CDSCO to issue NOC for export of drugs

Source-This post on CDSCO to issue NOC for export of drugs is based on the article “Centre takes away state powers for issuing NOC for export of drugs” published in “The Mint” on 4th May 2024.

Why in the News?

In a significant development, CDSCO will be the sole licensing authority to issue NOC for drug export. Earlier, state drug controllers had the jurisdiction to issue NOC certificates. This move comes amidst heightened global scrutiny of Indian-made drugs. This centralization of authority aims to enhance regulatory oversight and streamline the export process for pharmaceutical companies.

What changes have been brought?

1. Regulatory Process for Manufacturers to obtain NOC- Manufacturers seeking NOCs for the manufacture of unapproved, approved new drugs, or banned drugs solely for export purposes, must obtain it from the respective zonal office of the CDSCO.

2. States to hand over NOCs issued to CDCSO- All state/UT drug controllers are required to hand over all NOCs issued to the respective CDSCO Zonal offices.

About CDSCO

1) About CDSCO: The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. It is the National Regulatory Authority (NRA) of India.

2) Regulated under: The Central Drugs Standard Control Organisation (CDSCO) is under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. It has nine zonal offices, seven sub zonal offices, eighteen Port offices, seven central laboratories and six mini labs spread across the country.

3) Function: CDSCO is responsible for approving drugs, conducting clinical trials, setting standards, ensuring quality control of imported drugs. It also shares the responsibility of granting licences for specialized categories of critical drugs such as blood and blood products, IV fluids, vaccines, and sera.