XLN
Food & Drugs Control Administration

A. Problem Analysis

 1. What was the problem before the implementation of the initiative?
FDCA has been entrusted to ensure availability of quality medicines through licensed pharmacies and wholesalers by Health & Family Welfare Department of Government of Gujarat. It is responsible for promotion& protection of public health inGujarat, which has a population of more than 62 million. FDCA head office is located in Gandhinagar and has 25 circle offices in various districts across the state. The jurisdiction of some of the circle offices is beyond one district. Each circle office is headed by an Asst. Commissioner and assisted by 4-5 Drug Inspectors/Sr. Drug Inspectors for the field duties. Key responsibilities of FDCA Circle offices are: 1. Issuance of licenses: To retail pharmacy and wholesalers / stockists / C&F agents for sale of medicines. 2. Enforcement: It includes regulating distribution and sale of drugs and cosmetics manufactured in Gujarat State or those coming from other states. FDCA is also responsible for ensuring that drugs available to citizens are safe, efficacious and meet the prescribed standards. FDCA regularly monitors to ensure that manufacturing of spurious drugs is prevented and substandard drugs are recalled immediately. The sale of license procedure was earlier decentralized. It was carried out manually and lacked harmonization in all Circle Offices.Some problems were identified as a result of this. 1. Multiple illegal enrollments: It was noticed that some Pharmacists had illegally enrolled their names in multiple pharmacies in different districts. During a drive conductedfor verification of Pharmacists in pharmacies in the State, it was observed that there was absence of Pharmacists in various pharmacies and subsequently licenses of such pharmacies were cancelled by the FDCA. 2. Tedious licensing procedure: The procedure for issue of sales license was tedious and time consuming. Right from the collection of application form to the issuance of the sales license, the applicant had to visit the circle office several times.No standard procedures existed across circle offices. 3. Disconnect because of distance: It was difficult to manage field offices from the head office at Gandhinagar. (i) The information related to sales licenses granted, suspended, cancelled, pharmacists etc. was not readily available with head office and hence effective monitoring of the circle offices was difficult. (ii) The details of samples drawn by Drug Inspectors & Senior Drug Inspectors were not immediately available to Head Office. (iii) Difficulty in compilation and retrieval of information asked for by Parliament & citizens under the Right to Information (RTI) Act. 4. Procedural delays: The administrative procedure for “Not of Standard Quality” (NSQ) report was lengthy. After receipt of NSQ test report from laboratory, it took more than two months to convey the information to dealers, and by the time the NSQ information reached the dealers, most of stock was consumed and drug recall was not possible. Thus the very objective of FDCA to protect public health was not being met. 5. No information access to public: No system for public to access the information related to pharmacies, NSQ drugs, Blood Banks and availability of blood.

B. Strategic Approach

 2. What was the solution?
Secretary, Health & Family Department of Government of Gujarat,expressed his concernsabout the problems emerging in Gujarat State for implementation of Drugs & Cosmetics Act, 1940 and Rules 1945. In the year 2006, Dr. S.P. Adeshara, then Commissioner, proposed a web based information technology solution to the problem which resulted into the currentinitiative – Xtended Licensing& Laboratory Node (XLN) being developed. Dr. H.G. Koshia, Commissioner, FDCA and FDCA officers’ team with IT solution support from Mr. Harish Advani, Sr. Technical Director, NIC, Gujaratactively contributed to the design and implementation of the initiative. The various stakeholders of the XLN development are: 1. All circle offices of FDCA 2. FDCA’s Head Office 3. Food & Drug Laboratory (FDL) 4. Gujarat Medical Services Corporation Ltd. (GMSCL) (earlier known as Central Medical Store Organization - CMSO) (Government of Gujarat’s central drug purchasing & distributing agency to all Government hospitals & dispensaries) 5. Gujarat State Pharmacy Council, Pharmacies (Retailers) and Wholesalers of drugs and Blood Banks The initiative “XLN- Xtended Licensing & Laboratory Node” is a web based IT solution, http://xlnindia.gov.in , with data stored in the central server. It has evolved over some time after implementation was initiated on 1st January 2007. XLN has the following objectives: 1. Standardization of procedures &bringing about transparency in administration. 2. Effective monitoring of the circle offices through theonline IT application. 3. Ensuring that a pharmacist does not illegally enroll his name in multiple pharmacies in different districts - The software restricts him to one pharmacy only at a particular point of time. 4. Reducingthe number of personal visits to the circle offices by the applicant for expediting the decision on their application and to reduce their difficulties. 5. Providing details of samples drawn by Drug Inspectors & Senior Drug Inspectors and test reports to Head Office immediately. 6. Ensuring quick & effective recall of NSQ medicines through mass messaging (SMS). 7. Providinga seamless link between FDCA, Food & Drug Laboratory (FDL), Gujarat State Pharmacy Council and the Gujarat Medical Services Corporation Ltd. (GMSCL). 8. To provide information regarding medical stores / wholesalers and Blood Banks operating in Gujarat State to the public Strategies adopted to solve the problem: 1. Under the leadership and guidance of FDCA Commissioner, FDCA team & NIC Team discussed various aspects of the FDCA functions in several brainstorming sessions and worked out a plan for development of XLN- Xtended Licensing & Laboratory Node. 2. Several workshops were held with all Assistant Commissioners & Drugs Inspectors to demonstrate the software and to get their feed back. 3. FDCA Commissioner ensured computer access in circle offices with theGujarat State Wide Area Network (GSWAN) / internet connectivity. 4. FDCA team constantly monitored all circle offices to ensure that the details of more than 30,000 licenses issued before 1st January 2007 were keyed in the software to generate database, and that the sales licenses issued after 1st January 2007 were issued only through the software. 5. FDCA team also constantly monitored all circle offices to ensure that details of each and every sample drawn by Drug Inspectors & Senior Drug Inspectors are keyed in and necessary forms are generated through the software. 6. NIC provided technical support for implementation of the solution.

 3. How did the initiative solve the problem and improve people’s lives?
Display of real time ranking of all Circle Offices on the basis of their performances resulted into a very rare phenomenon of internal competition among government officers for better ranking. Integration between stakeholders allowed exchange of information. Mass SMS alerts for “Not of Standard Quality Drug” (NSQ) sent to all dealers, Government Hospitals, GMSCL, Drugs Inspectors, Drugs Controllers of other States, media personnel ensures immediate taboo on sub standard drugs. Information made available in the public domain on XLN’s web site includes NSQ drugs, pharmacies, Blood Banks, upcoming Blood Donation camps, availability of particular Blood Group and Blood Component etc. On the basis of the batch no. of the drug purchased, it can be verified whether the drug has been declared as NSQ or not through the XLN web site or by sending an SMS [XLN BATBatch no.] to 9227500958. Other information which can be availed through SMSincludes Pharmacist’s name & current location and availability of particular Blood Group in nearby Blood Banks. The applicant can also get status of his/her application through SMS. Replication of XLN in other ten States allows seamless exchange of interstate information.

C. Execution and Implementation

 4. In which ways is the initiative creative and innovative?
The XLN project was implemented in 4 phases totally. 1. Licensing 2. Laboratory 3. Legal Modules 4. MIS / RTI / LAQ related compiled Reports & Querying Tools. With the help of the following elements, over a period of time,XLN has gradually evolved into a ruggedand stable tool. 1. Gujarat State Wide Area Network (GSWAN) infrastructure was leveraged for connectivity. Funds for manpower for preparing IT solution and funds for mass SMSwere provided by the Government of Gujarat. 2. The technicalaspects of the solution were facilitated by National Informatics Center, Gujarat. They were also responsible for data storage, mirroring of data and regular backups. 3. Active participation and firm determination of FDCA and NIC officers for implementation of XLN 4. Collaboration between all stakeholders. 5. On request from other State Drugs Controllers, in order to promote and protect public health, Government of Gujarat allowed complimentary replication of XLN in other states. XLN has been successfully replicated inten States of India and other requests from six other states are under process covering almost 70% of the geographical area of the country. XLN Chronology: 1. Gujarat State Wide Area Network (GSWAN) was setup across the state. 2. Government of Gujarat provided hardware infrastructure to all district offices. 3. National Informatics Centre, Government of India, extended technical support forsystem requirements, analysis, database designing, and development 4. All Circle Offices were instructed to key in the legacy data of existing firms as on 31st December, 2006. 5. 1st January 2007 onwards, all Circle Offices were instructed to process all applications related to Pharmacies through XLN only. 6. Gujarat State Pharmacy Council’s data of Registered Pharmacists was linked with XLN. 7. Gujarat Medical Services Corporation Ltd. (GSMCL) also linked to XLN. 8. All Drugs Inspectors and Senior Drugs Inspectors were instructed to key in the details of samples drawn by them for test & analysis and generate mandatory forms through XLN. 9. XLN was linked to Drug Laboratory and Test Results of drug samples were keyed in XLN. The facility to upload scanned copy of Test Report was later added. 10. Availability of information on the public domain for the benefit of citizens. 11. Active interaction with various stakeholders and inviting their suggestion for improvements in XLN. 12. Replication of XLN in other states. 13. Blood Banks were asked to key in Stocks of each blood group’s Blood Bags and Blood Components available with them every day in the morning and the information is also made available in public domain. 14. We have participated in several state and national level awards. The feedback received from experts during evaluation has been a valuable input for improvising on the existing solution.

 5. Who implemented the initiative and what is the size of the population affected by this initiative?
Stakeholders involved in implementation and maintenance of XLN are: 1. All circle offices of FDCA, FDCA’s Head Office 2. Food & Drug Laboratory (FDL), Gujarat Medical Services Corporation Ltd. (earlier known as Central Medical Stores Organization - CMSO) (Government of Gujarat’s central drug purchasing & distributing agency to all Government hospitals & dispensaries) 3. Gujarat State Pharmacy Council, 4. Pharmacies (Retailers) and Wholesalers of drugs 5. Blood Banks 6. National Informatics Center, Gujarat
 6. How was the strategy implemented and what resources were mobilized?
1. Gujarat State Wide Area Network (GSWAN) was already existing and hence the infrastructure could be leveraged for XLN 2. Internet connectivity was obtained through special permission from Government of Gujarat for few district offices where GSWAN connectivity was not available. 3. The computers and printers available with FDCA were made use of to reduce additional expenses. 4. We were also able to successfully leverage the experience of FDCA officials in streamlining operations. 5. National Informatics Center, Gujarat, was responsible for developing the solution, maintaining the database and supporting the technical aspects of the project. 6. Central Server hosting, mirroring of data and regular backups are being supported by NIC. 7. Arranging brainstorming workshops with FDCA officers, specially end users, and NIC team at regular intervals to upgrade the XLN. 8. Encouraging the users to communicate their feedback / suggestion through e-talk with the NIC team. 9. Encouraging the users to communicate with users of other districts through e-talk. 10. Though the software development & server hosting was done by Government of India’s department - NIC, NIC was required to appoint software engineers for several months to assist the NIC team and FDCA made payment of approx. Rs. 10,00,000 (Approx. US $ 20,000) as their salary. The funds were provided by the Government of Gujarat.

 7. Who were the stakeholders involved in the design of the initiative and in its implementation?
1. Eradication of illegal multiple enrollment of pharmacists resulting in better compliance with law. 2. The system led to greater transparency, accountability and elimination of corrupt procedures.Decisions were made within the time frame. This was also the end of the so called “red tapism & bureaucracy” in the department.As a result of the system, the drug administration was better monitored. Update on the status of the application through SMS and online access was provided. eLicenses could also be printed by applicants. 3. Mass SMS alerts for “Not of Standard Quality Drug” (NSQ) is being sent to all dealers, Government Hospitals, GMSCL, Drugs Inspectors, Drugs Controllers of other States, and media personnel. This ensures immediate taboo on NSQ drugs and thus protects public health. 4. Information made available on XLN’s web site includes NSQ drugs, pharmacies, Blood Banks, upcoming Blood Donation camps, availability of particular Blood Group and Blood Component etc. On the basis of the batch no. of the drug purchased, it can be verified whether the drug has been declared as NSQ or not. This can be done through the XLN website or by sending an SMS “[XLN BATBatch no.]” to 9227500958. Other information on demand, through SMS, includes Reg. Pharmacist’s name and current location. Further, availability of particular Blood Group in nearby Blood Banks can also be checked. The applicant can also get status of his/her application information through SMS. 5. Display of real time ranking of all Circle Offices on the basis of their performances resulted into a very rare phenomenon of internal competition among government officers for better ranking.

 8. What were the most successful outputs and why was the initiative effective?
1. Brain storming workshops with FDCA officers, specially end users, and NIC team were arranged at regular intervals to upgrade XLN. 2. A committee of five senior officers headed by Joint Commissioner was formed to periodically evaluate the activities. 3. Users were encouraged to communicate their feedback / suggestion through e-talk with NIC team. 4. Users were encouraged to communicate with users of other districts through e-talk. 5. Incorporation of suggestions received from other States where XLN has been replicated. 6. Suggestions made by juries during spot visits of FDCA for various awards like “National e-Governance Award”, “Prime Minister’s Award for Public Administration” etc. were incorporated into the solution.

 9. What were the main obstacles encountered and how were they overcome?
1. GSWAN connectivity was not available in some of the Circle offices located in private buildings. Government of Gujarat granted special permission to obtain broad band internet connections to overcome this problem. 2. Government Officers and Clerical staff were not equipped with knowledge of basic computing. They were sent for computer training conducted by the Government training institutes. 3. Some of the Government Officers and Clerical staff were apprehensive about using XLN but the same was enforced by the FDCA Commissioner on all officials. 4. Computers and printers provided by Government were not sufficient as compared to the work. FDCA Officers had to wait for availability of computer even after office hours to complete the task. The FDCA Commissioner continuously followed up for sanctioning of more hardware and this was finally granted thereby bringing ease into operations. 5. Existing dealers were also issued user IDs and passwords to access the online information related to their firms, process online application and update their cell numbers. With the help of the local Chemist & Druggist Association and local FDCA officers, XLN has been able to build up the data base of mobile numbers. 6. As a part of extension of public service, it was decided to upload information of upcoming Blood Donation camps, Blood Stocks of each blood groups available with Blood Banks. All Blood Banks were personally contacted by the Circle Officers and they were given user IDs and passwords to key in daily stock of each blood group’s Blood Bags available with them. Constant pursuance by FDCA officer, Blood Banks’ willingness and positive response from citizens are the key to success for this project.

D. Impact and Sustainability

 10. What were the key benefits resulting from this initiative?
Benefits to Government (G2G):- 1. XLN interlinks FDCA, GMSCL, Drug laboratory and Pharmacy Council for co-ordination and monitoring. 2. Display of real time ranking of all Circle Offices on the basis of their performances. 3. Real time statistical reports becoming available. 4. Drug laboratory can immediately view the sample data entered by Drug Inspectors. No. of samples tested increased from 2409 to 6792 during 2005 to 2011. 5. The test result entered by the laboratory can be immediately viewed by the concerned circle offices, Head office of FDCA and GMSCL. 6. Drug Inspectors are alerted to initiate prompt action in various cases like: i. 24 hours Pharmacy operating without 3 Registered Pharmacists. ii. Pharmacy operating without a mandatory Registered Pharmacist. iii. Firms “NOT INSPECTED” since last 1 year. iv. Firms whose Renewal is due in coming month. v. Pharmacist at multiple locations within Gujarat. 7. Administrative uniformity, accuracy, speed, transparency and instant accessibility of information through XLN helped to increase performances of circle offices. During year 2005 to 2011, number of disposal of applications increased from 6103 to 10827 and no. of raids increased from 4 to 22. 8. As XLN is replicated by other tenstates, access to their databases on – drug inspectors, sales licensee etc. 9. Maintains the history of all data. Benefits to citizen (G2C):- 1. Citizen can locate nearby Pharmacies. 2. Information about 24 Hours functional Pharmacy is available. 3. Information about all NSQ Drug Samples. 4. Citizen can also verify whether the drug purchased has been declared as NSQ by Government Drug Laboratory or not. 5. Information about upcoming Blood Donation Camps, availability of Blood Bags of each Blood Group and Blood Component with the Blood Banks Benefits to Business Community (G2B):- 1. Status of an application with reasons can be accessed. 2. XLN compels the Drugs Inspector and Assistant Commissioner (Licensing Authority) to follow FIFO (First in, First Out) system after lapse of predetermined time limit for each stage and prevents “Red Tapism”. During year 2006 to 2011, no. of days to expedite various applications reduced drastically - fresh License from 36 to 15 days, renewal of licenses from 180 to 30 days and other applications from 60 to 40 days. 3. Wholesalers can get information of any Pharmacy. 4. Availability of registered Pharmacists in any particular area can be accessed. 5. SMS alerts sent to ALL pharmacies & Wholesalers for drug samples declared as “Not of Standard Quality” (NSQ) by Drug Laboratory which helps them to stop sale / distribution and recall from the market. Example of NSQ Alert message: “FDCA-GJ Alert: LOPRO TABLETS Batch:LP-03 Mfg:04-2011,Exp:03-2014 Mfg by: DANISH LABORATORIES declared SUBSTANDARD,STOP USE/SALE/ DISTRIBUTION, RECALL URGENTLY” This is the first ever initiative taken by any Drug Controller to ensure effective recall of NSQ medicines and thereby protecting public health. This SMS is also sent to other State Drug Controllers and select media personals. Impacts of XLN initiative: 1. XLN has enhanced trust, confidence and image of FDCA for better regulation and public services among all stakeholders including citizens. 2. XLN received appreciation for better public services at several conclaves and published in various print media. 3. “To make public Services efficient and corruption free”, Government of Gujarat rewards its various departments for their exemplary initiatives. During March 2012, Dr. H.G. Koshia Commissioner, FDCA, Gujarat was awarded the first award under above category for the FDCA, Gujarat’s initiative of XLN. 4. XLN initiative received “CSI IT Excellence Runner up award” from the Computer Society of India, a premier computer society association operating since more than 50 years in India. 5. Government of India conferred “National e-Governance Gold Award 2012-2013 for Exemplary Re-Use of ICT based solution” on FDCA and Dr. H.G. Koshia, Commissioner, FDCA for XLN initiative. 6. XLN received an e-India Award 2013& Certificate of Excellence for Government initiative in Healthcare. 7. Responses and awards received for XLN initiative have boosted moral of FDCA team and motivated them to serve better. 8. XLN has further strengthened the position of FDCA, Gujarat as leading State Drug department in the country.

 11. Did the initiative improve integrity and/or accountability in public service? (If applicable)
1. FDCA, Gujarat conceptualized the XLN application and implemented it from 1st January 2007 and since then it is being successfully implemented. XLN has proved to be very cost effective. XLN works as per the regulatory provision of Drugs & Cosmetics Act – 1940 and Rule – 1945. XLN has stood the test of time since more than six years with respect to financial, social and economic, cultural, environmental, institutional and regulatory sustainability. 2. Till 2010, FDCA, Gujarat was the only state in INDIA to implement this project. The benefits of XLN were discussed during various conclaves and they were also published by media at several occasions. Dr. Surinder Singh, the then Drugs Controller General (India), Government of India visited FDCA, Gandhinagar in Gujarat and personally studied the XLN project. He praised the initiative and recommended XLN to all the other State Drug Controllers on several occasions. Thereafter, FDCA, Gujarat received request from various State Drugs Controllers to replicate XLN in their States. In order to protect public health, Government of Gujarat permitted other State Drugs Controllers to replicate XLN in their States. During 2010-2014, tenother States namely, Maharastra, Karnataka, Andhra Pradesh, Kerala, Chhatisgarh, Goa, Himachal Pradesh, West Bengal, Madhy Pradesh,etc. successfully replicated and implemented XLN. Several other States are also in the pipe line to replicate XLN in their States. These states cover more than 70% of the geographical area of INDIA. 3. Dept. of Electronics & Information Technology, Govt. of India has identified XLN as a RAPID ROLLOUT & REPLICATION Project.

 12. Were special measures put in place to ensure that the initiative benefits women and girls and improves the situation of the poorest and most vulnerable? (If applicable)
Implementing XLN has been a learning curve for the department and FDCA has identified some crucial takeaways from the project. FDCA realized that is essential to confront a problem head on instead of avoiding it. By realizing the loopholes in the existing administration, they were able to understand the need for a full proof solution which could lead to better drug administration. Vision is key to innovation and FDCA has demonstrated that by producing a simple yet effective solution which is now being replicated by states across the country. A major reason that the solution is a cost effective one is that FDCA was able to identify low cost, yet effective resources such as the existing infrastructure of GSWAN or the technical expertise of NIC. Effective utilization of such resources has led to a stable and cheap solution. Implementation of XLN also required teamwork on behalf of the FDCA and this is one of the biggest learning from the implementation of the project. Identification of strengths and weakness of the team member helped in taking measures to groom the team and divide responsibilities based on strengths. Effective training programs were organized to overcome weakness and this helped in creating a healthy environment for running XLN. The biggest learning from the project, however, has been that spreading knowledge and sharing ideas leads to much bigger impact on the community. This led to replication of XLN across several states of India and is now ensuring stronger drug administration in other parts of the country.

Contact Information

Institution Name:   Food & Drugs Control Administration
Institution Type:   Government Department  
Contact Person:   Hemant Koshia
Title:   Commissioner  
Telephone/ Fax:   Telephone : +91-79-23253417 Fax: +91-7
Institution's / Project's Website:  
E-mail:   comfdca@gujarat.gov.in  
Address:   Block no. 8, Dr. Jivaraj Mehta Bhavan,
Postal Code:   382010
City:   Gandhinagar
State/Province:   Gujarat
Country:  

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