New NOC process in works for export of unapproved drugs
CDSCO) is looking at a revamp of the process of granting of No Objection Certificates (NOCs) for the export of unapproved drugs, a move that is aimed at reducing pressure on manpower and boosting regulatory efficiency.
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So far, the NOCs for all unapproved drugs are buyer specific and quantity specific and each time a company received an order to export they had to apply for NOCs. Going ahead, the regulator is changing it to blanket NOCs that will be country specific and will be based on the history of exports of a particular drug by a company in the past year, given the drug is approved in the importing country.
«Till now what was happening is that for all unapproved drugs in India,...the NOC was buyer specific and quantity specific. I am giving you NOC for making only for this customer and this quantity. If the same customer gives a repeat order you have to come again and apply again,» Drugs Controller General of India Rajeev Raghuvanshi told reporters on the sidelines of the Indian Pharmaceutical Alliance's (IPA) Global Pharmaceutical Quality Summit 2025.
«Now we are changing it based on history, suppose the customer in the last one year have exported 10 crores of tablets so I will give you a blanket NOC for 10 crore tablets. Now it is not specific to a customer and you just have to show that this product is approved in that country,» he added.
