Regulatory mechanisms to monitor clinical trials in the pharmaceutical industry should be strengthened and awareness has to be created among all the stakeholders on the guidelines laid down for clinical trials by the Central Drugs Standard Control Organisation, according to Gurumurthy Parthasarathi, Professor at the JSS College of Pharmacy, here on Saturday.

Speaking to The Hindu on the sidelines of the 7th Asian Conference on Pharmacoepidemiology, he said that zonal offices of the Central Drug Standard Control Organisation and the State Drug Control Administration should be adequately staffed to oversee the conduct of clinical trials across the country.

Dr. Parthasarathi said that better understanding of the role of the pharma industry in health care delivery would help safeguard the health of the people and also help address larger public health issues. Quoting from a study conducted by JSS University on a sample size of over 3,600 patients, he pointed out that close to 7 per cent of the patients came to hospital because of adverse drug reaction and 15 per cent of the patients developed adverse drug reactions after being admitted to hospital.

‘Encourage research’

Raghurama Bhandary, Additional Drugs Controller for Karnataka, said that understanding drug efficiency and adverse drug reactions would help in providing better treatment for patients. He also spoke at length on the need to encourage research in the pharma sector.

Krathish Bopanna, president of the Indian Society of Clinical Research, said that epidemiological research in pharma sector would help improve quality of prescription. “The government needs to sponsor research and also encourage public private partnerships in research projects in this field,” he added.

The conference was jointly organised by the International Society for Pharmacoepidemiology (ISPE), JSS University and Indian Society for Clinical Research. Participants discussed medication safety and effectiveness, and the role of the pharma sector in health care delivery. The conference stressed on the need to encourage stakeholders to gather data with regard to effects of drugs so that it can helps research activities .


Drug testing on trialJanuary 14, 2013