The Ayurveda industry has raised its serious concerns over the opinion of the latest parliamentary standing committee report on Drugs and Cosmetics Act (Amendment Bill) - 2007 to include Ayurveda, Siddha and Unani (ASU) medicines under the scope of definition of clinical trial of drugs.
The 30th report on the Drugs and Cosmetics (Amendment) Bill - 2007 from the department - related parliamentary standing committee on Health and Family Welfare presented to the Parliament in the third week of October has opined that ASU drugs should not be excluded from the scope of definition of clinical trial of drugs since the definition of drug as given in the Act is applicable to both allopathic and ASU drugs.
In the Para 8.6 of the report, the committee also points out that even though ASU drugs are formulated by methods different from that used for modern allopathic drugs, the chances of harm that a drug may likely cause are similar and cannot be ruled out.
The industry sources points out that while the current law as such does not permit any new molecule or new material for the ASU drugs and the does not define the term new ASU drug, the suggestion for implementing clinical trials in the system is not applicable. Only drugs specified in any of the books specified in the first schedule of the Drugs and Cosmetics Act can be used for manufacturing ASU drugs.
The Ayurvedic Medicine Manufacturers Association of India (AMMOI) has come out with its protest, suggesting that the move will impede the growth of Ayurveda industry in the country. "The question of application of clinical trials shall be taken up if the law is modified to provide for the use of new molecules or materials other than those approved and permitting parenteral dosage form, as and when it is required," pointed out the association.
"The question of what should be norms for the clinical trials and the options for ASU Drugs is a million dollar question. The opinion, if approved by the parliament, will create serious consequences in the ASU industry. We will conduct campaigns within the members of parliament to object the suggestion in the houses," said Dr D Ramanathan, general secretary, AMMOI.
The Ayurveda Drug Manufacturers Association (ADMA) is also studying the report for further action. "We have only seen the relevant parts of the report and are waiting to study the full report before coming up with a response. We expect more such details to be revealed from the report, once the whole report is studied. However, we think that there are methods to gauge different systems of medicines and you cannot apply a single measure to all the systems of medicines," said Ranjit Puranik, general secretary, ADMA.
The AMMOI has also raised its concerns over the recommendations to set up 10 zonal offices for the upcoming Central Drug Administration (CDA) instead of one office in each state. The association comments that such an act will adversely affect the Ayurveda industry in states like Kerala, as the zonal offices are supposed to be established in major cities where the modern pharmaceutical companies are active.