Roundtable: Is the DCGI doing a good job at regulating clinical trials in India?
The clinical research industry has taken a huge leap in Indian healthcare. To ensure that patient safety is the prime focus for clinical trials, laws and regulations need to be streamlined and adhered to. Experts take on whether the Drug Controller General of India (DCGI) is doing a good job at regulating clinical trials inIndia?
Dr Madhuri Jadhav
Senior Associate Director – Clinical Operations, Karmic Lifesciences
The DCGI has been instrumental in drafting the Indian GCP guidelines and incorporating Schedule ‘Y’ to the Drugs & Cosmetic Act. About the limitations, the DCGI set up is totally a centralised enforcement body with no role of the state FDA and can further improve on the number of technical/scientific staff. While the penal provisions are too strict, the industry reads about violations only through mass media. The biggest challenge is shortening the time-lag (current 4-8 months) to award permission for clinical trials while ensuring adequate guidance on the approval process. Overall, there are more positives than negatives. A long term strategy is indeed the hour’s need for India to be competitive in the clinical trial.
Dr Rajan Narasimha Vikram
GM & Head – Clinical Research and Pharmacology, Columbia Asia Hospitals Pvt Ltd
The Indian pharmaceutical and clinical trial industries have grown phenomenally. A pivotal initiative was taken in 2005, to amend the provisions of the Schedule ‘Y’ of the Drugs & Cosmetics Act and this was disseminated by conduct of countrywide national training workshops for all stake holders on GCP guidelines and regulatory requirements for clinical trials in India. DCGI has also introduced guidelines to ensure safety and well being of the clinical trial subject quality, integrity and credibility of clinical trial data generated in India. The initiatives of the DCGI are commendable and more such measures will enable the Indian clinical trial industry to reach where it needs to be.
Dr Radheshyam Naik
Consultant – Medical Oncologist, HCG
The regulatory approval process inIndiahas become progressively streamlined. Regulatory bodies in India are gearing up to meet the challenges in the global scenario by trying to increase qualified manpower and bringing in more academic expertise (other than in DTAB) to discuss necessary improvement strategies. Taken together with the introduction of an Indian clinical trials registry listing all clinical trials and sites in India, these changes though incremental, signal CDSCO’s desire to improve oversight of clinical trials and provide clarity for the sponsors and CROs who conduct clinical trail. As its regulatory processes become more streamlined,India is poised to take the lead in the global clinical development process.
Over the years the DCGI has definitely helped strengthen the clinical research industry inIndiaby way of its laws, regulations and amendments. However, there are a few loopholes that exist even today. It is important that the DCGI continues to introduce contemporary laws and regulations to help further strengthen the clinical industry.