General

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 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.