India has long been known as the "pharmacy of the world," largely because of its booming pharmaceutical sector, which creates low-cost generic. The pharmaceutical sector in India has, however, suffered a number of difficulties in recent years that have hurt its standing as a dependable source of high-quality medications.

The issue of quality control is one of the major issues that India's pharmaceutical industry is currently facing. The quality of several Indian pharmaceutical companies' products prompted concerns from the US Food and Drug Administration (FDA) in 2018. This resulted in fewer Indian pharmaceutical companies gaining FDA approvals, which caused these companies to lose business.

The pharmaceutical business in India also faces challenges due to a lack of R&D spending. India is the third-largest manufacturer of pharmaceuticals in the world, yet it only devotes 0.8% of its GDP to R&D, which is much less than other nations such as the US and China. Due to a lack of innovation, generic medications have been produced, which are frequently thought to be of poorer quality than their branded counterparts.

The COVID-19 pandemic has also had an impact on India's pharmaceutical business, causing supply chain interruptions and a decline in demand for non-COVID medications. India imports over 70% of its active pharmaceutical ingredients (APIs) from China, which has become more apparent as a result of the pandemic.

Concerns about drug safety

For patients, regulators, and pharmaceutical corporations alike, drug safety is a major concern. Adverse medication reactions can have serious health repercussions, are expensive to litigate, and harm a company's brand. There are several solutions to this problem.

• Carrying out stringent clinical investigations to validate the security of medications before they are introduced.

• Investing in pharma vigilance programmes to keep an eye on the security of medicines once they are sold.

• Promoting open dialogue and cooperation between the pharma sector and regulators to guarantee the security of pharmaceuticals.

• Creating fresh methods and technologies to forecast drug safety more accurately.

Drug Counterfeiting

Drug fraud is a serious issue, particularly in developing nations. Some drugs may have fatal or serious side effects, or even both. In order to stop the production and distribution of fake medications, regulatory control needs to be strengthened.

• Informing patients about the risks of fake medications and how to spot them.

• Enhancing cooperation between business and law enforcement in the fight against fake medications.

• Creating cutting-edge technology, like blockchain, to monitor the medicine supply chain and stop counterfeiting.

The pharmaceutical sector needs to acknowledge and resolve these issues on a priority basis. By embracing innovation, collaboration, and ethical practices, the industry has the ability to greatly enhance outcomes for global health.

Thankfully, the Indian government and the industry are trying to overcome these issues and re-establish India as a trusted source of high-quality pharmaceuticals.

(The writer is managing director, BDR Pharmaceuticals. Views expressed are his personal)