January 01, 2002

'31'

PROCEDURE FOR APPROVAL FOR MANUFACTURE AND IMPORT OF NEW DRUGS STREAMLINED

EVALUATION FEES TO BE LEVIED FOR EXAMINATION OF LITERATURE ON NEW DRUGS

    The Government has amended the Drugs and Cosmetic Rules, 1945 streamlining procedures for approval for manufacture and import of new drugs and prescribing evaluation fees for examination of technical literature submitted by the applicants along with the application.

    Under the amended rules, Application Forms/Approvals have now been prescribed for making applications for various types of permissions/approvals of new drug made to the Drugs Controller General (India), to facilitate submission of specific information in proper formats. The applications are normally accompanied with voluminous technical information in respect of toxicity, safety, details of clinical trials, etc., but may lack certain other vital information required for consideration. Separate forms have been prescribed for the first time for filing applications for different categories of new drugs.

    As the technical data submitted by the applicant needs detailed examination of the technical literature in consultation with experts to review safety and efficacy of new drugs proposed to be marketed in the country, provisions have been made for prescribing evaluation fees for consideration of such applications. The system of levying such fees is prevalent in almost all developed countries. The fees required to be paid for different types of permission/ approvals are as under:

1.

Investigation New Drug (New Drug invented in the country

a) Human clinical pharmacology (Phase-I)

Rs.50000/-

b) Exploratory trials (Phase-II)

Rs.25000/-

c) Confirmatory trails (Phase-III)

Rs.25000/-

2.

Review of Dossier as per Schedule Y

(For permission for approval for manufacture of a new drug in the country)

Rs.25000/-

3.

a) Subsequent application by the same applicant for modified dosage form or new claim

Rs.15000/-
b) Application after one year of the grant of application for the import or manufacture of a new drug

Rs.15000/-

    Schedule Y to the Drugs and Cosmetic Rules, which prescribe requirements and guidelines on clinical trails for import and manufacture of new drugs, has also been amended to make Post Marketing Surveillance (PMS) study mandatory. A new appendix 1-A has also been introduced to provide for specific requirements for approval of new drugs to guide subsequent applications for permission to manufacture the drug already approved.

    It has also been provided that no clinical trials for a new drug, whether for clinical investigation or any clinical experiment by any institution shall be conducted except under the permission from the Drugs Controller General of India.

    Provision has also been introduced for suspension or cancellation of the permission given to an applicant, if he fails to comply with the conditions of approval. However, an appeal against such an order to the Central Govt. within 60 days of the order is permitted.

    The above changes in the laws governing the grant of permission for new drugs have been made with a view not only to streamline the examination of the application for introducing new drugs in the country in more scientific and rational way but also expediting their disposal.