The import of eythromycin thiocyanate, claimed as an intermediate for several bulk drugs, has come to a standstill with customs authorities refusing to clear the product after categorizing it as a bulk drug. The authorities are insisting on import registration certificate for the "bulk drug" and refuse to go by the importers' explanation that it is an "intermediate" thereby resulting in non-clearance of the product from the ports.
The exporters have complained to the Drugs Controller General of India (DCGI) and have sought a clarification from the office of the DCGI on the status of the drug.
When contacted DCGI sources informed that they are aware of the difficulties being faced by the exporters and are trying to clear the confusion regarding the status of the drug at the earliest. They also confirmed that erythromycin thiocyanate is not a bulk drug but an intermediate used for the manufacturing of several bulk drugs.
The office of the Director General of Foreign Trade (DGFT) however feels that the product is a bulk drug used to make veterinary medicines. They are of the opinion that the importers have to go through all required formalities before they could clear the product.
The exporters complain that the absence of a clear cut directive had resulted in some customs officials clearing the drug as intermediate while others withholding the consignment claiming it as a bulk drug. Of late, the clearances from almost all the transit points have been stalled, they said.
The pharma industry associations are also known to be approaching the DCGI to sort out the issue and get the consignments cleared at the earliest.