Pharmabiz
 

FDCA leads the way in modernization

Thursday, August 6, 2009, 08:00 Hrs  [IST]

Gujarat Food and Drug Control Administration (FDCA) has been acclaimed for its efficiency in monitoring and controlling the fast growing pharma industry in the state. In the last two years, the administration has been implementing online governance of all its day-to-day activities. In fact, the FDCA is the first drug regulatory body to implement e-governance in the country. H G Koshia, commissioner, FDCA who is spearheading the modernisation programmes in an interview with Gireesh Babu details on the modernisation projects and the latest activities of FDCA. Excerpts… The Gujarat Food and Drug Control Administration (FDCA) is one of the first to implement e-governance for day-to-day activities. Could you elaborate on the modernisation programmes of the FDCA? Yes, we are in a very much advanced stage of modernisation when compared to many other state drug regulatory offices in the country. The pharma industry in the state has developed far ahead with its modern facilities and infrastructure and our plan is to give a corporate look to the office and its facilities. When the industry representatives come to our office, they should feel that their regulator is also well developed to guide them in the related matters. The government is spending Rs 1.55 crore to modernise the infrastructure and equipment of the FDCA. We are renovating the three-winged building of FDCA in Gandhinagar with modern furniture and interior decoration. When it comes to e-governance, we have initiated our works almost two and a half years back. We are issuing sales licence successfully through online from 2007 in collaboration with the state pharmacy council. The licences issued and the applications under procedure could be monitored through our intranet throughout our 18 district offices. Gujarat has issued a total number of 55167 sales licences and 24761 wholesales and retail sales premises licences. The online facility promises a transparent and speedy disposal of applications and helps us to monitor various issues related to pharmacies and pharmacists working there. We have also introduced software to issue different certificates like Certificate of Pharmaceutical Products (CoPP) and non-conviction certificates. A software for issuing pre-sales certificate is ready for application and more than 200 certificates has been issued on a trial basis. The e-governance system ensures that the issuance of CoPP certificates will be decided within 24 working hours from the time of receiving the application. At present, we are working closely with the National Informatics Centre (NIC) to launch software for issuing product permission online. This needs a lot of preliminary works like collecting data on the existing products in the state and to prepare programmes convenient to the industry players too. We had discussions with the Gujarat State Board of Indian Drug Manufacturers Association and various industry representatives to assess their opinion on the issue. In order to collect the product details, individual log in IDs and passwords were issued to more than 900 manufacturers and they were asked to enter details of products marketed in the state. Information on more than 80,000 product licences has already been entered in the system and we have verified the complete data. After completing collection of data from the in-house manufacturing firms from mid June, we have started the procedures to collect data from the loan licensees. We are expecting to complete the e-governance programme within next four to five months. The FDCA has also conducted programmes to train its entire staff to work online and has supplied adequate operating systems to 18 district offices. The training programmes were started almost seven years back and almost all the officers in FDCA are now well acquainted with handling online programmes. The administration has also increased its staff strength recently. Could you comment on the induction of more drug inspectors and the addition of other amenities? The state public service commission has appointed 17 drug inspectors, who have started working in our various district offices. However, we still need more manpower to handle the day-to-day activities. Three posts of junior commissioners are vacant out of the six posts sanctioned. There are 12 Assistant Commissioner posts filled at present while the total sanctioned posts are 25. In total, there are 1118 sanctioned posts and only 776 are filled in the department at present. The clause mandating 18 months experience with Schedule C, C1 drugs as eligibility for appointing drug inspectors was a major obstacle to appoint adequate number of staff in this section earlier. In 2006, we had intimated the PSC on 35 vacant drug inspector posts and could only fill 17 posts because of this clause. Last month, the PSC has agreed to omit the clause and now we are going to seek appointments in 35 drug inspector posts. We have recently increased our strength in transportation systems. At present, there are 18 four -wheelers and has allocated Rs 25,000 per month for 12 district offices to spend on hiring vehicles. Could you elaborate on the number of licences issued by the FDCA? At present, we have a total number of 3275 licensed manufacturing units in the state. Out of this, 789 are own manufacturing licences and 2290 loan licences in allopathic drug segment. There are 602 licenses issued for ayurvedic manufacturing units 368 for cosmetics manufacturing and 15 for homoeo drug manufacturing, including own and loan licences categories. What are the regulatory activities you have carried out in the last one year? In 2008-09, FDCA has conducted 1833 inspections in manufacturing sites and 12184 inspections in sales premises. Based on the test reports and investigation reports prepared, stop manufacturing licenses were issued to 22 odd manufacturing companies for non compliance of standards. Warning letters to another 28 facilities were issued for the same reason. Product licence of eight manufacturers has been withdrawn and 88 were suspended during the period. In total, Rs 20 lakh worth drugs were found not of standard quality and have been destroyed as per the regulation. However, Gujarat has comparatively less prevalence of spurious drugs. There are some cases reported, but the number of cases and the quantum of drugs seized are very small.

 
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