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Pharma Export do not need NOC: CDSCO

Pharma Export do not need NOC: CDSCO

New Delhi: In order to improve ease of doing business Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, Government of India has issued an order notifying that pharmaceutical companies will not have to obtain clearance from drug regulatory authority for exporting drugs and medical devices.

In its notice, CDSCO has mentioned that without obtaining No Objection Certificate (NOC) from regulatory authorities, all pharma exporters can exports anywhere within or outside India without any imposed conditionality.

Earlier this facility was available only for pharma exports to the US, Canada, Japan, Australia and European Union, but now the Drug Controller General of India (DCGI) has passed the rule for all other countries as well.

The notice clearly stated that the NOC for export consignments to any other countries shall not be insisted (upon), if such bills are filed by the manufacturer himself, having a valid license under the Drugs and Cosmetics Act and rules.

The notice further added that this is being done to bring ease in the drug regulatory practices in India relating to export of drugs, medical devices, and cosmetics. All the stakeholders are however required to comply with the regulatory requirements of the importing countries as per their specific needs.

Below is the attached notification of CDSCO.

Source: self
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