title: An Indian manufacturer's perspective for harmonization of guidelines for similar biotherapeutic products.
abstract: This review focuses on the scenario of Indian manufacturers, biotherapeutics approvals in India and important aspects which need to be precisely analyzed and resolved from the Indian perspective to facilitate implementation of global guidelines for the manufacture of these products, to best serve the public health needs of the developing countries.
authors.affiliation: Bharat Biotech International Limited, Genome valley, Shameerpet, Turkapally, Hyderabad, Andhra Pradesh, India. cherishpv@bharatbiotech.com
authors.forename: P V Cherish
authors.initials: PV
authors.lastname: Babu
mesh_terms: D003906:Developing Countries; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000379:methods / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D007194:India; D007880:Legislation, Drug / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations