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THE PHARMA REVIEW (JUNE 2008)

Need for NFI More Acutely Felt

Prof. Harkishan Singh

Abstract: The medico-pharmaceutical professions viewed that creation of an autonomous Indian Pharmacopoeia Commission could better serve the objective of preparation, publication and distribution of the national pharmacopoeia. The necessity of such a body was articulated by me at a meeting of the Drugs Technical Advisory Board held on 24 December 1982. My suggestion for setting up an autonomous commission was accepted by the Board in principle and I was requested to prepare a working paper on the subject, which I did and sent it to the Drugs Controller (India) in July 1983. The Ministry kept silent on the issue for over two decades and then made use of the feasibility expressed in the working paper in support of setting up a commission but otherwise what was created was far from being autonomous. The case made in the working paper was for an autonomous commission, and not for a commission with guided autonomy which got to be established.

I felt piqued and published a well-reasoned paper giving all the background and projections on the subject. The article 'Indian Pharmacopoeia Commission : What kind of Autonomy?' was widely publicized in several journals during 2005. Having taken a public stand, I declined to be a part of this Commission in any form. There is a need to examine the composition and structuring of the Commission afresh, so that what has been established is in tune with its counterparts in the better developed countries.

Recently, the Indian Pharmacopoeia 2007 has been published. With time there will appear comments on the accuracy and on the standards laid in the respective monographs. The change which immediately catches one's eye is the departure from the usual practice of making the respective categories and doses as part of the monographs. The reason given by those involved in preparing the publication is that the pharmacopoeia is a book of drug standards and there is no need of including the category to which a medicinal substance belongs or to recommend a dose for it. The explanation given is valid. However, the practising physician and pharmacist look for a ready source of authentic drug dosage. So far the pharmacopoeias published in India have been of help for this information. A publication of a formulary type can cover this kind of vital material. In our country the National Formulary of India which used to be a helpful compendium has become defunct and there is no hope of its revival.

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