Government to further fix the drugs recall mechanism

Government is considering a clear and more effective guideline to deal with the issue of recall of drugs which are Not of Standard Quality (NSQ). Drug Consultative Committee (DCC) under the ministry of health and family welfare has approved the recommendation of the sub-committee for effective recall system. “Committee recommended that Central Drug Standards Control Organization (CDSCO) shall immediately publish such data/reports on its website for which the State and Central Drug Control Authorities shall inform such cases of NSQ to the CDSCO by email at enforcecell.div@cdsco.nic.in immediately after such declaration by the Govt Analysts”. Committee also recorded in its minutes that “It shall also be ensured that the reports of NSQ drugs after declaration shall be informed by the State or Central laboratories immediately to the concerned Drug Control authorities.”

The sub-committee of DCC had recommended all the central, state and UT authorities shall share the details of the drug which have been found of Not of Standard quality. Nodal officers will be appointed in each state, UT, CDSCO zones, sub zones and the constitution of special committee at the central level, amendment in Rules, usage of Whatsapp Group etc.

The sub-committee of DCC on drug recall had recommended three parameters in stages: First is the strengthening of Existing System which included short term measures “to be done immediately with present infrastructure, IT support system, online system, published guidelines to ensure effective recall of NSQ drug and uniform implementation of the same by all the SLAs, UTs and CDSCO e.g appointment of nodal officers in each state, UT, CDSCO zones and subzones, constitution of special committee at the central level etc, amendment in Rules, use of currently available electronic media like Whatsapp group etc.”

Second is the medium term goal, Creation of Drugs Control websites for uploading Not of standard quality reports, development of Mobile App based system and more. 

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Third is the Long Term plan that includes development of online portal/ web-based services connecting pan India  including all stakeholders, Heads of Government testing laboratories at Central and state levels, regulators at all levels-Drugs Inspectors, stockist, distributors,  wholesalers, retailers as association and individual entity, all association of manufacturers etc.  

To ensure that all the cases of NSQ drugs are dealt properly the Drug Consultative Committee noted “ it was also recommended to update the status of action taken (up to its logical conclusion as per Drugs and Cosmetics Act and Rules) by the respective authorities on Not of Standard Quality drugs specially those identified under the National Drug Survey program.