Drug Companies to shell out a lot more after hike in regulatory fees

The Ministry of Health & Family Welfare has vide a draft Gazette notification dated 29th December, 2015 proposed a multi-fold hike in fees for product registrations, manufacturing and product licenses and clinical trials for drug companies. The hike in the regulatory fees is likely to impact both domestic as well as multinational pharmaceutical companies operating here. 

The revised proposed fees for few of the categories are as detailed below:

Sr. No

Category (Import)

Existing fee (USD)

Proposed Fee (USD)

1. Site registration for importing drugs

1,500

10,000

2. Product registration charges

1,000

5,000

Category (Domestic)

Existing Fee

(INR)

Proposed Fee

(INR)

3. Local manufacturing and loan licensing

6,000

50,000

4. License to import drugs

1,000

10,000

5. Site inspections

1,500

15,000

6. Clinical Trials – Phase I

50,000

2,50,000

7. Clinical Trials – Phase II & Phase III

25,000

2,50,000

Note: The proposed draft amendments rules above are open for public comments for the next forty-five days w.e.f 29th December, 2015 & shall be taken into consideration on or after the expiry of the period of forty-five days.

While the Government intends to take a final call on the draft amendments following public comments received in the next 45 days, the notification further states that the government will consult the Drugs Technical Advisory Board (“DTAB”) within six months. Once the fee structures are approved, the above amendments will be part of the Drugs and Cosmetics (8th Amendment) Rules, 1945.

 

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