The production and sale of Ayurveda and Siddha proprietary medicines have come to a standstill in Tamil Nadu as the manufacturers of Indian Medicines are unable to get licences for new products or renew the old ones. The companies are going on only with the production of certain conventional medicines, it is learnt.

According to technical experts, the delay in issuing fresh manufacturing licenses is due to the apathy of the department of Ayush as it has so far not prepared a set of protocol for clinical trials of traditional medicines, though it issued a government order in this regard way back in January 2010.

Without putting any blame on the state authorities for the cause of delay, the industry people said the reason behind rejecting the applications for fresh licences is due to the lack of established protocols for clinical trials. Developing the norms is the sole responsibility of the Ayush department. Since the Ayush department has issued notice for clinical trials and study reports, the state authorities are compelling the manufacturers to comply the norms before applying for new licences. This situation has brought the industry into a standstill.

The department of Ayush insists that clinical trials need to be carried out for all new formulations as per the protocol of clinical trials developed by the Central Council of Research in Ayurveda & Siddha (CCRAS), (before bifurcation of the two councils). Unfortunately, CCRAS has not developed the set of protocols for most of the clinical trial conditions of the new products that the manufacturers want to introduce.

To overcome the situation, the manufacturers association in Tamil Nadu met the ISM authorities in the state in 2011 and suggested several ways. But, due to the lack of specific Rules/protocols or guidance from the Centre, even the authorities are also in a quandary without knowing how to help the manufacturers, manufacturers said.

The ISM technical expert and the secretary of Centre for Traditional Medicines & Research (CTMR) in Tamil Nadu, Dr T Thirunarayanan responded to the issue saying that the present situation is mostly affecting the Siddha medicine manufacturers of Tamil Nadu because the ayurvedic manufacturers can get licences from other states and carry on their work. Since Tamil Nadu is the hub of Siddha and most of the medicines are manufactured in the state, the adverse effect of the ‘Ayush apathy’ affects only the Siddha manufacturers. He wanted all the Members of Parliament from the state to intervene in the matter in order to save Siddha system from the spiraling crisis.

He said, to overcome the present plight, he along with the manufacturers submitted a proposal to the government that until CCRAS develops a protocol the manufacturers association will prepare a set of norms for clinical studies in consultation with technical experts, and submit it to the government. If the government approves the proposal, the association themselves will carry out the studies and submit the report to the authorities. But so far, the department of Ayush has not responded to this proposal, he said.

“The clinical trial reports, they want, would cost around Rs.50 lakh for one product. How many companies in Tamil Nadu can afford this? Only a few companies can,” he said adding that when there was no established set of protocols for clinical studies, why did the Ayurveda, Unani, Siddha Technical Advisory Board (AUSTAB) advise for clinical reports.

In Tamil Nadu, the district Siddha medical officers are also working in the capacity of drug inspectors. Because of their heavy workload in the PHCs, most of these DSMOs are unable to visit the factories for inspection. This situation also delays in issuing licenses, both for fresh and renewal, said Dr Thirunarayanan.