Re-Registration Circulation Letter

As you are aware, registration of manufacturing sites are in force w.e.f. 1.1.2003 under the provision of Drugs & Cosmetics Act and Rules there under.

As per Rule 28-A of the Notification, the Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.

Provided that if the application for a fresh Registration Certificate is made nine months before the expiry of the existing certificate, the current Registration Certificate shall be deemed to continue in force until orders are passed on the application.

As per Rule 28, a Form 10 Licence unless, it is sooner suspended or cancelled, shall be valid for a period of three years from date of its issue.

Provided that if an application for a fresh licence is made three months before the expiry of the existing licence the current licence shall be deemed to continue in force until orders are passed on the application.

As the registered manufacturers have already submitted the requisite documents at the time of initial registration, it has been decided by this Directorate in consultation with the Ministry of Health that for issue of fresh registration certificate for the already registered drugs, the following information / documents may be submitted by the applicant for examination: -

1. An application in Form 40.
2. US$ 1500 in respect of site registration and US$ 1000 per drug or equivalent in Indian rupees may be credited Bank of Baroda under Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines" and a copy of the receipt alongwith treasury challan in TR6 shall be submitted along with the application. It may be ensured that the TR6 challan issued by the Bank shall be for the exact amount specified above.
3. Schedule D (I) duly filled.
4. Schedule D (II) duly filled alongwith the following documents: -
   1. A copy of the current / valid manufacturing licence of the manufacturer issued by the Drug Regulatory Authority where the manufacturer is located.
   2. A copy of the current / valid WHO GMP certificate / Free Sale Certificate / CPP issued by the Drug Regulatory Authority of the respective country.
5. Original Registration Certificate to be surrendered.
6. The applicant may not submit the following documents: -
   1. Power of Attorney (except in those cases where there is a change in the Indian Agent).
   2. Plant Master File (subject to the condition that there is no change in the Plant).
   3. Drug Master File (subject to the condition that there is no change in the process in manufacture of the drug)
   4. Stability data (unless there is change in stability and a shorter shelf life is assigned to the drug).
   5. Quality control test reports.
   6. Packing details unless there is a change in the packaged dosage form or in the package insert.

The manufacturer can either register additional drug (s) or delete any existing drug (s) at the time of fresh application. However, if additional drugs are added, then all requirements as specified in the Drug Rules shall be fulfilled.