Strong regulatory regime for plant-based drugs on the anvil

Drugs derived from plants will soon have to go through a strict regulatory process to improve their acceptance on the global stage.

The Drug Controller General of India is in the process of amending the Drugs and Cosmetics Rules to lay down specific parameters for the regulation of this category of drugs, also called phyto pharmaceuticals.

"We are going to have a strong regulatory regime for phyto pharmaceuticals in which India can become a global leader. At present there is no specific provision or parameter defined in the Drugs and Cosmetics Rules to determine the efficacy of such plant based drugs," Drug Controller General of India G N Singh said.

Schedule 'Y' of the Drugs and Cosmetics Rules will be amended to separately lay down guidelines and regulatory mechanisms for plant based drugs, which are not as dangerous as chemical or biological drugs and may not therefore undergo the same set of drug regulations as the latter category of drugs have to undergo.

"We are in the process of bringing in such a regulatory regime to encourage drug discovery in the sector," Singh said.

"At present, phyto pharmaceuticals are also considered drugs under the rules and have to undergo the same set of regulatory procedures as prescribed for chemical drugs. We will simplify the regulatory procedure for plant-based drugs so that manufacturers come forward for research and development. There has been a long standing demand for a separate window for this category of drugs," a Health Ministry official said.