Allopathic Drugs
Basic Requirements for Grant of Licences
Requisite Documents
Certificates
Fees Structure For Certificates
Wholesale Licences
Fees Structure of Licences

Product Regulated By FDCA, license procedure
Allopathic Drugs
Ayurvedic Drugs
Homeopathic Drugs
Cosmetics
Sale of Drugs
Forms
New Drugs Approval
Banned Drugs

 

 

 

 

 

 

 

 


 

Certificates Issued For Allopathic Drugs

 

The following Certificates are issuing to the manufacturers.

1. WHO GMP Certificate.

2. Certificate of Pharmaceutical  Products.(COPP)

3. State GMP Certificate

4. Licence Validity Certificate.

5. Performance Certificate.

6. Non-Conviction Certificate.

7. Market Standing Certificate.

In addition to the Drugs & Cosmetics Act, 1940 and Rules thereunder and the conditions of the licences, the Company should fulfill certain specifications as laid down under World Health Organizations. Those companies who have fulfilled the requirements of WHO specifications, they submit their application for WHO GMP  Certificate. For grant of the said certificate a Joint Inspection to be conducted by the Officers of Deputy Drugs Controller, West Zone, Mumbai and the Officers of this administration recommends to grant the WHO Good Manufacturing Practices Certificate. On the basis of the grant of WHO GMP Certificate, the company applies for COPP Certificate for Registration of their products in abroad.

Any firm desires to obtain a State Good Manufacturing Certificate (GMP) should submit their application along with a prescribed inspection format duly filled in and signed.  On the basis of the information furnished by the firm, the officers of this administration would carry out inspection at the firm’s premises. If anything adverse is reported in the inspection, the said points will be communicated to the firm and after the compliance of the same, the firm’s case will be considered for grant of State GMP Certificate.   The State GMP Certificate is a must to participate in Government Tenders.

The company’s licences are not renewed due to administrative problems in time, in such cases, the firm may be permitted to apply for a certificate showing the validity of their licences for further periods.  Such certificates can be utilised for export, Govt. Tender etc.

Likewise, many State Governments, Corporations even foreign countries is always asking for the non-conviction certificate stating that the particular company has not been convicted  in the court of law.  In such cases, this department issues non-conviction certificate showing the genuiness of the firm so that they can participate in such tenders.

Market Standing Capacity shows that the particular company has marketed such particular products since last many years and are having the capacity to manufacture according to the requirements on demand.

 

  
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