FIFO Applications List for the Provisional Enlistment of Alternative Medicines and Health Products

The Division of Health & OTC (non-drugs) is responsible for performing the enlistment of manufacturers, importers and their products under the Alternative Medicines and Health Product (Enlistment) Rules 2014.

The Division of Health & OTC, DRAP has published FIFO lists of applications received for the provisional enlistment of various categories of alternative medicines and health products. These lists contain the details of the applicants, the proposed name of the products and date of submission of application.

These lists are intended to provide transparency and accountability to the stakeholders and the public regarding the processing of the applications. It also aims to facilitate the applicants to follow up on their applications.

The list of pending applications can be accessed from the following link:

DRAP issued Consolidated Notification for Regulatory Fees

Drug Regulatory Authority of Pakistan (DRAP) issued a consolidated notification of Regulatory fess for various functions and services. This notification is issued under the section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act, 2012 (XX.I of 2012) read with sub-rule (3) of rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, and in supersession of all such previous Notifications. The Drug Regulatory Authority of Pakistan with the approval of the Policy Board has specified these regulatory fees. The Notification is provided as under: –

Lists of Applications for Provisional Enlistment of Alternative Medicines and Health Products

Following is the provisional list of applications are received for provisional enlistment of products with the Division of Health & OTC, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. Applicant firm are requested to furnish comments with respect to submitted applications within 30 days of the uploading of this list, if any. The comments received within 30 days of the publication of this list will be given due consideration, after which a final list will be uploaded on the website. Comments received after due date shall not be entertained. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of date mentioned against each application

These lists are prepared according to types of products and categories of applicant’ firms, as under:-

Cancellation of Enlistment Certificates (Form-6 and Form-7) of two alternative products manufacturers’ for non-compliance to minimum regulatory requirements.

Enlistment Evaluation Committee (EEC) has cancelled the provisional enlistment certificates of two (02) alternative products manufacturing companies for non compliance to minimum manufacturing requirement as per applicable rules. The Committee also cancelled / revoked all the product enlistment certificates issued on the name of these two firms. The cancellation letters have been issued by the Division of Health & OTC to the all concerned authorities.

Deficiency Letters from EEC meetings from 95 to 103

Submission of Deficient Information / Documents (Enlistment Evaluation Committee (EEC) 92nd meeting held on 30th July, 2021)

The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 92nd meeting held on 30th July, 2021 and the same have been deferred being deficient of the information / documents as specified in column (3) of the Table below which may be furnished within 20 days of uploading of this letter on official website of DRAP along with soft data as per Annexed Format at the end of this letter/document.

Submission of Deficient Information / Documents (Enlistment Evaluation Committee (EEC) 91st meeting held on 13th July, 2021)

The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 91st meeting held on 13th July, 2021 and the same have been deferred being deficient of the information / documents as specified in column (3) of the Table below which may be furnished within 20 days of uploading of this letter on official website of DRAP along with soft data as per Annexed Format at the end of this letter/document.

Date Wise FIFO List of Applications For Provisional Enlistment Of Products Applied By Nutraceutical Firms And Firms Having Herbal/Unani Sections Along With Nutraceutical Sections (FIFO List 2020)

“In continuation to the previous FIFO list uploaded on official website of Drug Regulatory Authority of Pakistan on 29th June, 2021 and after incorporating the responses submitted by the firms within the stipulated time, following is the list of applications received for provisional enlistment of products with the Division of Health & OTC Products, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of R&I date mentioned against each application.

Please note that formulations of all products of respective companies must be forwarded in MS Word & MS Excel Formats (Soft Copy) annexed at the end of this document (Annexure-I) to the official e-mail hotcdivisiongmail.com of Health & OTC Division with the title “M/s…………. FIFO List 2020” within 15 days positively. Soft Formulations should be provided as per data given in Form-3 already submitted with dossier in hard form. Any discrepancy found in the submitted data in soft and hard shall be liable to rejection of the product application.