Gujarat Food and Drug Control Administration (FDCA) has proved to be the market leader by continuously improving its regulatory strengths by embarking on projects that has grabbed global attention. Working as a team, it has revolutionised the way the drug regulatory body functions in the country, through its renowned e-governance programme. Dr H G Koshia, commissioner Gujarat FDCA shares in detail his future plans with Suja Nair Shirodkar. Excerpts
Can you enumerate the major achievements of Gujarat FDCA in the past year?
Gujarat FDCA has always been at the forefront of conceptualizing and adopting revolutionary e governance initiative in the drug regulatory segment. Time and again we have received accolades for our path-breaking initiatives developed and specifically designed to improve our healthcare delivery system in the state.
Safety of our patients have been our main focus, which has prompted us to take steps to boost our professional knowledge, skill and competence to explore our potential for disseminating information for public awareness with good governance in all functional areas of food, drug and cosmetics.
To further strengthen and promote the regulatory mechanism adopted by the state, we recently had undergone a training programme by the World Health Organisation (WHO), on the good regulatory practices (GRP) and national regulatory authority (NRA) assessment tool. Through this our officers were able to get hands-on training and workshop on NRA assessment tool which is focused on setting a benchmark for timely and efficient working of the system as per global standards, a goal which is in accordance with the Prime Minister’s vision.
Top United States Pharmacopoeia (USP) officials also visited our office to gauge the performance of the mobile drug testing laboratory, which is the first high tech on the go-spot-detecting drug testing laboratory of its kind in the country. They expressed keen interest in working closely with us to further enhance and train officials as per US requirements.
Early this month Mansukhbhai Mandaviya, the Union minister of state for chemicals and fertilizers also visited us and showed special interest in understanding the revolutionary not-of-standard quality (NSQ) drug recall SMS alert system.
In the past months we saw dignitaries from different regulatory bodies from across the globe coming to meet us to either know more about our revolutionary e-governance system or to ink some to collaboration. Top official from Department of Food and Drug Administration (DFDA), Myanmar; Bill & Melinda Gates Foundation; US FDA, MHRA etc are some of them. Apart from international regulators, we also work very closely with CDSCO and other drug regulatory offices from states like Odhisa, Madya Pradesh, Punjab, Haryana etc.
Please do highlight the measures taken by Gujarat FDCA to ensure best regulatory practices in the state?
To meet the changing drug regulatory requirements across the globe, we have been taking two-pronged measures. While we have always shown pro-active interest in adopting and updating our e-governance initiative from time to time, through our path breaking e- governance initiatives, like Xtended Licensing, Legal & Laboratory Node (XLN), DMLA and IDMLA which is manufacturing license software for FDCA officials and manufacturers; revolutionary NSQ drug recall SMS alert system, mobile food and drug testing lab, online complain module application etc, we have also been steadfastly working towards empowering our workforce.
We have been training all our officials on priority basis, by conducting continuous training programmes and induction training of newly appointed officers. This has helped us to not only sharpen our knowledge base, but also maintain and further improve the performance of FDCA to achieve newer landmarks.
Going an extra mile, we have also been motivating our officers to take up in service study in post graduation and Ph.D as well.
Any expansion plans in the coming year to further strengthen drug regulatory system in the state?
We are dedicated to serve our citizens with best services by upgrading our systems as and when needed. Keen to address the changing dynamics of the industry and regulatory structure we have been brain storming on new projects that would aid in ease of business.
Going ahead with this, we are planning to add two new food and drug district offices every year to our existing strength of 27 district offices. Also we plan to modernize our existing offices to meet the changing drug regulatory requirements. As of now we have completed the renovation of six offices already. The government has in fact sectioned our proposal to renovate and modernize four offices every year to meet the target.
There are in total four testing laboratories in the state, two dedicated food testing laboratories in Rajkot and Bhuj respectively and two state of the art food and drug testing laboratory at Baroda and Dethali in the northern part of Gujarat.
How challenging is your role as a regulator? How does your office ensure efficient implementation and monitoring of drug regulation in the state?
As regulators, our work is not simple especially since we regulate different spectrum in the healthcare sector which includes cosmetics, public testing labs, medical devices industry, disinfectants, allopathic, ayurvedic and homeopathic drugs, diagnostic reagents; blood bank and blood storage centers; pharmacies retail and wholesale and the food. What we do is ensure proper compliance and implementation of the food and drug regulatory practices like licensing of manufacturing units; giving approval for test and analysis; conducting post marketing surveillance and routine inspection and prompt investigation on complaints. We also undertake licensing of sales firms. All this requires lot of expertise and skilled manpower.
Apart from ensuring proper implementation and monitoring, we also make sure that the perpetrators who break the law are not spared. As punitive action, once found guilty we make sure that their licenses are either suspended or cancelled along with filing and building appropriate case against them as the situation demands. This we do with the help of our strong work force of highly skilled and trained food and drug officials.
What is the current strength of the Gujarat FDCA? Is it enough to meet the growing drug regulatory requirements in the state?
We are a strong team of 1403 officials consisting of drug inspectors, senior drug inspectors, assistant commissioners, deputy commissioners, joint commissioners headed by a commissioner. Having a competent workforce is a must to ensure robust and efficient services.
As of now there is a need to increase the current manpower strength to ensure better services, especially since Gujarat is a pharma hub. We are working with the state government on this subject and luckily for us the government has positively responded to our demand for additional manpower. Just recently the government sanctioned creation of additional post of five senior drug inspectors, two designated officers, and around 35 administrative staff to meet the regulatory demands. The recruitment process for the same is already in process.
All said and done, our backbone is our e-governance system, which has enabled us to ensure best services till date. Manpower crunch would have affected the way we delivered our services with respect to quality of work, if not for that. We are proud of it and can confidently say that our e-governance initiative has enabled us to handle work pressure with ease in a time bound manner.
Can you enumerate recent e- governance initiative undertaken by the Gujarat FDCA to ensure regulatory compliance and drug monitoring?
An e-governance initiative basically depends on upgrading, updating and developing new applications to meet changing requirements. We are currently working with NIC Gujarat for developing a new mobile application for consumers a.k.a. general public. This app is designed to empower people with an opportunity to access all regulatory data regarding safety of drug and food directly from the XLN software. NIC has already started its work on it, if things go as planned we may be able to launch it in a couple of months.
To develop and implement new e-governance projects in line with that of XLN and DMLA is on top of our agenda. However manpower issues at the NIC, and other technical problems are delaying our efforts to keep up with the process of strengthening the ongoing e-governance initiatives in the state. To address this we have already sent representation to the Centre requesting assistance for the same.
What are the major compliance and regulatory challenges faced by you as a regulator?
Gujarat is a major pharma hub making it a preferred destination. Thus it goes without saying that all this attention brings along its own challenges. While in general the industry is fairly very co-operative and good with compliance there are incidences of noncompliance especially among SMEs or MSMEs
It has come to our notice that some small-scale manufacturers are taking law for granted by overlooking certain regulatory features essential to ensure long shelf life of the products which in turn affects the quality of the drug. Lack of an efficient internal control or compliance system, inadequate utilization of technology to identify red flags, etc are other issues. We will take strict action against those who flaunt the law by being non-complaint.
It is imperative to understand that the success of the industry lies in jointly working with the regulators. As a regulator, I would urge all the stakeholder to ensue that they follow all the good regulatory practices and comply with the law of the land and work towards ensuring that the quality of the products are not compromised with.