IN THE HIGH COURT OF DELHI AT NEW DELHI
Yashwant Varma, J.
Bharat Serums & Vaccines Limited - Appellant
Versus
Union Of India & Anr. - Respondents
W.P.(C) 7946 of 2018, CM Appl. 30490 of 2018 (Stay) and W.P.(C) 8190 of 2018, CM Appl. 31389 of 2018 (Stay), W.P.(C) 9090 of 2020, CM Appls. 29370 of 2020, 9966 of 2022
Decided On : 22-09-2022
The provided legal document primarily discusses regulatory provisions related to pharmaceutical pricing, including the interpretation and enforcement of Paragraph 20 of the Drugs (Price Control) Order, 2013, and related statutory and policy frameworks. It focuses on issues such as overcharging, price revision rights, penalties, and the scope of monitoring versus fixing prices for scheduled and non-scheduled formulations. The document does not mention or address issues related to copyright law, intellectual property rights, or any copyright-related protections or violations. Therefore, it does not talk about copyright.
| Table of Content |
|---|
| 1. timeline of overcharging allegations against bharat serums and bard. (Para 1 , 2 , 3) |
| 2. disputes regarding the interpretation of paragraph 20 in relation to overcharging. (Para 4 , 5 , 6) |
| 3. court's observations on the application of paragraph 20 and its implications. (Para 7 , 12 , 18) |
| 4. arguments related to the enforcement of paragraph 20 and rights of manufacturers. (Para 14 , 15 , 16) |
| 5. conclusions reached by the court following the examination of legal principles. (Para 97 , 98) |
JUDGMENT
A. INTRODUCTION
1. These three writ petitions which revolve around Para 20 of the Drugs (Price Control) Order, 20131 assail demand notices issued by the respondent National Pharmaceutical Pricing Authority holding the petitioners guilty of overcharging and thus liable to deposit the overcharged amount together with interest thereon. Bharat Serums the petitioner in W.P.(C) 7946/2018 and 8190/2018 challenges the demand notices dated 26 June 2018 and 05 July 2018. The two demand notices relate to non-scheduled formulations named Histoglob and U-Tryp. Bard the petitioner in W.P.(C) 9090/2020 has challenged identical demand notices dated 07 November 2019 and 22 October 2020 in respect of 82 medical devices which were produced and distributed by the said petitioner.
2. Insofar as Bharat Serums is concerned, the respondents have held it to be in violation of Para 20 with respect to the sale and distribution of Histoglob for the period February 2014 to July 2018. The allegation of overcharging in respect of U-Tryp covers the period May 2015 to July 2018. Insofar as Bard is concerned, the respondents allege that medical devices were overcharged during the period January 2015 to January 2018.
3. In order to appreciate the issues which arise, it would, at the outset, be apposite to advert to the provisions of Para 20 which reads thus: -
'20. Monitoring the prices of non-scheduled formulations.-(1) The Government shall monitor the maximum retail prices (MRP) of all the drugs, including the non-scheduled formulations and ensure that no manufacturer increases the maximum retail price of a drug more than ten per cent of maximum retail price during preceding twelve months and where the increase is beyond ten per cent of maximum retail price, it shall reduce the same to the level of ten per cent of maximum retail price for next twelve months. (2) The manufacturer shall be liable to deposit the overcharged amount along with interest thereon from the date of increase in price in addition to the penalty.'
4. Bharat Serums has been found to have overcharged and thus liable for penal action under Para 20 in respect of the two non-scheduled formulations noticed above. It asserts that in the period under scrutiny, it had not overcharged prices and had merely rounded off the price of its drug. Insofar as Bard is concerned, it has taken the stand that the overcharging of medical devices occurred on account of a lack of clarity in respect of the format in which price disclosures were to be made and that the overcharging was neither deliberate nor intentional. Both the writ petitioners have also challenged the interpretation accorded to Para 20 by the respondents and the consequential quantification of overcharging by NPPA. Bard has also questioned the levy of interest asserting that it would be liable to pay the same on the overcharged amount only from the date of the demand being raised as opposed to the date when the overpricing occurred.
5. Both the writ petitioners assail the correctness of the view taken by the respondents that in case a manufacturer is found to have overcharged and thus acted in breach of Para 20, it would stand denuded of the right to claim a periodic increase which is envisaged under the said provision of the 2013 DPCO. As would be evident from a reading of Para 20 of the 2013 DPCO, a manufacturer of a non-scheduled formulation is entitled to increase the Maximum Retail Price of a drug provided that such increase does not exceed 1
Panipat Cooperative Sugar Mills v. Union of India [(1973) 1 SCC 129]
Anakapalle Cooperative Agricultural & Industrial Society Ltd. v. Union of India [(1973) 3 SCC 435]
Best Laboratories Pvt. Ltd. v. Union of India
Cynamide India Ltd. [Union of India v. Cynamide India Ltd.
Director of Enforcement v. M.C.T. M. Corpn. (P) Ltd.
DLF Qutab Enclave Complex Educational Charitable Trust v. State of Haryana (2003) 5 SCC 622
DLF Universal Ltd. v. Director, Town and Country Planning Department
Glaxosmithkline Pharmaceuticals Ltd. v. Union of India
Harishankar Bagla v. State of M.P. [AIR 1954 SC 465 : (1955) 1 CR 380 : 1954 Cri LJ 1322]
Narendra Kumar v. Union of India [AIR 1960 SC 430 : (1960) 2 SCR 375]
O.N.G.C. v. Association of Natural Gas Consuming Industries of Gujarat AIR 1990 SC 1851
Prag Ice & Oil Mills v. Union of India (1978) 3 SCC 459
Sri Krishna Rice Mills v. Joint Director (Food) [(1974) 1 SCR 418]
State of Rajasthan v. Nath Mal and Mitha Mal [AIR 1954 SC 307 : 1954 SCR 982]
Transmission Corporation of Andhra Pradesh Limited v. Sai Renewable Power (P) Ltd. (2011) 11 SCC 34
U.P. Power Corp. Ltd. v. NTPC Ltd. (2009) 6 SCC 235
Union of India v. Bhana Mal Gulzari Mal [AIR 1960 SC 475 : (1960) 2 SCR 627 : 1960 Cri LJ 664]
Union of India v. Cynamide India Ltd.
Vrajlal Manilal & Co. v. State of M.P. [(1969) 2 SCC 248 : (1976) 1 SCR 400
AI
The court affirmed that all formulations of a scheduled drug, including gel, are subject to price regulations, emphasizing NPPA's authority in price control over the formulations.
The validity of notifications issued by the Central Government under the DPCO 1995 for drug price control is upheld, confirming that they were not issued mechanically and that yearly norm revisions a....
Point of Law : Contents of policy document cannot be read and interpreted as statutory provisions and further holds that breach of a policy decision by itself is not a ground to invalidate the deleg....
The government's inclusion of drugs under price control must strictly adhere to its own established criteria to avoid arbitrariness under Article 14.
Definitions of ‘distributor’ and ‘dealer’ under DPCO are not mutually exclusive in Drugs (Price Control) Order, 1995.
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