S. Harachand, Contributing Editor10.14.14
Gilead Sciences’ decision to entrust Indian companies to make a 99% cheaper version for its new $1,000-a- pill HCV treatment sofosbuvir (Sovaldi) in September, came not as a great surprise. Rather, the news to license out the money-minting treatment has been received just as a token of appreciation to the generic hub of the world, which has earned a name for its prowess of developing cost-effective manufacturing processes.
Started as small-time vendors for generic manufacturing in the 90s, India’s outsourcing industry is tipped to become a one-stop shop for almost every service in the pharmaceuticals value chain—from discovery to commercialization. Companies from other geographies may excel in specific aspects in the contract services offerings but not across the spectrum of activities as is the case with India, experts point out.
However, it could be surprising to learn that much of this path-breaking transformatory process from preferred vendors to sought-after partners for the top-league pharma occurred during the period spanning little over a decade.
The floodgates were turned open for the contract services industry in 2005, when India formally announced its transition to product patent regime, following TRIPS obligations. Before that India recognized only IP related to novel processes of manufacturing of proprietary drugs and not the products per se, as a measure to foster the nation’s healthcare set up, which was largely driven by generic medicines.
Decades long experiments within what is called ‘reverse chemistry’, gained Indian companies unmatched skills in developing processes to produce complex molecules using technologies far cheaper.
Honing Skills
If the pre-2005 era won them mastery over the low-cost know-how, which lent the companies a unique edge in manufacturing, the onset of the product patent era encouraged the players to harness competency in drug discovery .
In fact, companies started honing core skills in various disciplines of pharmaceutical science in the years preceding the milestone event, soon after the country became a signatory in WTO in 1995.
In the run up to amend patent rules in accordance with the globalized trade, India assured in several regulatory reforms to bring up the pharma industry on par with mature markets.
In 2001, India formulated GCP guidelines for clinical research before legalizing them after four years under Schedule Y of India’s Drugs & Cosmetics Rules—the rulebook governing pharmaceuticals.
The preceding years also witnessed the companies going through hectic activity to improve manufacturing quality, even though the regulator could finally bring the country’s 20,000-odd manufacturers under WHO-mandated GMP standards in July 2005, after dithering the deadlines several times.
Full Solution Providers
compliance with international standards and improving IP environs sped up the growth of contract services industry several folds in the past years. Today, CMOs have graduated from just manufacturers to providers of end-to-end solutions. With as much as 50% cost arbitrage compared to their western counterparts Indian CMOs continue to be high on the radar of outsourcing companies with compelling cost concerns. Further, India is home for the largest number of US FDA certified facilities outside US. Companies from India continue to lead in DMF filings, as well.
India’s CRAMs market is expected to expand 30-50% by 2016 with the drugs of market worth US$430 billion losing patent protection, forecasts Investment Information and Credit Rating Agency of India Limited.
Revenues of CROs registered over 60% CAGR to $1.2 billion in 2010 from $22 million in 2002, according to a study. Large population of treatment naive patients enables faster enrolment. Again, faster recruitment means earlier market approval and considerable cost savings.
Currently, data management CROs are offering a broad portfolio of services pertaining to health records, health information services and clinical database management. IT-based companies like Tata Consultancy Services and HCL Technologies are providing client-based solutions.
Drug discovery CROs are also making news as big pharma companies are moving to invest on them. At present, many of them offer complete discovery and development solutions to clients. The pact between Endo Pharma and Jubilant Biosys; Takeda and Advinus are examples.
Another trend seen in recent years is MNCs’ growing preference for Indian generic companies as outsourcing partners. This has led to a few big ticket acquisitions including Abbott-Piramal, Mylan-Agila (Strides), Hospira-Orchid, etc., besides several partnership deals.
S. Harachand
Contributing Editor
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
Started as small-time vendors for generic manufacturing in the 90s, India’s outsourcing industry is tipped to become a one-stop shop for almost every service in the pharmaceuticals value chain—from discovery to commercialization. Companies from other geographies may excel in specific aspects in the contract services offerings but not across the spectrum of activities as is the case with India, experts point out.
However, it could be surprising to learn that much of this path-breaking transformatory process from preferred vendors to sought-after partners for the top-league pharma occurred during the period spanning little over a decade.
The floodgates were turned open for the contract services industry in 2005, when India formally announced its transition to product patent regime, following TRIPS obligations. Before that India recognized only IP related to novel processes of manufacturing of proprietary drugs and not the products per se, as a measure to foster the nation’s healthcare set up, which was largely driven by generic medicines.
Decades long experiments within what is called ‘reverse chemistry’, gained Indian companies unmatched skills in developing processes to produce complex molecules using technologies far cheaper.
Honing Skills
If the pre-2005 era won them mastery over the low-cost know-how, which lent the companies a unique edge in manufacturing, the onset of the product patent era encouraged the players to harness competency in drug discovery .
In fact, companies started honing core skills in various disciplines of pharmaceutical science in the years preceding the milestone event, soon after the country became a signatory in WTO in 1995.
In the run up to amend patent rules in accordance with the globalized trade, India assured in several regulatory reforms to bring up the pharma industry on par with mature markets.
In 2001, India formulated GCP guidelines for clinical research before legalizing them after four years under Schedule Y of India’s Drugs & Cosmetics Rules—the rulebook governing pharmaceuticals.
The preceding years also witnessed the companies going through hectic activity to improve manufacturing quality, even though the regulator could finally bring the country’s 20,000-odd manufacturers under WHO-mandated GMP standards in July 2005, after dithering the deadlines several times.
Full Solution Providers
compliance with international standards and improving IP environs sped up the growth of contract services industry several folds in the past years. Today, CMOs have graduated from just manufacturers to providers of end-to-end solutions. With as much as 50% cost arbitrage compared to their western counterparts Indian CMOs continue to be high on the radar of outsourcing companies with compelling cost concerns. Further, India is home for the largest number of US FDA certified facilities outside US. Companies from India continue to lead in DMF filings, as well.
India’s CRAMs market is expected to expand 30-50% by 2016 with the drugs of market worth US$430 billion losing patent protection, forecasts Investment Information and Credit Rating Agency of India Limited.
Revenues of CROs registered over 60% CAGR to $1.2 billion in 2010 from $22 million in 2002, according to a study. Large population of treatment naive patients enables faster enrolment. Again, faster recruitment means earlier market approval and considerable cost savings.
Currently, data management CROs are offering a broad portfolio of services pertaining to health records, health information services and clinical database management. IT-based companies like Tata Consultancy Services and HCL Technologies are providing client-based solutions.
Drug discovery CROs are also making news as big pharma companies are moving to invest on them. At present, many of them offer complete discovery and development solutions to clients. The pact between Endo Pharma and Jubilant Biosys; Takeda and Advinus are examples.
Another trend seen in recent years is MNCs’ growing preference for Indian generic companies as outsourcing partners. This has led to a few big ticket acquisitions including Abbott-Piramal, Mylan-Agila (Strides), Hospira-Orchid, etc., besides several partnership deals.
S. Harachand
Contributing Editor
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
