Tuesday, December 23, 2014

Cost of inventing new Drugs

The drug industry has been ever evolving, continuously introducing new and enhanced drugs into the market. This dynamic industry and the growing competition is forcing companies to invest more in Research and Development and come up with better drugs every day. The world average cost of bringing a new drug into the market has been estimated to be $1.3 billion. A single clinical trial of a high end drug can go up to $100 million and manufacturing cost can be 10 times as the trial cost. But the gamble here is the cost of failure. When dealing with medicines, slight variation in the percentage of a particular constituent can change the purpose of the drug. The final drug may have severe side effects, or may not perform the job as expected. Statistically, only 1 in 10 medicines that go for human clinical trials succeed. A 9 out of 10 failure accounts to a huge sunk cost for the companies.  Introduction of anti-Malarial drug ‘Synriam’ by Ranbaxy is one such example of successful innovation after rigorous trail failures. However, one does need more than just research and testing a drug. Intellectual property rights capability for drug research, new drug delivery system, state of the art packaging systems, automation, reliability and flexibility in manufacturing are a few factors that one needs, to develop top quality drugs.

To minimize quality defects, process capabilities must be improved by changing the system of measurement from percentage to six- sigma. India has more than a million pharmacists and scientists. 75% of this force is dedicated to retailing and distribution. Around 20% is involved in R&D, manufacturing and quality control.

A few programs aimed at improving the scope of healthcare in India has been initiated by the government in the past decade. An Open Source Drug Discovery program is one such proposal. It’s a CSIR led team India consortium with global partnership, introduced some time back with an aim to provide affordable healthcare to the developing countries. OSDD has more than 4500 registered users from over 100 countries. Its business model is based on open innovation in pharmaceutical research as it simultaneously carries out research in drug enhancement.

To be globally competitive, India needs courses in regulatory jurisprudence so that newer legislations are implemented and understood with uttermost importance and speed. Also, continuing education should be made a pre requisite for upcoming new pharmacists. A collaborative program with pharmaceutical industries and hospitals could help design a better education course for the students. This would ensure a good work force for the future dedicated in improving the quality of medication present in the healthcare market.



Anurag is the Chief Branding Officer at Brandcare . An ardent online reader, he writes blogs on varied interests.

http://brandcare.net/


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