Indian Pharmacopoeia-2014 comes into force

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The seventh edition of the Indian Pharmacopoeia (IP 2014), officially released in November last year by the Indian Pharmacopoeia Commission (IPC) has come into force in the country with no further extension of its implementation by the regulatory authorities.

The IP 2014 is presented in four volumes. The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and 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 now a days are omitted from this edition.

As per the original plan, the IP 2014 was to come into force from January 1, 2014. But, there were demands from industry to postpone the implementation because of the practical difficulties. This has prompted the Indian Pharmacopoeia Commission to delay the implementation, giving more time to the industry to adopt the changes.

Meanwhile the IPC has received inputs from its stakeholders on IP 2014 which require up-gradation/changes. The IPC has issued draft amendments (proposed) and has invited comments/suggestions from the experts and stakeholders within 30 days.

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 1 general chapter is first time being included in this edition.  It is hoped that this edition would 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.

Source: PharmaBiz


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