The bio-services sector, which is currently valued at $ 5-6 billion, is set to increase to $50 billion soon. India makes pharmaceutical products worth $30 billion every year. It is a world leader in generics. But soon bio-pharmaceuticals will take over the sector. Small companies are making it big in a short span of time. Growth is tremendous in this field and we should be prepared to meet this growth. This was stated by V K Subburaj, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilisers at a round-table on Unleashing Opportunities in Bio-Services Including Contract Research & Manufacturing which took place on the occasion of the Global Exhibition on Services (GES) in New Delhi.
The first-ever GES was inaugurated by Prime Minister, Narendra Modi on Thursday and it is a joint initiative of the Ministry of Commerce with the Confederation of Indian Industry (CII) and the Services Export Promotion Council (SEPC). One of the focus areas of GES is bio-services which is the second largest sector of biotechnology and pharmaceutical industry in India with about 33 per cent market share. The round-table discussed some of the challenges which needed to be addressed to further this growing opportunity and revitalise the sector with enabling policies.
Speaking at the round-table, Subburaj said, “Conducive atmosphere for growth has been missing in the past few years. This is about to change and the message should go out loud and clear everywhere.” The government is actively facilitating easing of regulations. The number of applications being filed for clinical trials in India has come down from 500 to 25 in the past three years. “We have all the hardware but software is missing. That is the reason why we are lagging behind. In the US more than 30,000 clinical trials take place every year. Israel does 4,900 clinical trials every year,” said Subburaj. Unless India provides equal opportunities, we will not grow. One job in clinical sector creates five jobs in IT sector.
Sudhanshu Pandey, Joint Secretary, Department of Commerce, Ministry of Commerce and Industry said the first edition of GES was to highlight the strengths of India in services sector. The regulatory regime had been the country’s weakest link so far. He said India was four-five times cheaper in terms of conducting a study, compared to other countries but that advantage was being wasted because of ambiguity of rules. That is going to change with the new policy on clinical trials coming in place in three months’ time. The pharmaceutical sector has a huge service component. Manufacturing is now being “servicised”. The cost-competitiveness of Indian manufacturing should not be equated with poor quality, he emphasised.
Rajiv Modi, Chairman, CII National Committee on Pharmaceuticals and Chairman & Managing Director, Cadila Pharmaceuticals said there were winds of change sweeping the government. It was time to look at the big picture and not lose sight of the fact that weaknesses and bottlenecks needed to be overcome at a fast pace.
Dr Eswara Reddy, Joint Controller General, Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare said India had a $6-7 billion market in CRMS. Of this, 65 per cent market was in the form of contract manufacturing. He said regulations were now facilitating bio-services by being clear and transparent. The Drugs and Cosmetics Act was silent on the role of clinical trials but the area was being regulated through rules. Complete e-governance system was in place. Accreditation of clinical trial centres was being done now. Track and trace system is going to be introduced soon for drugs in domestic market.
During the panel discussion, Himangi Bhardwaj, Senior Health Adviser, British High Commission said that people overseas were “confused” about India. They were enthusiastic about this market but didn’t know who to approach here. They didn’t have clarity on intellectual property and the regulations which governed foreign companies.
Rajesh Naik, Senior Vice-President, GVK Biosciences reiterated that there was confusion in the minds of overseas clients regarding India. Nupur Mehrotra, Vice-President, Scientific Affairs, Premas Biotech said it was essential to identify both weaknesses and opportunities. Meenu Batolar, Associate Director of Biogen Idec said there was a need for a cell or a platform where individual companies could also raise their concerns and have the confidence that their voice would be heard.