On July 10, 2019, Indian Pharmacopoeia Commission declared that the Government of Ghana has given recognition to the Indian pharmacopoeia after continuous efforts of Central government in achieving the recognition1.

Background

According to the resource information, Africa imports almost 70 percent of its drugs of which India makes a total contribution of around 55 to 60 percent. Moreover, Indian drugs are not only cost effective but also offer standard quality and have great potential and acceptance in various companies. Hence, to ease the process of drug import, the Ghana government planned to adopt India Pharmacopoeia. Based upon this, CDSCO, the highest regulatory body of India, supported and agreed to give a helping hand of Rupees 900 crore for training technical officers in Indian Pharmacopoeia along with improving the human resources, upgradation of laboratories, a training programme for regulator and revision of the Drug and Cosmetic Rule. The Indian Pharmacopoeia Commission has already submitted their application on January 16, 2017, to FDA Ghana with subject titled as "Recognition of Indian Pharmacopoeia Standards in Ghana" along with the letter from the High Commission of India. Prior to submitting this application Central Drug Standard Control Organization had agreed to provide the technical training to technical officers, helping in capacity building for drug testing and also to provide some basic standards necessary for drug testing.

Acceptance from FDA GHANA

Officials from the FDA of Ghana have accepted the proposal of Indian government and on July 10, 2019, have sent an acceptance letter to the Government of India. According to the officials from FDA Ghana, they do not reject any application containing an active pharmaceutical ingredient (APISs) and finished pharmaceutical products (FPP) controlled as per the Indian Pharmacopoeia. However, to undergo best regulatory practice, they have to perform the specification for Indian Pharmacopoeia with other officially recognized Pharmacopoeia like British Pharmacopoeia, US pharmacopoeia and International Pharmacopoeia. Any inadequacy found in APIs and FPP controlled as per the Indian Pharmacopoeia standards need to be addressed in order to comply with rules and standards of other officially recognized pharmacopoeia. Hence the FDA Ghana believes that Indian pharmacopoeia is an approved reference of the FDA when its monograph is compared with the monographs of the recognized pharmacopoeia.2

Conclusion

As per the source information the standards of the Indian pharmacopoeia are close to other officially recognized pharmacopoeia like British Pharmacopoeia, US pharmacopoeia and International Pharmacopoeia; hence, FDA of Ghana has decided to adopt Indian Pharmacopoeia due to standard quality and great potential and acceptance in various companies.

Footnotes

1 https://www.ipc.gov.in/news-highlights/655-recognition-of-indian-pharmacopoeia-by-flda-ghana.html

https://www.ipc.gov.in/news-highlights/655-recognition-of-indian-pharmacopoeia-by-flda-ghana.html

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