Zatranex Injection Reg No. 014217, Batch No.594 Manufactured By M/S. Zafa Pharmaceutical Laboratories (Pvt.) Ltd. Karachi
Year: 2021
Import of Short Shelf Life Material(s)/Product(s).
I am directed to refer to the subject cited above and to state that the “Recommendatory Committee to Recommend Import of Short Shelf-life Drugs” in its 50th Meeting held on 18th October, 2021 decided to issue the following Advisory: –
- The Manufacturers/Importers be advised to apply for pre-import permission for their import consignments with Short Shelf Life. Post import cases will be considered in very exceptional circumstances of Force Majeure.
- The Committee further advised to charge ‘Miscellaneous Fee’ (for each Batch of Short Shelf Life Material / Product being imported) for all cases recommended after May 2021.
2. The above recommendations of the committee have been approved by the Competent Authority i.e. CEO, DRAP and the same are being communicated for compliance in true letter and spirit. please.
Drug Product Recall: M/S. Gsk Pakistan Limited, Karachi issued voluntary recall of Nootropil Oral Solution (Batch No. WR7J)
Amendments in the Medical Devices Rules, 2017 (SRO 1500 (I) 2021)
S.RO.1500(I)/2021.- In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act,2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with approval of the Federal Government, is pleased to direct that the following amendments shall be made in the Medical Devices Rules, 2017, namely:-
In the aforesaid Rules,-
(a) in rule 6, in sub-rule (l).-
(i) for clause (c), the following shall be substituted, namely;- “(c) the manufacturing shall be conducted under the active supervision of competent technical staff, who shall be in-charge of production, a whole time employee of the manufacturer and having relevant qualification and experience as deemed appropriate by the MDB;”; and
(ii) for clause (e), the following shall be substituted, namely:- “(e) the in-charge of quality control shall be a whole-time employee of the manufacturer and shall possess relevant qualification and experience as deemed appropriate by the MDB;”; and
(b) in rule 63, in sub-rule (3), expression after the words “omit any”, the words “Form or” shall be inserted.
Holding Of Khuli E.Kachehri
As per directions of Prime Minister’s office for reaching out to public through Khuli E-Kacheri, CEO-DRAP has been pleased to schedule holding of 14th Khuli E-Kachehri through LIVE session on official Facebook page of DRAP (www.facebook.com/OfficialDRAP) on 24th November-202l (Wednesday) at 10:00 am to address public complaints relating to DRAP.
Minutes Of 313th Meeting of Registration Board Held on 16th, 17th & 18th November, 2021.
Drug Product Recall: M/S. Zakfas Pharmaceuticals (Pvt.) Ltd., Multan issued voluntary recall Of Biosal Injection (B.No. BSG038 To BSG055)
Public Notice: Manufacturers of Pharmaceuticals and Biologicals Drug
Public, in general, and Pharma Industry, in particular, is informed through this Public Notice that Drug Regulatory of Pakistan (DRAP) has deployed an improved version of online application management system namely Pakistan Integrated Regulatory Information management System (PIRIMS) for filling and processing of applications.
Applications for site verification, Lay out Plan approval, Grant of Drug Manufacturing Licence, Renewal of Drug Manufacturing Licence, approval of technical staff etc would be filed and processed on PIRIMS. Thereby, applicants would be able to file their applications from their offices/ homes and receive the regulatory communication / letters / shortcomings / reply through this online system.
Manufacturers of pharmaceuticals and Biological drugs are invited to file their applications for site verification, Lay out Plan approval, Grant of Drug Manufacturing Licence, Renewal of Drug Manufacturing Licence and post licence variance through PIRIMS. No application in hard form would be accepted after 15th November, 2021.
You are advised to register as well as upload data and submit your application using following address