The growth of the pharmaceutical industry is very much dependent on its research and development (R&D) sector.
Lawyer
Lex ORBIS IP Practice
But it is a fact that the Indian pharmaceutical industry has not traditionally attached much importance and has accorded only minimal investment to R&D.
However, of late, there have been several reports in the media about Indian pharmaceutical companies escalating their R&D.
In R&D, clinical trials play a prominent role as the effectiveness of drugs is very much dependent on these trials.
Trying process
Clinical trial is the scientific term for a test or study of a drug or medical device on people.
The drug development process starts in the research lab and ends with its launch in the market.
But the drug has to undergo several time-consuming and costly processes during this span of time.
Of the entire R&D of the drug, clinical trial accounts for more than 40%.
In order to trim overheads, clinical trials are often outsourced to developing countries.
New registry for clinical trials
The Clinical Trials Registry-India (CTRI) maintains the records of the clinical trials in India. The launch of the CTRI in July makes it easier for India to enter an elite group of a few selected countries that make clinical trials accountable through public disclosure.
The progressive attitude of the government towards clinical trials was reflected when Schedule Y of the Drugs And Cosmetics Act, 1945 was amended in 2005 to usher in better environment for clinical trials in the country.
The amendment permitted foreign drug trials to be conducted in India from phase 2 onwards.
Rapid growth
It is another fact that the clinical research industry is growing rapidly in India.
The pace of growth is tremendous.
In the past three years the sector has witnessed growth from around US$5 million to around US$25 million.
It is expected to enventually hold more than 20% of the global clinical trials.
Three phases
There are three important phases for clinical trials.
Phase one involves the initial introduction of an investigational new drug into humans. Mostly these studies are conducted on healthy persons.
The phase two tests would be on more persons and particularly on patients having the disease for which the drug is developed.
Phase three, which is the final stage, would have large number of patients and is monitored and watched over to see whether the treatment works well as a standard treatment.
The critical factor in the clinical trials is the time involved and the overhead costs incurred.
The time that goes into clinical trials is also an important factor for patents.
Clinical trials may take up more than 10 years from the maximum 20-year period protected by a patent.
This time lag could prove fatal to certain pharmaceutical companies.
In this scenario, it is pertinent to see the implications of CTRI on outsourcing opportunities.
Any positive move on the part of the government would create vast outsourcing opportunities, as India is the first choice of multinational companies due to the cost competitiveness.
Building trust
CTRI is to require that at least 20 items specified by the World Health Organization be declared to promote transparency and public faith in clinical trials.
While it is true that clinical trials are the next big business avenue, this potential has to be taken with a pinch of salt.
There are multiple factors that could affect the potential for outsourcing these clinical trials to India and stop the growth of this critical sector of the country’s pharmaceutical industry in its tracks.
One is a lack of patients in developed countries. Another is a lack of volunteers for the clinical trials. Another is cost effectiveness.
All three of these could be deemed critical factors.
It is also pertinent to note that the Drug Controller General of India has implemented Good Laboratory Practices for clinical trials in India but the impediment that may cripple the potential for outsourcing clinical trials to India is that there is no effective monitoring mechanism.
Once the regulatory system is polished, however, India could emerge as the hot spot for clinical research which would be vital in gearing up the economic structure of the country.
Vineed Abraham is a lawyer with Lex ORBIS IP Practice, a firm specializing in intellectual property with offices in New Delhi.
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