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Govt plans strict drug recall norms

The Drug Consultative Committee under the Ministry of Health and Family Welfare has approved the recommendation of the sub-committee for effective recall system

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The central government is considering clear and more effective guidelines to deal with the issue of recall of drugs which are Not of Standard Quality (NSQ).

The Drug Consultative Committee (DCC) under the Ministry of Health and Family Welfare has approved the recommendation of the sub-committee for effective recall system.

"The 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 government analysts." The 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."

STRINGENT NORMS

  • The reports of NSQ drugs after declaration shall be informed by the State or Central laboratories immediately to the concerned Drug Control authorities
     
  • Nodal officers will be appointed in each state, UT, CDSCO zones, sub-zones and the constitution of a special committee at the central level

The sub-committee of DCC on drug recall had recommended three parameters in stages. First, 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, for example 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 which includes the creation of drugs control websites for uploading NSQ reports, development of a mobile app-based system, etc. The third and long-term plan includes development of online portal/ web-based services connecting pan India including all stakeholders, including heads of government testing laboratories at central and state levels, regulators at all levels, drug inspectors, stockist, distributors, wholesalers, retailers as an 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 NSQ drugs, especially those identified under the National Drug Survey programme."

Zee Media Newsroom

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