Fee structure, new form for import certificate introduced amending NDPS Rules, 1985.

The Department of Revenue, under the Union Ministry of Finance, has revised and introduced a new fee structure for processing applications for manufacturing licence and import and export certificated for narcotic drugs and psychotropic substances through an amendment to the Narcotic Drugs & Psychotropic Substances (NDPS) Rules, 1985.

Through notifying the NDPS (Amendment) Rules, 2010, in July, the department has revised the fee for manufacturing license and renewal of manufacturing license for manufacture of synthetic narcotic drugs from Rs 50 to Rs 5000 per application.

The department has also introduced fee for issuance of import and exports of NDPS, through the amendment. According to this, Fee of Rs 1000 has been introduced per application for issuance of both import certificate for import of narcotic drugs and psychotropic substances and issuance of export authorization for export of the drugs.

The rule has also amended to insert two new rules to ensure that the reports, returns and estimates required to be submitted under any international conventions shall be submitted within the timelimit. This is a measure to assert that the obligations under the agreement with the International Narcotics Control Bureau (INCB).

Under the terms of international agreements, supervised by the INCB, India is obliged to maintain licit opium production and carry-over stocks at levels no higher than those consistent with world demand to avoid excessive production and stockpiling, and a resultant risk of diversion to illicit uses. The country has to submit the annual cultivation and licit usage of the NDPS products with the international bureau, every year.

The new rules inserted, namely 67D and 67E, specifies on the submission of reports and returns under international conventions and the estimates of requirement and quotas, respectively, by mandating that a central government officer should be assigned to collect and submit the information to the international agency.

In order to regulate the imports and manufacturing concentrate of poppy straw and the formulations, later, from the raw material, two new forms were also introduced through the amendment. Through this, Form No.4A is introduced for certificate of official approval of import under the provision to rule 54 and Form No.3A for the licence to manufacture concentrate of poppy straw from the poppy straw produced in the fields licensed for the purpose and for manufacturing drugs on the premises.

However, import of morphine, codeine, thebaine and their salts by manufacturers not exceeding a total of one kilogram during a financial year for analytical purposes is exempted from applying for import licence, provided the substances should be imported by any importer notified by the government after following the required procedure.

Under the Form 4A, if the import is for manufacture of formulations for export, the manufacturer shall ensure that no part of the drug imported under the certificate shall be sold or used to manufacture formulations for domestic sale, adds the notification.

Source : pharmabiz.com