Definition of new drug
For the purpose of this Part, new drug shall mean and include-
(a) A drug, as defined in the Act including bulk drug substance (or phytopharmaceutical drug) which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 of drug and cosmetic Act for the proposed claims: Provided that the limited use, if any, has been with the permission of the licensing authority.
(b) A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.
(c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration.
Explanation:
For the purpose of this rule:
(i) All vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21 of drug and cosmetic act;
(ii) A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval.
REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT AND / OR MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL TRIALS:
Application for permission:
(1) Application for permission to import or manufacture new drugs for sale or to undertake clinical trials shall be made in Form 44 accompanied with following data in accordance with the appendices, namely:
(i) chemical and pharmaceutical information
(ii) animal pharmacology data
- specific pharmacological actions, and demonstrating, therapeutic potential for humans shall be described according to the animal models and species used. Wherever possible, dose-response relationships and ED50s shall be submitted. Special studies conducted to elucidate mode of action shall also be described
- general pharmacological actions
- pharmacokinetic data related to the absorption, distribution, metabolism and excretion of the test substance. Wherever possible, the drug effects shall be corelated to the plasma drug concentrations;
(iii) animal toxicology data
(iv) human Clinical Pharmacology Data and as stated below:-
- for new drug substances discovered in India, clinical trials are required to be carried out in India right from Phase I and data should be submitted as required (data, if any, from other countries)
- for new drug substances discovered in countries other than India, Phase I data as required. After submission of Phase I data generated outside India to the Licensing Authority, permission may be granted to repeat Phase I trials and/or to conduct Phase II trials and subsequently Phase III trials concurrently with other global trials for that drug. Phase III trials are required to be conducted in India before permission to market the drug in India is granted;
- the data required will depend upon the purpose of the new drug application . The number of study subjects and sites to be involved in the conduct of clinical trial will depend upon the nature and objective of the study. Permission to carry out these trials shall generally be given in stages, considering the data emerging from earlier Phase(s);
- application for permission to initiate specific phase of clinical trial should also accompany Investigator‘s brochure, proposed protocol, case record form, study subject‘s informed consent document(s), investigator‘s undertaking and ethics committee clearance, if available
- Reports of clinical studies submitted should be in consonance with the format. The study report shall be certified by the Principal Investigator or, if no Principal Investigator is designated, then by each of the Investigators participating in the study. The certification should acknowledge the contents of the report, the accurate presentation of the study as undertaken, and express agreement with the conclusions. Each page should be numbered;
(v) Regulatory status in other countries as prescribed, including Information in respect of restrictions imposed, if any, on the use of the drug in other countries, e.g. dosage limits, exclusion of certain age groups, warning about adverse drug reactions etc. Likewise, if the drug has been withdrawn in any country by the manufacturer or by regulatory authorities, such information should also be furnished along with the reasons and their relevance, if any, to India. This information must continue to be submitted by the sponsor to the Licensing Authority during the course of marketing of the drug in India;
(vi) the full prescribing information should be submitted as part of the new drug application for marketing as prescribed. The prescribing information (package insert) shall comprise the following sections: generic name; composition; dosage form/s, indications; dose and method of administration; use in special populations (such as pregnant women, lactating women, paediatric patients, geriatric patients etc.); contra-indications; warnings; precautions; drug interactions; undesirable effects; overdose; pharmacodynamic and pharmacokinetic properties; incompatibilities; shelf-life; packaging information; storage and handling instructions.
All package inserts, promotional literature and patient education material subsequently produced are required to be consistent with the contents of the approved full prescribing information. The drafts of label and carton texts should comply with provisions of rules 96 and 97 of drug and cosmetic act. After submission and approval by the Licensing Authority, no changes in the package insert shall be effected without such changes being approved by the Licensing Authority; and
(vii) Complete testing protocol/s for quality control testing together with a complete impurity profile and release specifications for the product as prescribed should be submitted as part of new drug application for marketing. Samples of the pure drug substance and finished product are to be submitted when desired by the regulatory authority.
(2) If the study drug is intended to be imported for the purposes of examination, test or analysis, the application for import of small quantities of drugs for such purpose should also be made in Form 12.
(3) For drugs indicated in life threatening / serious diseases or diseases of special relevance to the Indian health scenario, the toxicological and clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Licensing Authority.
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