Very few drug candidates, complex drug approvals, crowded competition in generic segment, stricter regulatory vigilance, and control over rising healthcare costs are the broader challenges pharmaceutical businesses are faced with. Looking deeper, each area of pharmaceuticals, i.e. R&D, Manufacturing & Supply Chain has their own complexities and business challenges…

Business Challenges of Research & Development

• Rising costs of New Drug Discovery with very little time for investment recovery demands greater control of costs, material wastage and tracking of experiments and results
• A crowded competition in the generic segment calls for rapid development of Non-Infringing-Processes (NIP) and approval of Drug Master Files (DMF) and Abbreviated New Drug Applications (ANDA), which involve time consuming processes
• While increasing regulatory vigilance and audits stretch the resources of companies to the limit, compliance to cGLP/ cGCP is becoming stringent and preparation of CTD is a daunting task.

Business Challenges of Manufacturing

• As Active Pharmaceutical Ingredient (APIs) and intermediates become commodities, and dropping prices result in shrinking margins, companies need greater operational control for efficiency, productivity and reduced costs
• Excessive competition in the generic segment has put dosage forms manufacturers into a tight corner
• Stricter regulatory and statutory vigilance (cGMP, cGLP, US FDA CFR 210, 211 and CFR 21 part 11) can mean increased focus on processes
• Sudden demand-supply gap in raw material can lead to disruption in supply of formulation products and significant variance in cost of production.

Business Challenges of Supply Chain Logistics

• Non-availability of timely, critical information on issues like sales, profitability, shelf movement, outstanding payment status, samples distribution … across geographies and units can affect market share
• Inefficient demand management can mean direct losses due to lack of stocks
• Ineffective market intelligence can get you lagging behind a smarter competition
• Unwelcome surprises on batch expiry, breakages/ damages and pilferage can be nasty