The Ayush ministry’s revised draft of certain rules to further amend the Drugs and Cosmetics Rules 1945 proposes that licences for new Ayurveda, Siddha and Unani (ASU) drugs will be granted only after thorough examination by an expert committee formed for the purpose.
 
Once the D&C Rules are amended, the Ayush ministry will conduct the process of constituting the expert committee by selecting members from industry, academia and research areas. According to sources, the formation of the new Expert Panel is in the wake of the government’s decision to export Indian made traditional products to foreign markets. From collection of raw materials to formulation development, all the processes will be passed on through special expert committees.
 
Currently, each state has separate expert committee appointed by the respective governments to advise the ISM department on issuing licences for patent and proprietary medicines. It is also formed on the advice of the central government by the state authorities, but in future, the central government itself will constitute the expert panel. The state governments have constituted committees of experts in the respective ISM departments to advise the regulatory bodies on issuing licences for P&P products.
 
The draft suggests for formation of expert committees in each state by notification in the official gazette by the central government. The expert committee will be entitled with the power to examine the applications for licences for the new ASU drugs received from the state licensing authorities. This expert committee will also be entitled to study the observations and comments made by the ‘State Technical Committee for Ayurveda, Siddha and Unani Drugs’ constituted under rule 154A.
 
The proposal says that the committee will advise the Central Controlling Authority for Ayush, the formation of which is in the pipeline, as and when required, and will comprise a clinical pharmacologist as chairperson. Expert members will represent various sections such as Dravyaguna/Rasashastra, Toxicologist/Pharmacologist,  Regulatory Affairs and central agencies such as ICMR, DCGI, CDSCO and various Central councils of Ayurveda, Siddha and Unani.
 
Apart from the expert committee, the draft notification also proposes for a state level Technical Advisory Board to be constituted in each state on the lines of the central ASUDTAB.