Usha Sharma – Mumbai
Dr GN Singh, Drugs Controller General of India has indicated that the report on the CDSCO’s functioning could be ready within the next three months.
The report is in response to the issues raised by the 59th Report of the Parliamentary Standing Committee on the functioning of the CDSCO, which were presented to both houses of Parliament in May 8th this year. The issues pertained to the functioning of the organisation, including alleged approval of drugs without clinical trials.
The CDSCO had constituted a three-member expert committee consisting of Dr VM Katoch, Secretary (Department of Health Research) and Director General, ICMR; Dr PN Tandon, President, National Brain Research Centre, Department of Biotechnology, Manesar and Dr SS Aggarwal, Former Director, Sanjay Gandhi Post-graduate Institute of Medical Sciences, Lucknow to examine the validity of the scientific and statutory basis adopted by CDSCO for approval of new drugs.
It has already been three months since the committee was formed and when pressed why the report will take a further three months Singh admitted that while the three-member expert committee may take some time to present the data, the final report would be fairly comprehensive and in public interest.
The committee is also examining the validity of the scientific and statutory basis adopted for approval of new drugs without phase-III clinical trials on the Indian population.
The Government recently constituted committees of experts to give opinions/ recommendations to the CDSCO with respect to different categories of Investigational New Drugs/ New Drug proposals.
Speaking exclusively with Express Pharma, Dr GN Singh, Drugs Controller General of India indicated that his office is also contemplating making a rule that no patients enrolled on clinical trials should suffer during trials. To further protect the safety of patients/volunteers participating in clinical trials, the DCGI recently released a notice giving a comprehensive check list of what details should be included in the informed consent form.