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Meeting Quality Standards through FM

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India is known as the pharmacy of the world. Since the cost of manufacturing here is much lower than in the West, India’s pharma industry is the biggest producer of generic drugs, which are available at far more affordable prices than if manufactured in developed countries. Every year, billions of doses of essential, lifesaving medicines are exported to every part of the globe; in FY21, this value stood at $24.44 billion.

Revenues are projected to continue growing at 8-10% in FY22, with the subsequent year’s growth supported by growth of 7-9% in the domestic market, 12-14% in emerging markets and 7-9% in the European business.

So far, India has imported a major part of the Active Pharmaceutical Ingredients (API) required for pharma manufacturing. Aiming to make the country self-sufficient in this regard, the government has announced a Performance-Linked Incentive (PLI) scheme to incentivise the production of 53 APIs. The `9,940 crore package to boost the domestic API manufacturing industry is divided into two parts: `6,940 crore has been allocated for the PLI Scheme and `3,000 crore will be spent on setting up three bulk drug parks.

However, the growth of this sunshine industry is hinged on a single crucial factor – flawless facility management. Pharma units in India must meet not just domestic but also international regulatory standards (for the export market). Contamination during the manufacturing process by impurities can condemn an entire product batch; undetected contamination of medicines can endanger the lives of patients.

To understand how FM has a direct and crucial influence on the quality of drugs, read on.

1) FM challenges of pharma manufacturers

2) FM is central to pharma GMP

 

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