All around the World, Persons are in need of medicines; some of the medicines are manufactured and available to them locally. Remaining need of medicine has to be imported from other countries. This enhances the trade of the drugs from one place of the world to another. India occupies a third largest position in the world in the field of Pharmaceutical industry. CDSCO regulates the manufacture, sale, import, export, and clinical research of drugs.
DRUG: A medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body.
In India import of Drugs, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic 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 of drugs. If the drugs, fall within the definition of New Drug, the new drug approval is the pre-requisite for submission of application for Registration and or import of drug. The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General at CDSCO.
Drug and Cosmetic Act 1945:
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It Contains provisions for classification of drugs under given schedules.
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Guidelines for the storage,sale,display and prescription of each schedule.
| Rule | Permission for |
| 122A | To import New drugs |
| 122B | To Manufacturer of Newdrugs |
| 122D | To import or manufacture fixed dose combination |
| 122DA | To Conduct trail for New drug/investigational new drugs |
| 122DAA | Definition of clinical trail |
Requirements & Guidelines for permission to import and/or manufacture of new drugs for sale or to undertake clinical trials:
No New drugs are allowed to be imported into the country without the sanctioned of the licensing authority in writing. All drugs whose composition is not recognized as safe for the use by experts and which have not been used to any large extent or for any appreciable period of time are to be regarded as new drug.
Permission for the import of new drugs may be obtained from the licensing authority after furnishing to him documentary evidence of the standards of quality, Purity and strength of the drug. The application for import of new drugs including their fixed dose combinations should be accompanied as specified in schedule Y, provided that data on clinical trial for a drug may not be submitted, if the licensing authority decides to grant import permission without it in public interest.
| Form 44 | Application for grant of permission to import or manufacture a new drug or to undertake Clinical trail |
| Form 12 | Application for license to import drugs for the purpose of examination, test or analysis |
| Form 11 | License to import drugs for the purpose of examination, test or analysis (1yr validity) |
| Form 4 | Issue of import certificate (6 months validity) |
| Form 1 | Application for the issue of import certificate for import of import of narcotic drugs and psychotropic substances (6 month validity) |
Application for permission:
Application is made in FORM 44 accompanied with following data in accordance with appendices, namely
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Chemical and pharmaceutical information
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Animal Pharmacology data
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Animal toxicology data
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Human Clinical Pharmacology data
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Regulatory status in other countries
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Prescribing information
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Complete testing protocol for quality testing
Clinical trial:
A “clinical trial” in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its,
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clinical or;
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pharmacological including pharmacodynamics.
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adverse effects.
with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug.
Studies in Special population:
Information supporting the use of the drug in :
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Children
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Pregnant women
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Nursing women
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Elderly patients
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Patients with renal or other organ systems failure, and
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Those on specific concomitant medication
Post Marketing Surveillance:
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Periodic Safety Update Reports (PSURs) submitted in order to monitor for the clinical safety of the new drug
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Report all the relevant new information (Patient exposure)
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Summarize the market authorization status in different countries and any significant variations related to safety
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Indicate whether changes should be made to product information
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New Studies specially planned/conducted to examine a safety issue should be described in the PSURs
Special Studies BA/BE studies:
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For drugs approved elsewhere in the world and absorbed systemically, bioequivalence with the reference formulation should be carried out
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Evaluation of the effect of food
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Dissolution and bioavailability data to be submitted
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All bioavailability and bioequivalence studies should be conducted according to the guidelines for bioavailability and bioequivalence studies as prescribed (ICMR guidelines)
Stages involved in Drug importation:
Stages involved in Drug importation:
1. Phase 1
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Registering certificate
2. Phase 2
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Import License
3. Marketing
Phase 1:
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Application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer or authorized agent in India and undertakings specified in Schedule D-1 and Schedule D-II duly signed by on behalf of the manufacturer.
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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.
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(i). A fee of one thousand and five hundred US dollars shall be paid along with the application in Form 40 as registration fee for his premises meant for manufacturing of drugs intended for import.
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(ii). A fee of one thousand US dollars 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.
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The applicant shall be liable for the payment of a fee of five thousand US dollars 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 under rule 22.
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The applicant shall be liable for the payment of testing fee 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.
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A fee of three hundred US dollars shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged.
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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 Pharmacopoeia conformity.
Phase 2:
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An application for an import License shall be made to the licensing authority in Form 8 for drugs excluding Schedule X, and in Form 8-A for Schedule X drugs; either by the Manufacturer or by the Manufacturer’s agent in India who is having the wholesale license for sale or distribution of drugs and shall be accompanied by a License fee of one thousand rupees for a single drug and one hundred rupees for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer.
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Any application for import licence in Form 8 or 8-A, which shall be accompanied by a copy of Registration Certificate issued in Form 41 under Rule 27-A; in the case of emergencies the issue of Import License by the central government in Form 10 or 10-A without issuance of Registration Certificate under Rule 27-A, for reasons to be recorded in writing.
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A fee of two hundred and fifty rupees shall be paid for a duplicate copy of licence, if the original is defaced, damaged or lost.
Checklist for Import:
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Covering Letter
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Original Power of Attorney
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Copy of Import permission for new drug (s) in Form-45 (formulation) or in Form-45A (new bulk drug substances)
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Copy of Whole sale Licence(20B/21C) or Manufacturing Licence of the Indian agent/Corporate office address
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Authorization letter
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Schedule D (I) and Undertaking duly signed, dated and seal/stamped with name and designation of the authorized Signatory of the manufacturer or his authorized Indian agent.
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Schedule D (II) and Undertaking duly signed, dated and seal/stamped with name and designation of the authorized signatory of the manufacturer or his authorised Indian agent.
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Copy of Original Notarised
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Attested/Appostilled copy
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Original label /specimen label complying with Rule 96 and indicating name of the drug with pharmacopoeial specification, the importer name & address as per Wholesale license and Import License number. If proposed draft label/package insert whereever applicable, then duly attested either by the authorised Indian Agent or by the manufacturer is required to be submitted along with the application.
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Upload Form 40
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TR-6 Challan of Fees paid