Imported Drugs have to pay Govt for inspection

Govt to charge fees for inspection of imported drugs, drawing of samples for test at customs

The Union health ministry will soon charge fees for inspection of the imported consignments and drawing of samples of drugs including medical devices for test analysis at customs under the provisions of Drugs & Cosmetics Rules.  A proposal of the ministry in this regard has found favour with the Drugs Technical Advisory Board (DTAB), which is the highest authority under the Union health ministry on technical matters. The issue came up before the DTAB for its consideration of the proposal at its 71st meeting held on May 13, 2016.  Section 11 of the Drugs and Cosmetics Act, 1940 provides that the customs collector or any other officer of the government authorized by the central government in this behalf, may detain any imported package which he suspects to contain any drug the import of which is prohibited under this chapter and shall forthwith report such detention to the Drugs Controller, India, and, if necessary, forward the package or sample of any suspected drug found therein to the Central Drugs Laboratory. In this connection, the ministry proposed to charge fees for providing the services of handling the consignments of drugs and medical devices imported into the country at the various designated ports. The officer posted at the port is required to examine each and every consignment imported into the country to ensure that it conforms to the provisions of the Drugs and Cosmetics Rules, 1945 and also draw samples for test, at random, to ensure that the drugs imported conform to the quality parameters. For this purpose, the health ministry proposed to charge a fee of Rs. 500 or so, for examination of each consignment of drug or medical devices imported under the licence granted at Form 10 or 10A of the Drugs and Cosmetics Rules, 1945. The fee shall be required to be deposited in the designated head of account by the importer and the challan submitted along with the bill of entry at the port. After detailed deliberations, the DTAB agreed in principle for charging of fees for examination of the consignments. However, the quantum of the fee may be decided in consultation with the stakeholders by the government.