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Journal of Pharmaceutical Research

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Similar Biologics: Regulatory Prospective in India
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Journal of Pharmaceutical Research

DOI: 10.18579/jpcrkc/2017/16/3/118758

Year: 2017, Volume: 16, Issue: 3, Pages: 191-198

Original Article

Similar Biologics: Regulatory Prospective in India

A. Ramkishan 1*, Rajappan 2, Fahim Khan 3
  • Deputy Drugs Controller (India), Ministry of Health and family Welfare, Govt. of India, Kotla Road, FDA Bhawan, New Delhi, India
  • Ministry of Health and family Welfare, Govt. of India, Kotla Road, FDA Bhawan, New Delhi, India
  • Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health and family Welfare, Govt. of India, Kotla Road, FDA Bhawan, New Delhi, India
Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

No Abstract.

References

  • Drugs and Cosmetics Act, 1940 and Rules there under, 1945.

  • Guidelines in Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2016.

  • Guidelines in Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2012.

  • WHO TRS guidelines 2012.

  • ICH and EMEA guidelines

  • IP 2014 and NIB �PAC guidance document

  • 01 June 2017

Year: 2017, Volume: 16, Issue: 3


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