FICCI submits recommendations to government for regulatory reforms in pharma

The Federation of Indian Chambers of Commerce and Industry (FICCI) has submitted some of its recommendations for regulatory reforms in the pharma sector to high-level government authorities from the Department of Pharma, Ministry of Health & Family Welfare and Niti Aayog. The detailed recommendations cover four major areas: improvement proposals in new drug registrations; animal toxicity and testing; clinical trials, and shaping the R&D ecosystem for Indian pharma sector in terms of infrastructure and capacity building.

S Sridhar, Chairman, FICCI Pharma Committee and MD, Pfizer India said, “We welcome the Government’s initiative to accelerate regulatory reforms in India. FICCI has put together one of the most comprehensive recommendations with contributions from the foremost regulatory experts in Indian and global pharma. These recommendations will help deliver a modern, agile, pro-innovation and pro-patient regulatory system for India. The need of the hour is to ensure that the Indian drug regulatory system matches the best in the world and caters to the demands of the future where utmost safety must be ensured at utmost speed. With the keen interest and support of the CDSCO, the Ministry of Health and Family Welfare along with the Prime Minister’s Office, we will certainly see a change in drug regulatory system in India that ensures that homegrown innovations have the best chance to succeed and, at the same time, global innovative drugs are introduced without delay to start benefitting patients who are waiting for these breakthroughs.”

The recommendations, amongst others, also include:

• Easing the New Drug Application process
• Improving the Sugam portal to make it more user-friendly
• Streamlining the approval process for biosimilars with a single-window clearance
• Reducing the dependency on import for reagents, kits, animal feed with the creation of a suitable local vendor ecosystem for R&D raw materials
• Establishment of centres of excellence in specific disease areas such as oncology, neurodegeneration, inflammation and autoimmune diseases

The full report can be downloaded at http://ficci.in/spdocument/23240/FICCI-Report_Regulatory-Reforms-for-Pharma-Sector.pdf.

These recommendations come on the back of the government’s decision to form a high-level committee of experts to recommend reforms in India’s drug regulatory system so that approval processes can be fast-tracked.

“The committee chaired by Rajesh Bhushan, the OSD to the Union Health Minister comprises top drug and vaccine entrepreneurs of India along with officers nominated from the Department of Pharmaceuticals, Department of Biotechnology, Indian Pharmacopoeia Commission, Indian Pharmaceutical Alliance, and ICMR along with public health experts from AIIMS,” informed a PIB press release.