A high level inter-ministerial meeting convened here on May 20 has decided to finalize a methodology to ease the problems of the drug manufacturers arising out of the newly introduced import registration policy. The meeting was specifically held to discuss the problems of the persons who are importing bulk drugs for export purpose by making use of the advance license facility.

Repeated attempts to get a final picture of the decision taken failed to produce desired results as the authorities insisted that the minutes of the meeting are in the making and the final decision will be available only by late evening. However, the government is known to have given a considerate hearing to the main demand of the exporting community to avoid registration of bulk drugs that are meant for re-export as formulations.

The pharma companies, especially the small-scale sector, was after the ministry with this plea as many of the companies fear a major setback if the bulk drugs for such re-exports come under the compulsory license scheme.

The government is also known to have planned to make its decision to exempt drugs imported for clinical trials and for other R&D activities such as new formulation development from the newly introduced mandatory import registration norms after the meeting.

The director general of foreign trade (DGFT) has favoured the move to exempt imports under advance licences from the registration system. Operational since April 1, the system mandates every exporter of bulk drugs/formulations to India to register himself and his products with the Indian drug authorities under specified norms and pay a fee for permit. The registration norms, notified in the year 2001, were part of the move to harmonize India's drug regulatory standards with the International Conference of Harmonisation (ICH). The government had initially given a one-year window period up to January 1, 2003 for the drug industry to prepare for the system, which was later extended by another three months.

The rationale for the move to exempt imports under advance licence is that while the system was meant to scrutinize and monitor the quality of drugs imported into the country as per Indian drug authorities' specifications, imports under advance licences are not meant for domestic consumption. Advance licence imports are meant for value-added exports which need to meet the quality norms of the country to which the final product is exported and not that of India.

Basic Chemicals, Pharmaceuticals and Cosmetics Export Promotion Council and the Indian Drug manufacturers' Association (IDMA) have told the government that imports under advance licence could be exempted from the mandatory requirement as it would act as export deterrent.