India emerging as a big global terminus for contract manufacturing (CMO) unlike Research & Development (R&D) outsourcing, for example, Dishman Pharmaceuticals Ahmedabad based contract manufacturing company, so is Jubilant Organosys Limited, revenues of both companies from their contract research and manufacturing services (CRAMS) arose by 29% and 41%, respectively, in the last financial year.
That hasn’t got away the attention of even formulation players such as Dr Reddy’s Laboratories (DRL), Aurobindo Pharma Limited, Lupin Ltd and Wockhardt Limited. All of them have begun giving more focus to assuring outsourcing contracts from big pharma.
Reasons are many why India is preferred destination for contract drug manufacturing, according to Ernst & Young (E&Y) and the Organization of Pharmaceutical Producers of India (OPPI),
- Over 80 % of the 38 major and medium sized pharma companies across the globe graded India as favored destination.
- India Offers a significant cost-quality proposition in end-to-end research and development, with potential savings of over 60 % as compared to the USA, coupled with a strong supply of skilled manpower and capital efficiency.
- There are close to 100 US FDA-approved manufacturing facilities in India, more than in any other country outside the United States of America.
- Drug manufacturing outsourcing to grow over 43% annually, thrice the global growth rate.
- Lessening numbers of novel medicines, as against existing medicines going off-patent, high research and development (R&D) costs, and high pressure to bring down medical care costs are pushing big pharma to rope in strategic collaborators to contain production and drug development expenses.
- The Indian drug production outsourcing industry to grow over 43 % annually, thrice the global growth rate, estimations from E&Y also E&Y, points, “Most of the top multinational pharmaceutical companies prefer only 10-15 established Indian industry players for drug manufacturing; going forth the global companies align with the 2nd and 3rd tier of Indian drug manufacturing companies”.
- Indian CROs, CMOs and CRAMS provides a fairly large cost-quality proposition in end-to-end R&D activities, with possible savings of over 60 % as likened to the USA, coupled with a strong availability of highly qualified or scientific resources and capital efficiency.
Report from Confederation of Indian Pharmaceutical Industries ,about 40-50 new plants, in addition to the manufacturing units of major Indian pharmaceutical companies, were commissioned, conforming to the quality standards recommended by the United States Food and Drug Administration (USFDA) and the United kingdom Medicines and Healthcare Regulatory Agency (UK MHRA). With the outgrowth of so many players, margins have shrunk from up to 200 %, 4-5 years earlier to just about 15-20%.“Still, it is highly remunerative and all players are doing pretty well,” from CPHI. Therefore, it’s apparent why Indian pharmaceutical companies have been signing outsourcing deals fairly large.
Last year, Pfizer, entered into a partnership with a relatively unknown Ahmedabad-based injectable drug manufacturing specialist, Claris Life sciences, to access products that are off-patent and have lost exclusivity in the US, Canada, Australia, New Zealand and Europe.
Also, Pfizer had entered into a partnership with Aurobindo pharma limited to contract-manufacture 39 drugs to be sold across Europe and the US, expanding the focus of an earlier deal. Pfizer will handle the marketing after licensing each product from Aurobindo, which will handle all the steps to get approval to make generic versions, as well as manufacture these.
2016 3rd Quarter, GlaxoSmithKline (GSK), the 2nd largest drug maker in the world, went into a similar alliance with Dr Reddy’s Laboratories to access the current portfolio and future pipeline of more than 100 branded pharmaceuticals in the cardiology, oncology, gastroenterology, diabetes and pain management. The products will be manufactured by Dr Reddy’s, and licenced and supplied by GlaxoSmithKline in various countries in Africa, the West Asia, Asia Pacific and Latin America. In certain markets, products will be co-marketed by GSK and Dr Reddy’s Laboratories.
The partnerships from global companies are good news for India pharma, “these contracts definitely necessitate time-bound delivery and have to always keep up high level of good manufacturing standards, requires highly matched skill sets, capacities and effective facilities as to execute orders in time, as to supply with highly match able resources under pharma technical and non technical areas HarNeedi.com as a dedicated HR solution partner for(biopharma/CRO) serving effectively to Formulation, CRAMS, CMOs, CROs, Bulk drugs and Biotech players from past 8 plus years, trusted by many professionals and Pharma/Biopharmas. Amongst all this good news, what eats into is that Indian pharmaceutical companies have flunked to make much headway in R&D outsourcing. The worries are intellectual property (IPR) protection, branded generic market image and lack of experience in novel medicine development, it is the time for Indian pharmaceutical law makers to look to overcome current challenges and keep in place the necessary policies as to improve with the current challenges.