Delayed regulatory approvals, cumbersome multiple clearances, lack of access to capital and infrastructure support are hampering the growth of the India’s biosimilar industry. In order to speed up process, the Association of Biotechnology Led Enterprises (ABLE) has submitted a proposal to the Department of Biotechnology (DBT) to provide the biotech industry with a clear regulatory structure for the growth of the biosimilar sector.

Going by the disease profile, biosimilar drugs are proving to be the answer for conditions from cancer to cardiovascular conditions. Biosimilars drugs are cheaper by 30-40 per cent.

There is a huge market opportunity for biosimilars as 48 drugs valued at $73 billion are going off patent globally within the next 10 years. In India, around 20 companies including Biocon and Intas among others are gearing up to be part of the biosimilar producers bandwagon. A visible trend is the interest evinced by the pharma companies who have made efforts to enter the space.

Currently, in India it takes 14 to 16 months for the approval process and if procedural aspects are streamlined there would be reduction of 25 per cent of this time frame thus saving costs and time-to-market. Challenge for India is affordable healthcare and this is where ABLE took on the onus, to support the industry with a set of simple, faster and clear cut guidelines to in the bio-similar space, said Dr Satya Dash, chief operating officer, ABLE.

In its several rounds of interactions with the biotech industry, ABLE has now assessed the regulatory hassles which include technical lapses, procedural delays, number of windows for clearances and issues in the import-export of biological screens. The Form 12 which is a format for approval of strain imports to develop biosimilars needs annual revisions making it cumbersome for the industry. In order to create procedural efficiency, ABLE has called for a 3-year validity for Form 12, he added.


While there is ample access to biosimilar funding in the government through DSIR, DBT, CSIR among others, there is a paucity for late stage grants. This is where venture capitalists and private equity players must come in. Biosimilar production and research requires a state-of the-art plant, animal breeding facility for rodent and large animals, quarantine facility, cold chain units in airports and expansion of viral test facility across the country.

Indian biosimilar regulatory structure comprises DCGI, Review Committee Genetic Manipulation, Genetic Engineering Approval Committee and institutional board of Ethics Committee. The need of the hour is a single window clearance manned with a team of technical competent experts with a global perspective who constantly interact with the industry. “The presence of single window and proficient regulatory authority would automatically lead to investor confidence. This would also automatically help tackle problems of funding and modern facility”, said Dr Dash.