DRAP revises fee for various licences, other facilities

Rs22,500 set as fee for renewal of drug manufacturing licences

ISLAMABAD:

The Drug Regulatory Authority of Pakistan (DRAP) has revised its fee for drug manufacturing licences, drug registration, renewal, and site inspection. Following the policy board's approval, DRAP has also issued a formal notification regarding the fee revision.

According to the notification, the fee for issuance of drug manufacturing licences is Rs45,000 while the fee for renewal of drug manufacturing licences is Rs22,500.

Upon application for renewal after the expiry of licences, an additional fee of Rs7,500 per day along with the actual fee will be levied. Rs7,500 will be charged for site verification and layout of the pharmaceutical company while Rs7,500 for re-packing of drugs has levied. The registration fee for non-locally manufactured drugs is Rs 75,000.

Similarly, the registration fee for locally manufactured medicines has been fixed at Rs30,000, the renewal registration fee of non-locally manufactured medicines at Rs30,000, while the renewal fee for locally manufactured medicines has been fixed at Rs15,000.

According to the notification, the fee for extension of drug manufacturing contract is Rs 75,000 per product while Rs 15,000 for the advertisement of medicines in print media, Rs 22,000 for radio, Rs 37,000 for electronic media has been set.

Last week, the apex drugs regulator had sought input from the stakeholders over the registration of medicines with their generic names.

Last week, the apex drugs regulator had sought input from the stakeholders over the registration of medicines with their generic names.

The Pharmaceutical Evaluation division of DRAP has initiated proceedings in this regard and sought input from stakeholders.

Published in The Express Tribune, May 18^th, 2021.