Even after a month of the introduction of the new drug import registration provisions, drug regulatory authorities are yet to clear off the pending applications for import registrations in the country.
The list of pending applications to be considered as per the earlier norms are far from over and according to official figures, the number of applications pending with the authority as on April 22, 2003 comes to 156. It should be recalled that the backlog happened despite the best efforts of the office of the Drugs Controller General of India (DCGI) to clear as many pending applications as possible during the last few months. The DCGI had issued 268 registration certificates for finished formulations and 364 certificates for bulk drug imports as on February 15, 2003.
While the applicability of Notification No GSR 604 (E) dated August 24, 2001 was January 1, 2003, the government had given a three months extension considering the logistical difficulties expressed by the pharmaceutical industry associations. The associations led by the Indian Drugs Manufacturers Association (IDMA) had pointed out the impracticability in properly scrutinizing all pending applications by the concerned authority within the initial deadline.
During the period from December 15, 2002 to February 15, 2003, the authority had cleared 83 formulations and 52 bulk drugs. It is also known that the DCGI has found fault with 75 applications and have been rejected as on date. These applications, which were found deficient, need to clear all statutory requirements before it can be considered again. The authorities have stated that the applicants “have been advised for compliance”. As per the rules, the DCGI should not take more than nine months to dispose off a pending application for import drug registration.
Though receipt of applications is a continuous process, the authority is trying to clear off all pending ones at the earliest. All new applications will have to go through the registration provisions that are in force from April 1, 2003.