To ensure timely access to life-saving orphan drugs, the government has exempted mandatory sampling and testing of orphan drugs at port offices. Instead, the drug regulator has said that the consignment will be released by the port offices based on a legal undertaking submitted by the importer of these drugs.“Orphan drug availability can face challenges related to consignment issues at ports, leading to delays and potentially impacting patient access as they are usually small in quantity. The government was given a representation on the issue and we are glad that a decision has been taken,” said an executive with an association that works for children with orphan diseases.In a recent communication to the port officers and state drug regulators, the drug controller has said that the “required quantity of sample shall be forwarded to the concerned laboratory and the undertaking should say that the test report shall be submitted to the respective port office within 15 days of receiving from the laboratory.The decision has been taken following representations from various associations and importers of Drugs, organisations involved in the import and marketing of life-saving orphan drugs in the country.An orphan drug means a drug intended to treat a condition that affects not more than five lakh people in India.“Various challenges encountered in drug sampling and testing of orphan drugs at various port offices of CDSCO have been brought to the notice, such as small volume, high cost, requirement of specialised testing equipment, and unavailability of reference standards and testing methods at testing laboratories. These challenges may lead to a delay in the availability of such lifesaving orphan drugs to needy patients,” said the letter. ET has seen a copy of the letter.Considering the various representations received in the matter and to streamline the procedure for release of orphan drugs, the drug regulator has decided that such consignment shall be released by the CDSCO Port offices based on a legal undertaking submitted by the importer.
