With great opportunities comes greater responsibilities. Gujarat being at the forefront in attracting global investors to India particularly in the pharma sector, is always under intense scrutiny for its regulatory practices. Renowned worldwide for its efficient e-governance programme and stringent drug regulatory practice, Gujarat Food and Drug Control Administration(FDCA)  has played a crucial role in facilitating the growth and development of pharma industry of the state. Dr H G Koshia, Gujarat FDCA commissioner in an interview with Suja Nair Shirodkar talks about their consistent team effort which has helped the state establish itself as a reliable and dependable base for doing business. Excerpts from the interview:

What is the size of the Gujarat pharma industry?
Gujarat contributes to about 40 per cent of the national output and has significant number of large, middle and small scale players in the segments of API, formulations and medical devices. Apart from that we also have a substantial number of CRO’s, public testing facilities and research organisations which have been serving international organisations for research and clinical trials.

Pharma industry in Gujarat emerged in pre-independence days with the focus on indigenous  availability of essential medicines as against heavy dependence on imports. The next phase was during the era of seventies when Indian patent law came in to force and then was the phase of globalisation and liberalisation during the end of 20th century and beginning of the 21st century. During each of such game changing phases, Gujarat FDCA has been proactive in adopting efficient  administrative and regulatory systems to monitor the growth of industry and ensure due diligence to prevent  spurious and adulterated drugs coming to Gujarat from other states. This gave Gujarat an identity as the hub of quality medicines across the globe.

What has been the role of Gujarat FDCA in boosting the confidence of the stakeholders and promoting the state as a major pharma exporter ?
Gujarat FDCA has played a crucial role in facilitating the growth and development of pharmaceutical industry of the state under the vision and statesmanship of the first director B V Patel, ever since Gujarat state came into existence. The legacy and the heritage of governance with administrative and technical expertise has continued since then. It has been the top priority to ensure that the department is always spearheaded by highly qualified technocrats with sound understanding and exposure to pharmaceutical facets such as analysis, manufacturing trade, distribution, research etc.

We have a stringent drug regulatory norm in the state which ensures proper implementation of the Drugs and Cosmetics Act, boosting the confidence of the Gujarat pharma industry. Frequent inspection and efficient monitoring by the FDCA have played a crucial role in fuelling the export growth further. This has also helped Gujarat establish itself as a reliable and dependable base for doing business, opening up huge market for exports for Gujarat based manufacturers.

Most importantly, to gauge the stakeholders reaction to the latest drug regulatory changes and to have their suggestions on the same, we ensure that there is always continuous interaction and deliberation with them. Giving precedence on upgrading our drug regulatory knowledge, we have been interacting with international regulatory bodies and organisations like US FDA, MHRA, WHO, ISPE, DIA to name a few.

Can you highlight some of the key initiative undertaken by the Gujarat government in strengthening the drug regulatory system over the years?
The state government has always given us the highest degree of support and assistance to upgrade and strengthen our system by not only providing us with considerable financial support, but also by extending inter-departmental expertise to further the cause of our department.

The e governance initiative is one of such ambitious project spearheaded by the state government, successfully implemented by our department with the help of NIC. The Xtended Licensing & Laboratory Node (XLN) software has become a premium achievement of our department which has enabled us to attain commendable administrative excellence making Gujarat FDCA a leader in this area.

The modernisation of the entire infrastructure of the FDCA headquarter, district offices, laboratory upgradation, establishment of new testing laboratories and approval of required manpower for testing and inspectorate needs has always been diligently handled  due to the unerring support from state government.

What are the steps taken by the regulatory body to ensure that the provisions of the D&C Act are duly implemented?
We have been doing our best to keep a tab on the illegal activities and stop them on time. Till now we have been successful in busting illicit operations through our very effective, competitive and alert team. We are on constant vigil through our dedicated network of regulators, who are always connected to each other through a very systematic and strong system. The enforcement steps are driven by the data base which is generated  frequently, communication of which is immediately conveyed to the inspectorate staff. Thus it is ideal to say that through our existing information management system we are always able to have a professional approach to these kind of issues, within a short period of time.

Simultaneously, through our XLN software, which was mainly developed with an aim to control and to put a check on the activities of the stakeholders in the state to ensure public safety, we are able to efficiently 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.

In fact this is the first ever initiative taken by any drug controller in the country for regulating the drug distribution system aptly by bringing in place a system that will ensure effective recall of not of standard drugs instantly.

In fact, with a view to tackle the menace and to involve general public also in reporting of illegal or suspicious activities, we have also launched a toll free number 100 233 5500. Through this number, any person can report dubious activities regarding the quality of drugs, food or cosmetics, enabling us to get access to information or tips on illegal activities from anywhere across the state. Interestingly, with this move, the Gujarat FDCA has become the first state drug authority in the country to launch a toll free number on its website which aims to reach the public more actively.

Moreover, our laboratories undergo constant upgradation and are equipped with high-end instruments. Our responsibility is not only to combat spurious drug activities, adulteration or bust illegal rackets, but also to carry out surveillance of drug and food manufacturing units, to impart training to the stakeholders, to create public awareness and to see that an effective and transparent system of monitoring the quality of drugs is implemented across the state.

Do you think the state drug regulatory department is up to meet up the growing market challenges and changing drug regulatory set up?
We are a strong team of 84 drug inspectors, 42, senior drug inspectors, 26 assistant commissioners, six deputy commissioners, five joint commissioners headed by a commissioner. There are in total three testing laboratories in the state, two dedicated food testing laboratories in Rajkot and Bhuj respectively and one state of the art food and drug testing laboratory at Baroda. The work on the second food and drug testing combination lab built in Siddhapur in the northern part of Gujarat is already in the last stages.

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.

We are also in the last leg of procuring an advanced, on- the- spot mobile drug testing lab equipped with high-tech devices at a total investment of Rs. one  crore. The mobile testing lab is currently undergoing final stages of upgradation so as to meet the regulators requirement after which it will be launched in the state by end of August.

Through this initiative, we have further strengthened and hard-wired its regulatory mechanism to conduct surprise drug testing, while on the move across the state to check on counterfeit or substandard drugs.

Apart from that, we recently got an approval of Rs 39 crore from the state government for modernisation of the regulatory system in the state, which is a two- fold increase from last years allotment of Rs.19 crore which shows the keen interest of the state government has in preserving the health of the patients in the state. Thus, with recent sanctions, the staff is adequate and qualified.

All said and done, there  is an innate urge in us to keep on upgrading our regulatory and monitoring set up to meet the ever -growing regulatory challenges for ensuring best healthcare services to our patients. Thus all our focus will be directed towards infrastructural development, gaining latest medical and laboratories equipment for better and efficient drug testing and analysis, training of our officials getting high-end computers and better focus on e-governance etc.

Please highlight some of the major regulatory concerns or challenges faced by you as a regulator? How has the Gujarat FDCA tackled these issues?
One of our biggest regulatory concern is to keep close tab on the new entrants to the trade and industry, especially from those who do not have the core competence or background of the pharmaceutical profession. Since such new entrants are vulnerable to either quality compromises or inadvertent non-compliance, we have to be vigilant on their activities, as the reputation of the industry at stake.

The other challenge is to keep the department staff constantly updated with the new advances in technologies and analytical techniques etc. We therefore are focused on the training and refresher studies on r every level of the staff and thus keep them updated and vigilant round the clock to evolve the regulatory tools and systems to make them efficient and capable of monitoring new challenges for pharmacovigilance which might  emerge from new technologies.

As a regulator, do you think there is enough industry-regulatory interaction in the state as well as in the country? What is your views and suggestions on that?
Yes, certainly, there are adequate opportunities and platforms for the industry regulatory interaction in the country today, mainly because the only way we can have a successful regulatory set up is by winning the confidence and support of the industry. Gujarat is a shining example of the same. We have a strong industry who make our work easier with their regulatory friendly attitude.

However, I feel that we can further improve the level of interaction  far more meaningful by having an organised and long-term agenda based interaction instead of issue based or adhoc interaction.

How does Gujarat FDCA ensure business friendly model in the state while maintaining a stringent regulatory framework?
By firm and positive approach, counselling and proactive governance as against mere policing. We strongly believe that for having an effective regulatory set-up , we need the support of the stakeholders as well. So we have always maintained a good working relation with all our stakeholders by collaborating and interacting with them on a frequent basis.

We have always strived to simplify work for them by adopting a strong e-governance system that has helped us bring accountability within the system, building their confidence in us. In fact, the industry is  happy with the changes that the we have made in its administrative functioning, which has reduced lot of paper work and travelling of industry representatives to the head office. We are proud that the entire on-line system has been initiated in Gujarat and had been done in the interest of the industry at large.

Most importantly it helps us in performing our duties systematically in a time-bound manner without any unreasonable delay which is not only well accepted by the industry but also is easily accessible for interested parties bringing in transparency to the whole system.