The Ayurveda, Siddha, Unani (ASU) industry is vehemently opposing the revised Schedule Z of the good clinical practices (GCP) for clinical trials on ASU medicines issued by the Department of Ayush last month. The revised Schedule Z deals with the requirements to undertake clinical trials for ASU drugs which the industry claims is a highly unreasonable demand made by the government, threatening to wipe out the industry completely by maiming its growth perspective.
In its recently released draft guidelines, the Department of Ayush makes it mandatory for all ASU manufacturers to undertake clinical trials to manufacture ASU drugs for sale. It states that the application for permission to manufacture ASU drugs for sale or to undertake clinical trials should be made in form 24D accompanied with data in accordance.
It mandates that the approval for clinical trial on an ASU drug should be initiated only after the permission has been granted by the licensing authority under rule 152, along with the approval from the respective ethics committees. According to the draft notification, the licensing authority should be informed of the approval of the respective institutional ethics committees as prescribed and the trial initiated at each respective site only after obtaining such an approval for that site.
An expert from the industry pointed out that the stringent requirements for granting permission to manufacture ASU drugs is going to kill the industry which is already struggling to grow. “It is highly unprofessional on the part of the government to adopt provisions that go against the growth interest of the industry. We have already sent our representation to the government demanding immediate action to safeguard the interest of the industry at large,” he said.
Expressing concern over this issue, the industry pointed out that it is disturbing to know that the Department of Ayush has adopted and formulated this guidelines based on CDSCO document on GCP Guidelines that was released in 2001 for clinical trials on pharma products. They argue, “How can the government adopt something for the traditional industry that is in line with modern allopathic medicines. Ayurveda has been practised in the country from many years now based only on rich traditional knowledge, without depending on any clinical trials or any documentation. Moreover, it is not feasible and affordable for the small scale manufacturers who make up the most of the industry to carry out all ASU medicines research in India at all stages of drug development, whether prior or subsequent to product registration in India.”
Experts strongly assert that the industry will never be able to deal with the cost associated with the clinical trials which in itself is an unnecessary requirement forced by the government against the manufacturers of traditional medicines. Expressing concern over the grappling fate of the traditional drug manufacturers in the country, experts from the industry have asked the government to reconsider the provisions for the growth of the industry.