India hikes regulatory license charges for imported drugs

Price of drugs imported into India is set to increase in coming year. The move comes in wake of the Indian government increasing the regulatory license charges for new drugs and manufacturing facilities. The cost of these charges are very low when compared to other countries and the last revision was more than 10 years. Now, the government plans to revise these cost once in 3 years.

Government of India has consulted Central Drugs Standard Control Organization and other industry stakeholders before making it mandatory.
The proposal to increase the charges are under process.

Currently, the charges for regulatory license fee for registering one manufacturing site is USD 1000, which will be increased to USD 10,000. Similarly, the fee for a registration certificate for one product is to be increased to USD 5000 from the current USD 1000.

The move may result in increase of prices of imported pharma drugs and may result in local manufacturing of such drugs in India.

Be the first to comment

Leave a Reply

Your email address will not be published.