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DCGI issues guidelines to port officers on imports, exports of drugs
Joseph Alexander, New Delhi | Monday, July 27, 2009, 08:00 Hrs  [IST]

The Drug Controller General (India) has issued concrete guidelines for the department officers posted at the ports of entry and exit on the formalities, steps and actions to be taken while clearing the imports and exports of drugs.

The procedural guidelines assume significance in the wake of seizure of spurious drugs in many places in the recent past. Three cases of import of bulk drugs from unregistered source originating from China were detected at Chennai sea port by the officers sometime back. Similarly, a few consignments on the similar grounds were also seized in Mumbai, prompting the authorities to come out with sterner guidelines.

"The CDSCO through the officers posted at the ports, exercise control over drugs and cosmetics, which are imported into the country. This control is exercised under Chapter III of the Drugs and Cosmetics Act. For all practical purposes, the port officers function in an advisory capacity to the Customs Authorities. Any action for contravention of Section 10 of the Drugs and Cosmetics Act is resorted to by advising the Collector of Customs to take action under Section 11 of Drugs and Cosmetics Act, read with relevant provisions of Customs Act 1962," the DCGI said in the communication to the port officers.

Before recommending any action to the Customs under the provisions of Chapter III of the Act, approval from the DCGI is necessary. Drugs and cosmetics are imported into the country either by sea or air. Small quantities are also imported through foreign post/speed post/couriers. No drug or cosmetic shall be imported into India except through places mentioned under rule 43-A, it said.

"It is observed that certain Drugs are imported at the ICDs at Delhi, Pune, Indore, Bangalore, etc. which are not notified. In this connection, it has been decided by the Directorate that all such cases should be referred to the nearby ADC(I)/Port Office till the time these ICDs get notified by the appropriate authority," the letter said.

The tasks listed for the port officers included scrutiny of the bills during imports, checking of shipping bills, maintenance of statistics, liaisoning with customs collectors and state drug controllers, assistance to the industry with information, issuing of permits in Form 12-B, and preparation of reports, among other things.

"In the case of Narcotic Drugs and Psychotropic Substances Act & Rules, a certificate issued by Narcotics commissioner must be checked and details furnished to DCGI. Ensure that no New Drug is imported into the country unless its import is permitted by the Drugs Licensing Authority under Rules (Rules 122 A & 30-AA. Ensure that small quantities of drugs imported for clinical trials or for personal use are duly covered by Test License (11 or 11-A) or Permit License as (12 B) as the case may be," the list of duties said.

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