Ayurpark Healthcare and eight representatives of the Ayush industry in Karnataka have filed a writ petition in the state High Court against the notification issued by the department of health and family welfare appointing the Drugs Control department as the regulatory authority for Ayush sector under Rule 50(2) of the Drugs and Cosmetics Act.

The petitioners have stated that Rule 50(2) is not applicable to the Ayurveda Siddha Unani (ASU) drugs . The said notification is against the operational guidelines of the National Ayush Mission for quality control of ASU drugs. Feeling aggrieved over the state health and family welfare department move of appointing a drugs controller under Rule 50 (2), Ayurpark along with its representatives filed the writ petition.

“There is an Act called the Drugs & Cosmetics Act, 1940 and under this Act rules are framed. There is a separate rule for ASU drugs and allopathy drugs . Chapter IV of the Act deals with Allopathy drugs and Chapter IV –A of the Act deals with ASU drugs,” stated the petition.  

The ASU medicine comprises of bhasma, sindhura, rasa, rasayana. The process of manufacture of ASU drugs is totally different from Allopathy drug manufacturing. The administration and the enforcement of manufacturing of ASU drugs is totally controlled by Chapter IV-A of the Act and Rules, the petition stated.

Further the petition states that the ASU Drugs Technical Advisory Board(ASUDTAB) is constituted under Section 33-C of Chapter IV-A of the D&C Act to advise the Central and the state government on technical matters arising out of Chapter IV-A. Another Committee ASU Drugs Consultative Committee is constituted under Section 33-D to advise ASUDTAB on any matters related to securing uniformity throughout India. Thus under the Act and Rules, there is a complete difference. The system of ASU and the allopathy drugs is completely different in nature recognised by the statute.

“Chapter IV-A which pertains to ASU drugs and is administered by the department of Ayush under the Union ministry of health and family welfare, and enforced by the state licencing authorities from the state Ayush directorate.

Following the guideline issued by the National Ayush Mission for ASU drugs, the first respondent: Karnataka health and family welfare department  had issued the notification No. HFW 310 PIM data September 17, 2014 appointing the drugs control department as the controlling authority. It is issued in exercise of the power conferred under Section 33-G (4) which provides the government to appoint such authority to whom the inspectors are appointed under Section 33-G (1) as subordinates.

The petition stated, “ Rule 50(2) is a power conferred by Section 33 of Chapter IV of the Act . This Rule is not applicable to Chapter IV of the Act. The notification issued by the Ayurpark is under Rule 50 (2) made applicable to Chapter IV-A is therefore illegal.

The petitioners are aggrieved by this notification. They said that the present system is prevailing in the state for over 42 years in compliance with Chapter IV-A . But with the notification, the system is sought to be changed all of a sudden and that too is contrary to provisions of the Act and Rules. It wants the Karnataka High Court to quash the notification and direct the department of health and family welfare and concerned department to grant relief.