The importance and impact of approving new drugs in healthcare

Written by Praveen Sikri

There is no way to deny the role and importance of drugs and medicines in our lives. According to the data, about forty-eight percent of people in the United States have reportedly been using at least one prescription drug in the last thirty days in the United States, with more than sixty-eight percent engaging in some form in the physician’s office. Drug therapy. Although no comparative data are available for India, the drugs that constitute the single largest component of the Indian household’s out-of-pocket expenditure illustrate the role and value of drugs in our lives. If regular prescription medications or over-the-counter medications have such a high value in everyday health-related matters, imagine and consider the importance and impact of newly-approved medications for individual patients and families who will need them as well as health authorities. Every permanent disease of which is a challenge and every new cure will be the light of the proverb at the end of the tunnel.

The new approvals exceed the limits of previously approved drugs

If the same drug is re-approved to treat a new disease or a new population of patients or a group of patients, the introduction of a new approved drug usually means that the latest in question is the best treatment available anywhere in the world. Given the medical condition at a certain time. For example, for the past decade, diseases such as hepatitis B and C have been treated with therapeutic intent only in the hope of prolonging the patient’s life and not helping the patient to recover permanently. But in 2015, with the advent of new drugs on the market, hepatitis was transformed from a manageable condition into a condition that could be safely and easily cured by all-oral treatment options. Similarly, new advances in the treatment of breast cancer confirm that ten to fifteen years ago when a living person lived a maximum of four to five years, today, he can enjoy an extended lifespan of twenty to twenty-five years. Post treatment.

Growing number of new approvals: Accepting the global health challenge

In recent years, the number of new approvals has been steadily increasing. To illustrate, in 2020, the US FDA’s Center for Drug Evaluation and Research (CDER) approved 53 fancy drugs, the second-highest count in 20 years, slightly lower than the 59 approvals of 2018. Diseases covered by newly approved drugs range from infectious diseases such as Covid-19, HIV, chronic hepatitis C and hospital-acquired bacterial pneumonia, and ventilator-related bacterial pneumonia to flu-resistant diseases to a wide range of neurological conditions such as Parkinson’s disease. And muscular atrophy of the spine (SMA). Incidentally, this is the first orally approved drug for SMA In addition, the United States has seen the first FDA-approved therapies to treat the rare disease lupus nephritis, in addition to new approvals for cancers such as thyroid cancer and lung cancer. Undoubtedly, most of these diseases and disorders affect the world population. For its part, India approved 26 new drugs in 2019, 29 in 2020 and 26 in 2021, about half of the average approved in the United States.

Covid-19 has strengthened the role and importance of approving new drugs

We have seen how the ongoing epidemic has led to word-of-mouth shocks for new and innovative drugs that highlight the importance of newly approved drugs. From the WHO to the US FDA, our own drug authorities, each regulatory body has from time to time approved and announced new drugs and vaccines for the treatment of Covid-19 because drug companies and drug research firms have gone into overdrive. While the WHO approved two rheumatoid arthritis drugs, Tosilizumab and Sarilumab, for the treatment of Covid-19, ্ল ্ল ্ল ্ল প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম প্রথম Similarly, the Government of India has approved a variety of new therapies for Covid-19, including a monoclonal antibody cocktail, 2-deoxy-D-glucose (2-DG) and, more recently, Malnupiravi.

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 particular condition, in no country in the world should a patient have access to such treatment. Developing countries such as India (and others) carry the burden of high morbidity, especially with a number of rare diseases, and government regulations and bureaucratic procedures will not impede patient access to a new drug developed in developed countries. For example, India contributes one-fourth of the global understanding of multi-drug resistant (MDR) tuberculosis. Today, some advanced treatments for MDR-TB are available outside India, an example of which is a three-drug system in the United States consisting of bedaquiline, pretomanid, and linazolide, a treatment that also needs to be made available in India. Remember, access to a desirable new drug, yet unregistered, instant access to a needy patient anytime anywhere makes the much-discussed concept of globalization more meaningful and meaningful in our lives.

Emergence of alternative channels and facilities

In recent years, private consulting firms and facilitators have emerged in India who can legally ensure that a patient gets timely access to any newly-approved drug in developed countries, which often takes several years to register and get licensed for marketing, distribution and sale. Our country. Unless the need arises for an individual and not for business, and if a practitioner certifies that a patient has exhausted all available treatment options within the country, the government allows such drugs to be imported into the country. Consultants and facilitators with a good network with Global Pharma can source the desired drug and make it available to any needy patient at any time. With a range of services such as managed access programs, early access programs, empathetic user programs, and named patient services, these consulting firms can differentiate 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 should not be made available to a needy patient outside the borders of the producing country in a timely manner. Ensuring this makes globalization really possible with a human face.

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

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