Centre To Crack Whip On Spurious Ayurvedic Firms

State-level drug control authorities have been ordered to examine new ayurvedic drug approval requests and watch out if they contained any components of commonly used bulk drugs and intermediaries.

Cases have come to light of companies mixing antibiotics with herb extracts and passing them off as ayurvedic formulations.

Chemicals and fertilisers ministry sources said the mandatory tests and clinical trials would not be allowed to be waived for ayurvedic formulations.

The government allows waiver of trials if the medicine is already tried and tested and, if a specific disease needs to be tackled with a particular medicine. The quality control regimen would be further tightened and guidelines are being formulated for this, sources said.

 

The action follows complaints by consumer bodies, doctors and affected companies that drug companies, including some foreign ones, easily obtain manufacturing and marketing licenses for thousands of unscientific, useless and even harmful drugs. Sources said under the present decentralised licensing system, state-level drug administration bodies were empowered to test the efficacy and usefulness of drugs. Some state bodies had liberalised the process of giving out ayurvedic drug manufacturing licenses in order to boost Indian system of medicine. Unscrupulous companies took advantage of this as they could palm off cheaply sourced drugs as ayurvedic medicines and, on the other hand, claim various benefits given out by states and the Centre like duty concessions, tax holidays and subsidies.

Also, there was no price control for ayurvedic drugs. This was a major incentive to pass off price controlled vitamins and antibiotics as high priced ayurvedic medicines.

Some time ago, a drug called Essentiale, manufactured by the a French multinational was being marketed in India as an ayurvedic liver tonic under a licence from Maharashtra.

This was cancelled after the fraud came to light, but the company obtained another licence from Gujarat and continued till a notice was sent to all states not to approve the drug.

Cases had come to light of steroidal drugs being marketed as ayurvedic vitality-building medicines and dietary supplements.

These medicines were popular in the rural areas and enjoyed a multi-crore market with over a 100 brands.

Since it was difficult to conduct chemical analysis of every single drug, the government took action whenever such cases came to light.Some state bodies had liberalised the process of giving out ayurvedic drug manufacturing licences. Unscrupulous companies found it convenient to palm off cheaply sourced drugs as ayurvedic medicines.