200 odd Kerala Ayurveda units face immediate closure

Posted AtPharmaBiz

The Drugs control administration of Kerala has issued show cause notices to 25 non-GMP compliant Ayurveda drug manufacturing units, following the Department of Ayush notification to strictly enforce the rules on Schedule T compliance. Soon the department is likely to issue closure notices to 200 odd units in the state.

So far only 307 Ayurvedic drug manufacturing units out of the 1000 odd units in the state have satisfied with the requirements of Schedule T, according to the officials. Some units are in the final stages of complying with the norms and the department would take a practical stand to allow them more time to finish the work.

The DCA, which has only three drug inspectors under an assistant drugs controller to regulate the 1000 odd Ayurvedic units, is now carrying out inspection of the units. "The department is trying to accelerate the process and is likely to issue notices to about 200 units which have not complied with GMP within two months," said Jacob Titus, licensing authority (Ayurveda), Kerala.

He said that though the department had sent only show cause notice for non-compliance, license would be cancelled without another notice hereafter in the case of units that have not initiated any attempts to adhere to the rules. The department has so far completed inspection of 500 Ayurvedic manufacturing units this year.

The latest decision of government will affect about 700 Ayurvedic drug-manufacturing units in the state, according to Dr .D. Ramanathan, general secretary, Ayurvedic Medicine Manufacturers Organisation of India (AMMOI). Though the organisation also backs the decision of implementing standards, the government should consider that the majority of the units would have to close down by the decision, he noted.

November 10, 2005