Clinical research has travelled a long way, with early days’ manual processes transforming into heavily digitized, technology-enabled procedures with advancements in technology. The world’s primitive civilization relied on medical observation to analyze and determine herbs, drugs and available therapies that worked, and those that did not. India’s traditional Ayurveda texts that imbibe detailed observations on diseases and in-depth guidance on remedies are likely to be based on direct observations made by the ancient experts, however, there is no recorded documentation to support the statement. India’s growth and development in the field of medical research over the last few years have evolved the country into an engaging place for clinical trials. Cushioned by government support, investments and a new crop of the graduate workforce, India’s biotechnology industry is roaring.
Mukesh Kumar’s keen interest in health care space sprouted during his college days where he would attend multiple seminars, trips, symposiums, and even visited multiple companies. There, upon witnessing the deficiency of resources in the sector, the young Indian entrepreneur got inspired to revamp the biotechnology arena. To strengthen India’s hold in the clinical research arena, Mukesh laid the genesis of RAHE coaching cum training Institute in 2004 to nurture and skill the next generation to master Clinical Research under exemplary leaders and mentors.
“We maintain our qualitative standards in accordance with our Company’s SOP, ICH-GCP guidelines, CDSCO & USFDA standards, AYUSH Ministry and other respective authorities based on Clinical study.” asserts Mukesh Kumar, the man who contributed to India’s clinical research revolution with RAHE Life Science. Mukesh is among India’s prominent biotechnology entrepreneurs that are driving the wave of transformation in India’s biotechnology industry.
Today, RAHE Life Science, unit of RAHE Group delivers its quality services as one of the fastest-growing Contract Research Organizations to Pharmaceuticals industry, Biotechnological industry, Medical Devices industry, Government organizations, and many more. RAHE Institute which was started as an institute, is now making a name for itself in clinical research, trial execution, and other fields.
RAHE Life Science Specializations:
• Pre-Clinical and Clinical Trial from Phase-I to Phase-IV
• Execution of Post Marketing Surveillance
• Medical Writing, Translations and Publications
• Drug Regulatory Affairs
• Site Selection and Management (SMO)
• Clinical Data Management (CDM)
• Healthcare Studies/Survey
What has enriched RAHE Life Science’s accomplishments?
It is undoubtedly the determination and dedication of a team that is mentored and fueled by the inspirational leader, RAHE Life Science’s Director and CEO, Mukesh Kumar.
Mukesh is known for his expertise in the arena of Research & Development from Pre-Clinical, Clinical Trials Phase I, II, III and IV, Site Selection Management, Clinical Data Management, Regulatory Affairs and many more.
An adroit academic persona, Mukesh attained certain USFDA certifications in the healthcare industry and received a certificate in Drug Safety, Surveillance, and the FDA adverse event reporting system. Furthermore, he also received a Certificate in Patient Safety and Recruitment from MEDWATCH, USFDA. He also earned the ISCR (Indian Society of Clinical Research) membership and has been accorded with the designation of ‘Editor-in-chief’ for ‘The Clinical Research Plus (TCRP)’ Magazine. Mukesh also became the Member-Pharmacist of ‘The Clinical Research Plus – Independent Ethics Committee’ (TCRP-IEC), approved by CDSCO, Govt. Of India and an Executive Member of the Scrutiny Council of the Clinical Research Board from the year 2008-2014.
We sat down with the chieftain where he discusses the journey of RAHE Life Science and the road ahead.
What initially drew you into the biotech space?
India is increasingly becoming a preferred destination for clinical trials. By 2025, the Indian market is expected to reach US$ 3.15 billion with a CAGR of 8.7 per cent. The increasing demand creates a need for market expertise and research authenticity to optimize productivity with increased foreign investments and growing partnerships with local players. Being initiated as an academic training institute for Drug Inspector and Pharmacist Training in 2004, RAHE Group has its foundations on qualitative expertise as a contract research organization.
What factors have differentiated the organization among the pack?
We are providing our services in all types of healthcare such as Allopathic, Ayurveda, Nutraceuticals, Homeopathy, Medical Devices etc. Hence, we work in a percipient & assiduous manner to maintain our client base by always being the best in providing their required service up to their expectations. The client base we handle has been domestic till now, and we are working diligently to attain distinction at the global level also. From time to time, we have also been participating in various governmental programs, exhibitions, FDP, etc., to learn more and earn more.
In the Indian biotechnology sector, what is the most significant issue you foresee in the 2020s?
Drugmaker and sponsor companies are under pressure to replace the revenue loss caused by generics, increasing patent expiry, number of partnerships to identify biologics, and growing R&D costs, which has made drug development more expensive and complex. The market for clinical trials is mainly driven by increasing demand for innovative solutions in the healthcare industry, alliance between the pharma and biotech-medical device companies with CROs and advancements in technology. RAHE Life Science is catering quality services to Allopathic, Ayurveda, Nutraceuticals, Homeopathy and Medical devices. It prioritizes delivering tailor-made solutions that are well synchronized with clients’ preferences. We have established a strong foothold in the Indian as well as international market and strived hard to deliver consistent quality since Day 1.
What does your company do now in response to COVID-19?
A few of our company prospects and the way we are achieving them are mentioned below:
• Contribution in curbing the pandemic COVID-19 – We are doing so by conducting studies for the same indication/ in relevance and still about to get associated for major projects.
• Becoming India’s leading CRO – We are working hard and maintaining good relations with our clients with all due respect for fulfilling their work requirements with quality assurance. Also managing to enter at international level and rise to fame & success there. We want to be there for all of our national and international clients and make them feel proud of us for our way and quality of work. Furthermore, there are many more on which we are working and planning to get executed.
What makes RAHE Life Science stand apart?
RAHE Life Science works tirelessly to improve the clinical research measures with continued up-gradation and security checks. Technological know-how is a key part of our quality standards and operational protocols. The domain that we are avowed for is Clinical Research and hence, we do ensure that our clients take care of the subjects who are getting involved in the study and helping to predict the actual action of the drug. We perform the scrutiny of the results while adhering to the standards of ICH-GCP guidelines and Indian GCP guidelines along with the set rules of regulatory authorities, namely, CDSCO and USFDA. We, under any circumstance(s), imprint our presence and strive to be the best.
Our contribution to the revolution of the Indian Pharmaceutical market by the generic medicines goes in line with our efforts and attempts for getting approval of the drugs by working appropriately and adequately for reaching the utmost point of Research & Development for the respective drug and gaining all the information with every bit of pros and cons associated with it.
What is the company focusing its efforts on today? What are the plans associated?
We aim to provide end-to-end service to our respective clients with the best assurance by taking care of the quality of work we are offering to them. Our well-versed team works following clients’ requirements and coordinates to deliver fruitful results which are not only acknowledged by the clients but the assisting teams and founders as well.
The major focus of RAHE Life science currently is to derive ways of curbing the COVID-19 pandemic. Our main goal is to become India’s leading CRO. We are working hard and maintaining good relations with our clients by fulfilling their work requirements with quality assurance. Also, we are looking forward to entering the international market and make our name and fame there. We want to be there for all of our national and international clients and make them feel proud of us through our way and quality of work.”
Finally, before we close, what is that one life wisdom that you would like to share with everybody?
“Every individual has his/ her goal; focus on your goal with the whole of your soul.”
