitioners was only after the interim injunction of the Civil Court. It is contended that the impugned communications dated 12th September, 2008 and 24th October, 2008 direct for deposit of the overcharge amount calculated on the basis of the maximum retail price disclosed on the drug formulation of the petitioners. A trade margin is always built in maximum retail price of every article which is never received by the manufacturer. The overcharge amount included the trade margin which having never accrued to the petitioners, cannot be recovered. In the above communication interest could have been charged only from the date when the petitioners have been held to be defaulter and not from any prior period. No interest could have been charged under Section 7-A of the Essential Commodities Act, 1955. No interest could have been levied upon the petitioners for any period prior to issuance of the impugned communications. The communications dated 12th September, 2008 and 24th October, 2008 also hold the petitioners liable to pay overcharge during the period in which neither the petitioners manufactured nor sold the formulation in question. No interest could have been levied upon the petitioners for any period prior to issuance of the impugned communications. The communications dated 12th September, 2008 and 24th October, 2008 also hold the petitioners liable to pay overcharge during the period in which neither the petitioners manufactured nor sold the formulation in question. The petitioners did not manufacture or sale their formulation Unicontin (400 mg) from 17th July, 2006 to 18th December, 2006 and did not manufacture or sale Unicontin (600 mg) from 25th July, 2006 to 9th February, 2007 and without there being any credible evidence and justification the petitioners have been held liable to pay overcharge amount even for the above period. The petitioners cannot be held liable for the sale of the formulation by the retailers on higher price, which formulation has passed from the hands of the manufacturer. Any higher price charged by the retailers cannot be recovered from the manufacturers. 8. Dr. Ashok Nigam, Additional Solicitor General of India, refuting the submissions of counsel for the petitioners, contended that for challenging the notification dated 30th April, 2009 and 11th July, 2006, the remedy of the petitioners is to invoke Paragraph 22 of the DPCO 1995. Under Paragraph 22 of the DPCO 1995 any person aggrieved by any notification issued under paragraph 9 may apply to the Government for review of the notification. The remedy of the petitioners is, thus, to seek review under Paragraph 22 of the DPCO 1995 and the writ petitions challenging the notification be not entertained on this ground. 9. Replying the submission of the petitioners that continus release technology employed by the petitioners is different from controlled release tablets, it is submitted that continus release technology applying the dual system of diffusion and dissolution does not take out the formulation out of the notifications dated 30th April, 2009 and 11th July, 2006. The drugs manufactured by the petitioners are controlled release tablets and whatever methodology has been adopted shall not take out the same out of the purview of ceiling price fixed under the notifications. It is further submitted that drug manufacture licence granted to the petitioners is for manufacture of control release tablets, hence they cannot be heard in saying that drug manufactured by them is not covered by the notifications in issue. It is further submitted that drug manufacture licence granted to the petitioners is for manufacture of control release tablets, hence they cannot be heard in saying that drug manufactured by them is not covered by the notifications in issue. The petitioners are wilfully and knowingly indulging in gross violation of the DPCO 1995 and they have been deliberately selling the scheduled formulations at nearly 15 times higher than the price fixed by the respondents. A price fixation measure does not concern with the interest of an individual manufacturer. It is resorted to make available the drug at reasonable rate to community at large. The price control is resorted by the Government in the interest of general public. According to the provisions of the DPCO 1995 after issue of the notification fixing a ceiling price, the drug formulation cannot be sold on higher price to one fixed under the ceiling notification. It was the duty of the manufacturer to ensure that drug formulation is not sold at a price higher than the price as notified in the notifications issued under paragraph 9. The respondents by notification issued under paragraph 7 of the DPCO 1995 has fixed conversion cost, cost of packing material, packing charges and maximum aflowable post manufacturing expenses after full exercise of inviting information and details from all manufacturers. The formulations manufactured by the petitioners have been collected and cost has been analysed by the experts. The major cost in formulation of the petitioners is the cost of bulk drug Frusemide and Theophylline and the cost of bulk drug having already been fixed by the respondents, the same was taken into consideration while fixing the ceiling price. The petitioners did not submit required information in Form VI, as per paragraph 20 of the DPCO 1995, hence the power under paragraph 11 of the DPCO 1995 was also available to the respondents. In course of his submissions, learned counsel for the respondents has contended that no notification has been issued by the respondents extending the benefit of exemption, i.e., notification dated 2nd March, 1995 and neither the petitioners have sent the requisite papers nor are entitled for the benefit of exemption available to small scale industries. In course of his submissions, learned counsel for the respondents has contended that no notification has been issued by the respondents extending the benefit of exemption, i.e., notification dated 2nd March, 1995 and neither the petitioners have sent the requisite papers nor are entitled for the benefit of exemption available to small scale industries. It is submitted that the overcharge amount, which has been directed to be recovered from the petitioners in the second writ petition, was based on ORG - IMS and as per the certificate of chartered accountant submitted by petitioner No. 1. Under paragraph 16 of the DPCO 1995, after ceiling price notification, the drug formulation could not have been sold at a price exceeding the price specified in the notification. After issue of the ceiling price notifications the petitioners were obliged to send the price list and supplementary price list. It is further contended that petitioners are not entitled to claim any benefit of trade margin, which is included in the maximum retail price. Learned counsel for the respondents has referred to paragraph 19 of the DPCO 1995 for the submission that trade margin of 16% is already included in the maximum retail price. 10. Learned counsel for the parties have referred to and relied on various decisions of the Apex Court and the High Courts in support of their respective submissions, which shall be referred to while considering the submissions in detail. 11. From the submissions of learned counsel for the parties, as noted above, and the pleadings of the parties on record, following issues fall for determination in these two writ petitions : (i) There being statutory remedy available to the petitioners under paragraph 22 of the DPCO 1995 to apply to the Government for review of the notification issued under paragraph 9, the writ petitions challenging the notifications issued under paragraph 9 dated 30th April, 2009 and 11th July, 2006 be not entertained and dismissed on the ground of alternate statutory remedy. (ii) The notification dated 30th April, 2009 fixing ceiling price for the formulation frusemide+potassium chloride is arbitrary, unreasonable and has been determined without application of mind. The notification having been issued without taking into consideration the cost and efficiency of the major manufacturers (petitioners), the whole exercise is without jurisdiction. (ii) The notification dated 30th April, 2009 fixing ceiling price for the formulation frusemide+potassium chloride is arbitrary, unreasonable and has been determined without application of mind. The notification having been issued without taking into consideration the cost and efficiency of the major manufacturers (petitioners), the whole exercise is without jurisdiction. (iii) The price fixation vide notification dated 30th April, 2009 has been done in violation of paragraph 7 of the DPCO 1995 there being no price norms published in respect of frusemide formulation manufactured by the petitioners. The price norms fixed by the notification dated 13th August, 2008 under paragraph 7 were with regard to sustained release tablets. There being no price norms under paragraph 7 with regard to control release tablets manufactured by continus release system, the notification under paragraph 9 of the DPCO 1995 is unsustainable. (iv) There was no relevant details of cost and efficiency of the major manufacturers (petitioners) available with the respondents. It was incumbent on the respondents to have asked for relevant information regarding cost and efficiency of the petitioners, which having not done, the notification dated 30th April, 2009 is liable to be struck down as violative of mandatory requirement laid down under paragraph 9 of DPCO 1995. (v) The notification dated 11th July, 2006 has no application to the petitioners formulation called Unicontin (Theophylline Tablets 400 mg and 600 mg). The notification is applicable only to the sustained release/control release/delayed release/time release/extended release tablets whereas petitioners manufacture Unicontin on a totally different technology, which is known as diffusion and dissolution technology and commercially known as manufacture through the process of “continus release”. The continus release process is not covered by the notification dated 11th July, 2006. (vi) The notification dated 11th July, 2006 is not in accordance with the paragraph 9 of the DPCO 1995 it having not taken into consideration the cost and efficiency of major manufacturers. (vii) There has been no proper notification under paragraph 7 notifying conversion cost, packaging charges, process loss of raw materials and other factors as laid down in paragraph 7 of the DPCO 1995 and the price norms fixed under paragraph 7 were with regard to only sustained release tablets and no price norms were fixed under paragraph 7 with regard to petitioners’ formulation manufactured by continus release system. (viii) The orders dated 12th September, 2008 and 24th October, 2008 and the consequential recovery certificates dated 28th November, 2008 directing for depositing overcharge amount from the petitioners are unjustified, illegal and not in accordance with DPCO 1995. (ix) Whether the petitioners are not liable to deposit the overcharge amount for the period 17th July, 2006 to 18th December, 2006 with regard to Unicontin (400 mg) and for the period 25th July, 2006 to 9th February, 2007 with regard to Unicontin (600 mg) since the petitioners claimed to have stopped their manufacture after the issuance of notification dated 11th July, 2006 and started again only after interim injunction dated 22nd November, 2006 by the Civil Court, Ghaziabad in Suit No. 1823 of 2006? (x) The maximum retail price is fixed giving trade margin of 16% as per paragraph 19 of the DPCO 1995. The petitioners having never received the aforesaid amount, which was the profit of the dealer/retailer, the said amount cannot be recovered from the petitioners. From paragraph 13 of the DPCO 1995 the overcharge amount, which has accrued to a manufacturer, can only be recovered. (xi) The manufacturers are not liable for any sale made by dealer/retailer fifteen days after the issuance of ceiling price notification. The petitioners are liable to deposit the overcharge only with regard to batches of medicines, which are manufactured by the petitioners after issue of sale price notification. (xii) In the impugned orders dated 12th September, 2008 and 24th October, 2008 amount of interest has also been included since 2006, which interest could not have been charged/levied. The liability of payment of interest can arise only when an order is issued by the respondents demanding the payment of overcharge amount. Thus no interest is liable to be paid by the petitioners for any period prior to issue of the impugned orders dated 12th September, 2008 and 24th October, 2008. 12. Before we proceed to consider the respective submissions of the parties, it is necessary to look into the relevant provisions of the DPCO 1995. 13. The Essential Commodities Act, 1955 was enacted by the Parliament in the interest of general public for the control of the production, supply and distribution of trade and commerce in certain commodities. 12. Before we proceed to consider the respective submissions of the parties, it is necessary to look into the relevant provisions of the DPCO 1995. 13. The Essential Commodities Act, 1955 was enacted by the Parliament in the interest of general public for the control of the production, supply and distribution of trade and commerce in certain commodities. Section 3(1) of the Essential Commodities Act, 1955 provides that if the Central Government is of opinion that it is necessary or expedient so to do for maintaining or increasing supplies of any essential commodity or for securing their equitable distribution and availability at fair prices, it may by Order, provide for regulating or prohibiting the production, supply and distribution thereof and trade and commerce therein. Sub-Section (2) of Section 3 provides that without prejudice to the generality of the power conferred by sub-section (1), the Central Government by an Order provide for controlling the prices at which any essential commodities may be brought or sold. In exercise of the power under Section 3 of the Essential Commodities Act, the Central Government issued the Drug (Prices Control) Order, 1995. Paragraph 2(a) of the DPCO 1995 defines bulk drug, Paragraph 2(c) defines ceiling price and Paragraph 2(h) defines formulation. Paragraphs 2(a), 2(c) and 2(h) are as follows : “2. Definitions—In this Order, unless the context otherwise require, - (a) “bulk drug” means any pharmaceutical, chemical, biological or plant product including its salts, esters, stereo-isomers and derivatives, conforming to pharmacopoeial or other standards specified in the Second Schedule to the Drugs and Cosmetics Act, 1940 (23 of 1940), and which is used as such or as an ingredient in any formulation; 2(b) ........... 2(c). “ceiling price” means a price fixed by the Government for Scheduled formulations in accordance with the provisions of paragraph 9; ........... 2(h). “formulation” means a medicine processed out of, or containing without the use of any one or more bulk drug or drugs with or pharmaceutical aids, for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease in human beings or and, but shall not include - any medicine included in any bona fide Ayurvedic (inclduing Sidha) or Unani (Tibb) systems of medicines. any medicine included in the Homeopathic system of medicine; and any substance to which the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) do not apply.” 14. any medicine included in the Homeopathic system of medicine; and any substance to which the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) do not apply.” 14. Paragraph 9 of the DPCO 1995 empowers the Government to fix ceiling price of a scheduled formulation. Paragraph 11 deals with fixation of price under certain circumstances. Paragraph 22 provides for power to review. Paragraphs 9, 11 and 22 are quoted below : “9. Power to fix ceiling price of Scheduled formulations : 1.Notwithstanding anything contained in this Order, the Government may, from time to time, by notification in the Official Gazette, fix the ceiling price of a Scheduled formulation in accordance with the formula laid down in paragraph 7, keeping in view the cost or efficiency, or both, of major manufacturers of such formulations and such price shall operate as the ceiling sale price for all such packs including those sold under generic name and for every manufacturer of such formulations. 2.The Government may, either on its own motion or on application made to it in this behalf by a manufacturer in Form III or Form IV, as the case may be, after calling for such information as it may consider necessary, by notification in the Official Gazette, fix a revised ceiling price for a Scheduled formulation. 3. With a view to enabling the manufacturers of similar formulations to sell those formulations in pack size different to the pack size for which ceiling price has been notified under the sub-paragraphs (1) and (2), manufacturers shall work out the price for their respective formulation packs in accordance with such norms, as may be notified by the Government from time to time, and he shall intimate the price of formulation pack, so worked out, to the Government and such formulation packs shall be released for sale only after the expiry of sixty days after such intimation. Provided that the Government may, if it considers necessary, by order revise the price so intimated by the manufacturer and upon such revision, the manufacturer shall not sell such formulation at a price exceeding the price so revised. Explanation— For the purpose of this paragraph the “Scheduled formulation” includes single ingredient formulation based on bulk drugs specified in the First Schedule and sold under the generic name. ........... 11. Explanation— For the purpose of this paragraph the “Scheduled formulation” includes single ingredient formulation based on bulk drugs specified in the First Schedule and sold under the generic name. ........... 11. Fixation of price under certain circumstances : Where any manufacturer, importer of a bulk drug or formulation falls to submit the application for price fixation or revision, as the case, may be, or to furnish information as required under this Order, within the time specified therein, the Government may, on the basis of such information as may be available with it, by order fix a price in respect of such bulk drug or formulation as the case may be. ........... 22. Power to review : Any person aggrieved by any notification issued or order made under paragraphs 3,5,8,9 or 10 may apply to the Government for a review of the notification or order within fifteen days of the date of publication of the notification in the Official Gazette or the receipt of the order by him, as the case may be, and the Government may make such order on the application as it may deem proper : Provided that pending a decision by the Government on the application submitted under the above paragraph, no manufacturer, importer or distributor, as the case may be, shall sell a bulk drug or formulation, as the case may be, at a price exceeding the price fixed by the Government of which a review has been applied for.” 15. The issue, which needs to be considered first, is as to whether both the writ petitions challenging the ceiling price notification dated 30th April, 2009 and 11th July, 2006 can be entertained there being statutory remedy of review available under Paragraph 22 of the DPCO 1995. Paragraph 22 of the DPCO 1995 provides that any person aggrieved by any notification issued under paragraph 9 may apply to the Government for review of the notification within fifteen days from the date of publication of the notification. The challenge to the notification in these two writ petitions amongst other grounds, is on the ground that notifications are ultra vires to paragraph 9 itself it having not in accordance with the statutory requirement as laid down in paragraph 9. The challenge to the notification in these two writ petitions amongst other grounds, is on the ground that notifications are ultra vires to paragraph 9 itself it having not in accordance with the statutory requirement as laid down in paragraph 9. One of the submissions of the petitioners also is that the respondents were under obligation to call for relevant information from the petitioners relating to cost and efficiency of the formulation the petitioners being major manufacturers of the drug in question and the exercise of fixing ceiling price having undertaken without asking for any such information from the petitioners, the principles of natural justice have been violated and the entire exercise deserves to be set-aside. There can be no denial that against the impugned notification fixing ceiling price remedy under paragraph 22 of the DPCO 1995 is available to the petitioners but looking to the submissions of the petitioners challenging the notification as ultra vires to paragraph 9 of the DPCO 1995 and further submission that exercise is in breach of principles of natural justice, we are not persuaded to not consider the submissions raised by the petitioners on merits. 16. Learned counsel for the parties having addressed their submissions on all aspects of the matter including challenge to the notifications on merits, we proceed to examine the contentions of the parties on merits also and the writ petition cannot be thrown out on the ground of alternative remedy under paragraph 22 of the DPCO 1995. 17. The Issues No. 2 to 7 relate to challenge to the notification dated 30th April, 2009 and 11th July, 2006, which issues being interrelated, are being considered together. 18. Before we proceed to consider the issues, it is necessary to examine the status of the petitioners, i.e. whether the petitioners are small scale industries and are entitled for the benefit of exemption as provided by the notification dated 2nd March, 1995 issued by the Central Government under paragraph 25 of the DPCO 1995. The petitioners in paragraphs 6 and 7 of the first writ petition have specifically pleaded that they are small scale industries and are exempted from operation of paragraph 8 of the DPCO 1995 by virtue of notification 2nd March, 1995. A counter-affidavit has been filed by the respondents. The petitioners in paragraphs 6 and 7 of the first writ petition have specifically pleaded that they are small scale industries and are exempted from operation of paragraph 8 of the DPCO 1995 by virtue of notification 2nd March, 1995. A counter-affidavit has been filed by the respondents. In reply to paragraph 6 of the writ petition, it has been stated in paragraph 34 of the counter-affidavit that no comments are required. In paragraph 35 of the counter-affidavit, it is stated that notification dated 2nd March, 1995 is related to the exemption from operation of paragraph 8 of DPCO 1995 subject to fulfilment of the conditions as stipulated in the said notification. It was stated that no exemption is available to SSI unit in case of ceiling price fixed and notified under paragraph 9 of the DPCO 1995. It was stated that scheduled formulations, which is subject matter of instant writ petition, is covered by notification under paragraph 9 of the DPCO 1995. 19. In the second writ petition similar pleadings were made in paragraphs 6 and 7 claiming that petitioners are small scale industries registered with Directorate of Industries and entitled for exemption of Paragraph 8 of the DPCO 1995 under notification dated 2nd March, 1995. The averments of paragraphs 6 and 7 have been replied in paragraphs 41 and 42 of the counter-affidavit stating that the said averments need no comments and the petitioners may be put to strict proof thereof. In both the writ petitions the petitioners have filed their registration certificate as small scale industries with District Industries Centre, Ghaziabad and Meerut. The notification dated 2nd March, 1995 issued in exercise of power under paragraph 25 of the DPCO 1995 provides that small scale industries registered with any Central Technical Authority or State Directorate of Industries are entitled for exemption from operation of paragraph 8 of the DPCO 1995. The certificates filed by the petitioners registering the petitioners as small scale industries have not been denied nor the notification dated 2nd March, 1995 granting exempting to small scale industries from operation of paragraph 8 has been denied. The certificates filed by the petitioners registering the petitioners as small scale industries have not been denied nor the notification dated 2nd March, 1995 granting exempting to small scale industries from operation of paragraph 8 has been denied. Although during the course of submissions, learned Additional Solicitor General of India sought to contend that petitioners are not entitled for the benefit as small scale industries but there being no sufficient pleading on behalf of the respondents nor any satisfactory ground having been made out by the respondents as to why the petitioners be not entitled for the benefit of notification dated 2nd March, 1992, the petitioners’ submission is accepted that as small scale industries they are entitled for the benefit of the notification dated 2nd March, 1995. There is no dispute to the submission of the respondents that even small scale industries are liable to ceiling price notification issued under paragraph 9 of the DPCO 1995, which fact has also been specifically pleaded by the respondents. 20. In the second writ petition a submission (Issue No. 5) has also been raised by the petitioners that the notification dated 11th July, 2006 has no application on continus release technology, which is a technology adopted by the petitioners. The petitioners’ case in the writ petition is that notification dated 11th July, 2006 is applicable to CR/SR/DR/TR/ER tablets, which stand for controlled release, sustained release, delayed release, time release and extended release. It is stated that petitioners formulation Unicontin is based on a totally different technology, which is known as dissolution or diffusion technology and is commercially known as a formulation manufactured through the process of “continus release”. The petitioners’ case is that petitioner No. 2 entered into collaboration with M/s Mundipharma AG of Switzerland in the year 1990 pursuant to which it acquired by way of technology transfer the ‘’continus release dual mechanism drug delivery system technology’. The petitioners’ case further is that drug delivery system adopted by different manufacturers is either on dissolution or diffusion technology whereas the continus release drug delivery system achieves drug delivery in the human body by consumption of both “dissolution and diffusion technology”. The submission is that continus release being not mentioned in the notification dated 11th July, 2006, the notification is not applicable. 21. The submission is that continus release being not mentioned in the notification dated 11th July, 2006, the notification is not applicable. 21. Learned Additional Solicitor General of India submits that from the drug licence, which has been obtained by the petitioners (copy of which has been filed as Annexure SA-1 to the supplementary affidavit dated 8th February, 2009) it is clear that by order dated 3rd February, 2005 at Item No. 20 and 21 manufacture of item under “control release system of Theophylline” is indicated. Both, Unicontin (400 mg) and Unicontin (600 mg) are mentioned at Item No. 20 and 21 of the drug licence, which is to the following effect : “20. UNICONTIN 400 (Controlled release system of Theophylline) Each uncoated tablet contains: Theophylline Anhydrous IP 400mg (In a controlled release system) 21. UNICONTIN 600 (Controlled release system of Theophylline) Each uncoated tablet contains: Theophylline Anhydrous IP 600mg (in a controlled release system)” 22. There are other materials on the record to indicate that the petitioners’ stand was that they are manufacturers of control release Theophylline. Reference is made to reply dated 3rd May, 2008 submitted by the petitioners to respondent No. 2 in response to their notice dated 15th April, 2008. In the reply it has been stated that petitioners are major manufacturers of control release Theophylline (400 mg). It is not denied that technology to manufacture adopted by the petitioners is control release system, which is also referred as continus control release technology. In the reply the petitioners have repeatedly referred their formulation as control release system. It is, thus, held that diffusion and dissolution technology adopted by the petitioners for manufacture of their formulation but the end formulation is control release formulation and by mere adopting a different technology the petitioners’ submission that they are beyond the purview of the notification dated 11th July, 2006 cannot be accepted. There is one more reason for not accepting the submission of the petitioners. In the notification dated 11th July, 2006 note (c) provides as follows : “(c) For different packing material used or any special feature claimed, companies are required to approach NPPA for approval/fixation of specific prices.” 23. There is one more reason for not accepting the submission of the petitioners. In the notification dated 11th July, 2006 note (c) provides as follows : “(c) For different packing material used or any special feature claimed, companies are required to approach NPPA for approval/fixation of specific prices.” 23. In the event petitioners’ case is that their formulation has special feature, they ought to have approached the NPPA and mere statement that they adopted a different advance technology, the formulation will go out of reach of notification is misconceived. Thus the submission of the petitioners in second writ petition that notification dated 11th July, 2006 is not applicable on them, cannot be accepted. 24. Learned counsel for the respondents has placed reliance on the clarification dated 13th March, 2009 issued by the Directorate General of Health Services in response to the letter dated 12th March, 2009 issued by NPPA. By letter dated 12th March, 2009 clarification regarding controlled release /continus technology was sought for. The Directorate General of Health Services issued following clarification on 13th March, 2009 : “Please refer to your letter No. 17(193)/2009/Div.IV/NPPA dated 12.3.09 wherein you have asked for clarification if the controlled release tablet and controlled release tablet manufactured by continus technology are the same. It may please be noted that controlled release tablet of a drug can be manufactured by using various technologies to achieve controlled release of the drug via the oral cavity. Controlled release tablet formulation manufactured by using continus technology is also covered under the category of controlled release tablet.” 25. Now Issues No. 2, 3, 4, 5, 6 and 7 are being taken. The principal submission of the petitioners is that power conferred upon respondent No. 2 to fix the ceiling price of a schedule formulation is circumscribed to the extent, (i) the ceiling price has to be fixed in accordance with the formula laid down in paragraph 7; and (ii) the ceiling price has to be fixed, keeping in view the cost and efficiency, or both, of major manufacturers of such formulation. 26. The paragraph 9 of the DPCO 1995, as quoted above, empower the Government to fix the ceiling price of a scheduled formulation in accordance with the formula laid down in paragraph 7 keeping in view the cost or efficiency or both of major manufacturers of such formulation. 26. The paragraph 9 of the DPCO 1995, as quoted above, empower the Government to fix the ceiling price of a scheduled formulation in accordance with the formula laid down in paragraph 7 keeping in view the cost or efficiency or both of major manufacturers of such formulation. Paragraph 7 of the DPCO 1995 provides as under : “7. Calculation of retail price of formulation: The retail price of a formulation shall be calculated by the Government in accordance with the following formula namely: R.P. = (M.C. + C.C. + P.M. + P.C.) x (1 + MAPE/100) + ED. where “R.P.” means retail price; “M.C.” means material cost and includes the cost of drugs and other pharmaceutical aids used including overages, if any, plus process loss thereon specified as a norm from time to time by notification in the Official Gazette in this behalf; “C.C.” means conversion cost worked out in accordance with established procedures of costing and shall be fixed as a norm every year by notification in the Official Gazette in this behalf; “P.M.” means cost of the packing material used in the packing of concerned formulation, including process loss, and shall be fixed as a norm every year by, notification in the Official Gazette in this behalf; “P.C.” means packing charges worked out in accordance with established procedures of costing and shall be fixed as a norm every year by notification in the Official Gazette in this behalf; “MAPE” (Maximum Aflowable Post-manufacturing Expenses) means all costs incurred by a manufacturer from the stage of ex-factory cost to retailing and includes trade margin and margin for the manufacturer and it shall not exceed one hundred per cent for indigenously manufactured Scheduled formulations; “E.D.” means excise duty: Provided that in the case of an imported formulation, the landed cost shall form the basis for fixing its price alongwith such margin to cover selling and distribution expenses including interest and importer’s profit which shall not exceed fifty percent of the landed cost. Explanation—For the purpose of this proviso, “landed cost” means the cost of import of formulation inclusive of customs duty and clearing charges.” 27. The submission of the petitioners is that no price norms have been fixed under paragraph 7 of the DPCO 1995 so as to exercise power under paragraph 9 of the DPCO 1995. The submission has been refuted by the respondents. The submission of the petitioners is that no price norms have been fixed under paragraph 7 of the DPCO 1995 so as to exercise power under paragraph 9 of the DPCO 1995. The submission has been refuted by the respondents. The notification under paragraph 7 of the DPCO 1995 has been brought on the record as Annexure-11 to the first writ petition. It has been stated in the additional counter-affidavit filed by the respondents that a set of questionnaire as designed by the Cost Audit Branch of Ministry of Finance to elicit the information for various costs for CC, PC & PL Norms was sent to 470 pharmaceutical manufacturers across the country covering all type of pharmaceutical units. A press lease was also published in newspapers informing pharmaceutical units regarding NPPA’s study to revise these norms with a request to ensure the submission of data/information. The information was submitted by pharma companies and they were duly considered and after doing extensive exercise in this regard, the respondents notified the norms vide notification dated 13th August, 2008. By notification dated 13th August, 2008 the conversion cost, packing charges, process loss of raw material and other norms were fixed. To meet the above submission, the petitioners’ counsel contended that norms with regard to conversion cost as notified on 13th August, 2008 were only with regard to tablets “sustained release” and since the petitioners formulation is under ‘’continus control release system’, they are not covered by the said notification. A perusal of the notification indicates that conversion costs have been fixed 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 forms of drugs. It is not the case of the petitioners that different conversion costs are fixed for controlled release system at any point of time. The pricing norms fixed by the notification dated 13th August, 2008 cannot be said to be non applicable on the petitioners formulation. In the notification dated 30th April, 2009 Note (d) is relevant, which is as under : “(d). For different packing materials used or, different drug delivery systems or any other special features/forms claimed, the ceiling prices, as specified in Column No. 5 above, shall be applicable unless the companies approaches NPPA for specific price approvals for its formulations.” 28. In the notification dated 30th April, 2009 Note (d) is relevant, which is as under : “(d). For different packing materials used or, different drug delivery systems or any other special features/forms claimed, the ceiling prices, as specified in Column No. 5 above, shall be applicable unless the companies approaches NPPA for specific price approvals for its formulations.” 28. There being no case that for controlled release tablets different price norms were fixed at any point of time, the said notification cannot be said to be non applicable and the price norms as notified under paragraph 7 of the DPCO 1995 being available, the ceiling price fixed under paragraph 9 of the DPCO 1995 cannot be faulted at on this ground. Similarly with regard to notification dated 11th July, 2006 it has been specifically stated in the counter-affidavit filed in reply to the supplementary affidavit that notification dated 11th July, 2006 has been issued with due consideration of relevant norms, material cost/factors as per the provisions of paragraphs 7 and 9 of the DPCO 1995. The prices of the Theophylline bulk drug, which constitutes the main ingredient of the formulation were notified in 2005 and the conversion cost, packing charges and packing material cost norms have been notified in 2005 and 2006. The said averments having not been specifically denied, rather the notification dated 29th December, 2005 has been brought on the record, which is a notification issued under paragraph 7 of the DPCO 1995 notifying the pricing norms including conversion cost, packing charges and other details. To meet the submission regarding said price norms raised by the petitioners, it is submitted that the said norms were only for sustained release tablets. As observed above, the said notification cannot be said to be non applicable on the petitioners due to the above submissions as discussed above. 29. Now comes the submission that cost and efficiency of major manufacturers having not been taken while fixing the ceiling price in exercise of power under paragraph 9 of DPCO 1995, the notifications dated 30th April, 2009 and 11th July, 2006 are invalid. 29. Now comes the submission that cost and efficiency of major manufacturers having not been taken while fixing the ceiling price in exercise of power under paragraph 9 of DPCO 1995, the notifications dated 30th April, 2009 and 11th July, 2006 are invalid. The petitioners claim themselves to be the major manufacturers of the formulation in question and further claims that they being major manufacturers and none of their details of cost and efficiency being available with the Government they being exempted from the operation of paragraph 8 of the DPCO 1995, it was incumbent upon the Government to call for necessary information for their cost and efficiency. It is true that under paragraph 9 the Central Government can fix ceiling price of the scheduled formulation keeping in view the cost or efficiency or both of a major manufacturer of such formulation. Before we consider the submissions, it is necessary to find out the nature of power vested in the Central Government under paragraph 9 for fixing a ceiling price. 30. The Apex Court considered the provisions of Drug (Prices Control) Order, 1979 in a case where maximum selling price of bulk drug and retail prices of formulation was fixed by the Government. It is relevant to note the issues, which had arisen before the Apex Court, in the case of Union of India and another v. Cynamide India Ltd. and another, (1987)2 SCC 720 . In the said case notifications were issued by the Central Government fixing the maximum price of various indigenously manufactured bulk drugs. The notifications were questioned on several grounds by the manufacturers and they were quashed by the High Court on the ground of failure to observe the principles of natural justice. The Union of India filed the appeal challenging the order of the High Court quashing the notification. The Apex Court in the said case laid down that price fixation is more in the nature of legislative activity than any other and the legislative action plenary or subordinate is not subject to rule of natural justice. Following was laid down in paragraphs 5 and 7 of the said judgment : “5. 5. The second observation we wish to make is, legislative action, plenary or subordinate, is not subject to rules of natural justice. In the case of Parliamentary legislation, the proposition is self-evident. Following was laid down in paragraphs 5 and 7 of the said judgment : “5. 5. The second observation we wish to make is, legislative action, plenary or subordinate, is not subject to rules of natural justice. In the case of Parliamentary legislation, the proposition is self-evident. In the case of subordinate legislation, it may happen that Parliament may itself provide for a notice and for a hearing there are several instances of the legislature requiring the subordinate legislating authority to give public notice and a public hearing before say, for example, levying a municipal rate -, in which case the substantial non-observance of the statutorily prescribed mode of observing natural justice may have the effect of invalidating the subordinate legislation. The right here given to rate payers or others is in the nature of a concession which is not to detract from the character of the activity as legislative and not quasi-judicial. But, where the legislature has not chosen to provide for any notice or hearing, no one can insist upon it and it will not be permissible to read natural justice into such legislative activity. “7. The third observation we wish to make is, price fixation is more in the nature of a legislative activity than Any other. It is true that, with the proliferation of delegated legislation, there is a tendency for the line between legislation and administration to vanish into an illusion. Administrative, quasi judicial decisions tend to merge in legislative activity and, conversely, legislative activity tends to fade into and present an appearance of an administrative or quasi-judicial activity. Any attempt to draw a distinct line between legislative and administrative functions, it has been said, is ‘difficult in theory and impossible in practice’. Though difficult, it is necessary that the line must sometimes be drawn as different legal rights and consequences may ensue. The distinction between the two has usually been expressed as ‘one between the general and the particular’. ‘A legislative act is the creation and promulgation of a general rule of conduct without reference to particular cases-, an administrative act is the making and issue of a specific direction or the application of a general rule to a particular case in accordance with the requirements of policy’. ‘A legislative act is the creation and promulgation of a general rule of conduct without reference to particular cases-, an administrative act is the making and issue of a specific direction or the application of a general rule to a particular case in accordance with the requirements of policy’. ‘Legislation is the process of formulating a general rule of conduct without reference to particular cases and usually operating in future; administration is the process of performing particular acts, of issuing particular orders or of making decisions which apply general rules to particular cases.’ It has also been said “Rule making is normally directed toward the formulation of requirements having a general application to all members of a broadly identifiable class” while, “an adjudication, on the other hand, applies to specific individuals or situations”. But, this is only a broad distinction, not necessarily always true. Administration and administrative adjudication may also be of general application and there may be legislation of particular application only. That is not ruled out. Again, adjudication determines past and present facts and declares rights and liabilities while legislation indicates the future course of action. Adjudication is determinative of the past and the present while legislation is indicative of the future. The object of the rule, the reach of its application, the rights and obligations arising out of it, its intended effect on past, present and future events, its form, the manner of its promulgation are some factors which may help in drawing the line between legislative ‘’and anon-legislative acts. A price fixation measure does not concern itself With the interests of an individual manufacturer or producer. It is generally in relation to a particular commodity or class of commodities or transactions. It is a direction of a general character, not directed against a particular situation. It is intended to operate in the future. It is conceived in the interests of the general consumer public. The right of the citizen to obtain essential articles at fair prices and the duty of the State to so provide them are transformed into the power of the State to fix prices and the obligation of the producer to charge no more than the price fixed. Viewed from whatever angle, the angle of general application. The right of the citizen to obtain essential articles at fair prices and the duty of the State to so provide them are transformed into the power of the State to fix prices and the obligation of the producer to charge no more than the price fixed. Viewed from whatever angle, the angle of general application. The prospectivity of its effect, the public interest served, and the rights and obligations flowing therefrom, there can be no question that price fixation is ordinarily a legislative activity. Price-fixation may occasionally assume an administrative or quasi-judicial character when it relates to acquisition or requisition of goods or property from individuals and it becomes necessary to fix the price separately in relation to such individuals. Such situations may arise when the owner of property or goods is compelled to sell his property or goods to the Government or its nominee and the price to be paid is directed by the legislature to be determined according to the statutory guidelines laid down by it. In such situations the determination of price may acquire a quasi-judicial character. Otherwise, price fixation is generally a legislative activity. We also wish to clear a misapprehension which appears to prevail in certain circles that price fixation affects the manufacturer or producer primarily and therefore fairness requires that he be given an opportunity and that fair opportunity to the manufacturer or producer must be read into the procedure for price fixation. We do not agree with the basic premise that price fixation primarily affects manufacturers and producers. Those who are most vitally affected are the consumer public. It is for their protection that price fixation is resorted to and any increase in price affects them as seriously as any decrease does a manufacturer, if not more.” 31. The submission was pressed before the Apex Court in the case of Union of India v. Cynamide India Ltd., that in fixing the price of bulk drug the Government may take into account the average cost of production of such bulk drug manufactured by an efficient manufacturer and allow a reasonable return on net worth. The submission was pressed before the Apex Court in the case of Union of India v. Cynamide India Ltd., that in fixing the price of bulk drug the Government may take into account the average cost of production of such bulk drug manufactured by an efficient manufacturer and allow a reasonable return on net worth. It was submitted that the provision for an enquiry proceeding the determination of the price of a bulk drug and provision for review of an order makes the price fixation under the Drugs (Prices Control) Order, 1979 as a quasi judicial activity obliging the observance of the rules of natural justice. The said submissions were considered and rejected by the Apex Court in paragraphs 26 and 27, which are as under : “26. The submission of Shri Anil Diwan, learned counsel for the respondents was that unlike other price control legislations, the Drugs (Prices Control) Order was designed to induce better production by providing for a fair return to the manufacturer. Reference was made to the Hathi Committee report which had recommended a return of 12 to 14% post tax return on equity, that is, paid up capital plus reserves and the ‘Statement on Drug Policy’ which mentioned that ceiling prices may be determined by taking into account production costs and a reasonable return. Great emphasis was laid on the second clause of paragraph 3 of the 1979 Order which provides that in fixing the price of a bulk drug, the Government may take into account the average cost of production of such bulk drug manufactured by an efficient manufacturer and allow a reasonable return on net work, It was submitted that the provision for an enquiry preceding the determination of the price of a bulk drug, the prescription in paragraph 3 clause 2 that the average cost of production of the drug manufactured by an efficient manufacturer should be taken into account and that a reasonable return on net worth should be allowed and the provision for a review of the order determining the price, established that price-fixation under the Drugs (Prices Control) Order 1979 was a quasi-judicial activity obliging the observance of the rules of natural justice. The suggestion of the learned counsel was that the nature of the review under paragraph 27 was so apparently quasi-judicial and that the need to know the reasons for the order sought to be reviewed was so real if the manufacturer was effectively to exercise his right to seek the quasi-judicial remedy of review, that by necessary implication it became obvious that the Order fixing the maximum price must be considered to be quasi-judicial and not legislative in character, The provision for enquiry in the first clause of paragraph 3 and the prescription of the matters to be taken into account in the second clause of paragraph 3 further strengthened the implication, according to the learned counsel. It was contended that in any case, whatever be the nature of the enquiry and the order contemplated by paragraph 3, the review for which provision made by paragraph 27 was certainly of a quasi-judicial character and, therefore, it was necessary that the manufacturers should be informed of the basis for the fixation of the price and furnished with details of the same in order that they may truly and effectively avail themselves of the remedy of review. If that was not done, the remedy would become illusory. It was argued with reference to various facts and figures that the price had been fixed in an arbitrary manner and the Government was not willing to disclose the basis on which the prices were fixed on the pretext that it may involve disclosure, of matters of confidential nature. It was stated that the applications of the manufactures for review of the notifications fixing the prices had not been disposed Of for years though time was really of the very essence of the matter. The prices of formulations were dependent on the prices of drugs and it was not right that prices of formulations should have been fixed even before the applications for review against the notifications fixing the price of bulk drugs were disposed of. It was suggested that the delay in disposing of the review applications had the effect of rendering the original notifications fixing the prices unreal and out of date and liable to be struck down on that ground alone. 27. It was suggested that the delay in disposing of the review applications had the effect of rendering the original notifications fixing the prices unreal and out of date and liable to be struck down on that ground alone. 27. We are unable to agree with the submissions of the learned counsel for the respondents either with regard to the applicability of the principles of natural justice or with regard to the nature and the scope of the enquiry and review contemplated by paragraphs 3 and 27 while making our preliminary observations, we pointed out that price fixation is essentially a legislative activity though in rare circumstances, as in the case of a compulsory sale to the Government or its nominee, it may assume the character of an administrative of quasi-judicial activity. Nothing in the scheme of the Drugs (Prices Control) Order induces us to hold that price fixation under the Drugs (Prices Control) Order is not a legislative activity, but a quasi-judicial activity which would attract the observance of the principles of natural justice. Nor is there anything in the scheme or the provisions of the Drugs (Prices Control) Order which otherwise contemplates the observance of any principle of natural justice or kindred rule, the non-observance of which would give rise to a cause of action to a suitor. What the order does contemplate however is ‘such enquiry’ by the Government ‘as it thinks fit’. A provision for such enquiry’ as it thinks fit’ by a subordinate legislating body, we have explained earlier, is generally an enabling provision to facilitate the subordinate legislating body to obtain relevant information from any source and it is not intended to vest any right in any body other than the subordinate legislating body. In the present case, the enquiry contemplated by paragraph 3 of Drugs (Prices Control) Order is to be made for the purposes of fixing the maximum price at which a bulk drug maybe sold, with a view to regulating its equitable distribution and. making it available at a fair price. The primary object of the enquiry is to secure the bulk drug at a fair price for the benefit of the ultimate con I Sumer, an object designed to fulfil the mandate of Art. 39(b) of the Constitution. It is primarily from the consumer public’s point of view that the Government is expected to make its enquiry. The primary object of the enquiry is to secure the bulk drug at a fair price for the benefit of the ultimate con I Sumer, an object designed to fulfil the mandate of Art. 39(b) of the Constitution. It is primarily from the consumer public’s point of view that the Government is expected to make its enquiry. The need of the consumer public is to be ascertained and making the drug available to them at a fair price is what it is all about. The enquiry is to be made from that angle and directed towards that end. So, information may be gathered from whatever source considered desirable by the Government. The enquiry, obviously is not to be confined to obtaining information from the manufacturers only and indeed must go beyond. However, the interests of the manufacturers are not to be ignored. In fixing the price of a bulk drug, the Government is expressly required by the Order to take into account the average cost of production of such bulk drug manufactured by ‘an efficient manufacturer’ and allow a reasonable return on ‘net worth’. For this purpose too, the Government may gather information from any source including the manufacturers. Here again the enquiry by the Government need not be restricted to ‘an efficient manufacturer’ or some manufacturers; nor need it be extended to all manufacturers. What is necessary is that the average cost of production by ‘an efficient manufacturer’ must be ascertained and a reasonable return allowed on ‘net worth’. Such enquiry as it thinks fit is an enquiry in which information is sought from whatever source considered necessary by the enquiring body and is different from an enquiry in which an opportunity is required to be given to persons likely to be affected. The former is an enquiry leading to a legislative activity while the latter is an enquiry which ends in an administrative or quasi-judicial decision. The enquiry contemplated by paragraph 3 of the Drug (Prices Control) Order is an enquiry of the former character. The legislative activity being a subordinate or delegated legislative activity, it must necessarily comply with the statutory conditions if any, no more and no less, and no implications of natural justice can be read into it unless it is a statutory condition. Notwithstanding that the price fixation is a legislative activity, the subordinate legislation has taken care here to provide for a review. Notwithstanding that the price fixation is a legislative activity, the subordinate legislation has taken care here to provide for a review. The review provided by paragraph 27 of the order is akin to a post decisional hearing which is sometimes afforded after the making of some administrative orders ‘but not truly so.” 32. From the proposition as laid down by the Apex Court in Union of India v. Cynamide India Ltd., it is well settled that exercise of power under paragraph 9 of DPCO 1995 is a legislative activity and is in nature of subordinate legislation in which rules of natural justice are not attracted. Thus the submission of the petitioners that the petitioners being major manufacturers, it was inherent in the provisions of paragraph 9 of DPCO 1995 that information be sought from the petitioners regarding their cost and efficiency, cannot be accepted. 33. There is sufficient materials on the record to indicate that for the formulation frusemide there were large number of manufacturers. In the first writ petition (Writ Petition No. 33753 of 2009) an additional counter-affidavit dated 22nd October, 2009 sworn by Shri M.P. Singh, Director, National Pharmaceutical Pricing Authority has been filed giving details of major manufacturers of frusemide formulation. The Government had notified the price of frusemide bulk drug by various notifications and by notification dated 21st March, 2007 Rs. 1442 per K.G. was fixed the price of the bulk drug. In October, 2007 a fresh cost price study was taken up by issuing questionaire to bulk manufacturers of frusemide. By notification dated 5th June, 2008 price of bulk drug was fixed as Rs. 1225 per K.G. In paragraph 12 it is stated that prices for various formulations of Frusemide were fixed from time to time by issuing notifications prior to notification dated 30th April, 2009. The ceiling price was fixed for frusemide potassium chloride tablet also. In paragraph 13 of the additional counter-affidavit it has been stated that as per ORG data, M/s Sanofi Aventis is a major formulator of Frusemide formulations. The leading brands (six in number) of frusemide formulations has also been referred to therein. The ceiling price was fixed for frusemide potassium chloride tablet also. In paragraph 13 of the additional counter-affidavit it has been stated that as per ORG data, M/s Sanofi Aventis is a major formulator of Frusemide formulations. The leading brands (six in number) of frusemide formulations has also been referred to therein. It is stated that material cost of frusemide is based on notified maximum sale price for the same and the respondents has been notifying norms of conversion cost, packing cost, process loss and packing material cost in accordance with the provisions of DPCO 1995 with regard to which detail exercise took place in the year 2008 and norms were notified on 13th August, 2008. It is further submitted that formulation in question Diucontin K, i.e., Frusemide with Controlled Release Potassium Chloride tablets were collected as sample from market and duly analysed taking into account composition mentioned on the strip itself by an expert body. Copy of the detailed cost analysis of frusemide with controlled release potassium chloride tablet has been brought on the record as Annexure-1 to the additional counter-affidavit. Even if it is accepted that petitioners are exempted from obtaining price fixation under paragraph 8, they being small scale industries, the details of other manufacturers, who are obliged to get price fixation under paragraph 8, is always available with the Government. It is not the case of the petitioners that they are only manufacturer of the formulation in question. Insofar as frusemide formulation is concerned names of six major manufacturers have already been given in paragraph 13 of the additional counter-affidavit. 34. Insofar as the second writ petition is concerned, which relates to Theophylline, details of 41 Theophylline formulations have been given in Annexure-8 to the writ petition, which is the details collected by ORG/IMS filed by the petitioners themselves. Annexure-8 to the second writ petition itself refers to more than 15 manufacturers of Theophylline formulations. Apart from petitioners there are several manufacturers, who can be said to be major manufacturers. It is not the case of the petitioners that none of the details of other manufacturers was with the Government so as to initiate the price fixation activity carried out under paragraph 9 of the DPCO 1995. 35. Apart from petitioners there are several manufacturers, who can be said to be major manufacturers. It is not the case of the petitioners that none of the details of other manufacturers was with the Government so as to initiate the price fixation activity carried out under paragraph 9 of the DPCO 1995. 35. Learned Additional Solicitor General of India, appearing for the respondents, has also submitted that every manufacturers including small scale industries are obliged to submit details in Form-VI by virtue of paragraph 20 of the DPCO 1995. It has been submitted that no information in Form-VI has been provided by the petitioners which enables the Government to exercise the power under Paragraph 9 read with Paragraph 11 of the DPCO 1995. Sri Udai Lalit, learned counsel appearing for the petitioners, contended that Form VI details are not with regard to cost and efficiency of manufacturer. Learned Additional Solicitor General of India has referred to Column 6-B of Form-VI of DPCO 1995 and submits that relevant columns i.e. Column No. 4 (raw materials), Column No. 5 (packing materials) and other columns which require details of expenses are sufficient enough to have an idea of cost and efficiency of manufacturers. 36. The price fixation exercise under Paragraph 9 is a price fixation exercise which does not concern with an individual manufacturer or producer. The price is generally related to a particular commodity or class of communities or transactions. In the present case price fixed is of a schedule formulation. There being other manufacturers of the schedule formulation whose cost and efficiency has been taken into consideration by the Central Government, as pleaded by the respondents, we see no illegality in paragraph 9 exercise in fixing a ceiling price. It is also relevant to note that according to the notification dated 30th April, 2009 ‘’Note-(i)’ any other formulation/composition not covered in the above table that has any one of the schedule drugs in Column No. (3) as one of its ingredients, it shall be subject to the price ceiling at respective table No. 7. It is also relevant to note that according to the notification dated 30th April, 2009 ‘’Note-(i)’ any other formulation/composition not covered in the above table that has any one of the schedule drugs in Column No. (3) as one of its ingredients, it shall be subject to the price ceiling at respective table No. 7. Note (i) is quoted below : “(i) Any other formulation/composition not covered in the above table that has any one of the scheduled drugs in Column No. (3) as one of its ingredients, it shall be subject to the price ceiling at respective serial number of the table, as the case may be, unless the manufacturer has got hereafter specific price fixed by the NPPA for that formulation.” 37. When the above ‘’Note’ includes within the purview of ceiling price any other formulation which have any of the scheduled drugs in Column No. (3) and their formulation why the cost or efficiency of the manufacturers who have the scheduled drug in Column No. 3 in their formulation be not taken into consideration. The Central Government was fully justified to take into consideration the cost and efficiency of the manufacturers manufacturing their formulation on the basis of frusemide scheduled formulation. Thus the submission of the petitioners that their cost and efficiency having not been asked for and having not been taken into consideration, the notification issued under Paragraph 9 of DPCO 1995 is invalid and cannot be accepted. 38. The issues No. 8 to 12 have arisen in the second writ petition and they being interrelated are taken together. As noted above, in the second writ petition the ceiling price notification was issued on 11th July, 2006. The petitioners claimed that after issue of notification within fifteen days they stopped manufacture of their formulation and it was again started only when interim injunction order was issued on 22nd November, 2006 by the Civil Court, Ghaziabad. 39. Paragraph 13 of the DPCO 1995 provides for power to recover overcharged amount. Paragraph 13 of the DPCO 1995 is quoted below : “13. Power to recover Overcharged Amt. 39. Paragraph 13 of the DPCO 1995 provides for power to recover overcharged amount. Paragraph 13 of the DPCO 1995 is quoted below : “13. Power to recover Overcharged Amt. : Notwithstanding anything contained in this order, the Government shall by notice, require the manufacturers, importers or distributors, as the case maybe, to deposit the amount accrued due to charging of prices higher than those fixed or notified by the Government under the provisions of Drugs (Prices Control) Order, 1987 and under the provisions of this Order.” 40. Paragraph 16 of the DPCO 1995 contains an injunction that no person shall sell any bulk drug or formulation to any consumer at a price exceeding the price specified in the current price list or price indicated on the label of the container or pack thereof, whichever is less. Paragraph 16 of the DPCO 1995 is quoted below : “16. Control of sale prices of bulk drugs and formulations: No person shall sell any bulk drug or formulation to any consumer at a price exceeding the price specified in the current price list or price indicated on the label of the container or pack thereof, whichever is less, plus excise duty and all local taxes, if any, payable in the case of Scheduled formulations and maximum retail price inclusive of all taxes in the case of non-Scheduled formulations.” 41. The petitioners have been issued two orders dated 12th September, 2008 and 24th October, 2008 asking the petitioners to deposit the overcharged amount with regard to Unicontin (400 mg) and Unicontin (600 mg). In the notice dated 12th September, 2008 two periods have been mentioned for overcharged amount, first period being from 17th July, 2006 to 18th December, 2006, which is on the basis of ORG/IMS data and second period from 23rd December, 2006 to 7th September, 2007 as per the chartered account certificate submitted by the petitioners. With regard to Unicontin (600 mg) to periods are from 25th July, 2006 to 9th February, 2007 and 10th February, 2007 to 6th September, 2007. With regard to Unicontin (600 mg) to periods are from 25th July, 2006 to 9th February, 2007 and 10th February, 2007 to 6th September, 2007. The petitioners’ submission is that they are not liable to deposit any overcharge for the first period since during the said period they had stopped their manufacturer and sale if any was of the formulation, which were manufactured prior to issue of notification dated 11th July, 2006, which had already passed out of the hands of the petitioners and they had no control over the sale of the aforesaid drugs. Learned counsel for the petitioners submits that after issue of notification fixing ceiling price option is given to the manufacturer to close his production within fifteen days, hence the order directing for recovery for the first period for both the formulations is wholly unjustified. 42. A perusal of paragraph 13 of DPCO 1995 indicates that Government is empowered to require the manufacturer, importer or the distributor to deposit the amount accrued due to charging of price higher than those fixed/notified by the Government. The said provision does not require any deposit from the retailers. Paragraphs 14 and 15 of the DPCO 1995 are also relevant which oblige a manufacturer to carry into effect the price as fixed by the Government from time to time within fifteen days from the date of notification in the official gazette. Sub paragraph (3) of Paragraph 13 of DPCO 1995 enjoins a manufacturer to issue a price list and supplementary price list in Form-V to the dealer, State Drug Controller and the Government. Sub paragraph 14 sub clause (4) enjoins the retailer and the dealer to display the price list as furnished by the manufacturer or importer. Paragraph 14 of the DPCO 1995 is quoted below : “14. Carrying into effect the price fixed or revised by the Government, its display and proof thereof : (i) Every manufacturer or importer shall carry into effect the price of a bulk drug or formulation, as the case may be, as fixed by the Government from time to time, within fifteen days from the date of notification in the Official Gazette or receipt of the order of the Government in this behalf by such manufacturer or importer. (2) Every manufacturer, importer or distributor of a formulation intended for sale shall display in indelible print mark, on the label of container of the formulation and the minimum pack thereof offered for retail sale, the retail price of that formulation, notified in the Official Gazette or ordered by the Government in this behalf, with the words ‘retail price not to exceed’ preceding it, and “local taxes extra” succeeding it, in the case of Scheduled formulations. Provided that in the case of a container consisting of smaller saleable packs, the retail price of such smaller pack shall also be displayed on the label of each smaller pack and such price shall not be more than the prorata retail price of the main pack rounded off to the nearest paisa. (3) Every manufacturer or importer shall issue a price list and supplementary price list, if required, in Form V to the dealers, State Drugs Controllers and the Government indicating reference to such price taxation or revision as covered by the order or Gazette notification issued by the Government, from time to time. (4) Every retailer and dealer shall display the price list and the supplementary price list, if any, as furnished by the manufacturer or importer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.” 43. The scheme of DPCO 1995 indicates that obligation is on the manufacturer to carry into effect the price as fixed by the Government from time to time within fifteen days from the date of notification. There is no pleading in the writ petition that after issue of the notification dated 11th July, 2006 any price list and supplementary price list was sent by the petitioners to inform the dealer, retailer, State Drug Controller and the Government. In case the dealer continued to sell the formulation on higher price to the price as fixed by the notification dated 11th July, 2006, the manufacturer is liable to deposit the overcharge. As noted above, the object and purpose of Drug Control Order is to provide availability of drug on a controlled price to the consumer. 44. In case the dealer continued to sell the formulation on higher price to the price as fixed by the notification dated 11th July, 2006, the manufacturer is liable to deposit the overcharge. As noted above, the object and purpose of Drug Control Order is to provide availability of drug on a controlled price to the consumer. 44. The submission of the petitioners that the formulation, which was manufactured prior to ceiling price notification dated 11th July, 2006, having been passed out of the hands of the petitioners, the petitioners are not liable to deposit any overcharge in regard to the said formulation since they are out of the hands of the petitioners does not merit acceptance. The scheme of the DPCO 1995 indicates that after fixation of ceiling price on 11th July, 2006 the formulation in question could not have been sold in excess to the price fixed by the notification. It is true that if a retailer sells formulation on a higher price, no recovery is contemplated from the dealer but the recovery having been contemplated from the manufacturers or distributors under paragraph 13 of the DPCO 1995 and duty having been caste under paragraph 14 of DPCO 1995 on manufacturers to carry into effect the price of a formulation as fixed by the Government, the manufacturers cannot escape his liability to deposit the overcharge for a batch of drug, which was manufactured prior to the date of notification and had passed out from the hands of manufacturers. 45. Learned counsel for the respondents has placed reliance on a judgment of the Karnataka High Court in Writ Petition No. 38973 of 1998 (Glaxi Smith Klin Beecham (India) Ltd. v. Union of India, in which case the Division Bench of the Karnataka High Court rejected the submission of the petitioners, the manufacturer, that revised price will not apply to the existing stocks but only to new batches of drugs formulations to be manufactured after 15 days of the notification. Following was laid down by the Division Bench of Karnataka High Court in the above judgment : “Having regard to the provisions of para 14 of DPC Order, the petitioner who is manufacturer of Furoxene tablets, ought to carry into effect the revised price fixed as per notification dated 9th March, 1998 within 15 days from the date of the said notification or receipt of the Order of the Government. There is no dispute that the notification dated 9.3.1998 was published in the Gazette of India on the same date. While sub-para (2) of para 14 requires the retail price of the formulation as notified by the Government being displayed on the label of the container of the formulation and the minimum pack offered for retail sale, sub para (3) thereof requires the manufacturer to issue a price list and supplementary price list to the dealers and other persons specified therein indicating reference to price fixation/revision from time to time. Para 16 of DPC Order prohibits all persons including manufacturers/distributors/retailers from selling any formulation at the price exceeding the price specified in the current price list or price indicated on the label of the pack whichever is less. Thus,, a combined reading of these provisions makes it clear that every manufacturer and distributor is duty bound to issue a revised price list within 15 days from the date of the notification issued by the Government under para 9 of the DPC Order. It is also clear that manufacturers, distributors and retailers will be liable to sell formulations from the date of such revised price list (which is required to publish within 15 days from the date of notification) at the revised prices and not the prices mentioned on the label of the container or pack. In view of it, the contention of the petitioner that revised prices will not apply to the existing stocks but only to new batches of drugs and formulations to be manufactured after 15 days of the notification cannot be accepted. The provisions of the DPC Order are clear that prices should be revised within 15 days even in regard to the formulations which were manufactured prior to the date of notification or those manufactured within 15 days from the date of notification.” 46. The respondents having relied for realisation of the overcharge amount for the period, as mentioned above, on the ORG/IMS data the formulation having been sold at a price exceeding the ceiling price as fixed under paragraph 9 of DPCO 1995, paragraph 13 of the DPCO 1995 clearly became applicable and the submission of the petitioners that they are not liable for any overcharge amount during the above period cannot be accepted. 47. 47. Insofar as the second period, i.e., the period subsequent to grant of interim injunction by the Civil Court, Ghaziabad on 22nd November, 2006 is concerned, it is the categorical case of the petitioners that they started their manufacture from December, 2006 and manufactured the formulation and marketed the same, which was sold during the relevant period. The calculation for the second period of the overcharge amount is based on the chartered accountant certificate submitted by the petitioners themselves. The suit, which was filed in district Ghaziabad and interim junction was granted, was subsequently withdrawn by the petitioners. Thus the suit was dismissed as withdrawn and the interim order came to an end. The suit having been dismissed and the notification fixing ceiling price being throughout in operation, the petitioners are also clearly liable to deposit the overcharge amount for the second period. 48. The next submission of the petitioners that maximum retail price is fixed giving trade margin of 16% and the petitioners never received the aforesaid margin. The said amount had never received by it, it cannot be recovered as overcharge amount. Under paragraph 13 the manufacturer is liable to deposit the amount accrued due to charging of price higher than those fixed. The word “accrue” has been defined in Webster Comprehensive Dictionary Encyclopedic Edition in following manner : “ac-crue v.i. -crued, cru-ing 1 To come as a natural result or increment, as by growth: with to. 2 To arise as an addition, accession, or advantage; accumulate, as the interest on money: with from. 3 Law To become established as a permanent right. - n. A loop or false mesh in network which increases the number of meshes in a given row. [< obs. n. accrue an accession 49. The word “accrued” has been used in relation to manufacturer who is being asked to deposit the overcharge amount. By overcharge the amount accrued has to be determined and realised. Paragraph 13 of the DPCO 1995 does not use the phrase “deposit of overcharge amount”. Paragraph 19 of the DPCO 1995 deals with price of formulation sold to the dealer. Paragraph 19 of the DPCO 1995 is as follows : “19. By overcharge the amount accrued has to be determined and realised. Paragraph 13 of the DPCO 1995 does not use the phrase “deposit of overcharge amount”. Paragraph 19 of the DPCO 1995 deals with price of formulation sold to the dealer. Paragraph 19 of the DPCO 1995 is as follows : “19. Price of formulations sold to the dealer : (1) A manufacturer, distributor or wholesaler shall sell a formulation to a retailer, unless otherwise permitted under the provisions of this Order or any order made thereunder, at a price equal to the retail price, as specified by an order or notified by the Government, (excluding excise duty, if any) minus sixteen percent thereof in the case of Scheduled drugs. (2) Notwithstanding anything contained in sub-paragraph (1), the Government may be a general or special order fix, in public interest, the price of formulation sold to the wholesaler or retailer in respect of any formulation the price of which has been fixed or revised under this Order. 50. Under paragraph 19 of the DPCO 1995 the manufacturer is obliged to sell a retailer at a price equal to the retail price as specified by an order or notified by the Government minus 16% thereof in case of scheduled drug. For example, retail price of a drug is Rs. 100/-, the manufacturer is obliged to sell the drug to retailer for an amount of Rs. 84/- as 16% has been treated to be trade margin. The amount of 16% which is statutorily provided as trade margin for a retailer cannot be said to be accrued to the manufacturer. Thus while computing the overcharge amount the allowance of amount of 16% as provided under sub-paragraph(1) of Paragraph 19 has to be given to the manufacturer. The amount which has never accrued to the manufacturer cannot be recovered as overcharge amount. Thus the submission of the petitioners that while calculating the overcharge amount 16% has to be deducted, which had never accrued to the manufacturers, is accepted. 51. The last submission of the petitioners is that the petitioners are not liable to pay interest prior to the date of issue of orders dated 12th September, 2008 and 20th October, 2008 directing deposit of the overcharge amount. Paragraph 13 of the DPCO 1995 is enabling power given to the Government to require the overcharge amount to be deposited by notice. Paragraph 13 of the DPCO 1995 is enabling power given to the Government to require the overcharge amount to be deposited by notice. The notice for deposit of the overcharge is, thus, contemplated by paragraph 13 of the DPCO 1995 itself. 52. The liability to pay interest has been specifically provided under Section 7-A of the Essential Commodities Act, 1955. Section 7-A(1) of the Essential Commodities Act, 1955 is quoted as below : “7-A. Power of Central Government to recover certain amounts as arrears of land revenue [or as a public demand].—(1) Where any person, liable to— (a) pay any amount in pursuance of any order made under Section 3, or (b) deposit any amount to the credit of any Account or Fund constituted by or in pursuance of any order made under that section, makes any default in paying or depositing the whole or any part of such amount, the amount in respect of which such default has been made shall [whether such order was made before or after the commencement of the Essential Commodities (Amendment) Act, 1984, and whether the liability of such person to pay or deposit such amount arose before or after such commencement] be recoverable by Government together with simple interest due thereon computed at the rate of [fifteen per cent] per annum, from the date of such default to the date of recovery of such amount, as an arrear of land revenue [or as a public demand].” 53. Section 7A of the Essential Commodities Act, 1955 contemplates recovery by Government with simple interest on the due amount in case any default is committed in payment by a person liable to pay any amount. The order has been passed in this case by respondent No. 2 directing for deposit of overcharge amount by orders dated 12th September, 2008 and 24th October, 2008. The said orders direct deposit of the said amount within fifteen days from issue of the letter failing which recovery proceedings under the provisions of the Essential Commodities Act, 1955 were to be initiated. The default of the petitioner to pay overcharge amount shall arise after fifteen days from issue of the order. The liability to pay simple interest shall arise after a default is committed as per Section 7A(1). Thus no interest could have been charged prior to issue of the order dated 12th September, 2008 and 24th October, 2008. The default of the petitioner to pay overcharge amount shall arise after fifteen days from issue of the order. The liability to pay simple interest shall arise after a default is committed as per Section 7A(1). Thus no interest could have been charged prior to issue of the order dated 12th September, 2008 and 24th October, 2008. The orders dated 12th September, 2008 and 24th October, 2008 insofar as it demands respective amount towards interest cannot be sustained. 54. In the second writ petition an interim order was passed on 10th February, 2009 providing that no coercive action shall be taken by the respondents against the petitioners in the meantime. Subsequently by an order dated 28th May, 2009 after hearing the respondents the stay application was disposed of modifying the interim order dated 10th February, 2009 to the extent that subject to petitioners depositing 50% of the amount as determined by orders dated 12th September, 2008 and 24th October, 2008 further recovery against the petitioners shall remain stayed. After passing of the interim orders, the petitioners claim to have deposited an amount of Rs. 9,01,45,215/- by demand draft dated 18th June, 2009. 55. In view of what has been said above, the overcharge amount to be recovered from the petitioners in the second writ petition needs to be re-calculated in the light of the observations made above. The respondents while re-calculating the amount of overcharge to be realised from the petitioners shall adjust the amount already deposited by the petitioners indicated above. 56. Now we revert to the first writ petition again, the said writ petition was filed against the notification dated 30th April, 2009 on 7th July, 2009 in this Court i.e. within reasonable time of issuance of notification. Petitioners’ case in the first writ petition is that immediately after issue of notification dated 30th April, 2009 they have stopped manufacture of their formulation. No issue of overcharge is involved in the first writ petition. As observed above, the remedy was available to the petitioners of the first writ petitioner to invoke paragraph 22 of the DPCO 1995. In facts of the case of the first writ petition, we are of the view that petitioners are entitled for a liberty to make an application for review under Paragraph 22 of the DPCO 1995 within 15 days from today. In facts of the case of the first writ petition, we are of the view that petitioners are entitled for a liberty to make an application for review under Paragraph 22 of the DPCO 1995 within 15 days from today. We provide that in case a review application is made for review of the notification dated 30th April, 2009 under paragraph 22 of the DPCO 1995 within 15 days from today, the same may be entertained and decided on merits. 57. Coming to the second writ petition, no ground is made out to quash the notification dated 11th July, 2006. The prayer of the petitioners for quashing the notification dated 11th July, 2006 is refused. The petitioners after the notification filed the suit in the Civil Court, Ghaziabad and obtained an interim injunction order and had filed the present writ petition in this Court only on 7th February, 2009. They are not entitled for any relief qua the notification dated 11th July, 2008. The petitioners, however, are entitled for partial relief regarding the overcharge amount directed to be deposited by orders dated 12th September, 2008 and 24th October, 2008, as indicated above. 58. In result, both the writ petitions are disposed of with the following directions : (i) Writ Petition No. 33753 of 2009 is disposed of giving liberty to the petitioners to move an application for review under Paragraph 22 of the DPCO 1995 within fifteen days from today. In case application for review is accordingly moved, the same shall be decided on merits keeping in view the observations as made above. (ii) The prayer of the petitioners in Writ Petition No. 7400 of 2009 for quashing the notification dated 11th July, 2006 is refused. (iii) The orders dated 12th September, 2008 and 24th October, 2008 (Annexure-3 and 4 to the second writ petition) are modified to the following extent : (a) No interest from the petitioners can be charged for any period prior to 12.9.2008 and 24.10.2008. (b) Total overcharge amount is required to be reduced by 16% which amount was not accrued to the petitioners. (iv) The respondent No. 2 shall issue a fresh order in accordance with law regarding deposit of the overcharge amount as indicated above within a period of fifteen days from today. 59. Both the writ petitions are disposed of accordingly. 60. Parties shall bear their own costs. ————