The Indian Pharmacopoeia Committee (IPC) will introduce a general chapter on impurity standards for Active Pharmaceutical Ingredients (APIs) and dosage forms in its upcoming edition of 2007 for the first time in its history.
The new approach is envisaged to help the Indian companies in global market, with an effort to move close to the acceptance criteria for impurities in drug substance in the international harmonised standards. The edition will have specifications on level of identified impurities, unidentified impurities and the total allowable levels for the drug substances, according to a member of scientific committee, IPC.
The new chapter would also specify acceptance criteria for degradation of substances in drug products. Information of impurities associated with side effects or toxic reactions, including genotoxicity, will be included in the approach so that specific tests can be added in existing or new monographs of Indian pharmacopoeia. Simple tests could be done for these impurities, and this will not be a big burden for the industry, added the member.
"The collective wisdom of the scientific committee, with around 100 top scientists in the country, has developed a general approach for testing impurities in the drug products. The technocrats in the committee have deliberated the types of impurities and prepared our approach by considering both the current global requirements and the interest of manufacturers," Dr G N Singh, secretary-cum-scientific director, IPC explained.
The committee has taken the views and opinions of the industry and the scientists into consideration, and has come out with a collective decision on the issues related to impurity standards, he added. The committee has also scrutinised the monograph of drugs which are known for toxicity, before taking the decision. The standards are set to support the Indian pharmaceutical industry in the competitive global industry, as well as to provide equal opportunity for the small and medium scale companies.
"We have not added anything unnecessarily in the new edition and are sure that the IPC standards are second to none," said Singh. However, he refused to comment more on the specifications in the new edition.
Right from its formation, IPC has declared its objective to give special attention to the methods of manufacture used by the indigenous industry in selecting the pharmacopoeial tests for monitoring the toxic impurities of the concerned drug.
As Pharmabiz reported earlier, the manuscript of the fifth edition, the Indian Pharmacopoeia 2007 in three volumes, would be released in December to be made effective from April 2008. The Indian Pharmacopoeia 2007, with 300 additional monographs, will have 175 new monographs of chemicals and dosages forms and also will have monographs on vaccines, immunosera, herbs, herbal products, blood and blood-related products, biotechnology and veterinary products.