The Centre had made registration of imports of all drugs and pharmaceuticals compulsory from April 1, 2003. The objective was to bring an end to the inflow of poor quality drug materials 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 one year since 2003. However, imports of substandard and spurious APIs started picking up subsequently and the situation became quite bad especially during last year with customs seizing several consignments containing substandard drugs imported by traders in Chennai and Mumbai. Such drug materials of doubtful quality must be entering the country through other smaller ports where the customs scrutiny is less stringent. The main motive for the Indian traders who have been importing the APIs was only the lower price with no consideration for their quality. The Indian traders are just looking at the huge margin of 20 per cent or more 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.
In India, no checks were imposed by the office of DCGI before drugs and other materials were allowed to be imported even after the registration was made mandatory. As per the registrations norms, DCGI has the power to inspect foreign manufacturing facilities before clearing the applications. Yet, no inspection of manufacturing sites of exporting companies used to be carried out by the officials of DCGI. However for the first time since 2003, DCGI banned the import of raw materials from 10 Chinese drug companies early this month 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. The office of the DCGI found that Chinese firms did not submit GMP certificates before commencing the exports. What was done by the DCGI is a step in the right direction and such actions should continue with greater vigilance. Stringent scrutiny of applications for import registrations and onsite inspection of manufacturing facilities of the exporting firms have to be strictly enforced by DCGI considering the fact that a large percentage of formulations made in India are by using the imported APIs. For this, total coordination between the customs authorities and the office of the DCGI is required before clearing drug and chemical consignments from all ports.