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:
- Sampling should be made on the basis of √n + 1
- A composite of the quantity drawn should be made
- Divide this composite in three equal parts (approximately 30ml in each bottle)
Fee:
- Fee voucher to be generated on DRAP’s fee portal fee.dra.gov.pk by completing following steps:-
- 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 - Fee for each batch is Rs.23000/-
Document Required:
- Sampling Information Sheet.
- Certificate of Analysis by Manufacturer.
- Testing Request Letter.
- Copy of voucher paid in any branch of Allied bank.
Testing Time:
- The samples will be tested on the FIFO basis.
Dispatch of Samples
- Three bottles as mentioned under sampling per batch shall be sent to CDL along with the
documents mentioned above. - The firm is responsible to maintain the conditions of samples during transportation.
- 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