Biotech industry seeks removal of regulatory hurdles to accelerate growth of biologics

Mumbai, October 12, 2021:

In a bid to accelerate biologics and biosimilar development in India, biotech industry is looking for a slew of regulatory reforms including doing away with requirement of no objection certificate (NOC) for issuance of Form 29, scrapping provision requiring animal study approval for recombinant DNA products.

Form 29 is a license to manufacture drugs for the purpose of examination testing and analysis. NOC for issuance of Form 29 is issued by Central Drugs Standard Control Organization (CDSCO).

The industry is also looking for amendment to Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2016 to facilitate commercial stockpiling of biosimilar products before issuance of marketing authorization to speed up their launch in the market in line with US FDA.

Said Dr Samir Sangitrao, Vice President - Regulatory Strategy and Project Management, Bharat Serums and Vaccines Limited, “CDSCO should do away with NOC for Form 29 for R&D as it is not required anywhere in the world. Self-declaration should be accepted instead of NOC.”

He further said animal study approval for recombinant DNA products should be abolished as it is not required anywhere in the world. Even it is not required for pharma products. The tools of recombinant DNA research have changed dramatically in the last few years with new methods of gene-editing. The government should outline regulatory requirements based on product class, he added.

Commercial stockpiling of products before marketing authorization should be allowed in line with US FDA as biologics manufacturing and testing take months, stated Dr Sangitrao.

He expressed need to introduce e-labelling guidelines for biopharma products in line with Singapore. Singapore has published guideline for e-labelling. Instead of hard copy, e-package insert should be allowed, he added.

Currently, there are a number of agencies involved in biopharma products approval. The industry has long been demanding implementation of single window clearance for these products.

Dr Sangitrao also emphasized need to introduce interchangeable to Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2016.

Moreover, unlike the United States, India does not require biosimilars to be approved as “interchangeable” to allow pharmacists to switch patients from reference products without physician permission.

He also stressed on the need to have time bound approvals for clinical trials and marketing authorization.

He advocated for adoption of ICH guidelines which aims to provide uniform standards for technical requirements for pharmaceuticals for human use and becoming member of ICH and Pharmaceutical Inspection Coordination Scheme (PICS) as it will minimize international audits of biopharma manufacturing units.

The CDSCO should take leadership in regulatory policy and innovation and focus on policies for promotion of new chemical entity (NBE) and new biological entity (NBE) development, he opined.

In 2012, the CDSCO developed a guideline for approval of similar biologics, and in 2016 the regulatory requirement was revised to encourage more stringent evaluations of manufacturing process quality, safety, and efficacy. CDSCO has brought some important changes in its earlier guideline to try to align with other international agencies such as EMA and the World Health Organization.

India approved its first similar biologic in early 2000, prior to the European Union in 2006 and the United States in 2015. India is one of the leading manufacturers of similar biologics, and there is a thriving domestic market with 93 total products approved through 2019.

According to the Association of Biotechnology Led Enterprises, India’s biologics market will grow at a compound annual growth rate (CAGR) of 22 percent to hit USD 12 billion by 2025.The market currently is dominated by simple biologics, such as therapies for the treatment of diabetes (insulin), oncology (EPO and mAbs), autoimmune, and cardiovascular diseases. Similar biologics for insulin and EPO enjoy 80 to 85 percent market share in India.

However, complex biologics such as mAbs in Asia Pacific is estimated to be USD 5.94 billion in 2020 and is expected to reach USD 10.9 billion by 2025 at CAGR of 4.52 per cent, in that landscape India is the fastest-growing country.

Indian biotech companies who have received biosimilar approvals in EU, US, Japan so far are Intas, Biocon, Lupin, USV.PharmaBiz