The Drugs Controller General of India (DCGI) needs to work closely with pharmaceutical firms and state authorities to weed out the problem by following standard and defined protocols.
Medicines are important for us to get better from illnesses. These may be prescription or dietary supplements. They help prevent, treat diseases, and improve health. With the rising menace of counterfeit medications prevalent across the world, ensuring authenticity becomes the need of the hour. Nearly 10.5% of the medications sold worldwide are falsified, negatively impacting public health, pharmaceutical businesses, and a company’s reputation.
India’s tryst with fake and falsified drugs is no different. While India
stands tall as one of the biggest market leaders, supplying and
exporting generic drugs worth millions each year, the business of
spurious drugs is tarnishing its image.
As the demand for medicines surged during the COVID-19 pandemic, online pharmacies benefited largely which led to rising investments in this sector. However, the trade of spurious medicines and medical essentials also increased during this time. News reports of fake vials of medicines like remdesivir made headlines globally. Even though counterfeiting is a major challenge for any industry, the sale of sub-standard and falsified (SFFC) drugs has a greater impact since it affects human lives.
Challenges faced by the healthcare ecosystem
The sale of fake medicines that usually contain toxic or substandard active ingredients can adversely impact health outcomes and cause morbidity and mortality. India-specific challenges that need to be addressed include over-the-counter dispensing of medicines (often without a valid prescription), lack of insurance and the enforcement of consistent investigations against manufacturers of spurious medicines.
The Drugs Controller General of India (DCGI) needs to work closely with pharmaceutical firms and state authorities to weed out the problem by following standard and defined protocols. When a complaint is raised and the investigation is conducted, the directive from DCGI labels the drug as ‘Not of standard quality,’ without specifying whether it is a substandard formulation or a fake or falsified one. Stringent steps must be taken to punish those who are manufacturing and selling falsified or fake drugs in the name of the original pharmaceutical company, which is unaware of the same.
Additionally, the lack of quality control infrastructure makes it doubly hard for authorities to impose a strict vigil on the menace of counterfeiting in the pharma sector. Moreover, poor consumer awareness and supply-chain imbalances add to the burden. However, with the rising demand to put patient needs first, these infrastructural gaps need to be closed and upgraded wherever possible.
Benefits of digital tech for safe access to drugs
While
fake medicines impose dangers on India’s healthcare system and public
health, corrective actions are being taken to overhaul the manufacturing
and supply chain discrepancies. The adoption of digital technology has
been one of the steps taken to tackle the sale of spurious medicines. It
is also helping the industry modernize and weed out SFFC drugs.
Track and trace digital technology can strengthen the authenticity of
the product and stop blatant copying. Technological advancements can
also facilitate companies to adopt features like serialization, and
unique packaging with scannable barcodes which can help with more
consumer-focused content and awareness of what to look for. These can
also enable consumers to authenticate a product by simply using their
phones.
In 2019, the Central Drugs Standard Control Organization
(CDSCO) tabled a draft law establishing a uniform QR code on medicinal
packs for ethical compliance and industry-wide quality control.
Recently, the health ministry put out a draft Bill titled ‘Drug, Medical
Devices, and Cosmetics Bill-2022’ which addresses the potential gaps in
the sale of medicines through online pharmacies. Starting January 2023,
the government has mandated the use of barcode/QR codes on active
pharmaceutical ingredients (APIs), raw materials, and packaging
materials for domestically available brands.
Combating pharmaceutical counterfeiting is also essential to cut manufacturing losses and ensure patient safety. The pharma industry and the government must act together to establish uniformity in testing mechanisms and regulatory frameworks and enable punitive actions against fraudulent retailers and agencies. Higher authorities, including the CDSCO, Ministry of Health and Family Welfare, and Ministry of Commerce and Industry, must also actively promote programs that encourage consumer awareness and empower pharmaceutical companies.
