Summary
Drug manufacturers challenged ceiling prices on the ground that their sustained-release or continuous-release delivery technologies lacked applicable pricing norms. The Supreme Court upheld the notifications. The norms contemplated sustained-release formulations and the notification required companies claiming special delivery features to approach the pricing authority for specific approval. Having failed to seek or demonstrate such treatment, the manufacturers remained bound by the ceiling prices.
Issues
- Whether the manufacturers’ claimed delivery technologies excluded their formulations from the notified pricing norms.
- Whether failure to seek specific price approval affected their challenge.
Provisions considered
- Paragraphs 7 and 9, Drugs (Prices Control) Order, 1995Retail-price calculations and ceiling-price powers applied to the formulations; the notified norms and specific-approval mechanism addressed claimed delivery-system differences. (¶¶ 8, 10, 11, 12)
Held
- The conversion-cost notification covered sustained-release tablets and the manufacturers had not shown that distinct conversion costs had ever been fixed for their claimed systems. (¶ 10)
- The notification made ceiling prices applicable to different delivery systems and special features unless specific approval was sought. The appellants had not approached the authority for such approval. (¶¶ 10, 11)
- Manufacturers could demonstrate that their systems were unique or different before the authority. Their omission to do so did not displace their obligation to follow the notified norms and ceilings. (¶ 12)
Result
Appeals dismissed without costs. The High Court’s rejection of the challenges to the ceiling-price notifications was upheld.