Schedule D under D&C Rules to be amended to stop practice of import of APIs for further purification without registration
The Centre will soon amend the Schedule D of the Drugs and Cosmetic Rules to stop the practice of importing active pharmaceutical ingredients for further purification without following the process of registration and import license.
The move is initiated following the reports that many importers were importing bulk drug or APIs as Crude Drug or Feed Grade etc. for further purification. Such crude and feed grade drugs are nothing but impure or not of standard quality drugs imported from unregistered, non-GMP sources.
This type of drugs “which are produced at unregistered, non-GMP sources”, if imported by means of bypassing registration procedure under misleading names like Crude and Feed Grade and then by minor purification are sold for use in drug formulations cannot be considered safe for use and can put patient at risk, it was pointed.
The CDSCO had already pointed out this practice in the Guidance Document for Zonal & Port Offices, clearly stating that “the import of drug under dual use for purification or rendering it sterile will not be considered under dual use.” The international guidelines caution against exclusion of drug molecules imported for further purification from registration requirement.
As per this, the Schedule D (relating to substances not intended for medicinal use) will be modified by inserting a new clause: “the exemption excludes drugs imported for further purification only”.
The proposal in this regard was placed recently at the Drugs Consultative Committee (DCC) which agreed for the amendment. “The members agreed that the exemption provided under Schedule D should not be used for bypassing registration procedure and import of crude and feed grade drugs which could be sold as drugs after minor purification etc. The DCC therefore recommended Schedule D may be suitably amended to exclude drugs imported as non-drug items for purely purification and marketing as drugs,” DCC said.