India is rapidly becoming one of the best-considered settings for global pharma’s drug research and development (R&D). Many factors have contributed to this outsourcing attraction, namely: highly-skilled doctors, trained paramedical staff, and a strong research infrastructure.

Pharmaceutical consulting firms attribute the growth in pharma sales to transitional disease profiles, bigger access to medicines, and growing public health programs, and if the Indian economy keeps on growing, the local pharmaceutical market will experience a huge transformation in the years to come, reaching the top 10 around the year 2015. This will definitely have an impact on the global pharma industry in regards to R&D.

Previous estimations have valued India’s research market between $600 million to $1 billion dollars, and global clinical trials performed in this country are expected to continue growing importantly in the next few years.

There are various reasons as to why India is such a desired location for research and development:

1. The amendments made in the past regarding the schedule Y of India’s Drugs and Cosmetics Act of 1942, have turned the country into an attractive location for new trials. This amendment permits parallel trial conduct in India simultaneously with the rest of the world, eliminating, thus, the phase delay experienced before.

2. India is expected to be the most populated country by 2035, turning it into the youngest one. It holds 20% of the world’s population under 24.

3. This country has a varied patient population in regards to race, culture, and economic level; and many are inexperienced about treatment. They are less prepared to deal with pneumonia, Hepatitis B, diabetes, or cancer, thus, the more patients, the higher recruitment quota. Shorter recruitment timelines prevail in India and patients’ compliance is higher.

4. Many of the issues regarding patent protection and intellectual property rights are settled. India is compliant with the Trade Related Intellectual Property Rights Act (TRIPS). It holds a first-class data-processing infrastructure for biostatistics and bioinformatics, and huge generic drug-manufacturing facilities.

All of these are critical aspects for R&D costs, which have dramatically been increasing for the past few years. It is vital to streamline the development process as much as possible. Even though there are no language barriers, US pharma-related companies desiring to get established in India will have to invest a great deal in education, given that 70% of the population lives in rural areas and the poor go to the public system for preventive and inpatient care. However, many of these patients also get involved in clinical trials for their urgent healthcare needs.

Despite its many strengths, India presents challenges as well:

1. There are just about 500 GCP-trained investigators with experience in clinical trials. India has considerably fewer physicians and beds than the world average. However, these are expected to double in the coming years due to private investment.

2. CRO’s must have a well-structured IT system and a strongly-supported workflow strategy to back up the access to information in real time, and the monitoring, clinical liaison, and business development functions to control studies happening in other Indian sites.

3. CRO’s may have to hire more personnel to manage rural sites and create a database of prime Indian investigators for indications and therapeutic areas, in order to meet international regulatory standards.

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That is the question that many of our lawmakers are asking. Senators Dorgan (D-ND), Snowe (R-ME), McCain (R-AZ) and Stabenow (D-MI) brought that question to the forefront when they introduced the “Pharmaceutical Market Access and Drug Safety Act of 2009″ (S. 525) in March. Currently waiting to be placed on the Senate calendar, the bill would allow for prescription drug importation.

While a good-intentioned idea, the Partnership for Safe Medicines (PSM) believes that “Pharmaceutical Market Access and Drug Safety Act of 2009″ will undermine nearly two decades of drug safety policy. Throughout the past 16 years and under two administrations, no HHS Secretary-Democrat or Republican-has certified a drug importation plans-a clear indication of the extreme safety concerns associated with drug importation and the challenges with ensuring safety of the globalized drug supply.

Unfortunately, this legislation simply does not recognize the increasing vulnerability of the international supply chain. In fact, it would allow importation from several countries that have had recent problems with counterfeit pharmaceuticals in their own country. In the past three months alone, the Medicines Health products Regulatory Agency (MHRA)-the British equivalent of the U.S. Food and Drug Administration (FDA)-has issued two recalls for counterfeit insulin pens and inhalers. The European Union’s 2007 pharmaceutical counterfeiting data shows that almost 40 percent of fake medicines seized by the E.U. originated in Switzerland. And according to the Pharmaceutical Security Institute (a member of the Partnership for Safe Medicines), last year, there were 104 reported incidents of counterfeit medicines in Japan, while Germany and Austria were in the top 10 countries where counterfeit drugs were most frequently seized or discovered.

Any time consumers are subject to drugs from outside of the U.S.’s currently closed drug supply chain, there is a very real risk to their health and welfare. Foreign pharmacies are not subject to the FDA’s jurisdiction and the exporting countries’ equivalents of the FDA are not going to spend their limited resources scrutinizing drugs not earmarked for their citizens. It is both impractical and not their legal responsibility. Additionally, criminals continually use European parallel importation and trade laws to slip counterfeit drugs into the legitimate supply chains of member countries that allow it, such as the United Kingdom. Finally, there is no evidence that drug importation provides any real savings according to the Congressional Budget Office and independent academic analysis.

Policymakers should focus on lasting solutions built on access to safe, regulated drugs, ensuring prescription drug safety for all consumers and do not put the risk of policy failure on the most vulnerable groups-minorities, uninsured, seniors, and others on fixed incomes.