The Centre is planning to amend the Drugs and Cosmetics Act and Rules to bring the Sowa-Rigpa medicines under its ambit on the pattern of other Ayurveda, Siddha and Unani drugs, once the system is legally recognised.

Currently, the health ministry is looking to get the Indian Medicine Central Council (Amendment) Bill 2010 passed to formally accord the legal status to the traditional Sowa-Rigpa system which is popular in the Himalayan regions. The bill was presented in the Rajya Sabha in May this year after the Cabinet decided to approve the system and the bill has been referred to the Parliamentary Committee attached to the health ministry.

Though at present only a few companies are manufacturing the drugs for this system of medicine and scale of production is small, the government expects that there will be a rush of companies including major firms for grabbing a pie from the potential earnings. This will make the quality check a big task and hence the Act would be changed, sources said.

The government will also give special attention to the composition of the formulations and labelling of these drugs which will have also good export potential, against the backdrop of complaints raised about the Ayurvedic drugs in some countries. Some Ayush drugs got into trouble abroad citing usage of heavy metals therein beyond their approved levels. Since the medicines were based on time-tested formulation from treatises of Ayush systems, the matter was cleared up later with the respective countries after demonstrating the efficacy and safety of the drugs.

Since most of the preparations under the Sowa Rigpa system are based on canonical treatises akin to Indian systems of medicines, the composition of some of the medicines may involve the use of heavy metals such as mercury, arsenic etc. Once this branch of medicine gets formal status, the government wants to make sure that ingredients of Sowa-Rigpa medicines are also tested properly avoid embarrassment abroad.

Keeping in view the distinct nature and functionality of Amchi medicines, the same should be defined separately with specific provisions for their regulation, surveillance and monitoring under the scope of the Drugs and Cosmetics Act and Rules on the pattern of other Ayurveda, Siddha and Unani drugs (AS&U) from the outset, according to experts.