Indian Pharmacopoeia '07 To Be Released In Dec.

The manuscript of the fifth edition of Indian Pharmacopoeia, with 300 additional monographs, is ready and is slated for release in December to be made effective from April 2008, thanks to the massive work put jointly by the Indian Pharmacopoeia Commission and other experts.

The Indian Pharmacopoeia 2007, coming out in three volumes, will have 175 new monographs of chemicals and dosages forms. It will also have monographs on vaccines, immunosera, herbs, herbal products, blood and blood related products, biotechnology and veterinary products.

"It was made possible only because of the hard work of the scientists with the Commission, the scientific body members, experts from across the country and abroad including those from the private sector. We have been working day and night for four months to make it possible. The editing works are over and is being sent to the press now", IPC secretary-cum-scientific director Dr G N Singh said while thanking all those from the industry and academicians who contributed in the effort.

He said the coming edition will have lots of new features in user-friendly format. The scope of the same had been extended to include biotechnology, indigenous herbs, herbal products, viral vaccines and additional antiretroviral drugs and formulations inclusive of commonly used fixed dose combinations.

"The edition will be presented in a new style so that there is greater uniformity in editorial presentation. According to the policy of the commission now, monographs and pharmaceutical preparations are not elaborated, with exception of  those immunosera for human use, immunaserfor verinary use, some biological preparations, vaccines for human and veterinary use," he said.

But the new edition is presented in a user-friendly format using the latest advances in technological and experimental methods widely adopted in India and abroad. "Contents of appendixes are divided into by  and large in consonance with those now adopted internationally for monitoring quality of drugs," he explained.

The director said the scientists have been working without a break over the last few months and at least 100 experts from abroad extended assistance. Scientists from companies like Ranbaxy and experts from institutions like DIPSAR AIIMS also were among those who contributed to the massive efforts of updating the standardization documents of Indian drugs sector.

(Ref: The Chronicle Pharmabiz dated November 8, 2007)

New Pharma Min To Track Price Dodgers

Drug makers may not be able to avoid price control by making use of the division of powers between different ministries for long.

The Cabinet secretariat has moved a proposal to create a new ministry for pharmaceuticals that will deal with all issues in the sector under one roof.

This would not only put an end to companies benefiting from the lack of co-ordination between different regulatory agencies in the same sector, but also make it easier for the government to negotiate prices at the time of approving a new brand. The move comes at a time when the administrative agency for the sector - the ministry chemicals and fertilisers - has started bridging certain regulatory gaps to facilitate this. The chemicals ministry wants the price regulator attached to it to have a say when the health ministry gives marketing nod to a new brand.

This would help in preventing new brands of scheduled medicines from entering the market without  a mandatory price approval from the price watchdog NPPA. Co-ordination among the pricing and quality regulator is also essential in negotiating the price of a new brand by assessing how much better quality of life it will offer over an existing brand at what premium. The Cabinet secretariat has now sought views from different departments based on a proposal sent by CPM parliamentarian Sujan Chakraborty demanding a stand-alone ministry. Now many of the issues including pricing as well as policy making come under the ministry of chemicals and fertilisers. The pricing regulator is an autonomous body attached to this ministry and administers the drug price control order which is an administrative order issued under the Essential Commodities Act. It is understood that the chemicals ministry is not very much in favour of the current proposal.

(Ref: The Economic Times dated November 30, 2007)