India can emerge as the top ten destinations for drug discovery and clinical research in a decade, feels D S Brar, CEO and Managing Director of Ranbaxy Laboratories Limited. He wanted all stakeholders involved in drug research to join together to collectively enable the country to attain this status in near future.

Speaking at the two day conference on “Clinical Research: Road Map for India” in New Delhi on September 24, Brar, chairman of the CII National Committee on Drugs and Pharmaceuticals pointed out the issues that are to be sorted out before clinical research in India can attain global standards.

According to him, adequate infrastructure for carrying on GCP clinical trials, proper policies and systems for inspections and auditing of clinical trials, competent ethical committees and safeguards to protect the interests of the subjects who undergo clinical trials were some of the immediate requirements for enabling the country to achieve this growth.

He wanted the drug regulatory authorities, pharmaceutical industry, clinical research organizations, clinicians and also the potential subjects of clinical trials to work collectively to materialize this dream.

“Clinical trials involving eight million subjects and 0.5 million clinical investigations are taking place world over in a year. Compared to these figures, India is nowhere. The clinical trials situation in the country has little in common with what is taking place in other parts of the world. However, we have enormous untapped potential which we should make use of,” he said.

The two-day conference is having the presence of key government officials, industry leaders, International delegates, CROs and other service providers. The topics of discussion include evolution of clinical trials and its impact on clinical practice, clinical research and regulatory control, clinical research and skill base-Gap Analysis & challenges in the Indian context. Ethics in Clinical Research and a GCP QA System for the software of medicinal products are also to be part of the discussions.

According to CII, India has the potential to build internal capability and grow exponentially in the area of Clinical Trials and bring forth interest from a range of global pharmaceutical companies and CROs. A large and diverse patient population, networks of academic and medical centers/hospitals, well preserved genetically distinct population groups and a pool of qualified scientists, technicians and doctors are the distinct advantages that India offers.

The rapid advances in this area are set to place India on the global platform in the realm of clinical research and trials. There is an increased focus on upgradation of hospital infrastructure to meet GCP standards, regulatory guidelines and establishment of GCP complaint ethics committees. At present, a large number of bio-equivalence trials of approved products and bioavalability studies of generic products which are under formulation development, are being conducted in India.

India stands at the threshold of global development with the potential to emerge as the new lexicon for R&D and clinical research and trials. The conference is expected to provide the necessary interface and capability.