The Central Drugs Standard Control Organisation (CDSCO) would start physical inspections of foreign drug manufacturing sites as a pre-condition for granting import registration of drugs in the next phase of the recently introduced registration regime. This means, all pending drug import applications are to be scrutinized in the conventional manner, without the government insisting upon site inspections.

According to Ashwini Kumar, Drugs Controller General of India (DCGI), the regulatory authority would prefer a smooth transition from the earlier phase to the new regime and would start implementing the regulatory requirements only after the pending clearances are complete. He felt that the next phase could begin early next year, when site inspections would be made mandatory.

The present staff strength of CDSCO is too short to undertake on-site inspections. The agency is in the process of initiating a massive capacity building programme, which is expected to fill up the gap in near future, it is learnt.

The amended rules provide for case-to-case consideration of inspection of the premises of a foreign manufacturer. If it is required, an additional fee of 5000 USD is to be levied from the importer.

The Gazette Notification GSR no. 604 (E) dated 24.08.2001 amending the various provisions of the Drugs & Cosmetics Rules had also revised the import licence fees and increased validity period of licence. Further modifications had also seen drugs imported under Advance Licensing Scheme exempted from the registration requirements. The government had also extended these exemptions to drugs meant for clinical trials and R&D from the purview of the new rules.

As per the rules, foreign manufacturers have to apply for registration certificate for their manufacturing premises and the individual drugs to be imported. Authorized agents of foreign firms in India can make the applications. The validity of registration certificates will be three years from the date on which these are issued. A fee of 1500 USD is charged for the registration of overseas manufacturer's premises and fee of 1000 USD for every individual drug. The rules also provide for payment of testing charges by registration holders. The foreign manufacturer or his authorised agent in India is liable to report any change in the manufacturing and testing process of a drug.

The new registration and import licence scheme also covers diagnostic kits viz. HIV I & II, HBsAg, HCV and blood group reagents.