How to Import of Bulk Drugs 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:

Information for the Registration of bulk drugs:

Information required to be submitted by the manufacturer or his authorized agent with the application Form for the registration of a bulk drug/formulation/special product for its import into India.

The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a Computer Floppy:

1. General:

  • Name of the drug/formulation/special product, a brief description and the therapeutic class to which it belongs.
  • Regulatory status of the drug. Free Sale Certificate and/or Certificate of Pharmaceutical Products (CPP) issued by the Regulatory Authority of the country of origin. Free sale approval issued by the Regulatory Authorities of other major countries.
  • Drugs Master File (DMF) for the drug to be registered (duly notarised).
  • GMP certificate as per WHO-GMP format, or Certificate of Pharmaceutical Products (CPP), or written confirmation for active substances exported to the 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 duly notarised copy of the certificate equivalent to GMP certificate as per WHO-GMP guidelines issued by United States of America or Japan or Australia or Canada or the European Union for the purpose of marketing of the drug in their country.
  • List of countries where marketing authorization or import permission for the said drug is granted with date (respective authorisation shall be enclosed).
  • List of countries where marketing authorisation or import permission for the said drug is cancelled/withdrawn with date.
  • List of countries where marketing authorisation or import permission for the said drug is pending since (date).
  • Domestic price of the drug in the currency followed in the country of origin.
  • List of countries where the said drug is patented.

2. Chemical and Pharmaceutical Information of Drugs:

  •  Chemical name
    Code name or number, if any.
    Non-proprietary or generic name, if any. Structure.
    Physico-chemical properties. 
  • Dosage form and its composition.
    Qualitative and Quantitative composition in terms of the active substances(s) and excipient(s). List of active substance(s) separately from the constituent(s) of excipients. 
  • Specifications of active and inactive ingredient (s) including pharmacopoeial references.
  • Source of active ingredient(s), name and address.
  • Tests for identification of the active ingredient(s),
    Method of its assays and tests for impurity profile with reference standards for the impurities (Protocol to be submitted alongwith reference standards for the impurities / relative substances). 
  • Outline method and flow chart of manufacture of the bulk drug or finished formulation or special product.
  • Detailed test protocol for the drug with pharmacopoeial reference or in- house specification as approved by the registration authority, in the country of origin.
  • Stability data including accelerated stability and real time stability analysis
  • Documentation on pack size
  • Numerical expression on EAN bar code on the labels and cartons,
  • Safety documents on containers and closures.
  • Documentation on storage conditions.
  • Three samples of medicinal product/drug and outlet packing are to be submitted with batch certificates. Additional samples as well as reference substances with batch certificates including date of manufacture, shelf life, and storage conditions of reference substance may be required both during registration procedure and during validity of registration decision.
  • Batch test reports/certificate of five consecutive production batches in details of the medicinal product are to be submitted for every site of manufacturing premises.
  • Manner of labelling as per rule 96 of the Drugs and Cosmetics Rules 1945.
  • Package insert.
  • Details of safety handling procedure of the drug.
  • Details of PMS study report for marketing period not exceeding five years.

3. Biological and Biopharmaceutical Information of Drugs:

  • Biological control tests applied on the starting material, if applicable.
  • Biological control tests applied on the intermediate products, if applicable.
  • Biological control tests applied on the finished medical products, if applicable.
  • Stability of the finished products in terms of biological potency of the drug, if applicable.
  • Sterility tests, if applicable, specification and protocol therein.
  • Pyrogen tests, if applicable, specification and protocol therein.
  • Acute and sub-acute toxicity tests, if applicable specification and protocol therein.
  • Bio-availability studies and bio-equivalence data, if applicable.
  • Data relating to the environmental risk assessment for r-DNA products.
  • Other information relevant under the section.

4. Pharmaceutical and Toxicological Information of Drugs:

Executive summary of the product is to be submitted mentioning the specific and general pharmacological actions of the drug and pharmacokinetic studies on absorption, metabolism, distribution and excretion. A separate note is to be given on acute and sub-acute toxicity studies and long term toxicity studies. A specific study on reproductive toxicity, local toxicity and carcinogenic activity of the drug is to be elaborated, as far as possible.

5. Clinical Documentation:

A new drug as defined under rule 122-E of the Drugs and Cosmetics Rules, 1945 is required to be permitted separately by the licensing authority under rule 122-A of the said rules prior to its registration. Such a new drug requires a brief summary and clinical documentation, along with permission under 122-A of the said rules for its Registration Certificate.

6. Labelling and Packaging information of Drugs:

  • Labels should conform as per the specifications under the Drugs and Cosmetics
  • Package insert should be in English and shall indicate the following therapeutic indications:
    Posology and method of administration.
    Contra-indications.
    Special warnings and special precautions for use, if any.
    Interaction with other medicaments and other forms of interaction. Pregnancy and lactation, if contra-indicated.
    Effects on ability to drive and use machines, if contra-indicated. Undesirable effects/side effects.
    Antidote for overdosing. 
  • Package insert should indicate the following pharmaceutical information:
    List of excipients.
    Incompatibilities.
    Shelf life in the medical product as packaged for sale.
    Shelf life after dilution or reconstitution according to direction.
    Shelf life after first opening the container.
    Special precautions for storage.
    Nature and specification of the container. Instructions for use/handling. 

7. Specific information required for the special products


Hope above information is helpful to you...
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