Central Drugs Standard Control Organization Current Affairs - 2020

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Cabinet approves MoU between CDSCO and Saudi FDA

Union Cabinet has given ex-post facto approval to Memorandum of Understanding (MoU) between Central Drugs Standard Control Organization (CDSCO) and Saudi Food and Drug Authority in field of Medical Products Regulation. The MoU was signed on 29 October 2019 during the visit of Prime Minister Narendra Modi to the kingdom of Saudi Arabia.

Highlights of MoU

It would facilitate better understanding of regulatory aspects between two sides and will also enable better coordination in international fora. It will also help in increasing India’s export of medical products to Saudi Arabia.

About Central Drugs Standard Control Organization (CDSCO)

It is Central Drug Authority for discharging functions assigned to Central Government under Drugs and Cosmetics Act. It is the national regulatory body for Indian pharmaceuticals as well as medical devices. It functions under the Union Ministry of Health and Family Welfare.

It serves parallel function to European Union’s European Medicines Agency (EMA), Japan’s PMDA, United State’s Food and Drug Administration (FDA) and Medicines and United Kingdom’s Healthcare products Regulatory Agency.

Major CDSCO Functions: Approval of new drugs and clinical trials; Approval of certain licenses as Central License Approving Authority, Regulatory control over import of drugs; and meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB).

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Medicine Labels in Regional Language

The Ministry of Health and Family Welfare has said that in order to curb fake, sub-standard and expired drugs drug names and expiry date during tendering will be in Hindi/regional language along with English.

In the beginning, the proposal will be implemented for Iron tablets and polio drops as they are the drugs most commonly administered to children at government centres. The Health Ministry has stated that if the rollout is successful and the feedback encouraging, then the proposal could be extended to other medicines.

The government has taken the step to ensure that those seeking drugs under government schemes have access to all the requisite information about them. The decision to incorporate regional languages was taken as per the advisory of the Drugs Technical Advisory Board (DTAB).

Drugs Technical Advisory Board

Drugs Technical Advisory Board (DTAB) is the highest statutory decision-making body on technical matters related to drugs in the country. It is constituted as per the Drugs and Cosmetics Act, 1940. It is part of the Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.

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