To ensure that the industry does not suffer from lack of infrastructural facilities while dealing with clinical trials of traditional medicines, Gujarat Ayurvedic Aushadh Manufacturers Association (GAAMA) has urged the state government to identify good clinical trial institutes in the state.

In a suggestion made to the government, GAAMA stressed that they should take immediate steps to identify good pharmacy colleges in the state to act as clinical trial centres for the industry. Shah said that it would be more effective if the government would select those pharmacy colleges that are attached to the ayurvedic hospitals for better and efficient performance.

The demand comes in the wake of the problem faced by the industry to locate good clinical research organisations (CRO's) with expertise in this area within the state for conducting clinical trials of ASU products. The association claimed that it is surprising how the government overlooked such an important matter before notifying Schedule Z for traditional medicines.

Last year, the Department of Ayush had released a draft notification under Schedule Z dealing with the good clinical practices (GCP) for ASU medicines. The notification made it mandatory for all ayurveda, siddha, unani (ASU) units in the country to undertake clinical trials for ASU drugs. With this,  manufacturers seeking permission to market an traditional medicines should support the claims made by the drug with data generated by tests on human subjects as per the rules laid out by the government.

The notification 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 and 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.

Though the industry has been opposing this draft since its release claiming that it can been drawn in lines with the GCP for allopathic drugs without any reference to traditional medicines, very few steps have been taken by the government to appease their concern. Prabodh Shah, president, GAMMA stressed that the industry is in doldrums over the dearth of proper CROs in the state to handle this responsibility.

He said, “Though we have many reputed CRO's in the state their expertise lies in doing clinical trial for allopathic medicines and not in the traditional medicines. This situation has led to a large scale confusion and fear in the industry over the future of their business. What the industry need is a transparent organisation that is well equipped to deal with the requirements of the industry that is unique to it.”