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India pharma notes that phasing out medicines is a challenge. This is because product portfolio management and manufacturing processes are critical to maintaining a steady supply of medicines and ensuring that patient care is not disrupted. The manufacturing, sale, prescribing and consumption of medicines such as rofecoxib, nifedipine, rosiglitazone, ranitidine, terfenadine, astemizole, gliclazide, and nimesulide have been affected due to ADR (adverse drug reaction) updates and safety concerns.
When a medication is withdrawn from the market, whether due to safety concerns, regulatory issues, manufacturing problems, or commercial decisions, it can have significant implications for both the company and its customers. This discussion ensued after Novo Nordisk’s announcement of phasing out its Human Mixtard penfill by the year-end, stated a section of pharma companies.
According to Kaushik Desai, a pharma consultant, the decision by Novo Nordisk is not patient-friendly and the reasons are not convincing enough. It is going to be very difficult for patients particularly geriatrics to switch as they need to be closely monitored by the medical practitioners to arrive at a right dose.
Dr Sunil Chiplunkar, vice president, business development, Group Pharmaceuticals said that there are instances of product phase out. Vioxx or rofecoxib showed that safety issues which magnified into a business misfortune. A pall of gloom descended on the entire Cox 2 inhibitor category. Nimesulide is another target of ADRs which was reported in the post marketing phase with hepatic damage. Terfenadine and astemazole at one time were a top choice anti-allergic medicines which are now banned due to negative effect on cardiac function. The latest casualty is ranitidine due to suspected NDMA (N-nitrosodimethylamine), a carcinogenic impurity problem.
Phasing out medicines is an issue for doctors and patients. A doctor who has stabilized his patient on rosiglitazone or ranitidine or terfenadine or astemizole or nimesulide, needs to change medications due to withdrawal of the product or adverse reports on the medication. In India, patients then start to question the doctor why he put them on the suspect medication in the first place, since they do not understand the nuances of updated clinical information on ADRs. In case of Ayurveda products, such medicine obsolescence does not happen, this is cited by patients to doctors who get into arguments with their medical practitioner. Further, many patients do not follow-up regularly with their doctor. This puts doctors and patients in a quandary, since medicines get outdated or removed from market, Chiplunkar told Pharmabiz.
Pharma companies need to constantly look at their product portfolio and manufacturing since withdrawal of medicines affects routine pharma operations. Panacea Biotec enjoyed huge sales with nimesulide range. Once the ADRs started coming in on nimesulide this has had a financial impact on the company dealing with this medication. This is a professional hazard for pharma companies operating in allopathic space, he noted.
The challenges of managing product withdrawals in the pharma industry underscore the importance of flexibility, forward planning, and regulatory compliance. Another reason, why pharma companies phase out brands is due to change in priorities. When pharma brands come to maturity decline stage of the product lifecycle, the marketing company decides to phase out the brands and focus on the higher margin brands, we see this in case of Novo Nordisk that is going to stop manufacturing pen insulin. This is an opportunity for other nimble companies such as Lupin or Biocon, said Chiplunkar.
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