New Delhi based Apothecaries Limited has launched a non-governmental organization "Apothecaries Foundation" to foster the culture of Good Clinical Practices (GCP) in the country. Apart from organizing highly focused seminars and structured training sessions for investigators, the Foundation has also formed an "Independent Ethics Committee (IEC)" to oversee ethical aspects on behalf of interested sponsors.
The Foundation is in the process of preparing a team for independent GCP audits and has plans to accredit Investigators who would clear a test to establish their GCP skills. IEC of the Foundation welcomes medical institutions, which are keen to streamline the operations of their own ethics committees.
This first-of-its-kind move has stemmed out of the company's acute awareness of the chasm existing in the institutions engaged in clinical research in India says Brijesh Regal, chairman Apothecaries Limited.
According to Dr J.P. Gupta, President of the Foundation, "Apothecaries Foundation is an expression of our long term commitment to establish GCP culture in India. The fiercely independent members of Apothecaries IEC have been outstanding professionals in their own fields and are now contributing their experience to reinforce ethics in clinical research in India". Dr. Gupta has himself been the Director of Institute of Health & Family Welfare.
Dr. Sneh Bhargava, former Director, All India Institute of Medical Sciences (AIIMS), chairs the Apothecaries IEC. The members of the committee are Dr. S.D. Seth, National Professor of Pharmacology at ICMR, P.D. Sheth, President of IPA and Prof. Y.K. Gupta of Industrial Toxicology Research Centre (ITRC), Lucknow.
Apothecaries Limited, the 22 years old pharmaceutical services organization with tremendous strength in medical writing made a quiet entry into clinical research services in 1994 when Ranbaxy was looking for support on data management for three of their clinical trials in India. "There was no formal education in clinical research in India and Internet - as we know of it now - was also in its infancy then", says Madhulika, Director of Drug Development Services at Apothecaries.
Apothecaries operate from their 20000 sq. feet facility at New Delhi, which also houses a GLP compliant state-of-the-art Pharmacokinetics study facility approved by CDSCO.
"Aventis, Cipla, Eli Lilly, Glaxo and Dabur have found us responsible team-mates in whatever assignments they have given us", says Brijesh. With his e organizational skills and extensive formal training in clinical research including under US-FDA, this pharmacist has a long-term vision for Apothecaries CRO operations in India.
Subsequent projects provided opportunities to couple the GCP fundamentals with Indian realities of clinical practice. Management of clinical trials in gynaecology, rheumatology, cardiology, nephrology, dermatology, gastroenterology, vascular diseases etc., at various hospitals and clinics all across the country has now given a formidable depth to the experience of Apothecaries clinical research team. They provide a unique advantage of being an independent full-services CRO of Indian origin. "Being independent - unlike most other CROs which are extensions of pharmaceutical companies - inspires confidence in sponsors, while our Indian origin provides a unique strength of knowing local operating environment and delivering GCP compliance at realistic Indian costs" says Brijesh.