Opposition to the Union Health ministry's recent order to constitute an expert committee in each state to streamline the system for licensing of patent and proprietary ayurveda, siddha and unani products continues to mount, with the Indian Drug Manufacturers Association (IDMA) urging the ministry to keep the order in abeyance.
Taking strong exception to the order, IDMA's International Trade Sub Committee chairman DB Modi in a letter to the Ayush Department said that the quality standard for the exporting Ayush products is as per the registration data submitted and approved by the ministry of health of importing countries. If the manufactures are asked to approach expert committees for the product permission for exports, this may cause delay which will result in loss of valuable foreign exchange.
The opinion evolving in the industry is that since Schedule T which describes the GMP requirement for manufacture of Ayush products adequately takes care of the requirement of Ayush products, there is no need for separate expert committee for licensing of Ayush products. The industry feels that since the existing licensing authorities in the states are technically competent, there is no need to for separate expert committees.
The Ayush products have been in the market in the country and also in the international market for the last many years. The history of use substantiates safety and efficacy of the medicines. Constitution of expert committee would cause further delay in marketing of Ayush products. India is trying to increase its exports for Ayush products and such measures will prove internal non-tariff barriers for exports. Since the order calls for referring the matter to the Department of Ayush for advice in case of difference of opinion within the expert committee, it will further delay the export procedures, IDMA said.
The IDMA also asked the government to follow the usual procedure of publication in the gazette seeking comments from the stakeholders within 30 days before taking a final decision on the issue.
The Union Health ministry had recently issued a notification asking the state licensing authorities (SLAs) to weed out irrational Ayush formulations in the country. The ministry had asked the SLAs to constitute an expert committee to screen the applications for new ayurveda, siddha and unani products in future.
As per the new ministry directive, submission of 'proof of concept' and 'testing protocols' along with the application for obtaining license for any new patent and proprietary Ayush medicines shall be made mandatory. Development of testing protocols for patent and proprietary medicine will be the responsibility of the manufacturers.