Seven years after registration of imports of drugs and pharmaceuticals into India made mandatory, the inflow of substandard drug raw materials into the country has not subsided. The very objective of bringing this rule in 2003 was to bring an end to the entry of poor quality APIs originating from various countries particularly from China through a scrutiny of import applications and inspection of manufacturing sites of exporters. The regulation helped to arrest the inflow of unrestricted imports of drug materials into the country for some time since 2003. But, imports of substandard and spurious APIs started picking up subsequently and the situation became quite bad especially in 2009 with customs authorities seizing several consignments containing substandard drugs imported by traders in Chennai and Mumbai. Such drug materials of doubtful quality must have  entered the country through smaller ports where the customs scrutiny is less stringent. The main motive for some of the Indian traders who have been importing the APIs was only the lower price with no consideration for their quality. These traders are just looking at the huge margin they get if they import drugs from bogus manufacturers as against a much lower margin when they import from licensed manufacturers. Quality of drug raw materials from China has been under scanner of regulatory authorities of the US and Europe after the safety scare caused by Baxter's blood-thinning drug, heparin, in the US market after April 2008.

Inspection of manufacturing facilities before imports are commenced is a standard practice followed by most of the drug producing countries for ensuring quality drug raw materials. Drug registration rules have provided adequate powers to DCGI to inspect foreign manufacturing facilities before clearing the import applications. Yet, no inspection of manufacturing sites of exporting companies is being carried out by the officials of DCGI as yet. DCGI, however, banned the import of raw materials from 10 Chinese drug companies in June last year for supplying products without complying to basic drug manufacturing standards. DCGI cancelled the registration of these Chinese firms thereby stopping the import of products manufactured by them forthwith. These Chinese firms found to have not submitted the GMP certificates before commencing the exports. Such cases are bound to recur in future as well if the office of DCGI continue to delay overseas inspection of manufacturing facilities. One of the reasons for not commencing regular inspection of overseas sites is the inadequacy of the qualified inspectors for the job. This is something the Union health minister and senior ministry officials have to take care without any more delay.