Journal of Pharmaceutical Research

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Similar Biologics:Regulatory Prospective in India


Affiliations
1 Ministry of Health and family Welfare, Govt. of India, Kotla Road, FDA Bhawan, New Delhi, India
2 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
 

The development and utilization of Biotechnology-derived therapeutic products namely, recombinant DNA derived products emerges as the fastestgrowing segment in the pharmaceutical market. These products are larg  molecular weight and structurally complex molecules that are produced in living cells through genetic engineering. Biotechnology-derived therapeutic products are being developed over the past three decades and are under patent protection. The high cost of these therapeutic products has become a key issue in the battle concerning ever-increasing healthcare costs. The expiry of patent protection for biotechnology-derived therapeutic products of innovator origin has led to the development of Similar Biologics in India. Maintaining rapid as well as environmentally sustainable growth remains an important and achievable goal for India. In this concern, to meet unmet need and to append Make in India concept, pharmaceutical industry developed alternative similar biologics.
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  • 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


Abstract Views: 246

PDF Views: 70




  • Similar Biologics:Regulatory Prospective in India

Abstract Views: 246  |  PDF Views: 70

Authors

A. Ramkishan
Ministry of Health and family Welfare, Govt. of India, Kotla Road, FDA Bhawan, New Delhi, India
Rajappan
Ministry of Health and family Welfare, Govt. of India, Kotla Road, FDA Bhawan, New Delhi, India
Fahim Khan
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

Abstract


The development and utilization of Biotechnology-derived therapeutic products namely, recombinant DNA derived products emerges as the fastestgrowing segment in the pharmaceutical market. These products are larg  molecular weight and structurally complex molecules that are produced in living cells through genetic engineering. Biotechnology-derived therapeutic products are being developed over the past three decades and are under patent protection. The high cost of these therapeutic products has become a key issue in the battle concerning ever-increasing healthcare costs. The expiry of patent protection for biotechnology-derived therapeutic products of innovator origin has led to the development of Similar Biologics in India. Maintaining rapid as well as environmentally sustainable growth remains an important and achievable goal for India. In this concern, to meet unmet need and to append Make in India concept, pharmaceutical industry developed alternative similar biologics.

References