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Regulatory Updates

Notification: Directions of Registration Board on Labeling Requirements of Drug Products to Comply Pharmacopeial Specifications for Dissolution Testing

Asad Ullah Drugs, Notifications, Regulatory Updates , , ,

Registration Board in its 323rd meeting observed that various USP monographs for drug products prescribe more than one dissolution tests and that the pharmacopoeia in such cases recommends that “When more than one Dissolution Test is given, the labeling states the Dissolution Test used only if Test 1 is not used.”

Keeping in the USP labeling requirements narrated above and to comply to the Pharmacopeial specifications, the Board decided as under:

“The manufacturer shall mention the dissolution test Number on the secondary packing / unit carton of product for dissolution tests No 2,3 or 4 as per requirement of USP otherwise it would be presumed that dissolution test No.1 shall be performed on the finished product.”

Accordingly, the decision of Registration Board is circulated for information and compliance by relevant stakeholders / manufacturers.

Notification: Directions of Registration Board on Reference Product data submissions for conducting Pharmaceutical Equivalence and Comparative Dissolution Profile Studies

Asad Ullah Drugs, Notifications , , ,

Registration Board of DRAP has issued a Guidance document for applicants on submission of application on form 5-F (CTD) for registration of pharmaceutical drug products for human use. Submission of data of pharmaceutical equivalence and Comparative Dissolution Profile (CDP) is required under section 3.2.P.2.2.1 (Formulation Development) of Form 5F (CTD).

In order to further harmonize the submission of such data and ensure data integrity, Registration Board in its 322nd meeting held on 8th & 10th November, 2022 decided as under:

“Firm shall submit the image/picture/snapshot of the innovator/reference/comparator pack against which Pharmaceutical equivalence / Comparative Dissolution Profile studies have been performed and shall reveal the details of brand name, manufacturer, batch# and expiry date of the innovator/reference/comparator product in the section 3.2.P.2.2.1 (Formulation development) of Form 5F.“

Accordingly, above decision of Registration Board is hereby notified and circulated for information and compliance by relevant stakeholders / applicants.

Notification: Directions of Registration Board on the Drug Substance (DS) for Product Development, R&D, and Stability Testing

Asad Ullah Drugs, Notifications

The Registration Board of Drug Regulatory Authority of Pakistan grants registration to pharmaceutical and biologicals drug products for human and veterinary use. The Drugs (Licensing, Registering and Adverting), Rules, 1976 as amended requires that applicant shall submit applications for human use on Form 5F (CTD), along with submissions of product development, and stability studies, etc under the relevant modules.

For these studies, applicants firms have to procure the Drug Substance / Active Pharmaceutical Ingredient (API) from licensed pharmaceutical manufacturers only having valid Good Manufacturing Practices (GMP) Certifications and/or Drug Manufacturing Licenses form the relevant Regulatory Authority of the Country of origin.

The DRAP Authority, upon the request of Pharmaceutical Manufacturers Association has allowed the manufacturers to acquire Drug Substance / Active Pharmaceutical Ingredient (except controlled Drugs / Substance) from another Drug Manufacturing License (DML) holders which has already imported / procured from an authorized source, only for conducting product development and stability studies to submit application for registration to DRAP on Form 5F. However, all requirements of quality and traceability would be applicable in such cases and will be the responsibility of the manufacture/applicant. Further, the products so manufactured in NO case shall be allowed for commercial sale.

The directions of DRAP Authority and Registration Board is notified accordingly.

Stakeholders Comments are invited on the Draft Guidelines on Good Manufacturing Practices (GMP)

Asad Ullah Publications, Regulatory Updates , ,

Although the Drugs (Licensing, Registering & Advertising) Rules, 1976 under the Drugs Act, 1976 provides detail requirements on Good Manufacturing Practices (GMP), however, DRAP intends to provide a compiled GMP guidance document stipulating Drug Regulatory Authority of Pakistan’s (DRAP) expectations on GMP from pharmaceutical & biological drugs manufacturers.

This document is intended to provide guidance regarding Good Manufacturing Practices (GMP) for the manufacturing of pharmaceutical & biological drug in accordance with the Drugs (Licensing, Registering & Advertising) Rules, 1976, under the Drugs Act, 1976, the good manufacturing practices aim at ensuring that:

  1. Products are consistently produced and controlled to the quality standards appropriate to their intended use
  2. Products are manufactured as required by the marketing authorization or product specification; and
  3. All those risks have been diminished that are inherent in any pharmaceutical / biological production operation, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products.

This draft guideline is uploaded on the official website of DRAP dated 5th January, 2023 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, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at hasan.afzaal∂dra.gov.pk , or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

GOOD-MANUFACTURING-PRACTICE-QMSDownload

DRAP Newsletter: Volume 02-Quarter 01, 2023

Asad Ullah News & Updates, Press Releases, Regulatory Updates

The second volume of quarterly Newsletter of DRAP was issued on 1st January, 2023. This issue highlights the key initiatives and accomplishments of the outgoing year-2022, and welcomes the new year-2023 with reaffirmation to its commitments. DRAP is implementing its Strategic Plan 2022-25 with full zeal and devotion, to protect the public health through effective regulation for availability of safe, quality assured and efficacious therapeutic goods for the people of Pakistan.

DRAP_NewsLtter_Jan23

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

Asad Ullah Drugs, General, Regulatory Updates

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

Ethylene-Glycol-and-Diethylene-Glycol-1Download

Decisions of 52nd Meeting of Medical Device Board (Deficiency letters Local/Import)

Asad Ullah Medical Devices Board, Meeting Minutes, Regulatory Updates

The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 52nd meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment

Deferred-MDB-52Download

Decisions of 51st Meeting of Medical Device Board (Deficiency letters Local/Import)

Asad Ullah Medical Devices, Medical Devices Board, Meeting Minutes

The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 51st meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.

Deferred-MDB-51Download

Rapid Alert: Drug Product; Falsified Tablin 300mg Capsule identified in the market

Asad Ullah News & Updates, Product Recalls, Recall Alerts, Regulatory Updates

Rapid Alert

Suspected Falsified Product

DRAP Alert NoNoI/S/10-22-36
Action Date24th November 2022
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions
4. General Public
Problem StatementDuring the market surveillance activities in different areas of District Sheikhupura Punjab, Regulatory Field Force has identified the suspected sample for product and sent for analysis to laboratory. The Provincial Drugs Testing Laboratory, has declared the samples as “spurious”. The stated manufacturers on the label has informed that they have not manufactured this batch number of product.
Product detail is as under:-

Therapeutic Good Affected:-

SrProduct NameCompositionBatch #Manufactured by (as stated on label)
1TABLIN 300mg Capsule
Pregabalin 300mgBatch No. 699M/s Theramed Pharmaceuticals (Pvt) Ltd, Lahore.
Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate this batch of the product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The remaining stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of suspected products.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned product.

-Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using this product and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

-All therapeutic goods must be obtained from the licensed pharmacies, and other authorized / licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.
Suspected-Falsified-Product-in-market-Tablin-300mg-CapsuleDownload