Implementation of Indian Pharmacopoeia 2014 postponed to April, 2014
The Indian Pharmacopoeia 2014, which was released some time back, will be implemented only from April 1, 2014, thus giving more time to the industry to adopt the changes. The original plan was to make it in force from January 1.
There were many requests from industry to postpone the implementation because of the practical difficulties. This has prompted the Indian Pharmacopoeia Commission to delay the implementation, said Drugs Controller General of India (DCGI) Dr G N Singh, who is also the secretary of the IPC.
The new IPC had extended its scope by including the products of biotechnology, indigenous herbs, herbal products and veterinary vaccines. The seventh edition of pharmacopoeia, brought out by the Indian Pharmacopoeia Commission, also has additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations not in use these days are omitted from this edition.
The IP 2014, incorporates 2548 monographs of drugs out of which 577 are new monographs consisting of APIs, excipients, dosage forms, antibiotic monographs, insulin products and herbal products etc. 19 new radiopharmaceutical monographs and one general chapter is first time being included in this edition.
The edition, improved and revised version of the previous one, is expected to play a significant role in improving the quality of medicines which in turn promote public health and accelerate the growth and development of pharma sector. The IP-2014 is published in fulfilment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder and it prescribes the standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines.