Patient safety or affordability — What should India prioritise?

The Indian pharmaceutical industry is witnessing a tussle in setting quality standards. The recent revision of the Good Manufacturing Practices (GMP) intends to bring our pharmaceutical products at par with global standards at a time when India is promoting itself as a global manufacturing hub for generic medicines.

Improved quality benchmarks, as per the GMP revision, will ensure that pharmaceutical companies in India follow standard processes, quality control measures, and take no shortcuts, thus improving the quality of medicines available domestically and of those sold globally. The scrutiny the Indian generic drug industry has been facing due to mishaps in several countries should put us on a red alert in terms of quality and safety checks of our medicines.

This applies even more to biopharmaceuticals that treat complex diseases. The conundrum lies in the demand to waive clinical trials for biosimilars to reduce cost and increase accessibility against the need to ensure thorough tests in the interest of quality assured biosimilars and patient safety.

Biosimilars are medicines that are close in structure and function to a biologic medicine — similar, but not the same. Biologics are produced using a living system — microorganisms, plant cells, or animal cells. Such medicines are, therefore, more targeted, and effective in treating severe and life-threatening diseases such as cancer. Thanks to quality innovator biologics, we are seeing breakthroughs even in metastatic cancer, enabling patients to not only live a long life but also a quality life.

Trastuzumab (Herceptin) is a biologic well-known for targeted cancer treatment. Herzuma and Ontruzant are its biosimilar copies. Biosimilars are not identical to biologics in terms of quality, safety, and efficacy. Reason: the process of development is entirely different for both. Clearly, a different process means a different product, making it critical to undertake trials and ensure that these products deliver value to patients and more importantly, are safe for them. Patients should not have to pay the price of side-effects by using drugs that are not quality assured.

We need to urgently reconsider the balance between low-cost bio-drugs and safety to protect priceless patient lives.

Cost versus safety

The complex composition of biologics entails a higher level of manufacturing complexities, thus a higher price along with better efficacy.

The 2016 Biosimilar Guidelines allowed for a waiver of confirmatory clinical safety and efficacy studies. Further relaxation of the guidelines and throwing the market open without proper quality checks, particularly in a country with a poor pharmacovigilance system to monitor long term adverse effects, will be hazardous to patient safety.

Biosimilars call for thorough clinical trials to prove therapeutic equivalence and safety, so they are globally accepted and safe, which is not the case currently.

India and its global counterparts

The required size of clinical trials for approval in India is among the smallest globally, and significantly smaller than the requirements of the Food and Drug Administration (FDA) or the European Medicines Agency (EMA) — two of the most renowned medical associations across the world.

The 2016 guidelines allowed for a minimum of 100 patients for clinical trials, putting the statistical validity of trials under question. No such waivers have been granted by the FDA or the EMA. Many more such differences remain to level Indian biopharma to global benchmarks.

Patient safety

Biosimilars may improve affordability and accessibility, increasing equity but clinical trials and efficacy studies are vital requisites to ensure bio-drugs are safe and efficacious. Affordability cannot and should not be evaluated at the cost of patient safety, which is paramount. Would it be prudent to make drugs accessible that are not thoroughly tested and, hence, have potential unknown effects that patients must suffer? This can prove to be fatal to patient lives and to Indian pharma’s zealous plans of becoming the ‘bio-pharma hub’ of the world.

The Indian regulatory framework must maintain an equilibrium between affordability and patient safety. Curtailing clinical trials or elimination increases the probability of getting a biotherapeutic product with compromised safety and efficacy. This will not only result in loss of precious patient lives but also irreversibly dent the global view of Brand India.

[Amitav Banerjee, a Professor in a Medical College in Pune, Chairperson, Institutional Ethical Committee, National Institute of Virology, Pune (ICMR)]

Disclaimer: The views expressed above are the author's own. They do not necessarily reflect the views of DH.