The pharmaceutical industry in India has raised concerns about the increasing challenge of phasing out brands and medicines based on safety updates, regulatory, or commercial choices. The subject has gained prominence again after Novo Nordisk announced its Human Mixtard Penfill insulin product will be phased out by the end of the year.

Key Highlights

Impact On Patient Care And Supply

• Phasing out drugs impacts portfolio management and manufacturing continuity, threatening interruption in patient treatment.

• Drugs such as rofecoxib, ranitidine, rosiglitazone, and nimesulide were phased out over time because of adverse drug reactions (ADRs) and safety issues.

Issues Raised On Novo Nordisk's Action

• Novo Nordisk's withdrawal of Human Mixtard Penfill is regarded as challenging for patients, particularly the elderly.

• Monitoring and adjustment of dose will be necessary for patients changing therapies.

Historical Context Of Withdrawn Drugs

• Rofecoxib (Vioxx) was withdrawn due to cardiovascular risks, affecting the entire Cox-2 inhibitor class.

• Nimesulide was associated with hepatic injury during post-marketing stages.

• Terfenadine, astemizole, and ranitidine were withdrawn due to cardiac and carcinogenic issues respectively.

Strain On Physicians And Patients

• Physicians find it hard when patients stabilized on a drug need to be switched owing to withdrawal.

• Patients tend to query previous prescriptions, generating tension between physicians and patients.

• Ayurveda products are not affected by such obsolescence, contributing to patient confusion.

Business And Strategic Implications For Pharma

• Withdrawal of drugs impacts sales and financial health, as in the case of Panacea Biotec's nimesulide effect.

• Strategic realignments towards more margin-friendly products also drive brand exits.

• Firms such as Lupin or Biocon can exploit gaps in the market left by such departures.

Leaders' or Officials' Statements
"Novo Nordisk's decision is not patient-friendly and the reasons are not strong enough. It will be extremely tough for patients especially geriatrics to switch since they have to be observed strictly by the medical practitioners in order to reach a proper dose,"
– Kaushik Desai, Pharma Consultant"This is a pharma professional risk for companies dealing in allopathic space… We see this in Novo Nordisk case which is going to discontinue production of pen insulin. This is a chance for other agile players like Lupin or Biocon,"
– Dr Sunil Chiplunkar, Vice President, Business Development, Group PharmaceuticalsPhasing out drug brands presents Indian operations with operational, clinical, and communication issues. In a constantly changing landscape of patient safety and commercial imperatives, pharma firms have to reconcile regulatory requirements with continuity of treatment—along with planning for portfolio changes involving physicians as well as patients.