Sunday September 19, 2021

SHC seeks comments on plea against licence fee increase for certain drugs

SHC seeks comments on plea against licence fee increase for certain drugs

The Sindh High Court has directed drug regulatory authority and its policy board to file comments on a petition against the imposition of a 100 per cent increase in licence fees for the manufacturing of certain drugs.

The pharmaceutical manufacturers association and others have challenged the DRAP’s notification in which the licence fees for the manufacturing of certain drugs has been increased by 100 per cent.

The petitioners’ counsel submitted that the impugned notification was illegal and imposed unreasonable restrictions on the manufacturers’ business, and that the interests of the petitioners would be prejudiced by it.

He submitted that provisions of the drug regulatory act do not provide legislative parameters or a legislative policy for determining the amount and nature of fees to be levied and no rules have been framed by the respondents in respect of the levy of the fees.

He stated that the drug regulatory law does not lay down any guidelines and there is no definite criterion which DRAP is required to follow while exercising its powers in respect of levy of a fee.

He further argued that DRAP while issuing the impugned notification had exercised complete, unguided discretion, and that the notification was liable to be struck down. The counsel stated that the notification would lead towards an acute shortage of economically priced essential drugs and also all imported drugs, which would have a disastrous impact on the general public access to medicine in the country.

He submitted that due to implementation of the notification, the market would be inundated with low-quality and sub-standard drugs. The court was requested to declare the DRAP notification with regard to increase in the licence fees for certain drugs is illegal and liable to be set aside.

The counsel for DRAP sought time to file comments on the petition. A division bench headed by Mohammad Shafi Siddiqui directed DRAP and others to file comments within two weeks with an advanced copy to the counsel of the petitioners.