Govt may review IP Commission to empower scientific committee

Jayashree Padmini - New Delhi

The government may make minor structural changes to the constitution of the governing body of the Indian Pharmacopoeia (IP) Commission and empower the scientific committee. This is following representation from stakeholders including the IP Committee members.

The health secretary, in a meeting held on April 21, 2005, is said to have agreed in principle that there is a need to have professional experts in the governing body. The secretary said that it would be difficult to make major changes in the al-ready issued Order of March 22, 2005. However, he has agreed that the chairman of the scientific committee—who will be an eminent scientist and a technical expert—will be made co-chairman of the governing body.

Further, it has been decided that the scientific committee will be authorised to function in an autonomous manner.

The IP Committee chairman Dr Nityanand had sought the intervention of the health secretary in the IP Commission formation as the notified organisational structure failed to reflect professional expertise.

In his letter to the secretary, Dr Nityanand demanded a quick review of the IP Commission Order dated March 22, 2005 in order to provide the Commission adequate independence and autonomy.

He pointed out that in the context of the Indian pharmaceutical industry emerging as a key player in the global market, the Indian pharmacopoeial specifications needed to be continuously updated so as to maintain the confidence in Indian drugs in the international market. This calls for a highly competent body with technical expertise and infrastructure support to develop and publish reference standards.

Dr Nityanand also urged not to dissolve the existing IP Committee till the time the scientific committee and expert groups of the new IP Committee are fully operational.

This is in view of the fact that the ongoing work on Addendum 2005 should not be delayed. The Addendum contains a number of monographs on anti-retroviral drugs and herbal drugs made by Indian companies and most of these are not available in any other pharmacopoeia.

It may be noted that the previous health secretary, Dr Prasada Rao had assured that the IP Committee would be autonomous and would consist exclusively of experts in related subjects to IP. He had also agreed that the CEO who would be designated as secretary-cum-scientific director on the lines of British Pharmacopoeia Commission, would have full administrative and financial powers to manage the IP Committee in accordance with the Rules to be formed by the governing body.

In the series of meetings and discussions with the health ministry, it was also agreed that the commission would have its own laboratory to develop validation methods.

However, when the notification came in, all the assurances were set aside and the whole scheme has been reformulated. Dr Nityanand quoted in the letter that, even the present order regarding the composition of the governing body states ‘‘Chairman who shall be person of eminence with academic distinction in teaching or with experience in regulatory affairs relating to drugs’’; the Order in its next line states that the secretary will head the body. ‘‘How could this be justified?’’ asked Dr Nityanand.

When the BP and USP used to bring out updated Addendum every year and new edition every five years, the IP had only four editions between 1955 and 2005. Now the British Pharmacopoeia (BP) and US Pharmacopoeia (USP) started bringing out new editions every year to keep the specifications regularly updated to enable the pharmaceutical manufacturers to make available drugs of international standards. India appears to be left behind, quoted sources.

— jayashreep@expressindia.com