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IN THE HIGH COURT OF JUDICATURE AT BOMBAY, ORDINARY ORIGINAL CIVIL JURISDICTION
MANISH PITALE, SHREERAM V.SHIRSAT
Franco Indian Pharmaceuticals Pvt. Ltd. – Appellant
Versus
Union of India – Respondent
| Table of Content |
|---|
| 1. formulation pricing based on nlem 2011 essentiality. (Para 1 , 2 , 3 , 4 , 5) |
| 2. sr formulations exempt without schedule inclusion. (Para 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13) |
| 3. ceiling prices only for scheduled formulations. (Para 14 , 15 , 16 , 17 , 18 , 19) |
| 4. all delivery forms of essential drugs controlled. (Para 20 , 21 , 22 , 23) |
| 5. definitions restrict ceiling to first schedule. (Para 24 , 25 , 26 , 27 , 28) |
| 6. specific orders needed for sr/cr ceiling prices. (Para 29 , 30 , 31 , 32 , 33) |
Judgment :
Manish Pitale, J.
The petitioner No.1 in Writ Petition No.2216 of 2015 is an entity engaged in the manufacture, marketing and distribution of pharmaceutical formulations and petitioner in Writ Petition No. 885 of 2015 is the Indian Drug Manufacturers Association (IDMA), which is a registered association of manufacturers of drugs and pharmaceuticals in India. Both the petitions raise issues pertaining to the interpretation and implementation of the Drugs (Price Control) Order 2013 (hereinafter referred to as ‘DPCO 2013’ for short). The petitioners contend that the respondent No.3 i.e. the National Pharmaceutical Pricing Authority (NPPA) is wrongly interpreting DPCO 2013
Ceiling prices under DPCO 2013 apply only to formulations expressly listed in First Schedule or added by specific orders; unspecified variants like sustained release not covered, barring pricing auth....
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....
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 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.
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 court established that price control provisions for scheduled drugs do not apply to non-scheduled formulations, particularly when distinct packaging technologies are involved.
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