5 Times price hike in registration pharma APIs or Products Import 

NEW DELHI:

Indian drug maker of importer who import API from outside of India will now have to pay 5 times more to the government of India to register their products. There overseas manufacturing facilities also been audited by the Indian regulator. This sole implementation taken by the government to increase domestic manufacturing of medicines.

In India registration charges are cheaper as compare to other regulated country.

After a meeting between the Central Drugs Standard Control Organisation and industry stakeholders in August, the ministry is once again planning a hike in fees for several regulatory submissions for foreign drug makers, said two senior health ministry officials. A similar move was suggested in December 2015 as well.

All stakeholders present agreed, in principle, to a increase in fees (as per the 2015 draft notification).

“Members also stressed (the need) to update fees periodically after three years, instead of 15 years. The proposal for amendment in rules is under process.” In India, Revision of fees is necessary, as rates have not been updated for more than 15 years.

India charges much smaller than other countries for regulatory licences. Now, the Indian regulator will be at par with world regulators (in the fees that it charges).

The health ministry is expected to soon release a draft proposing higher fees for import licences, registration certificates for manufacturing sites overseas and CDSCO’s inspections of these sites.

Prospective planning can be summarized as,

The ministry is planning to increase the fees to register one manufacturing site to $10,000 from $1,500 currently. It has proposed that the fee for a registration certificate for one product be hiked to $5,000 from around $1,000 now and make it valid for three years.