1. For pharma’s sake, drug regulatory agencies need to cooperate

For pharma’s sake, drug regulatory agencies need to cooperate

The pharmaceutical Sector in India is at the crossroads. Having established itself as the world leader in the space of generics—accounting for one-fifth of the global generic export volume (IBEF)—it has begun to take the next leap, and is regarded as an emerging hub of pharmaceutical research and innovation.

By: | Published: April 27, 2017 6:22 AM
Glenmark Pharmaceuticals, US health regulator, IND, USFDA, Kurt Stoeckli, DNA-derived, IMS sales data, BSE There is now a widespread perception, quite justifiable, that corruption has hurt the poor and increased inequality in the country, and the government has been trying to tackle it in various realms to win over public support. (Source: Reuters)

The pharmaceutical Sector in India is at the crossroads. Having established itself as the world leader in the space of generics—accounting for one-fifth of the global generic export volume (IBEF)—it has begun to take the next leap, and is regarded as an emerging hub of pharmaceutical research and innovation. On the other hand, the Indian government, as part of a series of steps to improve health security in the country, wants to give a major push to access to generic medicines through not only the government-owned Jan Aushadhi stores, but also doctor prescriptions at large. There is now a widespread perception, quite justifiable, that corruption has hurt the poor and increased inequality in the country, and the government has been trying to tackle it in various realms to win over public support. Lack of access to medicines, in particular, hurts people in the most personal ways and has led to widespread feelings of inequality at two levels. One, there are people who can afford world-class healthcare within and outside the country, while others can barely afford two square meals a day, forget healthcare. No wonder, India is the world’s capital of premature mortality (both at the child and adult levels), despite being the world’s largest exporter of generic medicines—the second level of inequality. No government which wants to be re-elected can afford to ignore this anymore.

Medicines are made to cure people. While this may sound obvious, it can only become obvious in reality through a series of steps taken by the government and the pharmaceutical industry, more so by the former. Let us focus on former’s role as citizen health is the responsibility of the government—and on account of that, it also has the responsibility to encourage as well as harness the potential of the pharmaceutical industry, which may have humanitarian motives, but works by and large on the principle of profit. This, too, may sound obvious, but is more often forgotten than remembered. The first encouragement that the pharmaceutical industry needs from the government is to discover and manufacture medicines. Generics are copies of existing drugs—we also need newer and better medicines, which have to be discovered through pharmaceutical research and development (R&D), an area in which the private pharmaceutical industry needs to have sufficient incentives to invest.

You May Also Want To Watch:

Thanks to structural transformation of the economy and the workforce as well as medical advances for detection, we are discovering diseases at a much more rapid pace than we are discovering drugs to treat them, leading to increasing inequality between demand and supply of new and better drugs. Any government would want to limit costs of healthcare, especially in the wake of the ever-rising detection/known burden of diseases and ever-increasing need for better health of the workforce. Even in rich countries like the US and Japan, political leaders have moved to cut health care costs, and India can be no exception.

However, this is not the only lesson that the US and Japan offer to rapidly growing countries like India: they also have dynamic ecosystems for pharmaceutical R&D. The Modi government, therefore, needs to give a simultaneous push to clinical trials in the country—a subject on which we are releasing a well-researched report based on interactions with various stakeholders within India as well as in four continents (North America, Europe, Asia and Africa).

Another responsibility that the government has towards protection and promotion of public health is strengthening the role and functioning of the drug regulatory landscape in the country. There are already some plans in place within the government towards this end. Cooperation among drug regulatory authorities (DRAs) of various countries to achieve their public health objectives and promote ease of doing business for the pharmaceutical industry should be an objective. In developing countries like India, DRAs usually have limited resources and capacities. Cooperation and collaboration with developed DRAs means avenues for learning as well as rational use of their limited resources and capacities, first, by not reinventing the wheel, and second, by focusing on issues for which resources and capacities are not available elsewhere. The approach should rather be to participate in international forums, learn from them as well as influence them wherever required and possible. If our leaders can participate confidently in multilateral forums like the United Nations and be a signatory to a set of international health goals—previously under the MDG, and now under the SDG framework—why should our drug regulators shy away from international participation and cooperation when that helps in the achievement of our public health objectives?

 

  1. No Comments.

Go to Top