Dr. Rakshit Trivedi
General Manager – Analytical Development (MDI & DPI), Sinnar R&D
For the longest time, things seemed to be moving smoothly for us to file our product for lung disease (Fenoterol Hydrobromide /Ipratropium bromide Pressurized Inhalation Solution) for the European market. Our deadline was clear: June 29th, 2020. This required a special “in-vitro & characterization study” to be conducted at the Aurangabad plant starting mid – April, and we seemed to be moving on time to meet our targets. Then, out of nowhere, a nationwide lockdown was announced due to COVID-19, threatening all our plans for a timely data submission. To make things more complicated, Aurangabad was one of the hardest hit zones with the infection spreading rapidly across the region.
We had long discussions contemplating if we should conduct or postpone the study, which would need at least 62 days to finish. We were well aware of the many travel restrictions and risks involved, so we paused our efforts for a month. This now meant only half the time to finish our activities! But our team strongly echoed one sentiment - where there’s a will, there’s a way. We took a leap of faith and decided to leave for Aurangabad to begin the study. And then began a new set of challenges.
We struggled to get e-passes for inter-district travel, which finally were issued to us only a night before we planned to leave! The transit was dreadful with at least 5 police checks registering our details. When we finally reached Aurangabad, we learned that only one hotel (with no laundry services), right in front of the COVID care center, was taking reservations, that too 30 kms away from the plant. We tried our level best with the government authorities, friends and local contacts to get a reservation at a hotel closer to the plant, with better facilities and food. But when that seemed to go nowhere, we had to make do with what we had in hand.
During the 48 hrs. of our quarantine, with support from the local admin team (Mr. Sanjay Kulkarni), we successfully arranged for daily local transit and for the vehicle to be sanitized on a day-to-day basis. With these basics in place, we were relieved and focused on planning for the project. We knew there was no room for any setback given our stringent timelines. We planned our activities in every shift with the help of the local QC department to facilitate timely completion of the 6 M analysis of the product in 20 days. We then started the execution of our first protocol. For the first couple of days, things ran smoothly and then began another roller coaster ride. The HPLC columns were not working as per desired performance. We were anxious and contacted several vendors, but they had no new columns in stock since things were stuck at customs. We decided to keep an online check of the systems under run. We made up our minds to work round the clock.
So, there we were, doing 12 hour shifts, passing on the baton to the next person with utmost precaution, leaving no stone unturned. The protocols were now being executed at the pace we desired. Things seemed to be on track until it started raining very heavily. Aurangabad had not seen such torrential rain in a decade or two. To make matters worse, there was no electricity in the hotel and the generator was out of order. The hotel’s only chef couldn’t cook due to electricity failure! We had to rattle the hotel’s management to get the lights back on. We advised them to get the spares from other hotels which were shut down. For a few days we had candle light dinners till late. With only one chef catering to the 50 in-stationed people, we were eating whatever he was able to cook with limited resources. We even bought fruits, salad and snacks from the market, so that we eat on time, lest we fall sick.
The entire team was putting in all their zeal and hard work with eyes on the prize. The study was going on smooth with 24 hrs. watch on all the activities, every step was taken with utmost care and precaution. With physical activities done, data compilation was a huge task and over it, re-confirming the data and statistics. Our eyes were immensely strained but we promptly submitted the entire data a whole two days in advance to the Regulatory team. Putting all the dark patches behind us, with a feeling of contentment, we could now return to Nashik. Although we again faced hurdles with e-passes for the return journey, our site Admin Officer Ms. Nisha Dayama put in all the efforts to bring us back safely to our abodes on the 22nd of June, 2020. All of us returned safe and healthy with no COVID-19 infection.
This entire episode not only became an inspiration for the larger team at Sinnar, but also taught us perspective on how we view challenges. Every obstacle presents an opportunity to reinvent ourselves, and even achieve what seems impossible. An activity that was planned to take 62 days and to achieve it in less than half the duration under such unprecedented conditions was surely no ordinary feat. It pushed us to re-organize ourselves to achieve synergies / efficiencies and gain on lost time.
A butterfly comes out with beautiful wings, but is able to fly only when it has struggled to come out of the dark cocoon. We learned to keep our cool in intense situations, to communicate and make-up for each other’s weaknesses, by letting go of personal differences to accomplish something others can only dream of. We revisited how each one in the team had a special way of contributing to a cause. Best of all, we took care of each other, complemented and helped each member perform their part, leaving no loose ends.
I extend my congratulations and hearty gratitude to the below team members who supported each other and worked round the clock to deliver results.
Ms. Madhuri Jain
Mr. Jayesh Kothawade
Mr. Sunil Dave
Mr. Parashram Sadgir
Ms. Chitra Shingte
Mr. Rajesh Dharpawar
Kudos to all the efforts by the team under the guidance of our leader, Dr. Rajesh Ankam.
Special thanks to the following individuals from Aurangabad plant for accommodating our schedule / process and shouldering the responsibilities with us.
Mr. Pravin Bhite
Mr. Arun Jain
Mr. Abhai Kumar Karsulkar
Mr. Dnyaneshwar Patil
I would also like to extend my thanks to the below admin members for their unending support, availability at odd hours and cooperating with us during tough times.
Ms. Nisha Dayama
Mr. Sanjay Kulkarni
Let us all collaborate and challenge our limits to continue reaching such milestones together!