Policy, markets and knowledge: Strategic synergies in Indian pharmaceutical firms

Technology Analysis and Strategic Management

Volumn 19, Issue 5, 2007, Pages 565-588

  Chaturvedi, Kalpana ^a   Chataway, Joanna ^a   Wield, David ^a  

^a OPEN UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

COMMODITY MARKET; INDUSTRIAL POLICY; PHARMACEUTICAL INDUSTRY; STRATEGIC APPROACH; TECHNOLOGICAL DEVELOPMENT;

ASIA; EURASIA; INDIA; SOUTH ASIA;

EID: 34548593677     PISSN: 09537325     EISSN: 14653990     Source Type: Journal    
DOI: 10.1080/09537320701521309     Document Type: Article

References (52)

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41. A Para III filing is made when the ANDA applicant does not have plans to sell the generic drug until the original drug is off patent; A Para IV filing is made when theANDA applicant believes its product or use of the product does not infringe on the innovator's patent listed in the Orange Book or where the applicant believes such patents are not valid or enforceable. In Para IV filings, patents are validly circumvented. If successful the generic drug company gets an exclusive marketing right (EMR) to sell the drug for 180 days.
42. For more details see Chaturvedi & Chataway, op. cit., Ref. 2.
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46. Hatch-Waxman Act granted chemical drug manufacturers the option of filing an Abbreviated New Drug Application (ANDA). The rationale for Hatch-Waxman was to enable manufacturers to sell lower cost drugs immediately upon expiration of a pioneer manufacturer's patent.
47. KPMG, op. cit., Ref. 1.
48. BLAs: Under current law, biologic manufacturers are not granted expedited FDA approval of their product like generic small molecule (chemical pharmaceutical) manufacturers. The Drug Price Competition and Patent Term Restoration Act of 1984 (commonly known as 'Hatch-Waxman') grants chemical drug manufacturers the option of filing an Abbreviated New Drug Application (ANDA). There is no such mechanism for biologics.
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52. The conduct of clinical trials is governed by the Drugs and Cosmetic Rules (DCR), 1945, subordinate legislation of Drugs and Cosmetics Act, 1940. The government has decided to amend DCR and has emphasized the incorporation of Good Clinical Practices (GCP) protocols, which includes the legally binding safety of patients and strict accordance to ethics. Earlier, in 2002 the government had established national Good Laboratory Practices (GLP), a Compliance Monitoring Authority that certifies compliance with OECD norms and principles for Indian companies, laboratories and testing facilities.