By Raju Vernekar
Mumbai, June 26
The Gambia, a West African country, has decided to Pre-test the medicines imported from other countries, including India, to address issues related to substandard and falsified medicines entering the country.
Markieu Jannesh Kaira, Executive Director, Medicines Control Agency (MCA), Gambia, vide letter dated June 15 has informed Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI) that the Gambia has introduced the regulation of pre-shipment document verification, physical inspection, quality control testing and issuance of Clean Report of Inspection and Analysis (CRIA) for pharmaceuticals to address issues related to substandard and falsified medicines entering the country.
The regulation will be implemented from First July. All shipments arriving into the Gambia with Bill of Lading (LADING) dated on or after First July will be required to produce CRAI for Customs clearance at the Port of Entry in the Gambia.
The samples of each batch of all products in the shipment shall be withdrawn by the sample inspector for the purpose of analytical testing to be carried at the MCA approved laboratory. The CRAI certificate will be valid for 90 days from the date of issuance. As such the drug exporters should ensure proper testing of medicines before shipment, Kaira has stated in his letter.
In view of Kaira’s letter, the DCGI in a communication dated June 20, has informed the drug exporters from all Indian states and Union Territories that the Gambia regulation requires all pharmaceutical products to be inspected and sampled for testing to ensure conformity to qualify standards prior to shipment from India.
Cough syrup
In another development, DCGI has advised the manufacturers/exporters of cough syrup from Maharashtra not to submit samples of cough syrup for testing at Central Drugs Testing Laboratory (CDTL) Mumbai till all pending samples get analysed. At present the CDTL, Mumbai, has the highest number of pending samples.
The number of samples of cough syrups pending in different laboratories across the country are: CDTL Mumbai, Mumbai Central- 89, IPC Gaziabad, Uttar Pradesh- 50, Regional Drugs Testing Laboratory,Chandigarh-14, Food & Drug Laboratory, Vadodara, Gujarat-06 and Combined Food & Drug Testing Laboratory, Jammu, Patoli Mangotrian Jammu- 06.