The Central Drugs Standard Control Organization (CDSCO) has established a new unit — the “Coordination Division” — as India broadens the mandate of its drug regulatory authority beyond just quality testing.
The division is responsible for several functions, ranging from preparing monthly reports for the Cabinet to managing special assignments from senior leadership. It has been entrusted with six key priority areas.
According to the document, “A new Division titled ‘Co-ordination Division’ is hereby created within CDSCO (HQ) with immediate effect.”
With multiple tasks at hand ranging from approval and regulation of drugs, vaccines, cosmetics and medical devices, CDSCO is running risk-based inspections and audits across the country at pharmaceutical firms, medical device-making units, contract research organisations and private and public laboratories.
The health ministry has also asked CDSCO to wipe out the concerns of counterfeit medicines from the Indian market while pushing small and micro pharmaceutical manufacturers to upgrade their units on par with global standards.
“Amid the ongoing changes at the CDSCO, the industry is experiencing delays of at least one to two months in the processing of requests and applications. Given the limited manpower and an expanding list of responsibilities, this new arm has been introduced to free up key personnel, allowing them to focus on handling priority areas,” a senior government official said, requesting anonymity.
List of tasks
The document further details the work responsibilities shifting from other departments to the new coordination division, with the first being “submission of monthly summary to Cabinet”.
Currently, the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC) division were responsible for the task.
Also, the new division will be responsible for “monitoring coordination requirements in CDSCO that are not specifically allocated to other sections”.
It will not only collate the “achievement of CDSCO objectives as directed by the ministry from time to time”, but also monitor the “circulation of general circulars, training circulars or vacancy circulars among other tasks, which till now was being done by the administration division”.
The charge of collecting and collating sample data related to the strengthening of states’ drug regulatory system (SSDRS) scheme has also been given to the new division, transferring it from the GCT & Ethics Committee.
“Any other work as assigned by the competent authority from time to time,” the order issued by the drug regulatory agency said. News18