India’s CDSCO outlines procedures for state inspections of manufacturers
Among the requirements, CDSCO recommends that all GMP (good manufacturing practice) inspections should last between two and five days, depending on the size of the manufacturing unit, the number of products manufactured and the complexity of the products.
And unlike the US FDA, which usually follows up its inspections with a Form 483 or notification that a plant has been cleared, CDSCO calls on its inspectors to “summarize and discuss the observations with the manufacturers” on the final day of the inspection.
The final report on the inspection must be finalized within a week, and then it’s forwarded to the State Licensing Authority and copied to CDSCO.
The State Drugs Control Organizations also must begin qualifying inspectors ad ensure that they perform at least five inspections annually in order to maintain their training and experience.
As far as the inspections are concerned, CDSCO doesn’t go into too much detail but calls for them to focus on product development, quality attributes, stability data to establish shelf life in India’s climate, deviations and change control procedures.
The call for more scrutinized inspections comes as CDSCO is looking to crack down on unauthorized drug approvals and manufacturing licenses, which it revealed last year to be a problem. In January 2013, the regulators set an 18 month deadline by which manufacturers would have to pull unapproved drugs.
Clinical Trial IT System
CDSCO’s work to clean up the manufacturing industry comes as the regulator is trying to get up to speed with clinical trials regulations and is proposing an online submission system.
The system for online submissions of clinical trials will aim to “streamline the process of approval, maintaining comprehensive database and monitoring of clinical trials for ensuring the protection of rights, safety and well beings of trial subjects and authenticity of the data generated,” CDSCO says.
The regulator includes on appendix for what needs to be uploaded to the system before a clinical trial is initiated. The information includes “details for the identification of the Sponsor, local applicant identification, brief description of the investigational product, information on the use of placebo, information regarding the use of the comparator, site/ warehouse responsible for the release of the investigational medicinal product, brief summary of the protocol which includes the medical condition in which the trial is proposed, information regarding the disease prevalence in India, whether the disease is a rare disease, main objective of the trial, principal inclusion and exclusion criteria and the endpoint of the study.”