The Indian Pharmacopoeia Commission (IPC) has finally come out with the long awaited Indian Pharmacopoeia (IP) Addendum 2005. It contains 46 new monographs including three for bulk drugs (adenine, fructose and lopinavir), 22 for large volume parenterals, ten for antiretroviral formulations, ten for medicinal plants (herbal drugs) and one for Oxygen 93 Per Cent. The new addendum to IP is to be effective from June 30, 2006.
The last edition of the IP was published in 1996. It was updated by additions and amendments introduced through Addendum 2000, Veterinary Supplement 2000, and Addendum 2002. The Addendum 2005 is a companion volume to the IP 1996.
Addendum 2005 has also added new drugs and preparations to the Indian Pharmacopoeia 1996 with a view to keep it updated. Some monographs like those for doxycycline HCl capsules, intraperitoneal dialysis solutions, oral rehydration salts and oxygen have undergone major changes. A new appendix on gas detector tubes has been incorporated and appendices on tests for sterility, plastic containers, sterilisation and biological indicators have been replaced with new versions.
The additions in the Addendum 2005 are didanosine tablets, indinavir sulphate capsules, lamivudine oral solution, lopinavir, nelfinavir mesylate tablets, nevirapine oral suspension, stavudine capsules, stavudine and lamivudine tablets, zidovudine capsules, zidovudine oral solution, zidovudine, lamivudine and nevirapine tablets (all antiretroviral drugs), anticoagulant citrate phosphate dextrose adenine solution, dextran 70 injection, fructose injection, glycine irrigation solution, invert sugar injection, invert sugar and sodium chloride injection, multiple electrolytes and dextrose injection type I, multiple electrolytes and dextrose injection type II, multiple electrolytes and dextrose injection type III, multiple electrolytes and dextrose injection type IV, multiple electrolytes and dextrose injection type V, multiple electrolytes and dextrose injection type VI, potassium chloride and dextrose injection, potassium chloride, sodium chloride and dextrose injection, sodium bicarbonate injection, compound sodium chloride and dextrose injection, sodium chloride and fructose injection, sodium chloride irrigation solution, compound sodium lactate and dextrose injection, half strength compound sodium lactate and dextrose injection, modified compound sodium lactate and dextrose injection, compound sodium lactate solution for irrigation (all large volume parenterals), ashwagandha, bacopa, bhuiamla, centella, garcinia, ginger, kalmegh, sallaki, turmeric, vasaka (all medicinal plants) and some others like adenine, fructose and Oxygen 93 Per Cent.
The price of a single copy of the Addendum is Rs 2000 (India) and $150 / £ 75 (abroad). As per the Drugs and Cosmetic Act, 1940, the IP is the legally recognised book of standards for the quality of drug substances and their preparations included therein. IPC, the statutory body that is given charge of framing IP, is a society registered under the provisions of the Societies Registration Act, 1860.