Drugs Registration Rules, 2038 (1981).

These Rules are framed in exercise of the powers conferred by section 40 of the Drugs Act, 2035 (1978). They contain provisions and procedure relating to obtaining: recommendation letter to establish drug industry (Rule 3); product licence for manufacturing the drug (Rule 4); registration of drug prior to its sale and distribution (Rule 4A); registration prior to importation (Rule 4B); recommendation letter for exportation or importation of drug (Rule 5); certificate of registration for sale and distribution of drug (Rule 6); licence for publicity or advertisement of drug (Rule 7); and licence for clinical trial of new drugs (Rule 8). The Schedules contain the format for the various applications mentioned in the Rules.