You have been associated with the Gujarat FDCA office for the last 24 years and last five as the commissioner, what paradigm shift have you witnessed in Gujarat FDCA?
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Dr HG Koshia
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The major shift has been in e-governance and administration. The Gujarat FDCA has been able to establish it as a watchdog and custodian of healthcare as against a mere enforcing agency. The other major shift has been in the approach and style of governance. With the utilisation of electronic gadgets and e-governance tools, administration has been networked across the state for effective and harmonised administration. Be it licensing for sales or manufacturing, be it sampling, analysis and cognitive corrective actions or proceedings –the FDCA administration has followed a result-oriented and businesslike approach.
The XLN network system has been a path-breaking step by the Gujarat FDCA which has been subsequently adopted by other state administrations. This e-tool has integrated the headquarters with all district centres as well as all the testing laboratories of Gujarat. The data so compiled and generated has not only provided quick clearances for licences, renewals, product permissions and pharmacovigilance but has also been a great tool to ensure compliance by trade and industry as per the Drugs and Cosmetics Act and various rules thereunder. This has also helped the administration, and especially the vigilance branches of FDCA, to control the menace of spurious and look-alike drugs.
At one point of time Gujarat was a pharma manufacturing hub, however the industry has slowed down lately. What have been the reasons for the slowdown? Have you planned any strategies to revive and attract more domestic and multinational pharma companies in the state?
It is not true that the Gujarat-based pharma industry has slowed down. In fact, Gujarat-based pharma units have expanded their activities outside Gujarat but their effective control and management has been from their Gujarat headquarters. The move of Gujarat’s big pharma houses to expand their facilities outside the state has been a strategic approach to concentrate Gujarat operations for higher value added and regulated markets. This in turn has achieved higher growth in value terms from Gujarat.
More and more investments in Gujarat’s pharma sector has come from US-based pharma companies that already have their presence in India. Many more are in the process of establishing facilities for specialised APIs and finished dosages for regulated markets.
What are the issues pertaining to regulatory compliances that you had to overcome as the head regulator of the Gujarat FDCA?
Simplified and smoother administrative functions by use of e-governance, especially e-licensing has spared the technical resources and manpower of my department to focus more on compliance monitoring, vigilance, sampling and analysis. This has obviously brought a sense of compliance readiness in the minds of trade and industry captains.
What responses did you receive for the pharma sector from the Vibrant Gujarat initiative, run by the Gujarat Government and how encouraging were they? Do you have any plans to run more programmes like this to encourage more investments in the pharma sector?
Vibrant Gujarat has attracted the greater attention of pharma sectors from across the world. There has been ancillary investments, leveraging on the growth of pharma sector in Gujarat, especially in the area of pharma machineries, pharma automation support systems, primary packaging component manufacturing and high-tech packaging sector, to cater to modern and state-of-the-art pharma manufacturers of Gujarat.
There has been a tremendous pull for highly skilled manpower, catering to the demand of soft skills for the pharma sector. All these have been due to the biennial Vibrant Gujarat over the last 10 years.
I look forward to developing more innovative schemes and models to attract further investments in pharma sector through Vibrant Gujarat seminars by working in close cooperation with the industry department of the Gujarat state.
Under your leadership, the department has managed to break the glass ceiling and has introduced various programmes like e-governance, brain storming sessions with US FDA drugs regulators, high-end drugs testing labs, scanning drugs procurement process under the Jan Aushadhi programme etc. How have these helped Gujarat-based pharma companies to grow fast?
The initiatives from our administration has generated a positive and vibrant environment for existing pharma entrepreneurs to expand, grow and forward integrate. They have been marching towards global markets and high end regulated markets. They have been investing in research and intellectual properties with confidence and assurance due to the supportive environment that Gujarat as a state provides.