Requirements and guidelines for permission to import or manufacture of new drug

Application for permission to import or manufacture new drug for sale or to undertake clinical trials under these Rules shall be made to the Central Licencing Authority accompanied with following data in accordance with the Table 1 or Table 2 or Table 3 or Table 4 of the Second Schedule as the case may be, namely:—

1. chemical and pharmaceutical information;
2. 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 ED50 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 co-related to the plasma drug concentrations;
3. animal toxicology data;
4. human clinical pharmacology data as prescribed and as stated :— for new drug substances discovered or developed in India, clinical trials are required to be carried out in India right from Phase I and data should be submitted as prescribed; for new drug substances discovered or developed in countries other than India, Phase I data should be submitted along with the application. After submission of Phase I data generated outside India to the Central Licensing Authority, permission may be granted to repeat Phase I trials or to conduct Phase II trials and subsequently Phase III trial concurrently with other global trials for that drug. For a drug going to be introduce for the first time in the country, Phase III trial may be required to be conducted in India before permission to market the drug is granted unless otherwise exempted; the data required will depend upon the purpose of the new drug
5. 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 phases;
6. application for permission to initiate specific phase of clinical trial should also accompany investigator’s brochure.
7. 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 was undertaken, and express agreement with the conclusions. Each page should be numbered;
8. 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 Central Licencing Authority during the course of marketing of the drug in India;
9. the full prescribing information should be submitted as part of the new drug application for marketing.
10. 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 rule 96 and rule 97 of the Drugs and Cosmetics Rules, 1945. After submission and approval by the Central Licencing Authority, no changes in the package insert shall be effected without such changes being approved by the Central Licencing Authority;
11. complete testing protocol 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;
12. if the application is for the conduct of clinical trials as a part of multinational clinical development of the drug, the number of sites and patients as well as the justification for undertaking such trials in India should be provided to the Central Licencing Authority along with the application.