The drug importers in the country are annoyed over what they termed as 'the avoidable delay' in the process of renewal of import registration licences by the office of the Drug Controller General of India (DCGI). The entire process which should not normally take more than two or three months now takes more than a year, for reasons best known to the authorities only.

According to sources in the industry, there is a lot of delay in renewing the import registration by the DCGI office, adversely affecting the business. For the renewal of import registration licences a fresh application of registration certificate has to be made nine months before the expiry of the existing certificate. Ideally, the DCGI's office is bound to take action on the application within six weeks from the time they receive the application for renewal of re-registration of import licences. However, there are complaints that the importers are not getting the registration renewal even after one year of putting up the application.

Import registration is the registration of the manufacturing site of a foreign manufacturing unit and the products manufactured therein, intended for import into India under the Drugs & Cosmetics Rules. All the biological and non-biological drugs, including bulk drugs, finished formulations, vaccines, critical diagnostic kits, syringes, needles, sutures, catheters, medical devices and internal prosthetic implants fall under the preview of the import registration.

The Form 10 is referred as an import license and it can be obtained by any Indian agent/distributor/manufacturer having valid wholesale drug license or manufacturing license. The Indian agent has to apply on Form 8 and Form 9 has to be issued by the company having valid Form 41. Form 10 is valid up till the validity of Form 41 unless it is sooner suspended or cancelled.

Though DCGI Dr Surinder Singh could not be contacted, sources said that the main reason behind the delay is due to the shortage of qualified staff in the DCGI office.