BENCHMARK FOR FIVE FOLD FEES HIKE BY ...

MOH
Mohammad Shahbaz Alam
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 ease cdsco 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
New Drug Approval (Form 45)
Subsequent New Drug Approval
(Form 46)
Site Registration ( Form 41)
Drug Registration (Form 41)
Clinical Trial (Phase 1)
Clinical Trial (Phase 2, 3)
Import Test License (Form 11)
Import License (Form 10)

Duplicate Copy

Current Fee
INR 50,000
INR 15,000

Proposed Fee
INR 250,000
INR 50,000

USD 1500
USD 1000
INR 50,000
INR 25000
INR 100 for 1st drug
INR 50 for additional
INR 1000 for 1st drug
INR
100
for
additional
INR 250

USD 10,000
USD 5000
INR 250,000
INR 250,000
INR 100 for 1st drug
INR 50 for additional
INR 10000 for 1st drug
INR 1000 for additional
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 cdsco without 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.

Email: medicarechief@gmail.com