When it comes to rating the best drug regulatory body in the country with respect to pro-active steps taken towards regulatory upgradation and good governance initiatives, Gujarat Food & Drugs Control Administration (FDCA) takes the prime spot. From being one of the pioneers in initiating the e-governance programme in the country's drug regulatory system to initiating industry friendly policies, Gujarat FDCA has always been in the forefront under the exceptional leadership of Dr H G Koshia, commissioner, of the state drug regulatory body. Dr Koshia shares his future plans and challenges when it comes to adopting best patient centric practices in the state with Suja Nair Shirodkar. Excerpts from the interview
What is the overall contribution of the Gujarat FDCA in setting up high parameters for ensuring efficient regulatory mechanism in the state?
Gujarat FDCA has the legacy of pioneering contribution right from the time of B V Patel and his eminent successors, providing robust and efficient set up for effective and focused performance. During the last few years, FDCA team of Gujarat has endeavoured to reinforce the system with modern tools of administration, based on IT platform in co-operation with NIC and other nodal agencies.
Training has been another feature which has been incorporated for enhancing the performance of the officers and keep them updated with the progress of pharmaceutical industry and global impact on Indian pharmaceutical Industry.
The monitoring of samples for tests analysis for food and drugs have also been given top priority. This system has been made intensive and extensive enough to cover up the sampling of all types of dosage forms and product range as well as coverage in terms of remotest corners of the state. This has proved very important to get the true picture of the quality of drugs moving in the market. The state drug laboratories have been provided adequate infrastructure in terms of modern instruments for analysis as well as qualified staff.
Can you highlight some of the major challenges that you have faced as a drug regulator in the state and how you and your team handle those challenges in the light of the recent regulatory changes?
The major challenges include the pressure to cope up with the growth of the pharma and food sector in terms of licensing and monitoring. This has been handled efficiently by FDCA headquarter at Gandhinagar and district offices by successful execution of the IT platform XLN.
Gujarat has been in the forefront for exports to regulated markets. Their performance in these markets and their compliance to the international guidelines is the reflection of the overall Good Manufacturing Practices (GMP) environment and monitoring by FDCA in the state. FDCA officers have therefore been constantly provided training and have been interacting with team of inspectors coming from various countries.
The vigilance towards possible menace of the spurious and substandard drugs has always been a challenge. The investigation branch of FDCA is ever vigilant and is supported by the entire senior team to be watchful for preventing the passage of spurious drugs in the state or manufacture of such drugs in the state.
The e-governance initiative of the Gujarat FDCA has been in the news for all the good reasons, what has been the overall impact and contribution of this initiative especially the XLN software in ensuring effective regulatory compliance in the state?
E governance initiative has been of immense help in meeting the timely servicing of the licensees , monitoring of samples and the analysis and the actions required for consequence of failure of drugs upon analysis. The initiative has helped all the stake-holders and has made their tasks more efficient and productive by reduction in their time for follow up and seeking information about the status of matters.
This well accepted initiative was developed by FDCA to help the regulators perform their duties more effectively by enabling speedy disposal of various application while bringing in transparency to the system. The beauty of this system is that it is tailor made to address not only the needs of the regulatory officials but also helps in bringing in more productivity to the whole process.
In fact we trying to continuously evolve the existing software by adopting new changes to it, like the online application for additional API product licences that was launched recently. Under FDCA online application programme for additional API product licences, all the manufacturers who wish to apply for API product license in the state will from now on have to compulsorily apply for the same through online only. The Gujarat FDCA is also working on launching online applications for additional product licenses for formulations as well.
How has it helped the state regulatory body in handling the key issues within Gujarat when it comes to regulatory issues ?
The e governance initiative has been of great help in tracking and generating the quick information, be it for the purpose of providing information to the policy -makers, be it to investigate the matter of spurious drugs, be it to analyse the performance of the district offices or the testing laboratories managed by the FDCA.
What are the measures taken by the FDCA to sensitise and ensure that the pharma units in the state implement all the regulatory requirements as necessitated by the Centre like the New DPCO?
FDCA is regularly interacting with the industry and trade through the associations such as IDMA, chemists and druggists associations, especially during the announcement of new policies, notifications for ensuring the smooth and uniform implementation of regulatory guidelines. Various seminars are conducted regularly by the joint efforts of all the stake holders and subject matter experts to disseminate the proper information and interpretations about regulatory changes.
What is the current status in the state with respect to the implementation of the new drug pricing policy? Have you started the inspection of the chemist shops and other stakeholders to verify the situation?
The matter must now be regarded as sub judice and further update is expected from judiciary on September 23 . We shall be following the further directions upon the hearing in the matter. Our teams are geared up with the backup plan and task forces to monitor the implementation of the same.
Any suggestions on how to tackle these issues so as to boost the confidence of the stakeholders about the government policies?
Industry needs to be responsive in terms of providing data and their suggestions when policy makers invite their contribution before passing the ordinances or notifications. Industry has remained reactive rather than proactive.
Can you elaborate on the future plans and the new projects of the Gujarat FDCA that are currently under pipeline with respect to strengthening the monitoring and regulatory mechanism in the state?
We are establishing a new modern-state of the art testing laboratory for food and in the second phase for blood testing laboratory in North Gujarat with a planned outlay of Rs.60 crore. Interestingly, just recently the Gujarat CM has announced formation of seven new districts in the state. On this occasion, our administration is actively involved in the process of establishing district offices for all these new districts, so that the healthcare needs and safety of the patients are not compromised in the slightest during the whole process.
As a drug regulator where do you see the Gujarat pharma industry including the CRO industry, machinery and medical device industry going in the coming years?
Gujarat pharma industry and all its facets will continue to be the leaders. The industry is in the advanced stage of modernization in terms of the technology profile and is gearing up for embarking upon the international business to regulatory countries in a big way.
What would be your suggestion to the stakeholders in the state when it comes to regulatory compliance and requirements?
Regulatory compliance –as a continuous state of compliance is the key to success for global business. Regulatory compliance is a window to the world.