Significance and Impact of New Drug Approvals on Health Care


By Praveen Sikri

There is no denying the role and importance of drugs and medications in our lives. According to the data, nearly forty-eight percent of people in the United States have used at least one prescription medication in the past thirty days in the United States, with more than sixty-eight percent of doctor visits involving a form of drug therapy. Although there is no comparable data available for India, the fact that medicines constitute the major component of Indian household out-of-pocket expenditure illustrates the role and value of medicines in our lives. If ordinary prescription drugs or over-the-counter drugs have such value in the daily affairs of health, imagine and consider the importance and impact of newly approved drugs for patients and families who would desperately need them as well as for health authorities for whom each persistent disease is a challenge and each new cure would be the proverbial light at the end of the tunnel.

New approvals exceed threshold crossed by previously approved drugs

While the same drug, if reused, is re-approved to treat a new disease or a new patient population or a new cohort of patients, the launch of a newly approved drug usually implies that the latest innovation in question is the best treatment available anywhere in the world for any given medical condition at any given time. For example, until the last decade, diseases such as hepatitis B and C were sought to be treated only with curative intent in the hope of extending a patient’s life and not really helping the patient to permanently get rid of the disease. But in 2015, with the emergence of new drugs on the market, hepatitis went from being a barely manageable disease to one that could be easily and safely cured by all-oral treatment options. Similarly, new advances in the treatment of breast cancer mean that, unlike ten to fifteen years ago, when a survivor lived four to five years maximum, today he or she can enjoy an extended life expectancy of twenty to twenty-five years. after treatment.

The Ever Growing Number of New Approvals: Meeting the Challenges of Global Health

In recent years, the number of new approvals has steadily increased. To illustrate, in 2020, the US FDA’s Center for Drug Evaluation and Research (CDER) approved 53 new drugs, the second highest number in more than 20 years, slightly lower than the 59 approvals in 2018. The diseases covered by the newly approved drugs covered a wide range from infectious diseases such as Covid-19, HIV, chronic hepatitis C and influenza prevention, including nosocomial bacterial pneumonia and ventilator-associated bacterial pneumonia, to neurological conditions such as Parkinson’s disease. and spinal muscular atrophy (SMA). Incidentally, it was the first orally administered drug approved for SMA. Additionally, the United States also saw the first FDA-approved therapy to treat the rare disease lupus nephritis, apart from new approvals for cancers such as thyroid cancer and lung cancer. Undoubtedly, most of these diseases and disorders have a global footprint that affects people around the world. For its part, India had approved 26 new drugs in 2019, 29 in 2020 and 26 in 2021, almost half of what was approved on average in the United States.

Covid-19 has heightened the role and importance of new drug approvals

We have seen how the ongoing pandemic has led to a global rush for new and innovative drugs demonstrating the importance of newly approved drugs. From the WHO to the US FDA to our own drug authorities, every regulatory body was approving and announcing new drugs and vaccines for the treatment of Covid-19 from time to time as pharmaceutical companies and drug research organizations the drugs went into overdrive. While the WHO has approved two rheumatoid arthritis drugs, tocilizumab and sarilumab, to treat Covid-19, Veklury or remdesivir has been approved as the first drug in the United States for the treatment of Covid-19 patients. Similarly, the Indian government has also authorized a range of new treatments for Covid-19, including a cocktail of monoclonal antibodies, 2-deoxy-D-glucose (2-DG) and, more recently, molnupiravir, among others.

Developing countries need alternative channels: makes globalization more meaningful

At a time when a newly developed drug is known to have the best therapeutic effect for a certain condition, nothing should prevent a patient from accessing such treatment in any country in the world. Developing countries such as India (and others) with a particularly high disease burden, including several rare diseases, government rules and regulations and bureaucratic procedures should not impede a patient’s access to a new drug developed in advanced countries. For example, India contributes a quarter of the global burden of multidrug-resistant tuberculosis (MDR). Today, there are some of the most advanced treatments available outside India for MDR-TB, an example being a three-drug regimen of bedaquiline, pretomanid and linezolid in the United States, a treatment that must also be made available in India. Remember that instant access to a desired, but unregistered, new drug to a patient in need anywhere and anytime makes the much-vaunted idea of ​​globalization more meaningful and useful in our lives.

Emergence of alternative channels and facilitators

In recent years, consulting firms and private facilitators have emerged in India who can legally ensure that a patient has timely access to any newly approved medicine in advanced countries, which often takes years to register. and authorized for marketing, distribution and sale in our country. As long as the requirement is for an individual and not a business, and if a practitioner has certified that a patient has exhausted all treatment options available in the country, the government allows these drugs to be imported from outside into the country. Consulting and facilitation firms, well networked with the global pharmaceutical industry, can procure the desired drug and make it available in no time for a patient in need. With a range of services such as the Managed Access Program, Early Access Program, Compassionate User Program and Named Patient Service, these consulting companies can mean the difference between life and death for a patient and his family.

Therefore, if registered regular prescription drugs and over-the-counter drugs can be made available, there is no reason why newly approved drugs cannot and should not be made available on time. a patient in need outside the borders of the country of manufacture. It is by ensuring this that globalization with a human face becomes truly possible.

(The author is the CEO of Ikris Pharma Network. The opinions expressed are personal and do not reflect the official position or policy of


Comments are closed.