While the Tropical Botanical Garden and Research Institute (TBGRI), Thiruvananthapuram, has appointed a high-level committee to probe the controversy over its herbal compound, Jeevani, following a series of articles published in Pharmabiz, Arya Vaidya Pharmacy (Coimbatore) Ltd. (AVP), the former manufacturing and marketing license holder of the compound, has demanded TBGRI an extension of the license period.

Informed sources told Pharmabiz that the TBGRI committee comprising of a select group of experts and scientists, would assess the present patent and trademark status of the compound, reports on Nutrisciences Innovations LLC of US filing a trademark right in U.S., review of technology transfer and its results, possibility of retrieving the trade mark rights and floating global tenders to offer manufacturing license etc.

The committee would submit its preliminary report within ten days. Based on that, an expert steering committee appointed by the Kerala Government and TBGRI would decide the future course of action and fate of Jeevani, said the top level TBGRI source.

Meanwhile, AVP is learnt to have written an official letter to TBGRI, demanding an extension of its seven-year manufacturing and marketing license period, which expired in November 2003. Since TBGRI was not able to make available 'Aarogyapacha', the main raw material for Jeevani, during the license period in contrary to the assurance and understanding during the technology transfer in 1996, the deal had been an unviable proposition for the company. The company was not able to cater to the orders as per the demand, and TBGRI should offer an extension to honor its commitments, demanded AVP.

However, a top-level source said that TBGRI was unlikely to consider an extension to AVP for "reasons like the controversy, lack of transparency and communication gap between the two partners".

Interestingly, the company has not mentioned about the controversy in the letter, or tried to clarify its stand on the mysteries related to the status of trademark and the allegations on its relationship with Nutrisciences, according to the source.

It is to be noted that AVP had neither communicated or clarified with the TBGRI nor to the media about its alleged role and stand on the loss of trademark rights to the U.S. firm, despite the controversy was widely discussed in the media after the Pharmabiz newsbreak during the last week of January, this year. In an informal talk with Pharmabiz, last week, a top level AVP management official had reiterated its earlier stand that the company was not aware of the US trademark, and denied the allegation from various quarters pertaining to the US trademark registration was done with the knowledge of AVP.

It may be noted the sailing was rough for Jeevani during its seven years of existence in the market. AVP, which was awarded the exclusive manufacturing and marketing license for the world-renowned compound in 1996, was ambitious about Jeevani, touted like the Korean Jinseng. AVP had set up an exclusive GMP certified manufacturing facility at Thennalapuram near Palakkad in Kerala. The company had orders worth several crores of rupees from abroad, including a major order from Israel and a few other European countries. AVP had an understanding with TBGRI to supply Aarogyapacha from the Agasthyar hills, the natural habitat of the herb, and was ready to offer the tribal Kanis Rs 100 per kilogram to collect the herb from the forests.

However, the forest department prevented the supply citing Aarogyapacha was not figuring in the 'Minor Forest Produce list'. Forest officials also felt destructive cultivation and smuggling of the herb was rampant, and hence to enforced a blanket ban. AVP could make only 25,000 bottles of the drug, and thereafter, had to often discontinue or scale down production due to lack of raw material.

Then AVP tried to cultivate Aarogyapacha near Thirunelveli in Tamilnadu. The experiment failed as the herb was found to grow only in its natural habitat. A Bangalore based biotech company offered to develop saplings and herb at its nursery with U.S. technology, and AVP invested further. That attempt also did not meet with much success.

The Kerala Drugs Control Department cancelled the license to manufacture Jeevani saying that Aarogyapacha was mentioned in the traditional Ayurvedic texts as Varahi, and hence Jeevani was not an original invention. AVP moved High Court against the decision, and got permission to continue production.

By that time, it was late and the license period was over. Sources say AVP has lost many million rupees in the bargain, than the returns from its sales, during the manufacturing period.