The national guidelines for stem cell research and therapy are being formulated jointly by the Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT), Science and Technology Minister Kapil Sibal said on Monday.

A drafting committee has formulated the guidelines, which will be put on the ICMR website to elicit response from all the stakeholders before finalising them, Sibal told the Rajya Sabha.

India is not taking any assistance from the US on stem cell research, he said during question hour adding however that the US has shown keen interest in collaborating with India in the area.

The draft policy document has also been sent to National Institute of Health (NIH), US Department of Health and Human Services for suggestions, he added.

The comments received from NIH have been taken into consideration along with other comments while the programme on stem cell research has also been discussed with US experts, Sibal said.

http://www.hindustantimes.com/news/181_1703447,0004.htm

India's Ranbaxy Laboratories has stepped up its efforts to dominate the domestic novel drug delivery system (NDDS) market, in-licensing two new drugs from Europe in as many weeks.

One of the recently acquired products stems from a deal with the Indian arm of French company Ethypharm, the other comes from Netherlands-based Pharma company, Eurodrug Laboratories.

The company already has 30 NDDS products on the market in India and plans to bring in five more by the end of the year.

"The NDDS market is a niche segment that is continuing to grow and we are focusing heavily in this area," Ranbaxy spokesperson, Krishnan Ramalingam, told In-PharmaTechnologist.com.

The recent exclusive licensing deal with Ethypharm is for its novel analgesic drug, Trambax (Tramadol), a tablet that melts rapidly in the mouth without water, allowing it to be used anywhere at any time - of particular value in many parts of India.

This is achieved through Ethypharm's proprietary Flashtab technology, which it is using in several drug applications to make medicines more palatable and easier to swallow.

A Flashtab formulation typically combines Ethypharm's T-Mask taste-masking crystals with specific excipients (such as flavourings) to provide a palatable oral formulation that has the ability to disperse in the mouth in less than 30 seconds.

The technology combines both taste masking and rapid dispersion, is not limited by the particular characteristics of the active ingredient, can handle doses up to 650mg and - claims the company - is less costly to manufacture than other more complex competing systems.

Ethypharm will manufacture the drug using this technology on behalf of Ranbaxy from its Mumbai facility.

While still used in only a minority of oral medicines - with estimated annual sales $1.7bn (€1.5bn) in 2002 - fast-melt delivery is experiencing 40 per cent growth a year as companies turn to it to differentiate their products in the marketplace.

Other companies offering fast-melt technologies include Cardinal Health with its Zydis system, CIMA Labs (OraSOLV, DuraSOLV) and Eurand (AdvaTab).
Just prior to the Trambax deal, Ranbaxy also inked a deal with Eurodrug Laboratories, for the asthma product Synasma (doxophylline) - a novel xanthine bronchodilator for chronic bronchitis, asthma and chronic obstructive pulmonary disease (COPD).

However the deal is non-exclusive, with Ranbaxy's large Indian rival, Dr Reddy's Laboratories also given permission to market the drug in India, although under a different brand name.

Eurodrug has already been selling the drug in Europe, Latin America and a few Asian countries such as Korea, Philippines and Thailand, before its foray into India.

Synasma is claimed to be superior to currently available xanthine analogues, such as theophylline and aminophylline due to its "unique technology."
However, Ranbaxy did not provide the details of this technology, nor the reason for the superiority of the product, which will be manufactured by Eurodrug in the Netherlands.

"This product will build on the oral asthma franchise of Ranbaxy, and strengthen the company's position in the fast growing Indian asthma segment," said Sanjeev Dani, regional director of Ranbaxy in India and The Middle East.

India has an estimated 15-20m asthmatic patients and the estimated prevalence rate in 5-11 year old children is between 10-15 per cent.

With a growth rate of 14 per cent, as opposed to just 9 per cent globally, the Indian market for respiratory diseases is one of the fastest growing therapeutic segments in India, with asthma drugs accounting for 30 per cent of this market.

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http://www.in-pharmatechnologist.com/news/printNewsBis.asp?id=67966

PRESS TRUST OF INDIA
Posted online: Thursday, May 25, 2006 at 2045 hours IST
Updated: Friday, May 26, 2006 at 1028 hours IST

NEW DELHI, MAY 25: The Monopolies and Restrictive Trade Practices Commission (MRTPC) has stated that any boycott of a pharma dealer by traders associations shall be treated as restrictive trade practice.

Disposing a petition filed by a Mysore-based pharma dealer, the MRTPC held that circulars issued by the Karnataka Chemist and Druggists Association (KCDA) to boycott the applicant was against the nature of fair trade.

"Any boycott of any dealer and\or association, in any manner, written or oral shall, be treated as restrictive trade practice and shall be stopped," said Justice B K Rathi, Chairman of the Commission.

KCDA, which clocks business worth Rs 3,000 crore, had banned Ramakrishna Services, a distributor and stockist of Novartis from carrying on any business.

The association had also directed pharma-company Novartis not to supply its drugs to him. Following the directions, the pharma major not only cancelled the supply despite accepting money in advance but also started the process to appoint another stockist in Mysore.

The aggrieved stockist then approached the Commission after serving mandatory legal notices to both the pharma company and KCDA and contended that under the drugs (price control) order, 1995, no manufacturer and distributor can refuse sale of any drug to a dealer without good and sufficient reason.

The commission also observed that KCDA had directed all Pharma manufacturers to not appoint stockists or dealers without its No-Objection Certificate. It also published a list of persons affiliated to it and asked them to appoint only these as their stockist/dealer.

Further, the commission also noticed that KCDA was frequently boycotting pharma manufacturers citing various trade issue. Its recent victim was Glaxo and Pfizer. Later, Glaxo had to bend down and accept all its terms and conditions.

However, during the proceedings, Novartis claimed that the cheque issued by the complainant had bounced and so it had stopped the delivery.

"Reply made by Sandoz was bald and blatantly false. It tried to camouflage the restrictive trade practices adopted by it significantly," commission observed.

However, it agreed to supply in lieu of payment by demand draft.

Disposing the matter, the commission ordered KCDA to immediately restrain itself from issuing NOCs. It also directed KCDA not to issue directions to the pharma companies to distribute their products only to its members only.

http://www.financialexpress.com/latest_full_story.php?content_id=128353