Karnataka Indian System of Medicine Association (KIMMA) lodged a complaint to the Jurisdictional Police station against Prerana Associates for having manufactured ayurveda drugs for sale without obtaining license. The police under the supervision of KIMMA seized the drugs.
The Prerana unit is located in Bangalore on a 500 sq. ft area and did not have any equipment installed except for a small manual PP cap sealing machines which was also seized by the police.
Now the Association has gathered from sources that the Karnataka Directorate of Ayush would issue Form 25-D which is an approval for Schedule T good manufacturing practices) compliance for the unit.
KIMMA secretary JSD Pani in a communiqué to the State Directorate of Ayush stated that if licenses are issued for non-compliant Schedule T units like Prerana which was an unscrupulous manufacturer not adhering to Schedule T norms and still operating under the garb of a GMP compliant facility, would set a bad precedence. He warned the directorate of Ayush that the 100 manufacturers who have either lost their licenses or discontinued themselves for having failed to provide adequate space would also be approaching them to get their licenses.
Further, the KIMMA secretary brought to the notice that there was a proposal to issue license without consulting the experts in ayurveda approved by the state government as stipulated under Rule 154 of the Drugs and Cosmetics Act 1945. Pani stated that such a practice would only tarnish the image of the licensing authority and would have a serious impact the industry in Karnataka.
Pharmabiz has reported in November 2005 that the Karnataka Directorate of Ayush had issued a notice warning public that ayurveda medicines Miracle Ayurveda Pain Killer Oil and Dentofresh Dantamanjana manufactured by Prerana Associates in Bangalore are being sold in the market without certification and validation of products from the licensing authorities. The sale and the stock of the medicines were prohibited as no licenses had been issued to the manufacturers from the Directorate of Ayush, stated sources.
The drug licensing authority had also cautioned the public not to use the Prerana products and in case any sale or stock of the medicines were noticed, they should immediately intimate the to the Directorate Licensing Wing or a complaint could be given at the nearest police station.
Dr. BN Prakash, director, Karnataka Directorate of Ayush was not available for comments.