Understanding Medicine Quality - Understanding regulatory processes and how they impact quality and costs


7 min read

Saransh Chaudhary
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Medicine is an integral part of our lives, playing a crucial role in maintaining and improving our health. Because it directly impacts the treatment's effectiveness and safety, medical quality is extremely important. Numerous regulatory procedures are in place to guarantee that medications are high-quality, safe, and effective. Let us dive deeper to examine the importance of pharmaceutical quality, the regulatory mechanisms that oversee it, and how these mechanisms affect the costs and quality of pharmaceuticals. Medication of poor quality may be harmful to a patient's health and can be unsafe or ineffective. This emphasizes how crucial it is to comprehend and control the quality of medications.

The quality of medicine refers to its safety, efficacy, and consistency in meeting predetermined standards. This has been covered in detail in our previous blog. Regulatory bodies worldwide are responsible for overseeing the quality of medicines. These bodies establish guidelines and enforce regulations to ensure that pharmaceutical companies adhere to high standards. India has set up regulatory agencies to monitor the pharmaceutical industry to guarantee the efficacy, safety, and quality of generic medications.

The two primary organizations accountable for this are:

The Central Drugs Standard Control Organisation, also known as CDSCO, is the regulatory body that oversees clinical trials, establishes quality standards, and authorizes new medications.

The National Pharmaceutical Pricing Authority, also known as NPPA, regulates drug prices to ensure affordability and prevent exploitation.

However, a significant challenge to the nation's pharmaceutical quality emerges with the role of state drug controllers. These state controllers can give the green light to medicines already approved by CDSCO. This recent shift in approval dynamics raises questions about the potential compromise in quality standards, as these state authorities are often understaffed or have lower auditing standards compared to the CDSCO, resulting in some substandard quality manufacturers getting approved. Hence, the quest for a more uniform and stringent approach to drug approvals remains a focal point in India's pharmaceutical narrative.

Now that we have broken down the regulatory process, let’s further understand its impact on quality and cost.

Medicine quality is non-negotiable. To maintain high standards, the Indian pharmaceutical businesses that want to sell in India comply with the Schedule-M guidelines under the Drugs and Cosmetic Act. This compliance is verified by the State Drug Control Authorities whereas those who want to export comply with the WHO guidelines which are considered more stringent and are audited jointly by both state and central drug authority. Then there are companies like Venus, alongside other industry leaders, setting a gold standard by adhering to even more rigorous regulations established by authorities in Europe or the United States. This elite group of top regulatory bodies worldwide is collectively known as the "Stringent Regulatory Authority (SRA)." Manufacturers holding accreditation from one or more SRAs are recognized for producing medications of the utmost quality. In essence, they stand at the pinnacle of the pharmaceutical landscape, ensuring a commitment to the highest standards in the pursuit of excellence. Following these procedures guarantees the efficacy and safety of medications, improving the standing of Indian generics on the international scene. Having summarized a brief understanding of how these processes impact quality let’s understand their role in determining the cost of these generic products as well.

The impact on cost is mainly due to 2 factors:

  1. Cost-Effective Production: The triumph of the Indian generics market can be largely attributed to its prowess in cost-effective production. This success is grounded in the ability to minimize research and development expenses, coupled with a commitment to competitive pricing strategies. By streamlining the production process and optimizing resources, the Indian pharmaceutical industry ensures that generics are not only of high quality but also remarkably affordable. This economic advantage has not only made healthcare more accessible domestically but has also positioned India as a global hub for cost-effective pharmaceutical solutions.

  2. Government Initiatives: The Indian government has proactively intervened to regulate drug pricing, instigating a positive transformation in healthcare accessibility. Through intricately crafted policies and initiatives, the government has focused on ensuring that essential medicines remain within reach for the masses. This strategic approach has had a tangible impact on healthcare affordability, creating a more inclusive and accessible healthcare landscape for the citizens. By taking these measures, the government plays a pivotal role in fostering a healthcare system that prioritizes the well-being of its population and highlights the importance of making essential medicines an integral part of public health.

With this strategy, Indian pharmaceutical companies may continue to supply high-quality products at reasonable prices. Government programs like price negotiations, Jan Aushadhi Stores, drug price controls, and increased healthcare access all help to make healthcare more affordable by guaranteeing that a large number of people can afford needed medications.

Together, these factors make India a significant player in the global generics market, offering cost-effective and high-quality medications for patients domestically and worldwide.

At Davai, we ensure that the drugs are supplied only from trusted manufacturers who guarantee us quality stock and thus save the other parties any losses.

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