Release of Guidance Manual for Compliance of IP
Release of Guidance Manual for Compliance of Indian Pharmacopoeia (IP)
The Guidance Manual for Compliance of Indian Pharmacopoeia (IP) was released by Dr G N Singh, Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission and the Drugs Controller General (India) in presence of Prof S K Gupta, Advisor, Pharmacovigilance Programme of India on 12th December 2012 at Indian Pharmacopoeia Commission, Ghaziabad. This Manual has been published by the Indian Pharmacopoeia Commission IPC) in collaboration with Central Drugs Standard Control Organization (CDSCO) and WHO-Country Office for India. Dr Singh and Dr Gupta appreciated the efforts of all members involved in the preparation of this Guidance Manual. The need for this publication was felt during the interaction with stakeholders in the IP related workshops-cum-symposia organized by the IPC.
Unless the norms prescribed in IP, the officially recognized book of standards for drugs as per the Drugs and Cosmetics Act 1940 and Rules 1945 there under, are understood and adopted by the stakeholders, the purposes of the publication of its new version may to not be achieved. The stakeholders are the regulatory officials, pharmaceutical industry private drugs testing laboratories etc. This Manual is not an Addendum or Supplement to the IP or a part of it. It is intended to enable the users of IP to perform the activities related to performance of the tests or associated activities prescribed in the IP and also to understand or interpret the requirements of IP for proper compliance of the requirements thereof.
This Guidance Manual is first of its kind for Pharmacopoeial Standards in India. The nations which may be in the process of bringing out such Manual, it will be useful for them. This will go a long way to enable the regulatory bodies in the discharge of their duties to streamline the functions of their own laboratories and also the in-house laboratories of drug manufacturers and commercial drugs testing laboratories. Surely the industry and commercial laboratories will also respond positively by adopting the IP norms rigorously.
This Guidance Manual can be procured from the office of the Secretary-cum-Scientific Director, IP Commission, Sector-23, Raj Nagar, Ghaziabad-201002 (UP) through Demand Draft for Rs 300/- (Rupees Three Hundred Only) issued in favour of "Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission" payable at Ghaziabad. The price in foreign currency is $ 5.41, £ 3.45. For more details please contact IP Secretariat, IP Commission,
Tel 0120-2783400, 2783401,2783392
Email : ipclab@vsnl.net
Content of Guidance Manual (Click to See)
