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Registration Procedure in India.

Foreign principal can register the product in India through their office in India or they can register through any Indian agent.

The registration charge is USD 1500 (for Plant Registration) and USD 1000 per prodcut (for product registration). So the total charge to register one product is USD 2500 (USD 1500+USD 1000 per prodcut). But if the manufacturer want to register another product from the same plant they have to pay only USD 1000 for the product as the plant is already registered for other product. But if the plant will be different for the second product then the charge will be USD 2500 again.

Once registered the registration certificate will be valid for 3 years unless there is no change in the company constitution or manufacturing procedure of the product.

Normally it will take around 9 months to 1  year to register one product. Manufacturer has to send the registration documents (documents required for registration is mentioned hereunder) to Drug Controller General of India  (DCGI) and then DCGI will scrutinize all the documents and if it found o.k. then DCGI will ask to test 3 different batch  sample in Central Drug Testing Laboratory.  Once the sample is approved then agent has to submit the sample passing report to DCGI and then the registration certificate will be issued.

DOCUMENTS RQEURIED FOR REGISTRATION

 

S. No.

 

CONTENTS/PARTICULARS

 

Remark

 

 

 

 

Application  in  Form-40,  date,  sign  and  Sea l/Stamped  of  Indian  agent  or Manufacturer.

By Ethachem

 

  • Name & Address of Authorized Agent in India.

 

 

  • Names & Address of Manufacturer & its Factory Premises.

 

 

  • Name of the drugs to be registered.

 

 

  • Specify No. of sites involved in the manufacturing of the drug (s).

 

 

Original Power of Attorney

 

 

  • Executed & authenticated either in India before a First class Magistrate, or in the country of origin before such an equivalent authority, the certificate of  which is attested by the Indian Embassy of the said country (original copy).

 

 

  • Name of  the manufacturer & its manufacturing site as per Form-40 along with the name of the drugs

 

 

  • Name and address of the Indian Agent.

 

 

  • Name  of the Proposed  Products

 

 

  • Duly signed, dated with name & designation of the signatory by both Indian agent & the manufacturer

 

 

TR-6 Challan  of  fees paid (1000USD for one drug or its equivalent in Indian currency).

 

 

  • Bank’s Stamp.

 

 

  • Name of drugs

 

 

  • Address of manufacturing site and Indian agent

 

 

  • Head  to  Fees Deposited (“0210 -Medical and Public Health, 04-Public Health, 104-Fees and Fines)

 

 

Schedule  D  (I)  and  Undertaking  duly  signed,  dated  and  seal/stamped  with  name  and designation  of  the  authorised  signatory  of  the  manufacturer  or  his  authorised  Indian agent.

 

 

Schedule D (II) duly sign, dated and seal/stamped with name and designation of the authorised signatory of the manufacturer or his authorised Indian agent.

 

 

Notarised copy of Plant Master File (PMF).

 

 

Notarised copy of Drug (s) Master File (DMF)

 

 

Copy of Manufacturing Licence  , GMP ,  FSC for bulk drugs  notarized.

 

 

Attested/Appostilled  copy  of  Product  Registration  Certificate  (SFDA)  /certificate  of suitability from (EDQM).

 

 

BUSINESS LICENSE  NOTARIZED

 

 

MATERIAL SAFETY DATA SHEET (MSDS)

 

 

CERTIFICATE OF ANALYSIS OF FIVE BATCHES