Central Drugs Standard Control
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Dte.GHS, Ministry of Health and Family Welfare, Government of India

 

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Re-Registration Circulation Letter

 

NO. 6-1/2004-DC (Pt-1 [RC])

Directorate General of Health Services

(Drugs Control Section)

 

Nirman Bhawan, New Delhi

Dated 20th Dec 2004

CIRCULAR

Sub: - Re-registration of manufacturing site along with their manufactured drugs-reg.

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.

 

(ASHWINI KUMAR)

Drugs Controller General (India)

To

  1. The Deputy Drugs Controller (I), C.D.S.C.O. (East Zone), Nizam Place, 2nd Floor, 234/4, A.JC. Bose Road, Kolkata-700020.
  2. The Deputy Drugs Controller (I), C.D.S.C.O. (West Zone), Central Govt. Quarters, CGHS Dispensary Building, Antop Hill, 1st Floor, Mumbai-400037.
  3. The Joint Drugs Controller (I), C.D.S.C.O. (North Zone), Segment Wing A, 1st Floor, Central Govt. Office, Building Kamla Nehru (Central Govt. Enclave), Hapur Road, Ghaziabad-201002.
  4. The Deputy Drugs Controller (I), C.D.S.C.O. (South Zone), 26, Haddaws Road, 2nd Floor, Shastri Bhawan Annexe, Chennai-600006
  5. The Assistant Drug Controller (I), C.D.S.C.O., Sub-zonal, 1-10-1 to 8, Sardar Patel Road, Begumpet, Hyderabad-500 016
  6. The Assistant Drug Controller (I), Office of Assistant Drug Controller (I), CDSCO, sub-zonal office, Old Terminal Building, Air Cargo Complex, Airport, Ahmedabad-380 016
  7. DDC (R)
  8. DDC (RNS)
  9. The President, All India Manufactures’ Organizations, Jeevan Sahakar, Sir Pherozshah Mehta Road, Mumbai-400001.
  10. The President, Association of the Indian Pharmaceuticals Manufacturers, 2, Jawaharlal Nehru Road, Kolkata-700013.
  11. The President, Indian Chemical Manufacturers Association, Mumbai, Mumbai Regional Office, Sir Vithaladas Chambers, 16, Mumbai Samachar Marg, Mumbai-400023.
  12. Resident Director, Indian Drugs Manufacturers Association (IDMA), A-2/29, (First Floor), Safdarjang Enclave, New Delhi-110029.
  13. The President, Organization of Pharmaceutical Producers of India (OPPI) Cook’s Building, Dr. Dadhabhai Naroji Road, Mumbai-400001.
  14. The President, Pharmaceuticals and Allied Manufacturers & Distributors Association Limited, C/o Mumbai Chambers of Commerce and Industry, Ballard Estate, Mumbai-400038.
  15. The President, All India Organization of Chemist and Druggist, 110/111, Dadar Manish Market, Gr. Floor, Sanapati Bapat Marg, Dadar (WR), Mumbai-400028.
  16. All India Organization of Chemists & Druggists, 301, Manish Commercial Centre, 216-A, Dr. Annie Besant Road, Worli, Mumbai-400025.
  17. The Chemexcil, Jhansi Castle, 7, Cooperage Road, Mumbai-400 039
  18. The Bulk Drug Manufacturers Association (BDMA), C-25, Industrial Estate, Sanathnagar, Hyderabad

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