Jyoti J Sardesai, Director, Goa FDA, the first woman to hold this post, speaks on her journey and the current scenario of pharma sector in Goa
Brief us about your journey from drug inspector to the Director of Goa FDA?
I am an alumnus of Goa College of Pharmacy. After graduating in Pharmacy from University of Bombay in 1984, I joined the pharma industry and after eight years of experience in public as well as private sector companies, I was selected by the State Public Service Commission for the post of drug inspector, and I joined Goa FDA in March 1992.
After 13 years, I received my first promotion as Assistant Drugs Controller in 2005. I then completed my Post Graduation in Pharma Sciences from Goa University in Pharmacology. In 2010, I became the Deputy Director of the Department and in December 2017, I was promoted as Director of Goa FDA.
Concurrently, I have worked as a designated officer for the licensing of food establishments, and also held the positions of Public Information Officer, Public Grievances Officer, Chairperson of the screening committee for NSQ drugs and Chairperson of the Committee for sexual harassment etc. I have also served as the Nodal Officer for Goa State Litigation Policy, and Survey to detect the extent of Spurious and Sub standard Drugs, carried out by CDSCO.
As the first woman director in Goa FDA, how do you see the current scenario of women leaders in pharma industry and what are the challenges you have faced?
Interestingly, I was the first woman drug inspector to join the Department in Goa. In fact, I was selected by State Commission for two more Gazetted Officer positions, namely, Junior Scientific Officer in FDA and Scientific Officer at Goa College of Pharmacy at the same time. It was my choice to be a drug inspector, when the number of women drug regulatory officers in our country was pretty low.
I am happy and proud to say that today, nearly 60 per cent of my drug and food regulatory officers in Goa are ladies.
As is generally the case, being the first woman officer in regulatory duties, there were certain challenges that came my way, especially working extra hours, late night inspections and raids, and the general attitude of the stakeholders towards a lady regulatory official. But I must mention here the support that I received from my colleagues and bosses, which encouraged me to do my duties diligently.
Today, we see many women occupying senior management positions, including that of CEOs, in India as well as the world pharma industry, and they are doing as well as their male counterparts. I am sure they must have faced multiple challenges along the way, in defeating the conventional notions. But yes, today the glass ceiling is indeed broken.
According to you, what are the major reasons for the lack of women leaders in the industry?
Not only in pharma, but in any field, today there exists equal opportunities for women. Women are no less in qualifications, talent, intelligence, hard work and efficiency. According to me, in our Indian value system, for a woman, family requirements take priority over career requirements. Demands of the job such as late workings, travels, outdoor duties often clash with demands of family, including children. Here, positive attitude of the family members and their unstinted support matters above all else and plays a great motivating factor to the determination of working women.
Brief us on the issues faced by the pharma industry in Goa.
Goa today is a preferred destination for pharma manufacturing , predominantly for exports. We have about 70 manufacturing facilities, of MNCs as well as leading Indian companies, majority of them approved by international regulators viz. US FDA, MHRA, MCC, TGA, ENVISA, and even Japan. The rest of the facilities are certified under WHO-GMP scheme. Some of the aspects that attract these manufacturers to our state are pollution free environment, English literate workforce, availability of pharmacists, good connectivity by road, rail, sea as well as air, and encouraging government policies. Our department too, has over the years, played a positive role in facilitating the above, through a speedy and transparent functioning. In addition, good educational institutions, residential options and generally a good life also is a motivating factor for the senior management personnel to move to Goa. In addition, we have several blood banks as well as one public testing laboratory in Goa.
Goa is one of the states with a high number of pharma plants. What are the problems faced by FDA in carrying inspection on a regular basis and does the state FDA has sufficient drug inspectors?
In spite of the above positive aspects, some of the major issues faced by the pharma industry in Goa are adequate supply of quality power and water. For power, our state is dependent on the national power grid and we do not have any power plants here for public supply. So, there are certain restrictions. But the situation has improved in the recent years. For water too, the work of laying new and bigger pipelines and of augmenting the supply is currently on.
In issues of manpower supply, we have two pharmacy colleges in Goa, where 120 graduates pass every year. Additional qualified pharmacists are available from neighbouring states like Maharashtra, Karnataka, Odisha, AP etc, and so also other employees.
Goa FDA is engaged in regulating both, food and drug activities in the state. We have two distinct sections for each. The Director of Goa FDA is also the Commissioner of Food Safety.
We presently have nine drugs inspectors, two technical officers, three assistant drug controllers and two deputy directors. We are also equipped with a fully functional testing laboratory for food and drugs, in our own campus. It has Asst Chemists, chemists, Jr Scientific Officers and Sr Scientific Officers in the drug testing section. Yes, the current manpower is just sufficient for the existing pharma manufacturing as well as trading activities.
Goa being a smaller state, nothing is really that far, and moreover, our office is situated at a convenient and accessible location. The building is designed to be people friendly and our staff is trained to be responsive to the stakeholders’ needs.
Our drug inspectors carry out regular inspections, investigations, joint inspections with Central Drugs Regulatory Offers, participate as observers during overseas audits like US FDA, MHRA, ENVISA etc, and we have not experienced any serious problems in all these activities. The biggest contributor to this is the high level of regulatory and CGMP compliance by our manufacturers. Incidences of spurious and misbranded drugs are almost non-existent in Goa. Even the quantum of drugs not of standard quality is very small.
What initiatives have been taken by the state FDA to keep the drug inspectors update with the changes in regulations?
Our department has always believed in keeping our regulatory, technical and analytical staff updated with the latest changes, techniques etc, and our participation levels in the training sessions, workshops, seminars organised by CDSCO, NPPA, US FDA,WHO, IPC as well as FSSAI are very consistent and high. We have also provided conference hall and training facilities within our premises, which are used not only for our staff, but also for training and awareness activities of our stakeholders.
How is the state addressing the issue of counterfeit of drugs?
As mentioned earlier, we have not experienced a single instance of manufacturing of counterfeit drugs in our state. However, we have come across cases where counterfeit versions of the brands legally manufactured in Goa, were being manufactured elsewhere in the country and sold. Mostly, these have been popular brands with easy-to-duplicate packing, like bottles or strips. We have actively conducted investigations, often in association with other state regulatory officials, and taken the process to its logical conclusion, including prosecutions.
Two of the major initiatives that we plan to undertake are upgradation of our testing facilities with the aim of achieving NABL accreditation of our Food and Drug Testing Laboratory and opening a branch office of our Department in South Goa District.
For the laboratory, we are in the process of recruitment additional staff and procurement of sophisticated instruments and for the South Goa office, the site has already been allocated by the government. If all goes well, we will have both these projects on stream shortly.
The current issue of Express Pharma is on Women’s Day. Can you share a few inspiring words for women following your footsteps?
My humble message to fellow women would be simple and clear- give equal importance to career and family, work hard, keep yourself constantly updated in knowledge, techniques and regulations, keep high aim and work with determination to achieve it. And one last thing, be strong and never ask for concessions based on gender.
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