The finance ministry has said no company can import drugs under the open general licence without being registered with the ministry of health and family welfare.
In a circular issued yesterday, it says the Exim Policy for 2003-04 is expected to remove certain drugs from the restricted list, but the import of these drugs will have to conform to the conditions imposed by the ministry of health.
The health ministry recently amended the Drugs and Cosmetics Rules to introduce a new provision for the registration of foreign manufacturers of bulk drugs and formulations. The finance ministry says this condition must be satisfied before importing drugs.
The ministry is worried that Customs officials might feel that drugs, having come under the open general licence, need not satisfy any condition other than the payment of requisite duties and, therefore, allow the import of drugs without any reference to the health ministry.
The finance ministry also said importers would have to obtain a permission from the Drugs Controller of India before importing any drug.
The health ministry had issued a notification in August, 2001, raising the licence fee for drugs import and making import licences for bulk drugs mandatory.
The new registration requirements mandated by the finance ministry were expected to come into effect from January 1, 2003. But the government had decided to defer it by three months to coincide it with the announcement of the Exim Policy on March 31.
