Regulatory Updates

The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 91^st meeting held on 13^th 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.

List of Applications For Provisional Enlistment Of Products Applied By Herbal/Unani Firms.

“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 “hotcdivision∂gmail.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.

“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 “hotcdivision∂gmail.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.

The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 90^th meeting held on 17th June, 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.

Guidelines for holder of Drug Manufacturing License, to manufacture the Alternative Medicines and Nutritional Products & Food Supplements and Probiotics.

Guidelines for manufacturing of Alternative Medicines, Health Products and Probiotic by the DML holders.