Author(s): Lokesh. C, Sonia. K, Raju Kamaraj

Email(s): jackylokesh9019@gmail.com

DOI: 10.5958/0974-360X.2020.00193.6   

Address: Lokesh. C*, Sonia. K, Raju Kamaraj
Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulatur-603203, Kanchipuram, Tamil Nadu, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 2,     Year - 2020


ABSTRACT:
“Biologicals are restorative, therapeutic, analytic, preventive arrangements created or got from living life forms and their turn off for human use”. They incorporate serums, antibodies, counteragents, blood, antigens and blood segments, quality treatment, tissues and so forth. The Indian administrative expert (CDSCO), is the body that is in charge of the advancement and promoting of organic items in India. Biotechnology furnishes creative answers for therapeutic field with in excess of 200 biologic prescriptions and antibodies. These advancements benefit a large number of patients worldwide and in excess of 600 items a work in progress. “At present these items can likewise be created by makers other than the trend-setter, with the expiry of some of licenses. These new biotechnological prescriptions usually alluded to as "comparable biologics" offer a noteworthy chance to give more prominent access to sensible social insurance for a few lifesaving drugs. These might be viewed as extremely basic conservative/helpful component for the pharmaceutical market in India. The Indian Regulatory Authority is viewed as in charge of assessing security, adequacy and nature of all pharmaceuticals in India. The Department of Biotechnology in India is the office that controls the advancement, pre-clinical investigations of all Biologicals.


Cite this article:
Lokesh. C, Sonia. K, Raju Kamaraj. Regulatory Requirements for Biological product approval process in India. Research J. Pharm. and Tech 2020; 13(2):1050-1054. doi: 10.5958/0974-360X.2020.00193.6

Cite(Electronic):
Lokesh. C, Sonia. K, Raju Kamaraj. Regulatory Requirements for Biological product approval process in India. Research J. Pharm. and Tech 2020; 13(2):1050-1054. doi: 10.5958/0974-360X.2020.00193.6   Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-2-97


Recomonded Articles:

Author(s): Ravindranath S. Misal, Vishawas R. Potphode, Vijay R. Mahajan

DOI: 10.5958/0974-360X.2017.00218.9         Access: Open Access Read More

Author(s): Niharika, Navneet Verma

DOI: 10.5958/0974-360X.2016.00182.7         Access: Open Access Read More

Author(s): Peethala Prathyusha, Raja Sundararajan, Palyam Bhanu, Mathrusri Annapurna Mukthinuthalapati

DOI: 10.5958/0974-360X.2020.00507.7         Access: Open Access Read More

Author(s): Vijayalakshmi. S , Disalva. X, Chittaranjan Srivastava, Arun A

DOI: 10.5958/0974-360X.2019.00520.1         Access: Open Access Read More

Author(s): Dhara Parekh, Pankaj Kapupara, Ketan Shah

DOI: dharaparekh92@gmail.com         Access: Open Access Read More

Author(s): R Deveswaran, S Bharath, BV Basavaraj, Sindhu Abraham, Sharon Furtado, V Madhavan

DOI:         Access: Open Access Read More

Author(s): Suha Alnaeb, Youssef Alahmad, Saleh Trefi

DOI: 10.5958/0974-360X.2019.01035.7         Access: Open Access Read More

Author(s): R. P. Bhole, S. R. Jagtap, K. B. Chadar, Y. B. Zambare

DOI: 10.5958/0974-360X.2020.00189.4         Access: Open Access Read More

Author(s): Yarnykh T. G., Kotvitska A. A., Tykhonov A. I., Rukhmakova O. A.

DOI: 10.5958/0974-360X.2020.00614.9         Access: Open Access Read More

Author(s): Bahubali N. Patil, Vamshi Krishna Tippavajhala, Girish Pai K

DOI: 10.5958/0974-360X.2019.00140.9         Access: Open Access Read More

Author(s): U.S Mahadeva Rao, Khamsah Suryati Mohd, Abdurrazaq Muhammad, Bashir Ado Ahmad, Mohaslinda Mohamad, Rosmawati Mat Ali

DOI: Not Available         Access: Open Access Read More

Author(s): Narendra Chotai, Vishnu Patel, Harsha Patel, Uren Patel, Rajendra Kotadiya

DOI:         Access: Open Access Read More

Author(s): Prabhakar Panzade, Prashant K Puranik

DOI: Not Available         Access: Open Access Read More

Author(s): Mythili. L, GNK. Ganesh, C. Monisha, Kayalvizhi. R

DOI: 10.5958/0974-360X.2019.00426.8         Access: Open Access Read More

Author(s): Suchithra. A. B, S. Jeganath, E. Jeevitha

DOI: 10.5958/0974-360X.2019.01073.4         Access: Open Access Read More

Author(s): Vijaykumar T. Pawar, Shubhangi V. Pawar, Harinath N. More, Anita S. Kulkarni, Dinanath T. Gaikwad

DOI: 10.5958/0974-360X.2017.00724.7         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags