Pharmabiz
 

FDCA initiatives to spruce up regulatory mechanism

Our Bureau, MumbaiThursday, September 12, 2013, 08:00 Hrs  [IST]

The Gujarat Food and Drug Control Administration (FDCA) ,which is considered as one of the best state drug regulatory body in the country, is taking a slew of initiatives to safeguard public health as well as to strengthen the drug regulatory mechanism in the state.

In an ambitious plan to strengthen the drug regulatory mechanism in the state, the Gujarat FDCA has sent a proposal to the Central Drugs Standard Control Organisation (CDSCO) asking for an allocation of Rs.100 crore. The state drug regulatory body said that if approved, the funds will be utilised for modernising the office as per the latest regulatory requirements.

This move comes in the wake of the Drug Controller General of India’s (DCGI’s) insistence, recently wherein the DCGI had impressed upon the state drug regulatory officials across the country to submit their proposals for fund allocation under centre's capacity building programme. As per a highly placed source, this is a part of the capacity building measure taken by the centre wherein the last allotment in spite of repeated proposal for allocation for the same was made almost 10 years back.

Dr H G Koshia, commissioner of Gujarat FDCA said that he is hopeful that their proposal will be approved by the centre, as it is essential to constantly upgrade and modernise the drug regulatory system as per the changing regulatory norms. In a  boost to their above agenda, the Gujarat FDCA recently got an approval of Rs.39 crore from the state government for modernisation of the regulatory system in the state.

Capacity- building measures
The FDCA is likely to start the operation of its new food and drug testing laboratory in Gujarat by end of this year. Work on the new facility which is being built in Siddhapur in the northern part of Gujarat with an investment of approximately Rs.55 crore is almost ready. As per a report, the state drug regulatory body will be first starting the operation of the food testing lab within this year so that the samples of the food collected across the state can be sent to this lab for testing. Whereas due to the complex nature and high end technical know-how required to conduct testing of the drugs the regulatory body plans to start its operation by early next year.

However, Dr Koshia said that if additional funds are provided by the centre to procure high end testing and laboratory equipments, drug testing can be commenced by the end of this year.

Dr Koshia informed that the existing food and drug testing laboratory in Baroda has the capacity to test 7500 drug samples annually, of which the lab in baroda tests around 6000 to 6500 samples in a year. With this capacity building measure, the new drug testing lab will also be able to test around 7500 samples in a year, doubling the drug testing efforts in the state to ensure access to only safe and efficacious drugs across the state.

On the spot mobile drug testing lab
Amongst  the most ambitious projects undertaken by the Gujarat FDCA, is the initiative 7to set up on the spot mobile drug testing lab. The FDCA will soon be launching an advanced on the spot mobile drug testing lab in the state with a total investment of Rs.67 lakhs. The regulatory body has already got all the required funds approved from the state government for the same and is expected to float the tender for the same. With this initiative, Gujarat FDCA becomes the first and the only state regulatory body in the country to posses a high end technology based mobile van for instant testing of drugs.

FDCA pact with GSCBT
In a move to check the authenticity of the blood donation camps routinely conducted in the state by different organisations, the FDCA and the Gujarat State Council for Blood Transfusion (GSCBT) recently entered into an understanding to guide the citizens in verifying the legality of the blood camps by logging in and checking its credentials at the Gujarat FDCA’s website. Under the agreement, the Gujarat FDCA will be closely working with the GSCBT to disseminate all the information about the blood camps that are to be conducted in the state. For this, the state drug regulator has already added a new feature to its self-licensing software, Xtended Licensing and Laboratory Note (XLN), through which citizens can now get free access to all the blood camps being conducted in their locality in the coming seven days along with the details of the organisers, camp site, helpline number and other important citizen help centred information.

It is understood that as per the law, all the blood banks and other related organisations interested in conducting blood camps need to first get a no objection certificate (NOC) from respective state council for blood transfusion, only after that they are authorised to conduct the camps for the purpose of blood collection. As per the agreement, which was signed in early July, all the details of the authorised blood camps are sent to the state drug regulators office by the GSCBT to be uploaded on their website to be accessed by interested citizens.

 XLN initiative wins plaudits
In a move that further reinstates the expertise the state drug regulatory body in ensuring good governance in the state through IT, the FDCA was recently awarded the eINDIA 2013 public choice award for its self-licensing software Xtended Licensing and Laboratory Note (XLN). The software bagged the prestigious recognition in a national level competition organised by Elets Technomedia that focuses on IT in government, education, healthcare, under the category of government initiatives in healthcare. Gujarat FDCA has been streamlining its regulatory mechanism, through efficient use of information technology for some time now. The software that was developed and adopted by the state drug regulatory body got recognition for its capabilities to generate internal competition among officers for performance based ranking of circle offices by ensuring better planning and execution of duties by drug inspectors through various alerts through XLN.

Dr Koshia pointed out that this software was widely recognised and praised for its government to consumer (G2C) benefits that has helped them to effectively put all the relevant information on not of standard quality (NSQ) drugs, blood banks, pharma firms etc on public domain. 

 
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