What Happens When a DoP Review Application under DPCO Is Filed Late?
Under the Drugs (Prices Control) Order, 2013 (“DPCO”),[MG1.1] a manufacturer, importer or marketer of pharmaceutical drugs or medical devices can take recourse against the decision of National Pharmaceutical Pricing Authority (NPPA) to fix ceiling price or retail price by filing a review application before the Department of Pharmaceuticals (“DoP”) within 30 days from the receipt of the NPPA order.
In practice, there may be instances where an applicant is unable to approach DoP within the prescribed period, resulting in a delay in filing the review application. This article examines how such delays are treated and the practical steps available to an applicant seeking to have the matter considered on merits.
Does a Delay Automatically Bar Review?
The DPCO contains no restrictive exclusionary language such as "after the expiry period" or "not thereafter". Therefore, it is arguable that filing a review post the 30-day period does not automatically extinguish the review remedy. The applicant can file a condonation of delay application giving a reasonable cause for the delay along with the review application before the DoP invoking Section 5 of the Limitation Act, 1963 which deals with . It is the DoP’s discretion to allow the condonation or not. If allowed, the review application should be evaluated on merits and not outrightly rejected due to a procedural delay.
When Can Delay Be Condoned?
A condonation of delay application should not be used as an excuse to file the review application with significant delay. For example, minor procedural slippages, such as a delay of 2 days past the 30-day window are generally condonable if the reason for delay is sufficient. However, a 100-day delay may not be treated the same.
Once the DoP allows the condonation, it would proceed to evaluate the review application on merits.
Practical Realities
The DoP typically rejects review application which is filed outside the prescribed period of 30 days, on the ground of delay.
Judicial Recourse
If there is an administrative delay on part of DoP to decide the delay condonation or review application, or if DoP has mechanically rejected the delay condonation application and the review application, there may be an option of judicial recourse:
a. The applicant can file a writ petition before the jurisdictional High Court under Article 226 to seek directions for a time bound disposal of the review application by the DoP to prevent financial loss and inventory degradation.
b. If the DoP rejects the review strictly on grounds of limitation expiry without going into the merits of the application, the order may be challenged before the jurisdictional High Court. Under Article 226, High Courts have the power to set aside arbitrary rejections, condone reasonable delays and send the matter back to the authority to be decided on merits.
There are supporting High Court precedents where delay to file review application has been condoned.
Conclusion
Missing the 30-day window under the DPCO should not discourage a manufacturer, importer or marketer from pursuing the review remedy, if the delay can be justified. In such cases, instead of not pursuing review application altogether, the applicant may elect to pursue the review application along with a condonation of delay application, explaining the cause for the delay. Of course, the decision to condone the delay rests with DoP, but there are judicial remedies available to applicant in case of grievance.