Business Daily from THE HINDU group of publications
Tuesday, Nov 14, 2006

Cross Currency

Group Sites

Industry & Economy - Pharmaceuticals
Web Extras - Bio-tech & Genetics
New Pharmacopoeia edition provides fresh insights

Our Bureau

Exclusive monographs of 32 new molecules included

In the global arena, there is a growing effort towards harmonisation of regulatory procedures and practices.

Hyderabad , Nov. 13

Drug companies and researchers can look forward to some exciting information in the new edition of the Indian Pharmacopoeia. Exclusive monographs of at least 32 new molecules have been included, which do not find place in any other Pharmacopoeia, said Dr G.N. Singh, Director, IP Commission.

A total of 92 new molecules have been added with details through scientific monographs. Similarly, 30 monographs on anti-retrovirals (ARVs) and insights into medicinal plants and herbs are some of the highlights that would interest the pharma sector, he told at a meeting organised by the Pharmaceuticals Export Promotion Council (Pharmexcil), here recently.

Another major initiative of the IP Commission has been the creation of IP monographs for India developed vaccines. The idea is to get the requisite certification from procuring global institutions like the UNICEF, for Indian products to reach global needs.

Discussions have been taken up with the UNICEF and a Committee that includes Mr Srinivasan of the Indian Immunologicals Ltd (IIL), is looking into the issue.

The IP Commission has recently signed an MoU with the US pharmacopoeia. A similar exercise is being pursued with the EU. In the next few months, a large Indian delegation would go to the EU countries to study relevant issues. The objective was to accelerate exports through better acceptance of the Indian IP, Dr Singh said.

Regulatory Procedures

China was another focus area. Though language problems exist, since the Chinese pharmacopoeia is in their own language, the market and potential for drugs and medicines were huge for the effort. Earlier, the newly appointed Drug Controller of India, Dr M. Venkateswarulu, in his address said every month 3-4 complaints on the quality front were received on Indian exports of pharma products. Some importing countries were also trying to dictate.

In the global arena also there was a growing effort towards harmonisation of regulatory procedures and practices. The International Commission for Harmonisation (ICH) is a major initiative in this direction with the US, Japan and the EU ideas converging. However, India is not yet a member in the ICH.

Regulatory Needs

In this background, Dr Venkateswarulu urged Indian exporters to get conversant with the regulatory needs of the country to which they intend to export products. It was also important to take packaging, especially packaging compatibility seriously, as it can affect quality of product.

The other mandatory things were logistics (order to execution time is 45-50 days), labelling procedures and needs and awareness about narcotic and psychotropic drug substance declaration fulfillment of respective countries. As the penalties for non-adherence are very severe, he said.

More Stories on : Pharmaceuticals | Bio-tech & Genetics

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page

Stories in this Section
Rains likely to dampen coffee output hopes

StanChart NRI Swagat account
ICICI Bank NRI deposit scheme
UP has most working children
Chidambaram seeks more Arab investments
The elixir of life
Pollution threatens Digha sea resort
Tariff value on edible oil: A tool to fight inflation
Novo Nordisk survey to take stock of diabetes control
World AIDS Day to be observed
SC clears land acquisition for Reliance SEZ
Coal-bed methane: BP to begin exploration in 2007
New Pharmacopoeia edition provides fresh insights
L&T teams up with Mitsubishi
Steel industry urged to upgrade product offerings to auto sector
UK team meets Ashwini Kumar
Kirana stores, getting refashioned by Hind Lever
Adobe Senior Vice-President's son abducted
Govt cautious on FM radio phase III rollout
Students need better `finish' to succeed in corporate world
Bengal's footwear sector seeks full VAT exemption
Scientist bags Ranbaxy award
Grameen Phone — doing things with a difference
No compromise on workers' rights: CITU
Uncertainty over trade fair venue irks Bengal chamber
Meet on natural products
Vaghela pegs cotton production at 270 lakh bales
Cell cos fare poorly in quality survey
Crackdown at Kochi port yields results

The Hindu Group: Home | About Us | Copyright | Archives | Contacts | Subscription
Group Sites: The Hindu | The Hindu ePaper | Business Line | Business Line ePaper | Sportstar | Frontline | The Hindu eBooks | The Hindu Images | Home |

Copyright 2006, The Hindu Business Line. Republication or redissemination of the contents of this screen are expressly prohibited without the written consent of The Hindu Business Line