Compliance to the Notice Dated 13-03-2023 with Regard to Specifications and Data related Activity in PIRIMS

DRAP has deployed an online application management system “Pakistan Integrated Regulatory Information Management Systm (PIRIMS)” ‘ for processing of regulatory information related to licensing, registration, and inspections of pharmaceutical and biological drugs.

Transforming manual operation to PIRIMs, DRAP requested marketing authorization holders of pharmaceutical and biological drug products to review and update their finished products Specifications. Accordingly, a notice was uploaded on the website of DRAP on 13m March, 2023, with the direction to all Registration Holders of pharmaceutical and Biological drug products to update finished products Specifications and validated method of testing i.e. Pharmacopoeial or in case of non-availability in any pharmacopeia, Innovator / Manufacturer’s Specification, in the corresponding product profile / details in the PIRMS at http://pirims.dra.gov.pk.

The timeline for submission of requisite information on the PIRIMS has been further extended till 09th June 2023 on the request of pharmaceutical industry.

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: –

Stakeholders Comments are invited on the Draft Guidelines for Good Cold Chain Management Practices for Temperature-Sensitive Drug Products

The supply chain of Time and Temperature Sensitive Drug Products (TTSDPs) requires constant maintenance of temperature so that the cold chain remains integral to ensure that the product quality is not compromised. Registration holders of TTSDPs including manufacturers, Importers and exporters along with their authorized distributors, are required to provide suitable storage conditions throughout the life cycle of the product under the Drugs (Licensing, Registering & Advertising) Rules, 1976. Similarly, Pharmacies, Medical stores and other authorized sale outlets, and healthcare institutions are also required to provide suitable storage and distribution while dispensing TTSDPs under relevant provincial drug sale rules.

DRAP has drafted this guidelines to set out the principal requirements for the safe storage and distribution of time- and temperature-sensitive pharmaceutical products (TTSDPs). These guidelines intended to emphasize the increased importance of pharmaceutical cold chain management as a result of changing product environment, the requirements for Good Storage and Distribution Practices, current regulatory trends, quality management, risk assessment factors, and temperature monitoring system.

This draft guideline is uploaded on the official website of DRAP dated on 27th March, 2023, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to ajmal.sohaildra.gov.pk, copying at akbar.alidra.gov.pk, or can be posted at mailing address, Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

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.

Testing of Diethylene Glycol (DEG) & Ethylene Glycol (EG) at Central Drug Laboratory, Karachi

The Central Drug Testing Laboratory (CDL), Karachi, is providing facilities for testing of solvents (Glycerin, Propylene Glycol, and Sorbitol) used in oral preparations for the presence of any toxic impurities (e.g., Diethylene Glycol (DEG) and Ethylene Glycol (EG)) to the manufacturers and importers of pharmaceutical products. DRAP has already issued advisories and directions via letter F. No. 6-30/2022-QA dated October 21, 2022 and December 13, 2022 to the stakeholders for compliance.

Central Drug Laboratory has issued following guidance steps for manufacturers and importers for availing these facilities.

Sampling:

  1. Sampling should be made on the basis of √n + 1
  2. A composite of the quantity drawn should be made
  3. Divide this composite in three equal parts (approximately 30ml in each bottle)

Fee:

  1. Fee voucher to be generated on DRAP’s fee portal fee.dra.gov.pk by completing following steps:-
  2. a. Create Login / Enter Your Login Details
    b. Click on Generate Fee
    c. Select Division = Central Drugs Laboratory
    d. Select Payment Head = Central Drugs Testing laboratory
    e. Fee = Gas Chromatography
    f. Enter Details
  3. Fee for each batch is Rs.23000/-

Document Required:

  1. Sampling Information Sheet.
  2. Certificate of Analysis by Manufacturer.
  3. Testing Request Letter.
  4. Copy of voucher paid in any branch of Allied bank.

Testing Time:

  1. The samples will be tested on the FIFO basis.

Dispatch of Samples

  1. Three bottles as mentioned under sampling per batch shall be sent to CDL along with the
    documents mentioned above.
  2. The firm is responsible to maintain the conditions of samples during transportation.
  3. Sample should be dispatch on following Address:-
    Director, Central Drugs Laboratory
    4-B, SMCHS, Block B, Karachi

For any further assistance, Please contact to

Director, Central Drugs Laboratory, 4-B, SMCHS, Block B, Karachi or call at 021-34392159

DRAP finalized guidelines on Post Registration Variations of Pharmaceutical and Biological Drug Products

DRAP has finalized its guidelines on procedure and data requirement for post registration variation of pharmaceutical and biological drug products. This document will assist manufacturers and importers to incorporate variations in their product to account administrative changes, technical and scientific progress, or to improve or introduce additional safeguards.

These Guidelines will assist both Regulators and Industry on the regulation of variation / changes to the original registrations / Market Authorization of products in terms of procedures and criteria for the appropriate categorization, reporting of changes and subsequent approval as required. Data requirements are listed out to evaluate the impact of the proposed / intended change on the quality, safety and efficacy of the locally manufactured / imported finished pharmaceutical and biological drug products intended for human and veterinary use.

Registration holders of Pharmaceutical / Biological drug products for human and veterinary use are responsible for the safety, efficacy and quality of a finished pharmaceutical / biological drug product that is placed on the market throughout its approved life cycle. These guidelines are intended to provide supportive information for submission of post registration variation application by the registrations / marketing authorization holders of the finished drug products to implement a change. These guidelines will:-

  1. Facilitate the interpretation of the relevant regulations and decisions of Registration Board regarding post registration variations of registered drug products.
  2. Assist applicants to determine type of variation applies in each case with the classification entailing prior approval or intimation to DRAP.
  3. Provide guidance as per applicable SOPs on the conditions and other data requirements to support variance application.

The draft guidelines on data requirements for post registration variation were prepared three years ago and was available on the DRAP’ s website. Stakeholders have submitted their comments on the draft document and accordingly guidelines have been finalized after careful consideration of stakeholder’s comments.

For more information on Regulatory Guidelines published by DRAP, please navigate to Publications tabs on our website.