Gujarat, touted as the global pharma hub, also has a distinctive drug regulatory mechanism with a key focus on e-governance, which has already been replicated in 12 states and is poised for roll out throughout the country.
The Food and Drugs Control Administration (FDCA) which is headed by commissioner Dr H G Koshia, has a robust team working round clock to ensure that the health and life of the patients are not put at risk due to failure in effectively implementing the drug regulatory norms across the state.
According to Dr Koshia, his office has been upgrading and updating skills as per the latest drug regulatory requirements by working not only with the CDSCO but also with their international counterparts like MHRA, US FDA WHO etc as well to ensure best patient centric services. What makes the FDCA click in its endeavour is its firm stand on maintaining and monitoring the drug regulatory system while taking into confidence the support of the industry as well.
Laboratory capabilities
Good governance through modernisation and infrastructural development has always been a key focus area for the Gujarat FDCA which is quite evident by its ongoing efforts to strengthen and build its laboratory capabilities.
The Gujarat FDCA has a food and drug laboratory (FDL) in Vadodara and Patan and dedicated regional food laboratory at Rajkot and Bhuj to carry out testing of allopathic, ayurvedic and homoeopathic drugs, along with cosmetics and food articles.
These laboratories are equipped with state of the art testing facilities, AAS, spark emission, spectrophotometers, HPLC with auto sampler, gas and liquid chromatography, spectrophotometers and FTIR.
In fact, the state is all set to start the operation of its second food and drug testing laboratory this year. It is understood that the work at the food and drug laboratory located in Siddhapur in the northern part of Gujarat is almost in the last leg of completion, with only some installation work pending prior to its operation.
The new food and drug laboratory at Dethli village in Patan district is spread across 20,000 square metres, and is built at the cost of approximately over Rs. 80 crore. The newly established lab will play a vital role in reducing pressure from the existing food and drug testing laboratory at Vadodara, which has the capacity of testing 7500 drug samples annually.
Dr Koshia pointed that while today the existing lab tests around 6000 to 6500 samples a year, the new drug testing lab will help in further doubling the drug testing efforts in the state as it has the capacity to test around 7500 samples in a year.
Dr Koshia further added that apart from the existing food and drug testing laboratory, there are two dedicated food testing laboratories in Rajkot and Bhuj respectively and this will be the second food and drug testing combination lab for the dual purpose of testing food and drug samples from across the state.
“We are very committed towards providing only the best healthcare services in the state with key focus on availing only safe and efficacious drugs to all the patients across the state. We have been working hard in the last three-four years to get things rolling to help us cope with growing work pressure. This new lab which has been built to meet our expectation in tune with the latest technological advancement, further encourages and helps us to strengthen our system to meet the changing market dynamics,” he said.
Demand for new drug regulatory offices
Apart from the already existing labs and offices the Gujarat FDCA wants the state to have more offices, especially, in the aftermath of the re-organisation of the state to create seven new districts. Through this initiative, the drug regulatory body wants its presence felt in the area to ensure not only good governance to the people of these districts but also effective monitoring and implementation of the Drugs and Cosmetics (D&C) Act.
The state drug regulatory body hopes that the state government by next financial year will earmark funds to set up district offices and other logistics, while creating additional posts of assistant commissioners and other requisite official staff for better and timely delivery of duties in the new districts. It is understood that for the time being all the drug related regulatory work in the newly created districts are performed by drug regulatory department of the neighbouring districts from which it has been bifurcated.
Gujarat government on August 15 last year had created seven new districts for better administrative process. With this the total number of districts in Gujarat is now 33.The seven new districts created were Aravalli split from Sabarkantha; Botad created from parts of Ahmedabad and Bhavanagar districts; Chhota Udaipur split from Vadodara district; Devbhoomi Dwarka split from Jamnagar; Mahisagar created from parts of Kheda and Panchmahal; Morbi created from parts of Rajkot, Surendranagar and Jamnagar districts and Gir Somnath split from Junagadh.
First state with mobile drug testing lab
A state having many distinctions, Gujarat is the only state in the country that offers services of an advanced on the spot mobile drug testing lab equipped with high-tech devices at a total investment of Rs one crore to the patients across far flung regions of the state. Through this initiative, the Gujarat FDCA has further strengthened its regulatory mechanism to conduct surprise drug testing, while on the move across the state to check on counterfeit or substandard drugs.
This mobile drug testing lab has a near infra-red spectrophotometer; x ray fluorescence spectrometer; ion mobility spectrometer and the Raman spectrophotometer.
One of the best features of this high tech driven testing lab is its non destructive nature which gives on the spot result of the drugs tested without causing any damages to the original samples that have been collected for testing said Dr Koshia.
With the launch of the mobile drug testing lab, the state regulatory officials will be able to reach the remotest part of the state for conducting surprise raids to check illegal manufacturing of spurious or substandard drugs. Depending upon the success of this pilot project, FDCA may add one more mobile drug testing lab to its arsenal, it is understood.
Gujarat FDCA has becomes the country's first state regulatory body to posses such a high end technology based mobile van for instant testing of drugs.
Regulatory initiatives
The state regulatory body has been always in the forefront for ensuring that the drug regulatory norms as per the Drugs and Cosmetics Act are duly implemented across the state. In fact, over a period of time, the state FDCA has taken a number of initiatives to sensitize and educate patients, pharmacists and other stake-holders on the new drug prices as and when declared by the NPPA to ensure that the patients are not paying extra money for buying drugs that have undergone price revision under the DPCO 2013.
The Gujarat FDCA had also embarked on a massive vigilance drive across the state to crack down on incidents of malpractices among the strong 17000 plus retail outlets and over 40,000 plus pharmacists to check whether the retailers and pharmacists are adhering to the provisions of the Drugs and Cosmetics Act and rules especially relating to the clause that stresses on presence of pharmacists in the retail outlets.
Similarly in the recent past they have carried out strict action against Small Scale Enterprises (SME's) who have failed to comply with the Good Laboratory Practices (GLP), mandated through the revised Schedule L-1 under the Drugs & Cosmetics Rules, Third Amendment, 2008, which demands installation of necessary machineries and equipment in all pharma units.
e-governance initiative
Gujarat FDCA has been streamlining its regulatory mechanism, through efficient use of information technology for some time now. One of the biggest endeavours of the Gujarat FDCA is its self-licensing software, Xtended Licensing and Laboratory Note (XLN).
XLN is a software for transparent and speedy disposal of various licensing applications and reducing the time lag between the collection of samples to declaration of results to dissemination of information to stake-holders.
This software helps regulate the sales and manufacturing aspects related to drugs, food and cosmetics; issuance of licenses, etc. The best feature of this software is that it enables the registration of all the pharmacists and chemists which prevents multiple illegal enrolment of pharmacists and helps to put a check on the activities of the stakeholders in the state to ensure public safety and their welfare.
According to Dr Koshia this is a end-to-end on-line system, wherein no physical file is required., for approval of licenses. The USP of the whole system is that it has an auto reminder for renewal of licenses, with centralised approval system for licenses and helps maintain one database which can be accessed by states, with single signon for multiple states.
Dr Koshia further pointed out that this software has helped in creating internal competition among officers by ensuring better planning and execution of duties by drug inspectors through various alerts that XLN generates. Many state drug regulatory authorities across the country like Bihar, Punjab, Tamil Nadu, Kerala, Maharashtra and Goa have already adopted this software.
The state FDCAs efforts have won plaudits even from international agencies like Bill and Melinda foundation, WHO, African countries etc.
Dr Koshia said that it is quite encouraging to see the global recognition for XLN which was done with a view just to ensure effective implementation of the drug related rules and regulations within the state. “It is a proud moment for us when regulatory agencies not only from across the country but also from the globe shows keen interest in understanding and analysing the functionality and adaptability of Gujarat's established self-licensing XLN software. All this has inspired us to further strengthen the already successful programme.”
In fact so impressive is its e-governance initiative that the Gujarat model has already been replicated in 12 states and declared for rapid roll out in all states across the country by the Department of Electronics and Information Technology DeiTY,Government of India
Awards and accolades
The Gujarat FDCA is one of the only regulatory agencies in the country which has received recognition for its e-governance initiative globally. The fact that the DeiTY had recently selected the XLN software for the national rapid roll-out programme in 2013 is a testament to this.
Dr Koshia pointed out that this shows the overall ability of this software to enhance efficiency through digital services and ensuring a secure cyber space, which further empowers the citizens by way of faster and transparent services.