This paper is published in Volume-3, Issue-4, 2017
Area
Drug Regulatory Affairs
Author
Gopala Krishna Mukkamala, Sabareesh .M, Alagusundaram .M, Jayachandra Reddy .P
Org/Univ
Pharmaceutics and Drug Regulatory Affairs, India
Pub. Date
29 July, 2017
Paper ID
V3I4-1244
Publisher
Keywords
Latin American (LATAM) Countries, Marketing Authorization (MA), Pharmaceutical Market.

Citationsacebook

IEEE
Gopala Krishna Mukkamala, Sabareesh .M, Alagusundaram .M, Jayachandra Reddy .P. Pharmaceutical Market and Regulatory Issues for Export of Pharmaceutical Products to Latin American Countries, International Journal of Advance Research, Ideas and Innovations in Technology, www.IJARIIT.com.

APA
Gopala Krishna Mukkamala, Sabareesh .M, Alagusundaram .M, Jayachandra Reddy .P (2017). Pharmaceutical Market and Regulatory Issues for Export of Pharmaceutical Products to Latin American Countries. International Journal of Advance Research, Ideas and Innovations in Technology, 3(4) www.IJARIIT.com.

MLA
Gopala Krishna Mukkamala, Sabareesh .M, Alagusundaram .M, Jayachandra Reddy .P. "Pharmaceutical Market and Regulatory Issues for Export of Pharmaceutical Products to Latin American Countries." International Journal of Advance Research, Ideas and Innovations in Technology 3.4 (2017). www.IJARIIT.com.

Abstract

Indian Pharmaceutical industry is one of the world’s largest and most developed, ranking fourth in terms of volume and thirteenth in terms of value. The country accounts for an estimated 10% of global production and 2% of world markets in pharmaceuticals. The regulatory process to obtain marketing authorizations (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonization efforts, is highly country-specific. Complex and evolving ad-hoc requests from reviewers must be proactively addressed to avoid costly delays or show-stoppers to pharmaceutical products import from India. The comforts and confronts faced by pharma companies in India. It is of case study approach and presented the Indian pharma export advantages, the Government initiatives toward the export market, problems, the recent US trademark legislation issues, and the opportunities in a nutshell. Indian companies have focused on export prospects in both formal and informal markets globally. Keeping the high credibility of serving quality products in the complex market, India has gained a strong reputation among the global place.