At a time when the traditional medicine market in the country is getting newer dosage forms of proprietary drugs of Ayurveda, Siddha and Unani (ASU), no proper monitoring and regulation of such products are carried out by the central ministry of Ayush or by enforcement authorities of the states in any part of the country, according to information from various sources.

The products include capsules, syrups, drops, creams, emulsions, gel, herbal extracts, fine herbal fractions, new polyherbal combinations, mixture of extracts of many herbals etc. These new dosage formulations are manufactured and sold in the country and outside without a check by the Union Ayush ministry. It is high time, the government put a control on these patented products.

Presently, in every state in the country the alternative medicines are monitored and controlled by the ISM wing of the drugs control department or the FDA. In some states like Madhya Pradesh, separate Ayush ministries are there, and they undertake the responsibility of monitoring and regulation of the ISM drugs manufactured and marketed there, whether it is classical or patented (proprietary). However, for the overall control of the production and sale of Ayush drugs, similar to CDSCO for allopathy, there is no national drug regulator under the Union government.

It is seen that the regulatory bodies of Ayush everywhere are comparatively weak in operations mainly because of shortage of staff. This shows that very little control is put on the manufacturing companies, and they enjoy full freedom to manufacture and market any product under a licence from the authorities. According to information from reliable sources, in the north and north eastern states in the country, myriad number of companies are bringing out various kinds of Ayush drugs and food products every day claiming cure for various diseases and for health generation. It is alleged that very poor regulatory activities are carried out by ISM departments in these states.

According to Dr. Arul Amuthan, an ethno-pharmacologist from Manipal University, these patented or proprietary ASU formulations are not documented in the classical texts, hence they are not categorised under the Drugs and Cosmetics Act. The recent trend of the manufacturing companies is to bring out newer dosage forms every day. Though they are not mentioned in the classical literature, some of them are found to be successful. But their efficacy has to be proved by scientific methods of today under the regulatory mechanism. Several products are marketed all over India by various companies. So, the ministry of Ayush should initiate some measures to monitor and regulate these proprietary ASU drugs for the sake of health of the people and for protecting the credibility of the traditional medicines, he said.

Claiming cure even for the most difficult of diseases like AIDS, heart disorders, diabetes, asthma, obesity, sexual impotence and cancer, many types of medicines categorised as Ayurveda and Unani products are marketed directly and through online in the country. Several cases are pending with many judicial courts against many a product brought out by various manufactures. Strict regulatory mechanism is the only way out for preventing the sale of these proprietary ASU formulations.