As per Drug Act 2035, Department of Drug Administration (DDA) can take advice from the drug advisory committee (DAC) to check the safety, efficacy and quality of the drug which are not mentioned in the pharmacopoeias recognized by Schedule 1 of Drug Standard Regulation 2040 and establish the method of analysis for the analysis of such drug products. For this provision of Drug Act, DDA has formed a committee to assist DDA in establishment of analytical method, product (quality control) specification for non pharmacopoeial products.

The committee has so far prepared SOP for study of documents on non pharmacopoeial products for regulatory approval, guidelines for analytical method validation, check lists for analytical method validation for submission of application for registration, check list for evaluation of document submitted by the industry and protocol for the establishment of some of methods of non pharmacopoeial products and quality control specifications. This step will help in development of Nepal Pharmacopoeia too. The standard of drugs then will be as per Nepal Pharmacopoeia.

Nepal Pharmacopoeia has not yet been prepared therefore the standard of drug will be as per the quality control specifications and analytical methods suggested by the committee after the method is approved by DDA/ DAC for non pharmacopoeial drug products.