title: Recombinant drug development, regulation, and commercialization: an Indian industry perspective.
abstract: BACKGROUND
  The Indian biopharmaceutical sector comprises nearly 40 companies that manufacture and/or market 14 recombinant drugs that account for nearly 50 products. Among these, 22 companies have manufacturing facilities in India.
  
  
  OBJECTIVE
  The aim of the present study was to analyze the patenting trends, commercialization, and regulatory system for biopharmaceuticals in India.
  
  
  METHODS
  Representatives from 19 such biopharmaceutical companies were interviewed on aspects related to regulatory compliance, manufacturing, commercialization, and innovation in order to understand the challenges faced by them in the current regulatory and patent system.
  
  
  RESULTS
  The study revealed that 94% of the companies have filed patents and 52% are developing new biologic entities in areas such as diabetes mellitus, cancer, and congestive heart diseases. Forty-two percent of the companies consider delays in regulatory approval to be a major constraint for biopharmaceutical industry development. Almost all are of the opinion that uniform guidelines across countries would help to prevent delays in the commercialization of products.
  
  
  CONCLUSIONS
  A high proportion of representatives of the biopharmaceutical industry in India identified that elaboration of regulatory guidelines, defined submission requirements, and drug approval timelines are vital to the growth of the biopharmaceutical industry.
authors.affiliation: Rajiv Gandhi School of Intellectual Property Law, Indian Institute of Technology Kharagpur, Kharagpur, West Bengal, India.
authors.forename: Niharika
authors.initials: N
authors.lastname: Sahoo
authors.forename: Padmavati
authors.initials: P
authors.lastname: Manchikanti
mesh_terms: D003132:Commerce / Q000592:standards; D017277:Drug Approval / Q000379:methods*; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000379:methods*; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence* / Q000592:standards*; D007194:India; D010330:Patents as Topic; D004364:Pharmaceutical Preparations / Q000191:economics* / Q000592:standards*; D012926:Social Control, Formal
chemical_list: D004364:Pharmaceutical Preparations