When it comes to an industry- friendly regulatory body, the first name that comes to our mind is the Gujarat Food and Drug Control Administration (FDCA), which has shown its prowess and effectiveness in policing the regulatory requirements aptly across the state. Over the years, the state regulatory body has established a unique identity for itself as a leader in pioneering the e-governance system into the regulatory system of the country.

Today, with its wide expertise and knowledge, Gujarat FDCA  has created a niche for itself and to continue the momentum, it frequently keeps on updating and upgrading itself as per the changing needs of the times. Moving on the same lines, the Gujarat FDCA is soon planning to request the state government  to increase  fund allocation in the coming financial year for upgrading their office which will enable them to ensure strong functioning of the regulatory body and effective implementation of Drugs & Cosmetics (D&C) Act across the state.

It is also in the process of sending a three-point representation to the CDSCO, requesting them to make strategic changes in the present training module  for  the drug officials at the centre for  effective delivery of services. The aim behind this move is to provide   world class training to all Indian drug regulatory  officials  which will help in the smooth functioning and harmonisation of good regulatory practices throughout the country.

This representation had been made keeping in mind the larger interest of the drug regulatory system of India, so that it can be upgraded to  world class standard. Though  there is already a programme  by the centre for training the newly recruited drug inspectors , it was not effective enough to get the desired result due to  lack of professionalism . The FDCA is putting in efforts to  impress  the government on the  importance of adopting a different strategy for training  drug officials. It is of the view that   government took  immediate steps on improving the present system so that the newly recruited officials are acquainted with  their respective duties.

According to Dr H G Koshia, commissioner, Gujarat FDCA, effective training is an important aspect for proper implementation of regulatory practices as it will enable the FDA officials to have a greater understanding of their jobs and responsibilities. “Imparting proper training on how to conduct raid, draw samples, decipher the rules and regulation as given under the law, understanding the minutes of the duty is a very important aspect for any regulatory officer. However, it is unfortunate that in spite of the need for a well structured programme aimed at training the officials both new and the existing one, we are lagging  in this segment which structures the working of the whole regulatory system of the country.”

He pointed out that the government must provide an ideal platform that would enable new entrants with opportunities to undergo training to develop their capabilities in  performing their duties. He said, “We need a training programme that is both functional and effective in delivering hands on training to all the regulatory officials unlike the present one. Understanding the need for the same we want to     suggest and request to the government to adopt a strong and vigorous training regime throughout the country.”

Training module for  drug inspectors
For this purpose, the FDCA has also urged the government to create a new post at the centre specifically dedicated to look after the affairs of training the regulatory officials. As they believe that the creation of a separate post will ensure a well organised and responsible implementation of the training procedure in the system.

Dr Koshia insisted that for a far- reaching and effective implementation it would be reasonable to conduct this training in the zonal offices which will be both time- saving and affordable. “Most importantly, we want the government to take steps to ensure that the training programme is looked upon as a continuous process focused on sensitising not only the newly appointed officials but also re-educating and updating the experienced officials on the latest regulatory development,” he added.

With a view to ensuring effective services in the absence of the training programme supported by the central government, the Gujarat FDCA has formulated a special training module to train the newly appointed drug inspectors on their  duties. This training programme is either conducted in collaboration with the industry or at times by inviting other regulators from across the world to impart their skills and expertise in this area.

The state regulatory body wants the central government to adopt a similar strategy  at the centre as well so as to harmonise the training module throughout the country for effective delivery of services.

Increased fund allocation sought
To implement this plan effectively and competently across the state, it is essential to have a strong financial support from the government. Thus to initiate this progressive plan across the state, the FDCA has also  made a specific request to increase their fund allocation in the coming financial year for upgrading their infrastructure.

The  funds allocated will be utilised for recruiting and developing a strong work force of skilled manpower to meet the growing industry demand as well as to develop an ideal infrastructure to support the needs of the work force.

Dr Koshia point out, “Gujarat is considered to be a pharmaceutical hub of the country with growing market interest in the medical devices and healthcare sector. Thus to maintain the quality of the regulatory standards and to meet the huge demand arising from the state, it is essential for us to beef up our office accordingly. We have already begun the process of filing a report demanding increased allotment to address this issue.”

Every year there is a strategic increase in the funds allocated to Gujarat FDCA for its administrative purpose and recruitment activities. In the last three and half years itself the budget allocation had increased from Rs.7 crore to Rs.21 crore which is a huge achievement in itself.

Administrative revamping
Getting competent manpower to handle this responsible job is a huge problem. To address this issues and to ensure that there are enough regulatory officials with expertise in their field, the Gujarat FDCA recently started the training of the 65 drug inspectors (DI's) in the state who were selected in May 2011, under the revised recruitment rules of 2010. This  move will help in building up a strong DI workforce in the state, which will help in better regulatory implementation and policing. For this the FDCA's office has relaxed the previous norms in the recruitment rules so that they could get more  applicants for this post.

Dr Koshia says, “We were stuck in a logjam earlier as we had very limited options with respect to selection and recruitment procedure in our previous policy, which was considered as both stringent and complex. Thus to open up more avenues for deserving candidates and to fulfil the needs of the office, we took a collective decision and changed the norms based on a detailed analysis of the situation so as to address both the issues. Interestingly, after adopting the changes we were able to get applications from more deserving and eligible candidates, which includes the recently appointed 65 DI's.”

Dr Koshia informed that though these inspectors were appointed last year their approval came in just recently. At present these drug inspectors are undergoing training and will soon be ready to join the work force. This is the largest ever recruitment drive that took place in any of the state drug regulatory office in the country. With this, the total number of DI's in the state which includes both senior as well as junior inspectors comes to 135, the largest in any state.

Today there are 25 districts in Gujarat in which drug inspectors (DI's) are appointed according to the district size and the number of chemists shops in each of the districts. Ahmedabad has the largest number of DI's in the state i.e. eight to monitor the area due to its size and strategic location as many of the chemists and pharma companies are located their to the smallest district having just one DI in the area.

“Our agenda is to ensure that there is enough manpower to handle the growing market demand so that it will help us in maintaining the quality of  services as well ensuring public safety. Understanding the need for quality based services, the state government has always been supportive of our demands. Thus we are sure that the government will fulfil our demands through a planned budget for the effective functioning of the Gujarat FDCA in future as well,” Dr Koshia conceded.

However, expressing his concern over the man power shortage as far as drug inspectors are concerned, he pointed out that since 2005, there have been no new post allotted for drug inspectors which needs to be addressed at the latest as it may impact the over all performance of the regulatory body in the state if left unaddressed.

Cross-border collaboration
Early in the year, representatives from the United States Food and Drugs Administration (FDA) had visited the office of the Gujarat FDCA to discuss and demonstrate the use and importance of rapid screening method in testing. Gujarat FDCA is the only state regulatory body that the US FDA had visited during its visit to India, the rest being done through CDSCO's office.

The four-member delegation from the US FDA included Dr Lucinda Buhse, director, division of pharmaceutical analysis (DPA), Centre for Drug Evaluation and Research (CDER); Dr Benjamin J Westenberger, deputy director, DPA, CDER; Dr John Kauffman, research chemist, DPA, CDER and Dr Albinus D'sa, deputy country director, US FDA India.

During their visit , they gave hands on demonstration on the use of rapid screening methods on x-ray fluorescence; ion mobility; raman and near infrared analyser to the regulators and the stakeholders.