Major problem with the traditional knowledge has been lack of documentation and the Ayurveda and unani systems suffer from this draw back, according to Dr Gopakumar G Nair, a leading IPR consultant and past president of Indian Drug Manufacturers’ Association. He said that although the combination products under these systems are effective, many of them lack standardization and documentation. Getting internationally accepted dossiers is difficult for combination products, he said.

Single ingredient products are gaining prominence and it is convenient to create acceptable dossiers and validation procedures to identify active ingredients in single ingredient products. The ingredient in this can be easily be determined, validated and represented. A dossier that is in conformance with the ICH guidelines can be taken up to any part of the world, Dr. Nair said.

Synthetic drug pipeline is drying out and block busters are not easily coming into the markets. It is the time now for biological entities and designer drugs. Thus, single herbals are the best hope for herbal industry. In order to build the opportunities for Indian herbal industry, one needs to prove in the domestic markets, as overseas markets will not encourage a product that hasn’t made a mark in the domestic front.

Talking about the state of herbal industry in the country and issues that have impact on the industry, Dr Nair expressed that the Central Government has done too little to boost Indian System of Medicine (ISM). There has been absolutely no regulatory mechanism for approval of herbal raw material or for herbal registrations. For instance, if government expects one to carry out toxicology studies on turmeric with its anti-cancer properties, after household usage for many years, it would make no sense.

The Government should show the right path to herbal companies, not throw them out of their way. A clear road map should be drawn with the help of the private companies in the herbal industry. China and Korea have already achieved progress in the herbal sector. Indian Herbal industry too needs a serious push in the interest of global opportunities, the sector has. The documents prepared by government should be scientifically drafted and unambiguous, he opined.

He suggested that India should set up a separate Herbal Pharmacopoeia Mission on lines of Indian Pharmacopoeia Mission set up in early 2005 under the leadership of Nityanand. It is pitiable that Indian pharmacopoeia has been removing herbal products when US and other pharmacopoeia have been including more and more herbal products. If a separate Herbal Pharmacopoeia Mission cannot be set up, amendments should be made in the Drugs & Cosmetics Act to add herbal and nutraceuticals legally licensed under a separate license system.

The patent regime has been on the horizon for the last one decade. Despite the abundance of natural resources, there has not been sufficient awareness and due appreciation of the fact that patent regime is useful to the herbal industry. Patenting as a system or a culture is not by itself intrinsically bad, but it all depends on use / abuse of it. Indians are not taking note that they can protect natural resources through patenting and make good to larger population, Dr Nair added.