On October 5, 2018, the Central Government, in consultation with the Drugs Technical Advisory Board (DTAB), proposed rules to amend Drugs and Cosmetics Rules, 19451 (D&C Rules, 1945) with an intention to revise fee for various regulatory activities carried out by Central Drugs Standard Control Organization (CDSCO). The proposed revision comprises - the fee for issuing import licenses, manufacturing sites registration overseas and inspections of these sites therein2.
India's registration and inspection fees for pharma product exporters are very low compared to its foreign counterparts. Since the CDSCO last updated the fee structure in 2003, a sharp fee hike was imperative as the current fee structure does not automatically alter with inflation. The proposed fee revision in D&C Rules, 1945 are described below:
Import license: The proposed amendment of Rule 24(1) of D&C Rules, 1945, demands fee hike in case of import license from INR 1,000 to INR 10,000 rupees for a single drug. Additionally -
- For each additional drug by the same importer for import license for drugs manufactured by the same manufacturer, the additional fee raised from INR 100 to INR 1,000.
- For a duplicate copy of import license if the original is defaced, damaged or lost, the application fee raised from INR 250 to INR 2,500.
Manufacturing site registration for importing medicine: The proposed amendments to Rule 24A (3) of D&C Rules, 1945, have raised the site registration fee for importing medicines to India from US$ 1,500 to US$ 10,000. The applicant has to pay the amount or its equivalent in Indian Rupees along with the application in Form 40 for the registration of a single drug meant for import into and use in India. In addition -
- For each additional drug by same manufacturer, the additional fee is raised from US$ 1,000 to US$ 5,000.
- For an inspection of the overseas manufacturing premises by licensing authority, the expenditure fee is raised from US$ 5,000 to US$ 25,000.
- For making amendment in the registration certificate or for a duplicate copy of the Registration Certificate, the application fee is raised from US$ 300 to US$ 1,800.
Application for license for examination, test or analysis: The proposed amendment to Rule 34(3) of D&C Rules, 1945, has raised the import license fee for importing medicine for examination, test or analysis from INR 100 to INR 5,000 for a single drug. In addition - for each additional drug the additional fee is raised from INR 50 to INR 2,000.
Application for license to import small quantities of new drugs by government hospitals: The proposed amendment to Rule 34A (3) of D&C Rules, 1945 has raised the application fee for license to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients from INR 100 to INR 600 for a single drug. Further, for each additional drug the additional fee is raised from INR 50 to INR 300.
Application for permission to import new drug for clinical trial and marketing: The proposed amendment to Rule 122A (1) of D&C Rules, 1945, has raised the application fee from INR 50,000 to INR 2, 50,000. Further, for a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims, the application fee is hiked from INR 15,000 to INR 1,00,000.
Permission to import or manufacture fixed dose combination: The proposed amendment to Rule 122D (1) of D&C Rules, 1945, has raised the application fee for permission to import or manufacture fixed dose combination of two or more drugs from INR 15,000 to INR 1, 00,000.
Note – The draft rules published via Gazette of India is available at CDSCO official website for public comments.
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