Manipal Health Enterprises, a leading healthcare network of hospitals in India, has been awarded the accreditation by Association for Accreditation for Human Research Protection Programme (AAHRPP) for standard practices in Clinical Research. Now Manipal Hospital, Bengaluru and Kasturba Hospital, Manipal are the first Indian hospitals to be awarded AAHRPP in India.
The AAHRPP accreditation endorses hospitals which follow ethical and international quality standards in clinical trials. The accreditation process is rigorous and intense, which ensures safety and health of those who participate in clinical trials. It will increase the clinical research opportunity and will encourage reverse brain drain for many research inclined medical professionals from aboard. It will help the pool of clinicians to compete with the best globally.
The clinical trials in India have increased from 100 human studies in 2005 to 1000 in 2010. Globally the clinical trials industry will touch $35 billion by 2015. Now India accounts for $0.5 million of the global CRO market. Around 83 per cent of clinical trials are carried out of developed countries but is slowly shifting towards developing countries of India, China, central and eastern Europe apart from Latin America. Lack of transparency and reporting of outcomes are some of the major problems which hamper the growth of clinical trials.
Manipal Hospital is the 6th hospital in Asia to be conferred the AAHRPP accreditation. To earn this accreditation, we had to extensively demonstrate our safeguards in every level of research operation and our adherence to high ethical standards in research. Both these parameters were successfully fulfilled by the two hospitals of the group, stated Dr S C Nagendra Swamy, president and chairman quality council, Manipal Health Enterprises.
“Our certification indicates commitment to ethical standards in protecting research participants while ensuring that society continues to reap the benefits of research. The AAHRPP will further strengthen our efforts to improve the quality of research in India,” stated Rajen Padukone, CEO, Manipal Health Enterprises.
“Unfortunately India has the largest pool of patients suffering from cancer, diabetes and other maladies. This makes India a global hub for clinical trials, outsourced by other medically advanced countries. Hence protecting our trial subjects is of paramount importance. Given the poverty and illiteracy in our country, Indians are vulnerable to these malpractices. Therefore each institution/hospital should instill a strong Human Research Protection Program to safe guard the interests of their trial subjects said, Dr H Sudarshan Ballal, medical director, Manipal Health Enterprises.
D. Nagendraswamy S C, president and chairman of quality council of Manipal Health Enterprises, and Dr Pratibha Pereira, Dr K L Bairy along with Dr Pulgaonkar, medical superintendent, Kasturba Hospital Manipal, led the way for the accreditation. The team was assisted by Principal Investigators, Research Centre Staff and Support Staff of the hospitals and above all the Ethics committee of both the hospitals.
Union minister for health and family welfare Ghulam Nabi Azad presented the AAHRPP accreditation certificate to Rajen Padukone and Dr S C Nagendraswamy, Manipal Health Enterprises.