Gujarat Food and Drug Control Administration (FDCA), headed by a team of motivated task force with modern outlook and compliance mission, is constantly engrossed in its vision to maintain Gujarat as the best hub for attracting pharma, CRO, medical device and biotech companies not only from India, but also from international arena. Dr H G Koshia, commissioner, FDCA, the man behind the success story of the present Gujarat regulatory programmes in an interview with Suja Nair Shirodkar shares about their continuing and much acclaimed efforts to excel in efficiency in the drug control administration. Excerpts…

What is that makes the Gujarat FDCA different from other drug control departments in the country?
Gujarat FDCA, since its inception, has the rich heritage of result oriented governance. Apart from that, most of the officers in our team have working experience of pharma industry and exposure to national and international regulatory developments. Thus we have the comprehensive and wholesome view of all the facets of pharma profession which needs to be administered and controlled.

Most importantly, we have been provided with the modern infrastructure for governance, along with a young team which is very friendly with modern systems of communication and networking. We have always received extreme support from our secretariat, ministers etc. and to support that the pharma professionals, entrepreneurs of Gujarat are very progressive and compliance oriented rather than the approach of circumventing the rules. This provides us with enough quality time and priorities to focus on development of systems of administration and controls rather than just policing tasks.

The industry associations like IDMA Gujarat, chemists and druggists associations, etc are very constructive pressure groups.

What are the key issues and challenges that you and your team face in the state when it comes to regulatory compliance?
The issues and challenges for compliances are mainly for controlling the passage of spurious and substandard drugs into the state from certain other states of India. Thus the major challenge lies in the distribution and storage of medicines. We face similar challenge for the food products as well, as packaged food and its varieties and versions are proliferating.

The challenges are also in the field of cGMP enhancement in line with the newer WHO Guidelines as well as international guidelines such as ICH. We need to cope up with knowledge upgradation for our officers and this calls for a lot of investment of time and give priority for organised and systematic training of our officers.

The other challenge is to expand our infrastructure, manpower to cope up to the extremely fast progress of industry and trade in our state.  The progress is extensive and intensive in terms of geographical coverage across the state and this calls for ever increasing controlling points and establishing district level infrastructure with delegated powers as well as decentralisation of some of the powers.   Post licensing monitoring or pharmacovigilance of newer formulations and new drug entities is also required to be captured in the enforcement systems.

What are the measures taken by the FDCA to ensure that the pharma units in the state are implementing GLP which was introduced from last November 1?
Our data and subsequent checking has ensured that significant number of manufacturing units in the state, especially those having WHO GMP accreditation under joint inspection with CDSCO as well as those units which have been qualified for State GMP accreditation, have implemented and are compliant to schedule, even prior to the GLP implementation which was introduced from last November 1.

Have you started the inspection of the pharma units to verify the situation? Please give us the current status on how many units have complied to it as of now and how many are yet in the process?
Most of the existing units in the state are inspected since the introduction of GLP last November, either during the WHO GMP certification or State GMP certification process and license renewal stages of the companies. Only very limited number of units are yet to be checked and even they are in the process of inspection.

What are the new projects that the Gujarat FDCA is currently undertaking to keep up with the change in monitoring and regulation?

We have been trying to establish an effective and meaningful system of controlling not-of-standard products and to ensure that the recall is fast enough to prevent any penetration of not of standard or spurious drugs up to the consumer or the patient, once it has been detected and found not good for use.  For this purpose, we have developed an SMS alert system, as it will help in quick and extensive communication with product and batch details, to the district headquarters, all field staff and it can also be extended for creating public awareness on the same.

Recently, Gujarat FDCA had received ISO accreditation, the re-engineering exercise undertaken for ISO certification has helped for more integration in the functioning of the administration at the Headquarters as well as with district offices. Our Central testing laboratory Food and Drug Laboratory (FDL) at Vadodara is NABL accredited and is also scheduled for major renovation as well as expansion of modern testing facilities for modern and sophisticated instrumental analysis. The upgradation will also assist in speedy testing and thereby also accommodating increased sample testing.

The administration has also been strengthened with fresh recruitment of inspectors as well as analysts at FDL. Thus long pending issues on inadequate staffing to cope up with the increased workloads due to growth of manufacturing and distribution of pharmaceuticals in Gujarat is nearly resolved. FDCA is also in continuous dialogues with National and International organizations like DIA, FIP and even the offices of FDA in New Delhi and Mumbai and has increased its connectivity for information sharing and imparting training to its officers.

What are the key factors that attract the pharma, biotech, CRO & medical device sectors to Gujarat?
The industrial policies of Gujarat, strives for growth of the industry apart from that the quick and single window services of the administrative machinery are the primary factors for attracting entrepreneurs from India as well as abroad. The large pool of educational institutes and institutions like PERD centre, Niper Ahmedabad, management institutes like IIMA, training institutes like SPIPA Gandhi Labour Institute are also contributing factors to this. The ADC facility at Ahmedabad airport and infrastructure at ICDs in various parts of the state are great boosters to export-import business and for safe and quick cargo movement.

Overall entrepreneur mindset and work culture are also very positive influences in inviting pharma and other sectors like biotech to the state. Of course, our administration's role in facilitating the pharma licensing and required clearances with a positive and supportive approach are also considered strong aspects.

Where does Gujarat stand when it comes to initiating industry-friendly policies?
Gujarat is second to none when it comes to making pragmatic and industry friendly policies. This is a proven and well known fact across the globe now.

Any suggestions that you would like to make to the companies that would help in boosting the business in the state to another level?
The companies should focus on research and development with stronger emphasis on developing newer drugs with the advantage of CRO's of Gujarat. Moreover, the pharma companies in the state who have already excelled in the conventional API and formulation sectors needs to look into the scope of entering into the biotech sector and medical devices sector.