picNew Delhi : Renowned consumer activists have cut short attempts of biosimilar drug companies to take shortcut for marketing medicines.  The makers of this genre of medicines are batting for relaxation of conditions for marketing approval. The activists have said without mincing words that patient safety cannot be traded for access and affordability. On Biosimilars’ attempt to skirt prerequisites, the activists have put their feet down, saying the safety question should be off limits for any kind of compromise.

Hot on the heels of a letter written early on this month to secretaries of Union Health Ministry and Department of Biotechnology for cutting corners, consumer activists have red flagged the attempt citing recent mishaps due to ‘made in India’ medicines which have badly battered the image of pharmacy of the world that India prides itself upon. The makers seem to be in a hurry to capture the market coxing drug regulators to throw caution to the winds.

The letter in the name of representatives of various civil society, community organizations, health organizations and patient groups asks for waiving of conditions imposed by current Indian Biosimilar Guidelines namely mandatory animal studies and comparative safety and efficacy studies for marketing approval.  Branding these conditions major barrier in the way of biosimilars trying to enter the market, the letter flaunts the question of access and affordability. The argument of sidelining safety concern for making medicines affordable does not sit well with consumer interest advocates.

Prof. Bejon Misra, internationally renowned consumer policy expert, activist and Founder Director, Patient Safety and Access Initiative of India Foundation is categorical saying safety question cannot be given a go by when it comes to medicine, nowise.  In his official statement, prof Misra said, “Patient safety should be of paramount importance while approving pharmaceutical products in any market. Clinical trials and safety efficacy studies are vital requisites to ensure products launched in the market are safe and efficacious. The safety of patients cannot be compromised for the sake of affordability. There is no denying that biosimilars can significantly bring down the price of essential biologics that are used for critical diseases including cancer but that does not mean biosimilars are allowed without adequate safety studies. In fact, because biologics are different than conventional chemical molecules and are complex and difficult to develop, it is important that biosimilar undergo rigorous testing and clinical scrutiny to ensure they are safe and efficacious.  Comparative safety and effectiveness data is necessary to support the demonstration of biosmilarity. The Indian biopharma industry is already struggling to keep up with international quality and testing standards, given the existing regulatory inadequacy. Further relaxations in the current regulations will not only be bad for India’s reputation on the global map but also put Indian patients at a huge risk.

 Anurag S. Rathore, Ph.D., Coordinator, DBT COE for Biopharmaceutical Technology, Professor, Department of Chemical Engineering (Jointly with) Yardi School of Artificial Intelligence, Indian Institute of Technology, Delhi is equally concerned by the attempt and has unambiguously put his view points as follows.  

 “Indeed clinical trials continue to be the single largest contributor to the development and commercialization of a bio therapeutic product. This is even true for a biosimilar, class of compounds for which the quantum of required clinical trials is already substantially reduced. It is also true that biosimilars cost significantly more than their pharmaceutical generic counterparts, thereby impacting their affordability and accessibility. These facts have been fuelling calls for the reduction or even elimination of clinical trials as this would substantially lower the cost of manufacturing and make them more affordable. While these calls are gaining momentum, the regulators need to keep the delicate balance between affordability and patient safety. ”