The Drug and Cosmetic Act 1940 and Rules 1945 were passed by the India’s parliament to regulate the import, manufacture, distribution and sale of drugs and cosmetics. The Central Drugs Standard Control Organization (CDSCO) and the office of the Drugs Controller General (India) [DCG(I)] was established.
New drugs as defined under Rule 122-E of Drugs and Cosmetics Rules include unapproved drugs, modified or new claims, namely, indications, dosage forms (including sustained release dosage form) and route of administration of already approved drugs and combination of two or more drugs. A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier.
A drug, as defined in the Act includes bulk drug substance also which has not been used in the country to any significant extent. Bulk drug substance is also considered as new drug till 4 years.
The safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import and/or manufacturing and/or marketing in the country.
For development of any new drug the applicant is required to obtain license in Form-29 from State Licensing Authority based on NOC obtained from CDSCO. Test batches of new drugs for development and generation of data of any new drug should be manufactured only after obtaining the license in Form-29. Also, an applicant is required to file application in Form 44 along with prescribed fees in the form of treasury challan and all relevant data as per Schedule Y of Drugs and Cosmetics Rules, for seeking permission to import or manufacture of new drug substances and its formulations for marketing in the country or conduct of clinical trials in India. The documents include chemical and pharmaceutical information, animal pharmacological and toxicological data, clinical data of safety and efficacy, regulatory status in other countries etc., and results of clinical trials on local population.