Heavily debating regulatory challenges lying in front of the Indian pharmaceutical industry CII Pharma Summit 2013 concluded recently in Mumbai with many industry stawlwarts as attendees. As the regulatory environment around the world is getting more rigorous, the summit’s focus was to explore how the industry can navigate through the regulatory challenges and chart its strategies for growth.
During the event CII-PwC report on ‘India Pharma Inc: Changing Landscape of Indian Pharma Industry’ was also released. Sujay Shetty, Partner-India Pharma Life Sciences Leader, PwC India, provided overview on the report. Discussions on topics like CEOs’ interactive roundtable on regulatory impact on Indian pharma, spotlight on Maharashtra and health insurance, regulatory challenges and suggestions on the way forward for clinical trials in India and improving sales force effectiveness through the influx technology were well received by the audience.
The CII-PwC report pointed out that there is a slowdown in growth, at 9.8 per cent from 16.6 per cent in 2012, and said the impact is due to many reasons, including lower FDI, and due to new norms on pricing and marketing practices.
The report highlighted the pharma sector’s concern over the slowdown in clinical trials. The report said that India is seen as a great place for clinical trial for new pharma drugs, but in recent times, clinical trials have virtually ground to a halt, which in turn has impacted the development process of new drugs.
Dr Rajiv Modi, Chairman CII Pharma Summit 2013 and CII Gujarat State Council and and Chairman and Managing Director, Cadila Pharmaceuticals, said, “India has had an efficient pharma industry, which has been making affordable drugs not just for the Indian markets but has also been exporting them to the world. The sector is currently experiencing slow growth. Henceforth, both the Indian and foreign companies operating in India will have to device suitable strategies in order to be in the top 10 global markets by 2020.”
“India is a blessed market with a genetically varied people, which makes it good for clinical trials, but due to PIL (public interest litigations) in court, clinical trials have come down,” said HG Khosia, Commissioner, Food and Drug Administration, Government of Gujarat. He said that when a PIL was filed, the sector should counter it by giving the correct picture. “We are not against anyone, but we need new drugs to protect human lives,” he added.
The report also said the clinical research industry and the government need to work closely to create regulatory mechanism that allows sound and ethically correct trials so that the benefits of clinical trials can be brought to patients in the country.
Ninad Karpe, Chairman, CII Maharashtra State Council, pointed out that India is the third largest market by volume and fourth largest by value. “We are going through difficult times,” he said. “Growth has been good, but only in a particular zone.”
JP Parswani, Executive Director, Cadila Pharmaceuticals, said the slowdown provides the sector with an opportunity. “Big data, cloud computing, and networking are changing the way business is being done in India,” he said, and urged the sector to adapt to the changes.
“The challenge for the pharma sector today is to graduate to the next level, and to get into new areas,” said Dr KV Subramaniam, President and Chief Executive Officer, Reliance Life.
Sujay Shetty, Partner – India Pharma and Life Sciences Leader, PwC India, said there were other concerns too like the implementation of the National Pharmaceutical Pricing Policy, and the Uniform Code for Pharmaceutical Marketing Practices. “But some of these are good for the industry as a whole and will help the sector,” he added.
Hasit Joshipura, Senior Vice-President – South Asia, and Managing Director, India, GlaxoSmithKline Pharmaceuticals, said that the new norms will affect growth, but added that with state governments increasing their spending on healthcare, new opportunities were being opened up for the pharma sector. “India remains an underpenetrated market,” he added.
According to the report, India is perceived as an attractive destination for clinical trials but has been marred with genuine concerns. Clinical trials are an inherent part of the drug development process and cannot be dispensed with. The continuing search for new therapies and cost-effective alternatives to existing therapies will be realised in practice only after comprehensive clinical trials.
The clinical research industry in India needs to work closely with the government to create a regulatory mechanism that allows scientifically sound and ethically correct trials to be conducted so that the benefits of clinical trials can be brought to patients in India. The industry is also facing stricter regulations on manufacturing and quality practices in the domestic as well as he international markets. Indian companies will have to raise their compliance to US FDA regulations as they drive their major share of exports from the US market.
The implementation of the National Pharmaceutical Pricing Policy 2012 by the Government of India has resulted in margins erosion from 20 per cent and 10 per cent to 16 per cent and eight per cent for retailers and stockists, respectively. This decrease in the stockist margins led to a significant uncertainty among many stockists regarding the feasibility of staying in business due to lower profitability post the margin reduction.
EP News Bureau– Mumbai