A large number of exporters are losing huge export orders amounting to several crores of rupees due to some technical problems arising out of guidelines issued by the DCGI to the zonal offices. As per these guidelines, some old bulk drugs, that are listed in reputed overseas pharmacopoeias like USP, JP, BPC, FP etc. and duly licensed for manufacture/ export by respective state licensing authorities, are not being permitted for exports as they do not appear in the approved list of drugs by DCGI.

According to sources, the pharma exporters are facing immense difficulties in export of old pharmacopoeial (other than IP) bulk drugs not covered in the DCGI list, which is aimed for regulatory use of drugs within the country.

Sources said that these old drugs, which are not meant for domestic production and use, are only meant for exports to other countries with due approval by the importing country and necessary licences granted by local licensing authorities. They conform to the standards of reputed overseas pharmacopoeias and have been exporting for the last over 15 years.

Under such circumstances, compelling the exporters to take fresh approvals from DCGI office in Delhi would require long documentation and procedures and time, resulting in loss of exports. Some SME members exporting APls have informed that due to their lack of knowledge about DCGI office at Delhi, they could not comply with the requirements and lost their regular business worth crores of rupees.

Meanwhile, the Pharmexcil has taken up the issue and has written to the DCGI Dr G N Singh, urging him to ensure hassle-free exports for such old drugs by delegating powers to zonal offices to grant approvals for such pharmacopoeial bulk drugs if licences are already granted in the past by state licensing authorities. It has also suggested to the DCGI to process the applications from the exporters in the Delhi Office in a fast-track mode with stipulated time-lines of seven days where they are required to verify the pharmacopoeial status of the drug and licences issued by state drug controllers.

In the letter, Pharmexcil's director general Dr PV Appaji also suggested that the requirement for submission of huge documentation etc. may be waived with respect to drugs which are already covered under various reputed pharmacopoeias of other countries.