Express Pharma

It’s crucial to serialise the smallest usable unit of a pharma product, a distinct identity

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As a part of the Express Pharma’s January 2023 cover story, Vivek Sehgal, Director General (DG), Organisation of Pharmaceutical Producers of India (OPPI), shares his views below.

For the pharma industry, maintaining a reliable supply of high-quality medications for the patient population and other end users is a top concern. One scrutiny by the US Trade Representative (USTR) found over 20 per cent of the drugs in the Indian market to be fake. According to a report by the non-profit Authentication Solution Provider’s Association (ASPA), incidents of substandard and falsified products increased by 47 per cent during the peak of the pandemic from 2020 to 2021.

It is of prime importance to ensure that the quality of the processes that manufacture these drugs, along with the quality of the drugs, is maintained, as this will only help India achieve its health goals faster and more efficiently. Moreover, sub-standard drugs can have a catastrophic impact on human health as they can cause diseases to run a longer course and contribute to the escalating incidence of anti-bacterial resistance.

Current issues: Counterfeiting drugs is a global menace that is estimated to cost the Indian economy Rs 1 trillion annually. While falsified drugs resemble the original brand in looks, they are nowhere as efficacious, and can have an adverse impact as they contain poor doses of the prescribed active pharma ingredient. The pharma industry in India has, however, recognised the need for a proactive and unified quality management approach to mitigate risks and deliver breakthrough drugs. Industry standards such as Good Manufacturing Practice (GMP) and Schedule M (of the Drug and Cosmetics Act 1940), which lay down quality control metrics for production, facilities and equipment, laboratory controls, materials, packaging and labelling, are already in place. Moreover, the Indian government has set up a seven-member panel to prepare the country’s first-ever National Drugs Database. The registry will empower consumers and improve monitoring by providing information such as on a drug’s dosage, form, strength, manufacturer, marketer and importer. On the other hand, the health ministry has also changed the Drugs and Cosmetics Rules to make marketing companies equally accountable for drug quality, apart from the manufacturer. This will also call upon small manufacturers to up their quality game and take a stand against fake and spurious medication.

Future recommendations: It’s crucial to serialise or provide the smallest usable unit of a pharma product, a distinct identity. It makes it possible to discover the product’s past and present locations throughout the whole supply chain. Even blockchain technology might be taken into consideration for the entire network of medicine manufacturing, distribution and sales, preventing the entry of counterfeit and subpar medications. From an overarching perspective, the pharma production process itself needs to be subjected to stricter inspection and control to prevent the deterioration of the quality at any step. In the coming year, as a step towards enhancing the overall quality, providing financial assistance through loans and subsidies for pharma industry units to upgrade their manufacturing, infrastructure and systems to prevent the quality from depreciating right from the development of the pharma product to the last-mile delivery to the end customers: patients, could help. India is taking strides in the right direction, with a lot more focus on product monitoring and quality of APIs. Stakeholders and policymakers also need to take collective action to ensure regulation and compliance. Both the industry and the government are driving the quality revolution in India by making it a cornerstone for the industry’s and the nation’s progress.

To read more stories in the January 2023 edition, read our digital issue at :

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