The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has asked the union commerce ministry to take initiative to make Indian Pharmacopoeia (IP) recognised internationally as that will help significantly in monitoring and manufacturing quality drugs at affordable prices which can also be passed on to the importers thereby making them more competitive in the international market.
A Pharmexcil delegation led by its vice-chairman Ashutosh Gupta met senior commerce ministry officials including commerce secretary SR Rao and additional secretary Rajiv Kher in this regard on July 19.
The delegation apprised the officials that if Indian Pharmacopoeia is recognised internationally, manufacturers and importers will be at an advantageous position as this will enable to reduce the cost of drugs due to availability of reference standard samples at low cost for Indian pharmacopoeia monographs. It will benefit the importing country also as it will also reduce 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.
For instance, the delegation 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 exporters to the importers thereby making them more competitive.
Other members of the delegation included Pharmexcil director general Dr PV Appaji and its executive director Reghuvir Kini, Bhavin Mehta, Nipun Jain, Ranjith Puranik, etc.
Indian Pharmacopeia Commission is established by Ministry of Health & Family Welfare (MoHFW) 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.