VIVAN Life Sciences Blog
State FDA reports 10% hike in filing of applications after launch of online WHO GMP in 2012
Ever since the Maharashtra Food and Drug Administration (FDA) introduced the online WHO GMP Certificate Generation System in August 2012, there has been a 10% increase in the filing of applications for the WHO GMP certificate and its disposal by the state FDA.
WHO GMP Certificate Generation System is a robust system offering convenience and user-friendliness to the licensees in the form of 3 types of certificate namely Certificate of Pharmaceutical Products (CoPP), Unit WHO-GMP certificate and Statement of Licensing Status.
As of today over 17,000 applications have been successfully disposed off. The state today boasts of 390 WHO-GMP units with 223 own licenses and 167 loan licenses.
Earlier, Joint Commissioner (HQ) was designated for signing the various certificates issued under the WHO GMP certificates. Manufacturers from across the state had to come to Mumbai to apply for the certificates and had to submit a sizeable amount of data in the form of papers.
Besides creating an electronic storage of data for easy retrieval at any time, the new online system developed by software developer Hashtech has ensured in avoiding duplication or counterfeiting of the certificates by assigning a software generated unique authorization code to each certificate.
Ex commissioner Maharashtra FDA Mahesh Zagde introduced the online WHO GMP Certificate Generation System for the purpose of export registration in 210 WHO member countries.
Since then, the pharma exporters have been able to minimize their efforts for applying, processing and scrutinizing the applications in a transparent manner through a standardized procedure. This has not only led to an increase in the revenue collected by the administration but also exports of pharmaceuticals from the state, FDA officials said.
India boasts of maximum number of WHO – GMP certificate holders with the Maharashtra FDA granting large number of certificates considering the quantum of export of medicines to foreign countries.
Among the other unique attributes of the system, the SMS delivery system keeps the manufacturer updated when he is offline and authentication of the certificates can be verified by the authorities very easily.
The manual process was time consuming and entailed scrutiny of the application at three levels by the concerned authorities which once approved was sent by post as a Compliance Letter. This system was followed from 2000 to August 14, 2012. The application thus received was cumbersome as it was first received by the Drug Inspectors at WHO-GMP section and then by the Assistant Commissioner, WHO- GMP section followed by the final signatures on the certificates by the Joint Commissioner (HQ).
