Let us first understand how pharmaceutical companies file application and what are the investment require. How friendly was cdsco in filing application before increase of fee five fold and what are the facility or easecdsco offered to the pharmaceutical companies along with the fees hike?The government has proposed hike in regulatory fees for testing, manufacturing and selling medicines in the country, a move that is likely to impact both domestic as well as multinational pharmaceutical companies operating here.
The health ministry has proposed to increase application for the following services of cdsco.
|Type of Application||Current Fee||Proposed Fee|
|New Drug Approval (Form 45)||INR 50,000||INR 250,000|
|Subsequent New Drug Approval(Form 46)||INR 15,000||INR 50,000|
|Site Registration ( Form 41)||USD 1500||USD 10,000|
|Drug Registration (Form 41)||USD 1000||USD 5000|
|Clinical Trial (Phase 1)||INR 50,000||INR 250,000|
|Clinical Trial (Phase 2, 3)||INR 25000||INR 250,000|
|Import Test License (Form 11)||INR 100 for 1st drugINR 50 for additional||INR 100 for 1st drugINR 50 for additional|
|Import License (Form 10)||INR 1000 for 1st drugINR 100 for additional||INR 10000 for 1st drugINR 1000 for additional|
|Duplicate Copy||INR 250||INR 1500|
While the proposal has met with a strong opposition from drug makers facing pricing pressures in India, the move may not impact consumers as medicine prices are largely regulated in the country. On the other hand, some believe consumers may benefit from the move as a higher fee is likely to result in better regulatory checks and efficient processes.
The government and the regulator believe that fee hikes are much required and were long pending. “The pharmaceutical industry is growing with steep increase in revenue year after year. To tackle the increasing application load efficiently, we need funds and this has to be generated from the industry,” a senior official said. He added India is still charging less than what companies have to pay abroad.
The latest notification from the health ministry said the Central government “is of the opinion that circumstances have arisen which render it necessary to make the rules” even without consulting the Drugs Technical Advisory Board (DTAB), which usually examines any such proposal before issuance of notification. While the government intends to take a final call on the draft amendments following public comments received in next 45 days, the notification said the government will consult the DTAB within six months.
Every country regulated or non-regulated in nature gives tentative approval time except cdsco and it was there earlier on the website of cdsco.Justification lies on the three things, First thing drug application should contain finished formulation along with the application for test and analysis by cdscowithout charge because drug should not be given approval only on the basis of dossier.Second thing there should be time line of approval. Third thing cdsco should give financial punishment if the delay in submission of periodic safety update report.