The Food and Drug Control Administration (FDCA) of Gujarat will have a new look and working pattern within four to six months from now, as the office and its facilities are undergoing a modernisation programme. The modernisation programme, which includes a complete e-governance system and increased amenities, will enable the state drug regulator to perform faster and better, guarantees FDCA chief.
The Gujarat FDCA is renovating its head office at Ahmedabad with an allocated funding of Rs 1.55 crore for modern furniture and equipments to give a 'corporate look' to the visitors. The administration, which has recently increased with 17 more drug inspectors, will further request the state Public Service Commission (PSC) to notify 35 more vacancies of drug inspectors to fulfil the manpower requirements, said H G Koshia, commissioner, FDCA.
Apparently, the most important developments with the office will be the implementation of e-governance which is already implemented to certain levels of operations. "We have already implemented online documentation and approval process for issuance of sales licences and various certificates for the manufacturers like Certificate of Pharmaceutical Products (CoPP)," said Koshia. Once completed, the e-governance system will enable the office to issue certificates within 24 hours from filing of applications, he added.
The administration is currently working closely with the central government-run National Informatics Centre (NIC) to develop a software to issue manufacturing license and product permission for the pharma manufacturers online. The FDCA has been conducting meetings with the Gujarat State Board of Indian Drug Manufacturers Association (IDMA) for their response in the development.
The office has also issued individual log in identities and password to almost 900 manufacturers to feed data of their products and manufacturing facilities. As of now, almost 80,000 product licenses have been entered into the system and the verification of all the licenses has been completed, said Koshia. The FDCA is now issuing log in identities to the loan licensees to comprehend their product licence information,
The e-governance system is also expected to help the industry, which is currently finding difficulties in the huge procedural delay on receiving product approvals, renewal of license and certificates like COPP. "We are aware that the industry has difficulties related to their product approvals pending with us. It is because of the renovation process going on in this office and we assure that within three to four months the modernisation works will be completed and the procedures will be more easier than the early system," said the official.
Further, the efforts of the administration to increase the number of staff for smooth execution of procedures are also on the way. At present, there are only 776 posts filled up out of the total 1118 sanctioned posts to the office. Out of the 64 sanctioned posts for drug inspectors, whereas there are only 45 drug inspectors in the office including the 17 inspectors appointed recently. The FDCA has demanded the state PSC to notify vacancy of another 35 posts for drug inspectors.
This time, the appointment of drug inspectors will be easier as the PSC has sanctioned a request of the FDCA to remove the conditions seeking 18-month experience with parenteral drug manufacturing or testing for the candidates applying for the post. Though the PSC has notified vacancy of 35 drug inspector posts in 2006, only 17 has been able to match the criterion.
"We have requested the commission to remove the condition, as it is difficult to find enough eligible candidates. We will provide training to the newly appointed in the probation period to compensate the lack of experience with parenteral drug manufacturing and testing," informed Koshia.
Gujarat, the hub of pharmaceutical manufacturers and related industries, currently has around 3275 licensed manufacturers including 789 licenses owned by manufacturers of in-house allopathic products and 2290 loan licenses. Almost 602 licenses for ayurvedic manufacturing, 368 licenses for cosmetic products manufacturing and 15 licenses for homoeopathic drug manufacturing are also issued by the FDCA till now.