How to Import Medicine in India?

In India import, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Rules 1945. At present, bulk drug (Active Pharmaceutical Ingredients) and finished formulations are regulated under the said Act. Any substance falling within the definition of drug required to be registered before import into the country. Not only drug but the manufacturing site needs to be registered for import.

The application for Registration Certificate and import License can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General (I) at CDSCO, FDA Bhawan, Kotla Road, Near Bal Bhawan, New Delhi by the Local Authorized Agent of the foreign manufacturer having either manufacturing or sale License or by the foreign manufacturers having a whole sale License in the country through online application system “SUGAM”

Requirements:

Registration & licensing system in India

The applications for registration certificate & import license of drugs are processed as per the requirements prescribed under Drugs & Cosmetics Act & Rules.

Form and manner of application for import licence:

(1) An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8A for drugs specified in Schedule X, either by the manufacturer himself having a valid wholesale licence for sale or distribution of drugs under these Rules, or by the manufacturer‘s agent in India either having a valid licence under the Rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution, and shall be accompanied by a licence fee of one thousand rupees for a single drug and an additional fee at the rate of one hundred rupees for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer: Provided that in the case of any subsequent application made by the same importer for import licence for drugs manufactured by the same manufacturer, the fee to accompany each such application shall be one hundred rupees for each drug:
(2) Any application for import licence in Form 8 or Form 8-A, as the case may be, shall be accompanied by a copy of Registration Certificate:
(3) Fee of two hundred and fifty rupees shall be paid for a duplicate copy of the licence issued under this Rule, if the original is defaced, damaged or lost.

Grant of import licence.

On receipt of an application for an import licence in the form and manner prescribed, the licensing authority shall, on being satisfied that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10 or From 10A, as the case may be.

Form and manner of application for Registration Certificate:

(1) An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid wholesale licence for sale or distribution of drugs under these rules, or by his authorized agent in India, either having a valid licence under the rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs and shall be accompanied by the fee specified and the information and undertakings specified in Schedules D-I and D-II duly signed by or on behalf of the manufacturer.
(2) The authorization by a manufacturer to his agent in India shall be documented by a power of attorney executed and 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, and the original of the same shall be furnished along with the application for Registration Certificate.
(3) A fee of one thousand US dollars or its equivalent in Indian rupees shall be paid along with the application in Form 40 for the registration of a single drug meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional drug.
(4) The applicant shall be liable for the payment of a fee of five thousand US dollars or its equivalent in Indian rupees for expenditure as may be required for inspection or visit of the manufacturing premises or drugs, by the licensing authority or by any other persons to whom powers have been delegated in this behalf by the licensing authority.
(5) The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the Central Government in India or abroad, as may be required for examination, tests and analysis of drug.
(6) A fee of three hundred US dollars or its equivalent in Indian rupees shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.
(7) No Registration Certificate shall be required under these Rules in respect of an inactive bulk substance to be used for a drug formulation, with or without pharmacopoeial conformity.

Grant of Registration Certificate.

On receipt of an application for Registration Certificate in the Form and manner specified in Rule 24A, the licensing authority shall, on being satisfied, that, if granted, the conditions of the Registration Certificate will be observed, issue a Registration Certificate in Form 41.

Particulars of the manufacturer and manufacturing premises

  • Name and address of the manufacturing premises (Telephone No., Fax No., E-mail address) to be registered.
  • Name(s) and address(es) of the Proprietor /Partners / Directors.
  • Name and address of the authorized Agent in India, responsible for the business of the manufacturer.
  • A brief profile of the manufacturer‘s business activity, in domestic as well as global market. 
  • A copy of Plant Master File (duly notarised)
  • A copy of Plant Registration/approval Certificate issued by the Ministry of Health/National Regulatory Authority of the foreign country concerned (duly notarised)
  • A brief profile of the manufacturer‘s research activity.

Particulars of the manufactured drugs to be registered under Registration Certificate:

  • Names of drugs (Bulk/Formulation/Special product) to be registered meant for import into and use in India.
  • A copy of the approved list showing the bulk drugs/formulations/special products mentioned are permitted for manufacturing / marketing in the country of origin (duly notarized).
  • A copy of Good Manufacturing Practice (GMP) certificate as per WHO:GMP guidelines or Certificate of Pharmaceutical Products (CPP) or written confirmation for active substances exported to European Union which is equivalent to GMP certificate issued as per WHO:GMP guidelines, by the National Regulatory Authority of the country of origin or a copy of the certificate equivalent to GMP certificate as per WHO:GMP guidelines issued by National Regulator of United States of America or Japan or Australia or Canada or the European Union for the purpose of marketing of the drugs in their country, in relation to bulk drugs or formulations or special product meant for import into India
  • The domestic prices of the drugs to be registered in India, in the currency of the country of origin.
  • The name(s) of the drug(s) which are original research products of the manufacturer.
Hope above information is helpful to you...
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