Close on the heels of Finance Minister Arun Jaitley's announcement to amend Drugs and Cosmetics Rules in Budget 2017-18 to make drugs affordable, Indian Pharmaceutical Alliance has sought streamlining the process of new drug approval, transparent and clear regulatory process for biosimilar approval and revamping CDSCO structure and organisation to serve patients' interest at par with developed markets.
Today Indian pharma's biggest bottleneck in overseas market is functioning of our drug regulatory system which is taken into account to determine quality of drugs supplied by the country's drug makers. It is our long standing demand for restructuring and strengthening regulatory regime so that it can take science based decision to promote public health on the lines of global practices with minimum interference from bureaucracy, said DG Shah, Secretary General of Indian Pharmaceutical Alliance.
The authority of CDSCO needs to be in commensurate with responsibility. Currently there is complete mismatch between responsibility, accountability and authority of the drug regulator. The decision making power lies with bureaucracy while CDSCO has become merely an implementing agency.
In India, new drug approval process is quiet lengthy and cumbersome. At present there is three-tier committee comprising of technical committee, apex committee, committee of secretaries for granting approval which shall be modified to desirably one committee. There shall be utmost two committees. The first committee shall itself able to take a call on the proposal pertaining to new drug approval based on science. There is no merit in setting up committee of secretaries to look into the new drug approval because it is not conversant with medical science. Such proposals need to be framed, Shah said.
However NITI Aayog has already emphasised the need to reduce permission and approval process to 30 days.
Biosimilar approval procedures need to be less discretionary, transparent and simplified. India needs to make changes to biosimilar regulatory system in accordance with WHO and EMA guidelines. It will help biodrugs create a wave of low-cost competition in the domestic biotech industry, he concluded.