The regulatory authorities have assured the industry that the government would continuously address the emerging concerns of the biotech industry and bring necessary amendments to the newly-implemented guidelines on biosimilars, while the industry urged the government not to push the bar regularly to put pressure on companies.

In a round-table involving different stakeholders recently, the Central Drugs Standard Control Organisation (CDSCO) assured the industry that the new guidelines, first time introduced in the country after long years of deliberations, would be revised in time in accordance with the concerns by the industry.

The round-table was attended by Drug Controller General of India (DCGI), representative of the US Food and Drug Administration (FDA), senior officials from the CDSCO, officials from the Department of Biotechnology (DBT), leaders of the biotech industry, among others. It was held on the sidelines of the 10th anniversary celebrations of the Association of Biotechnology Led Enterprises (ABLE).

While expressing satisfaction over the guidelines, the industry termed it as robust and 'patient-friendly' more than being 'industry-friendly'. The industry leaders, on their part, assured support to the government's efforts in improving the regulatory atmosphere in the sector.

“We have a water-tight and nicely crafted set of guidelines now. We have supported it as regulatory atmosphere is a key component to the growth of the sector. As guidelines, they have to evolve constantly and amended as per the demands. However, the government should not push the bar regularly as many countries do,” commented ABLE president Dr P M Murali on the round-table.

“Some of the challenges that the industry is currently facing are the fuzzy regulatory environment that is currently delaying progress in the area. Healthcare sector is the most regulated in the world and delaying development further would hamper the progress of bringing out new generation medicines or healthcare products,” according to ABLE.

“Also, the government should come out with an affordable health policy that clearly states how IP of innovative companies are protected. This will cast away any doubts foreign companies have in setting research and development facilities in India,” ABLE leaders said.