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Indian pharmaceutical companies’ entry into the drug discovery and development field dates back to the early 1990s when India announced the signing of the World Trade Organization (WTO) agreement that introduced a product patent system from Jan. 1, 2005. Changes in the regulatory environment in the same year led to other developments with the emergence of the country as a favorite destination for “chemistry” outsourcing followed by “collaborative drug discovery as contract agencies where in-house strengths in chemistry of local companies was augmented with focus biology” (1).
Over the past few years, Indian pharmaceutical companies have been attempting to re-orientate their efforts toward developing new innovative medicines, Ang Wei Zheng, analyst of Business Monitor International (BMI) says. However, BMI maintains that the transition by Indian generic-drug makers will remain slow given the high risk levels associated with drug discovery.
Despite this, local companies made headway in this sector. In May 2012, Ranbaxy Laboratories launched Synriam (arterolane maleate plus piperaquine phosphate), a new drug for the treatment of uncomplicated Plasmodium falciparum malaria. Similarly, Cadila Healthcare launched Lipaglyn (saroglitazar) in June 2013, for the treatment of diabetes. Saroglitazar is claimed to be the first new chemical entity (NCE) discovered and developed by an Indian pharmaceutical company.
Local companies in drug discovery
Recently, Indian companies such as Bugworks in Bengaluru and Vitas Pharma in Hyderabad have ventured into drug discovery. Ang says, “The move of Indian start-ups into the drug discovery space will present a new source of innovative medicines to the Indian pharmaceutical sector. However, we expect their impact to come primarily through collaborations.”
The Indian business environment will remain highly challenging for start-ups due to low levels of intellectual property protection, pricing uncertainties, and delays in receiving clinical trial approvals. In addition, venture capital and private equity have not been actively supporting such biopharmaceutical start-ups, leaving such companies to turn towards larger multinational pharmaceutical companies and domestic drug manufacturers for funding, he adds. According to a study into life-sciences venture capital published in 2013, only 32 out of a surveyed 170 biotechnology firms in India were backed by venture capital (2).
Pharmaceutical companies operating in India face distinct challenges. Arvind Pachhapur, country head, intellectual property and science and legal business of India Thomson Reuters says, “They include insufficient innovation, limited access to high risk funding, short supply of skilled professionals, and specialized equipment.”
Low levels of intellectual protection continue to be a problem, Ang says. India registers a low score on BMI’s Pharmaceutical Risk/Reward Index (RRI)’s measure of Patent Respect (an index providing a globally comparative and numerically based assessment of a market’s attractiveness for innovative drug makers) compared to its Asian counterparts such as China and Indonesia (3). The low score is driven by the frequent threats to patents through compulsory licenses being revoked or rejected by the patent office.
Pachhapur says, “The clinical-trial segment also faces challenges such as regulatory uncertainty regarding conduct of trials, unethical practices, and approval delays.” It is estimated that it takes one year in India to gain regulatory approval of trials as compared with just 28 days in the United States. This is further compounded by regulatory uncertainty following the US Supreme Court’s ruling in 2013 to suspend 157 previously approved clinical trials, Ang adds.
As a result, Indian pharmaceutical companies have begun to move their operations outside of the country, despite the potentially higher cost. Lupin Pharmaceuticals has set up two research and development plants in the United States while Cipla said in July 2014 that it will invest $150 million in the United Kingdom for research and clinical trials. Clinical trials in India declined from 264 in 2009 to 174 by 2013, according to ClinicalTrials.gov (4).
India’s pricing regulation continues to undergo significant changes that create high levels of uncertainty in launching new drugs, Ang says. In September 2014, the government rescinded guidelines issued the previous May that would have given the National Pharmaceutical Pricing Authority (NPPA) the power to set prices of non-essential medicines. In December 2014, however, the NPPA announced that it will bring an additional 52 new drugs under price control. Consequently, drug makers have cut back on the number of medicines launched; data from the Central Drugs Standard Control Organization highlights a decline from 270 in 2008 to 56 as of November 2014.
Despite these challenges, industry players can still explore opportunities in the local business environment. Driving these prospects includes the country epidemiological transition with the burden of non-communicable diseases growing while the burden of communicable disease continues to decline, according to BMI’s Burden of Disease Database (BoDD) (5). In addition, drug-discovery companies in India are supported by a large pool of human resources with 14% of graduates in 2012 coming from science-related backgrounds. Furthermore, tertiary education remains strong, which drives the country’s score of 73.6 on BMI’s Operational Risk’s measure of Tertiary Education-above the Asia Pacific’s average (6).
According to Pachhapur, the government has taken many initiatives in accordance with India’s Department of Pharmaceuticals Pharma Vision 2020 (7), which is designed to make India a hub for end-to-end drug manufacturing. He says, “To encourage greater participation from industry players, the government may want to consider dialog and collaboration between the government policy makers, senior leadership of Indian pharmaceutical industry and key opinion leaders from research institutes and academia on ways to better support novel drug discovery in India. The regulatory guidelines should be amended to encourage global pharmaceutical companies to not only continue outsourcing their research and development activities to Indian companies but also work on end-to-end solution starting from drug discovery to commercialization in India.
“There is a need for speeding the regulatory processes at all stages of drug development starting from seeking licenses for initiating drug discovery, conducting clinical trials in India to obtaining regulatory approval for commercialization. Other areas to look into include speeding up the patent approval process and addressing issues such as the definition of patentability and compulsory licensing.”
Ang comments that the Indian government can look to the approaches adopted by other Asian governments. The Chinese government, for example, has abolished retail price caps and established a specialized court in November 2014 to handle intellectual property cases in Beijing. Japan’s move to set up the Japan Agency for Medical Research and Development (AMED) in April 2015 also represents another initiative to boost drug discovery.
BMI remains optimistic with regard to India’s pharmaceutical industry. “The development of new drug discovery in India has the potential to improve the overall healthcare system in the country. The introduction of new medicines will help alleviate the burden of diseases as it provides greater access to innovative medicines through the clinical trials conducted in India. The growth of the local pharmaceutical research and development sector can serve as a key driver of economic growth, and this will help increase income levels and improve the access to healthcare services,“ Ang says.
1. Tanjore Balganesh et al., Drug Discovery Research in India: Current State and Future Prospects (American Chemical Society, 2014), http://pubs.acs.org/doi/pdf/10.1021/ml500183c
2. J. Chakma, S.M. Sammut, and A. Agrawal, Nature Biotechnology, 31(3) (2013) pp. 195-201.
3. BMI, Pharmaceutical Risk/Reward Index, 2015.
4. Clinicaltrials.gov, www.clinicaltrials.gov/, accessed Feb. 2, 2015.
5. BMI, Burden of Disease Database, 2015.
6. BMI, Operational Risk Index, 2015.
7. Invest India, “Pharmaceuticals,” Investindia.gov.in, www.investindia.gov.in/pharmaceuticals-sector, accessed Feb. 2., 2015.
Article Details BioPharm International
Vol. 28, Issue 4
Citation: When referring to this article, please cite it as J. Wan, "Drug Discovery and Development in India," BioPharm International 28 (4) 2015.