The central government has decided to allow the regional offices of the Central Drugs Standard Control Organisation (CDSCO) to issue Form 10 licenses to import drugs into India. The notification to this effect is expected soon, it is learnt.
A license in Form 10 is required for import of any biological or other special product specified in the Schedule C or C (1) of the Drugs and Cosmetics Rules. The government decision is to help ease the workload of the central agency and also to see faster clearances of import license applications in the future. Currently, the office of the Drugs Controller of India in New Delhi is the sole authority to issue form 10 licenses. Form 10 specifies the period and the drug for which the license has been issued.
Confirming this to Pharmabiz.com, Ashwini Kumar, Drugs Controller of India said that the government is positive in bringing in the change. He said that the notification on allowing the zonal offices of DCI to issue form 10 licenses would be issued soon.
Once the notification comes into effect, the drug importers can approach any of the four CDSCO offices located at Mumbai, Kolkata, Chennai or Ghaziabad to get their import applications cleared.
The decision would bring in more responsibilities on the zonal offices that work in close collaboration with the State Drug Control Administrations and assist them in securing uniform enforcement of the Drug Act and other related legislations.
In a recent notification, the government had exempted drugs to be imported for clinical trials from import registration requirements including seeking Form 10 licenses from CDSCO. The notification had also exempted drugs imported for product / formulation development and data generation and drugs that are not yet approved and marketed in the country but are meant for export purpose only from these mandatory requirements.