By TIOL News Service

MUMBAI, AUG 05, 2016: APPELLANT had imported 'detrusitol SR Caps' for which bill of entry was filed and which, upon reference to Asstt. Drugs Controller, was found to have only less than 60% of its shelf life remaining. Under Rule 31 of Drugs and Cosmetics Rules, 1945, the licensing authority is not permitted to allow import of any drug having less than sixty percent of recorded shelf life as on the date of import.

The original authority confiscated the imported goods but allowed the same to be redeemed on payment of fine of Rs.2,00,000/- subject to re-export and imposed a penalty of Rs.1,00,000/-.

As the Commissioner (A) upheld this order, the appellant is before the CESTAT.

It is submitted that the medicine imported from M/s Pfizer Ltd, Italy is used to treat urinary problems and that, as on date of shipment, it had a shelf life of over 60% which fell marginally below the 60% benchmark when bill of entry was filed. Moreover, the supplier was willing to take back the consignment, the appellant added. Reliance is placed on the decisions in HUM India Fab Pvt Ltd. - 2008-TIOL-297-CESTAT-MAD & Joseph Eye Hospital - 2005-TIOL-1354-CESTAT-MAD in support.

The AR supported the impugned order.

The Bench observed -

++ It is seen that the option to redeem the goods had been exercised by appellant and goods re-exported. There is no doubt that the medicines had a residual shelf life that was below the threshold prescribed in the proviso to Rule 31 of Drugs and Cosmetics Rules, 1945. However, the deviation from the threshold was marginal. It is also seen that the competent authority was vested with discretion under Rule 31 of the Rules supra to allow imports even below the threshold. The licensing authority did not choose to exercise that discretion in this instance.

++ It is also seen that the goods have already been sent out of the country and that the goods did meet the norms at the time of shipment. Considering the circumstances, action under section 111 and section 112 of the Customs Act, 1962 was not entirely necessary. The importer had made a request to allow the re-shipment even as the goods were lying in custody before clearance.

The order of confiscation and imposition of penalty was set aside.

The Appeal was allowed.

(See 2016-TIOL-1964-CESTAT-MUM)