The Gujarat Food and Drug Control Administration (FDCA) has started a continuous training programme for the pharma industry in the state to equip the units with adequate technical know-how to handle the online application and follow up for product licences without mistakes, in an effort to make its much acclaimed e-governance programme a success.

The move is to reduce the occurrence of errors while entering and maintaining the product license information with the FDCA's online application programme, prior to full fledged implementation of online application programme for additional product licences for bulk drugs and formulations, said H G Koshia, commissioner, FDCA.

The training sessions would also help the office to identify the problems faced by the companies with the software developed for product license issuance. The administration has launched its first training programme in Mehsana and Baroda, Gujarat, and will continue to carry out similar programmes for the industry state-wide in near future.

“Though we have developed the module and has implemented it for the bulk drug manufacturers, we have to train the end users also on the methods, to make the system foolproof and promptly functioning,” said Koshia. The hard copy of the training module would also be issued to every pharma manufacturer in the state for future reference. “We are planning to complete the first phase of training for all allopathic drug manufacturers in a couple of months,” he added.

The FDCA has mandated the applicants for additional product license in bulk drugs segment to submit their applications online along with hard copy, as a first step to make the entire process of issuance of product licences paperless, in the middle of August. The administration is planning to implement the online application process to formulations manufacturers also, soon.

Further, it has also started meetings with the National Informatics Centre (NIC), the agency under which the softwares are developed, to revive its software launched in 2007 for management of sales licenses to make online applications possible. With the revised module, any individual can apply for sales licences online, which would be taken for consideration by the concerned regional drug control official in the state.

The new software would also be designed to implement an online drug alert system, which will enable the FDCA to alert the retailers on any adverse report on the batch-to-batch test reports released by the drug testing laboratory through short message services (SMS).

“At present, even if a drug or a batch of a particular drug is found not of standard or spurious in the drug testing lab, the alert process is so time consuming that a large number of it would be sold out before the retailers are alerted. It would be for the first time India, a state drug control office takes initiative to alert retailers promptly on such events with the support of modern technology,” said Koshia. The FDCA is in discussion with the major mobile phone service providers to implement the programme, he added.