Regulatory delays, poor research hamper biopharma innovation

Meena Menon

doi:10.1038/nindia.2015.149 Published online 5 November 2015

India’s biopharma sector has emerged as a study in contrasts – on the one hand, it faces challenges of poor research and innovation, lack of policy support and funding, and bureaucratic delays in approval of new drugs and vaccines. On the other hand, every ten seconds a child is vaccinated somewhere in the world with a product from the largest manufacturer of vaccines, the Serum Institute of India. 

Biopharma researchers and industry experts attending the 13th Bio Pharma India convention 2015 in Mumbai this week also felt that despite a traditionally lax intellectual property rights (IPR) regime, the regulatory framework is now slowly improving and the cheaper production of biosimilars has made India a source of affordable and quality products.

Long road for research, innovation

India is far behind in developing new biologics and biosimilars owing to the lack of a knowledge ecosystem and bio-manufacturing facilities, according to Askhaya Odak of pharma company Lupin Pharmaceuticals. “India has one of the most complicated requirements for approvals to develop biosimilars,” he said. Though industry protests had led to decentralising some of the procedure, it still takes more than one year for approval of pre-clinical studies. Once the Review Committee on Genetic Manipulation (RCGM) approves the studies, they have to be cleared by the Drugs Controller General of India, which does not have a clear time frame.

“Overarching guidelines” hamper research in biosimilar and molecular research, Subhadeep Sinha of pharma group Hetero Drugs Limited noted.

The country needs to develop an innovation climate for new drugs and vaccines, said Raj Mehta, President of Cadila Biotech.  Despite limitations, Cadila will soon be launching a new two dose nanoparticle recombinant anti-rabies vaccine, while Serum Institute of India in collaboration with the Massachussetts of Technology will produce the world's first non-serum vaccine soon. 

Though there’s a feeling in the western world that Indian drugs are not up to the mark, Mehta was optimistic and said the $20 billion Indian biopharma industry would be growing into a $100 billion industry by 2025. Many felt that it was time to change the global perception about India’s quality and standards. Arnaud Lefevre, managing director of UCB India remarked that Prime Minister Narendra Modi’s grant of Rs 1700 crore to the Federal Drug Administration agency to bring India’s regulatory regime up to international standards was promising.

Challenges for affordable healthcare

Innovation climate, lack of clear policy and public funded research have been hampering India’s ambitious goal to reach affordable healthcare to all. Leena Menghaney, the South Asia head of Medicines Sans Frontieres’ Access Campaign India, challenged the popular notion that the high cost of research in molecules was a disincentive to carry out work in this field.

In India, 30% people go without healthcare since they can’t afford it. Direct medical costs are the highest compared to the rest of the world, according to M D Sreekumar, CEO of Jan Aushadhi, a government initiative for affordable drugs.

The ambitious Jan Aushadhi programme launched in 2008 to set up low cost generic medicine shops across the country has not met with much success. The programme was reviewed in 2013 to create 3000 stores by March 2017. The Public Health Foundation of India, which analysed the status of the scheme, found that awareness about it was lacking and it was over-dependent on government support. The scheme is now being revived with a chain of rebranded stores and relaxed ownership permissions. Sreekumar said efforts were on to resurrect all the five public sector pharma undertakings with WHO accreditation. These undertakings will manufacture new molecules as also compete with private players.

Clive Fernandes, Principal Consultant to the US-based accreditation body Joint Commission International, said maintaining quality helps standardise drugs and decreases costs. Fernandes, also the Group Clinical Director of the Wockhardt Group Hospital in India, said in the debate about generic versus branded drugs, the focus should be on evidence based practices, standard processes and affordability. “We had a high end generic antibiotic but someone wanted a branded one. We got the bioequivalent checked and to everyone’s surprise the amount of active ingredient was 98% in the generic and 95 % in the branded drug,” he pointed out.