The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged the Kenyan government to recognise Indian Pharmacopoeia as that will help significantly in monitoring and manufacturing quality drugs at affordable prices which can be passed on to the Nigerian importers thereby making them more competitive.
In a letter to Dr F M Siyoi, Deputy Chief Pharmacist/Deputy Registrar, Pharmacy & Poison Board, Ministry of Medical Services, Republic of Kenya, Pharmexcil executive director Dr PV Appaji said that by compliance with Indian Pharmacopoeia, manufacturers/importers will be at an advantageous position and this will enable to reduce the cost of drugs due to availability of reference standard samples at low cost for Indian pharmacopoeia monographs.
If the Indian Pharmacopoeia (IP) is recognised, it will benefit Pharmacy and Poison Board in reducing operating cost of the testing laboratory, as the cost difference between the reference standards required for the testing of the raw material and finished product as per United States Pharmacopoeia (USP)/ British Pharmacopoeia (BP) and compared with IP is sizeable.
Giving an example, Dr Appaji in his letter said that the reference standard of Gentamicin sulphate USP approximately costs US$ 355 whereas reference standard of Gentamicin sulphate IP costs US$ 33. Moreover, the QCS testing charges are high as products are USP/BP but if the products are IP then the testing charges can be lower and the benefits can be passed on by the exporter to Nigerian importer thereby making them more competitive.
The Pharmexcil has forwarded monographs of some important drugs which are exported to Kenya and are listed in Indian Pharmacopeia, British Pharmacopoeia and United States Pharmacopoeia. “An examination of these monograph reveals that the stated specifications/standards are similar in nature,” Dr Appaji said.
Shedding more light on the Indian Pharmacopoeia Commission, the Pharmexcil informed the Kenyan government that Indian pharmacopeia Commission is established by Ministry of Health & Family Welfare (MoHFW), Government of India and has become fully operational from January 1, 2008. The commission deals with matters relating to timely publication of Indian pharmacopoeia which is the official book of standard for drugs included therein, in terms of the Second Schedule to the Drugs and Cosmetics Act, 1940 (D&C Act) so as to specify the standards of identify, purity and strength of the drugs imported, manufactured far sale, stocked or exhibited for sale or distributed in India/abroad.
“In view of the above, we request you to kindly take up the matter with concerned authorities, if necessary, for recognizing Indian Pharmacopoeia for the purpose of manufacture and exports of drugs for use in Kenya,” the Pharmexcil letter said.