Last week, the Drug Controller General of India issued an order extending the date of applicability for import registration of bulk drugs for manufacturers and importers from December 31, 2002 to March 31, 2003. The extension order was issued in consideration of non-clearance of several applications piled up at the DCGI office and also in response to a strong plea made by the Indian Drug Manufacturers' Association seeking an extension of the deadline. The extension order was not very much liked by the Bulk Drug Manufacturers' Association, but IDMA welcomed the step. The way the two leading associations have responded to the DCGI's order is understandable. DCGI certainly has to take a balanced view of the situation because of two reasons. Firstly, DCGI office could not examine a large number of applications although it is partly its own fault. Even after notifying the import registration order as early as September 2001, DCGI could not clear a large number of applications before the deadline of December 31, 2002. Inadequacy of staff and lack of expertise to handle such a job during the stipulated period could be a reason for this. Secondly, there are a number of genuine exporters of bulk drugs from various countries who could not apply for registration because of the detailed procedures and paper work involved in while applying for registration. A first time extension of the deadline is therefore justifiable.
Now the DCGI office has to examine all the pending applications and possibly a few hundreds more which may come up during the three-month period. A further extension of the deadline beyond March, 2003 will be difficult and BDMA will be first body to oppose it. The task, thus, is not going to be that easy for DCGI if it has to do a near perfect job. Currently applications are being cleared by the DCGI on the basis of papers submitted to it and not after physically inspecting the manufacturing sites of the exporting companies. Site inspection is extremely important considering the dubious background of certain companies based in China, Slovenia and some of the Asian countries. In this regard, the suggestion made by BDMA and IDMA to assist the DCGI to constitute a team of experts from the industry, research, testing laboratories, academics, etc is laudable. Such a team can undertake visits for inspection to the manufacturing premises of the applicants. Granting of import registrations without detailed scrutiny of applications including inspection of manufacturing facilities could defeat the very objective of regulating undesirable imports into the country. Absence of an import registration system, followed by the developed countries and several developing countries, has been the main reason for the import of poor quality active pharmaceutical ingredients at low prices into India for the last several years. One of the reasons, which forced closure of bulk drug units in the country, was this unrestricted import of low quality drugs and intermediates from various sources. If a revival of domestic bulk industry takes place as a result of stringent implementation of import registration rules that should only be welcomed.