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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.

Recall Alert: Drug Product; Paracet 1g/100mL Infusion by M/s Standpharm Pakistan Pvt Ltd, Lahore.

Asad Ullah Product Recalls, Recall Alerts, Safety Info

Recall Alert

DRAP Alert NoNoI/S/01-23-43
Action Date3rd January 2023
Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Paracet 1g/100mL Infusion,
Active Ingredient(s): Paracetamol
Company: M/s. Standpharm Pakistan Pvt Ltd, Lahore
Batch No. CIJI70
Manufacturing Date: 20-09-2022
Expiry Date: 20-09-2024
Problem / Issue CDL Karachi has declared the batch No. CIJI70 of Paracet 1g/100ml Infusion manufactured by M/s. Standpharm Pakistan (Pvt.) Ltd., Lahore as substandard & adulterated drug product.
Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

-Adverse reactions or quality problems experienced with the use of this product may 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 bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

-All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
    Paracet-1g-Inj-StandpharmDownload

    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

    Public Awareness: Availability of Drugs

    Asad Ullah Press Releases

    DRAP works closely with the manufacturing companies to ensure the availability of essential drugs in the market. However, shortages of drugs is a global phenomena and it may occur due to various reasons including the discontinuation of certain products, supply interruptions of materials and manufacturing or quality concerns, etc. DRAP is continuously working to minimize the impact of shortages on general public.

    For problem related to the drugs availability, DRAP can be reach out at its Toll- Free Number: 0800-03727, or through email at drugshortages∂dra.gov.pk within working hours from Monday to Friday 08:00 AM to 04:00 PM.

    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