Back
IN THE HIGH COURT AT CALCUTTA
Subhendu Samanta
IN THE MATTER OF : Palsons Derma Pvt. Ltd. – Appellant
Versus
Union of India – Respondent
| Table of Content |
|---|
| 1. overview of regulatory framework and petitioner background. (Para 1 , 2 , 3 , 4) |
| 2. key issues regarding formulation classification and pricing. (Para 5 , 6 , 7) |
| 3. arguments for distinguishing gel from cream and ointment. (Para 8 , 9 , 10 , 11) |
| 4. interpretation of dpco and manufacturer's obligations. (Para 12 , 13) |
| 5. discussion on interest payment guidelines and related case law. (Para 14 , 15) |
| 6. final decision on claim dismissal and interest calculation timeframe. (Para 16 , 17) |
| 7. order for stay deemed inappropriate. (Para 18) |
JUDGMENT :
Subhendu Samanta, J.
1. Petitioner No. 1 is a company incorporated under Companies Act, 1956, carries on business of manufacture and sale of various pharmaceutical products including manufacture of medicines of dermatological elements from the year 1985. Respondent No. 1 & 2 are the Officers of National Pharmaceutical Pricing Authority (NPPA), a statutory body authorised under Essential Commodities Act, 1995 and Drug Pricing Control Order 1995 [(DPCO)] 1995 to implement and enforces the selling price of identified scheduled Drugs and Scheduled Formulations.
2. (DPCO) 1995 seeks to control and restrict maximum selling price of schedul
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.
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 government's inclusion of drugs under price control must strictly adhere to its own established criteria to avoid arbitrariness under Article 14.
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.
Definitions of ‘distributor’ and ‘dealer’ under DPCO are not mutually exclusive in Drugs (Price Control) Order, 1995.
An indispensable Tool for Legal Professionals, Endorsed by Various High Court and Judicial Officers
Please visit our Training & Support
Center or Contact Us for assistance
Scan Me!
India’s Legal research and Law Firm App, Download now!
For Daily Legal Updates, Join us on :
Back to top
