In what could be a major step towards standardising herb-based drugs and pitching them at the global markets as recognised formulations, the government has set up an expert panel to set standards on phyto pharmaceuticals for registration as new drugs.
The seven-member panel, headed by former CDRI director Dr Nitya Anand and comprising experts from concerned areas including Ayurveda, will hold its first meeting on August 26 to begin the exercise. It is expected to finalise the recommendations within two months, sources said. Once the protocol and standards are set, herbal formulations can be registered as new drugs, after clearing all necessary procedures including different phases of clinical trials, and can be marketed across the globe as standard formulation packs just like the modern drugs. It will then come under the jurisdiction of CDSCO also.
The terms of reference for the panel included suggesting criteria of standards to be implemented as per Drugs and Cosmetics Act 1940 and rules there under, and recommending format of Indian Pharmacopoeia monographs of phyto-pharmaceuticals and new herbal drugs. The committee will also identify authenticated source for obtaining phyto-pharmaceutical reference substances.
After the committee submits the report which will go through the required route of DTAB and other formalities, rules of the Drugs and Cosmetics Act will be amended accordingly to include the phyto-pharmaceuticals under one of the Schedules. And the government hopes to see that at least a few herbal-based drugs from India would be there in the global markets as new drugs within the next five years.
Though India has been a major player in herbal drugs in the world, at present these drugs are not considered as new drugs. The manufacturers, who get licence from Ayush Department, market them as food supplements and crude drugs. No formulation has been included in the Pharmacopoeia too. This will be an effort to harmonise the standards of herbal drugs with the global parameters and ensure better recognition for Indian companies in the developed markets. With this scientific validation, these formulations can then be included in the pharmacopoeia too, it is expected.
Medicinal plants and their preparations belong to the oldest known health-care products that have been used by human beings all over the world. The World Health Organization (WHO) estimates that up to 80 per cent of the population of most developing countries use plant-based medicines. India has been a major contributor in the field, with a huge resource in medicinal plants.