Paracetamol, Pan D among 53 medicines to fail drug regulator’s quality test; raise safety concerns

Drug Quality Concerns in India: Over 50 Drugs, Including Paracetamol, Listed as ‘Not of Standard Quality’ by Central Drug Regulator

Introduction

India, known as the “pharmacy of the world,” is a leading global supplier of generic medications. However, maintaining the quality and safety of these drugs is a constant challenge for the country’s regulatory authorities. In the latest drug alert for August 2024, the Central Drugs Standard Control Organisation (CDSCO) flagged more than 50 drugs, including widely used medications like paracetamol, Pan D, and various vitamins and anti-diabetic drugs, as “not of standard quality” (NSQ). This revelation has raised serious concerns about the quality control measures in place for the production and distribution of pharmaceuticals in the country.

The drugs flagged in this report include products from well-known pharmaceutical companies like Alkem Laboratories, Hindustan Antibiotics Limited, Hetero Labs Limited, Karnataka Antibiotics and Pharmaceuticals Ltd, Nestor Pharmaceuticals Ltd, Priya Pharmaceuticals, and Scott-Edil Pharmacia Ltd. The findings have brought to light the critical issues surrounding drug quality assurance in India, necessitating urgent action to protect public health.

 Understanding the CDSCO’s Role and the Recent Drug Alert

The Central Drugs Standard Control Organisation (CDSCO) is India’s primary regulatory authority responsible for the approval, regulation, and monitoring of drugs, cosmetics, and medical devices in the country. The CDSCO conducts regular quality checks on pharmaceutical products to ensure compliance with established safety and efficacy standards. The organization releases monthly drug alerts listing medications that have been found to be substandard based on various quality tests.

The latest drug alert for August 2024 highlights several concerns, including:

1. Failure in Quality Tests: Some drugs failed the ‘dissolution test,’ which measures the time it takes for a drug to dissolve in the body, as per the standards outlined in the Indian Pharmacopoeia (IP). Others failed the ‘assay’ test, which measures the drug quality active ingredient, and the ‘water test,’ which assesses moisture content.
2. Spurious Drugs: Some samples were identified as spurious, meaning they were falsely labeled or did not contain the active ingredients as claimed. This poses significant risks to patient safety, as these drugs may not provide the therapeutic benefits required for treating specific health conditions.
3. Uniformity of Volume Issues: Certain batches had issues with uniformity of volume, which indicates that the drug formulation might not be consistent across all units, potentially leading to variable efficacy and safety outcomes.

 Major Drugs Flagged as ‘Not of Standard Quality’

The CDSCO’s report for August 2024 lists several commonly used drugs that were found to be of substandard quality. These include:

1. Paracetamol: A widely used over-the-counter analgesic and antipyretic, paracetamol is used to treat pain and fever. Substandard quality in this essential drug can lead to insufficient treatment of these conditions and potentially harmful side effects.
2. Pan D: A combination of pantoprazole and domperidone, Pan D is used to treat gastroesophageal reflux disease (GERD) and other related conditions. Quality issues in this drug could result in reduced efficacy and incomplete symptom relief.
3. Calcium and Vitamin D3 Supplements: These supplements are crucial for bone health and are widely used by individuals with deficiencies. Substandard supplements may not provide the required nutrients, affecting overall health.
4. Anti-Diabetic Pills: Medications used to manage diabetes, such as those containing metformin and glibenclamide, were also flagged. Poor-quality anti-diabetic drugs can lead to uncontrolled blood sugar levels, increasing the risk of complications like cardiovascular disease and neuropathy.
5. High Blood Pressure Medications: Drugs like Telmisartan and Atropine Sulphate, used to manage hypertension and other cardiovascular conditions, were identified as substandard. This can result in ineffective management of high blood pressure, potentially leading to severe health consequences.
6. Antibiotics: Common antibiotics such as Amoxicillin and Potassium Clavulanate tablets were found to be of substandard quality. Substandard antibiotics not only fail to treat infections effectively but also contribute to the growing issue of antibiotic resistance.
7. Vitamin and Mineral Supplements: Products like Shelcal (a calcium supplement), Vitamin B Complex with Vitamin C Softgels, and other vitamin C and D3 tablets were flagged. Substandard quality in these supplements can lead to nutritional deficiencies and associated health problems.

 Implications of Substandard Drugs

The presence of substandard drugs in the market has serious implications for public health and safety. Patients rely on medications to manage chronic conditions, treat infections, and improve their overall health. When these medications do not meet quality standards, they may not work as intended, potentially leading to a range of adverse outcomes, including:

– Therapeutic Failure: Substandard drugs may not provide the desired therapeutic effect, leading to worsening of the condition being treated. This can be particularly dangerous for patients with chronic diseases like diabetes and hypertension.
– Adverse Reactions: Variability in drug formulation can cause unexpected side effects, increasing the risk of adverse reactions in patients.
– Drug Resistance: In the case of antibiotics, substandard drugs can contribute to the development of antibiotic-resistant bacteria, making infections harder to treat and increasing the risk of outbreaks.
– Loss of Trust: Incidents of substandard drugs erode public trust in the healthcare system and the pharmaceutical industry, which can have long-term repercussions on health-seeking behavior.

 Regulatory Measures and Challenges

The CDSCO’s monthly drug alert is part of its ongoing efforts to monitor the quality of drugs in the Indian market. However, several challenges hinder effective quality control:

1. Regulatory Gaps: Despite stringent regulations, the sheer volume of drugs manufactured and sold in India makes it challenging for regulators to ensure compliance across the board. Inconsistent enforcement of regulations at the state level also contributes to the problem.
2. Resource Constraints: The CDSCO and state drug regulatory authorities often face resource constraints, including limited manpower and testing facilities, which can delay the detection and reporting of substandard drugs.
3. Lack of Data: According to the CDSCO, several states, including Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, and others, did not submit data for the NSQ alert in August 2024. This lack of data from state drug authorities hampers comprehensive quality monitoring.
4. Market Dynamics: The complex supply chain of the pharmaceutical industry, involving multiple manufacturers, distributors, and retailers, makes it difficult to trace the source of substandard drug quality and hold accountable those responsible.

 What Can Be Done to Improve Drug Quality?

Addressing the issue of substandard drugs requires a multifaceted approach involving regulatory reforms, industry collaboration, and public awareness:

1. Strengthening Regulatory Oversight: There is a need for stronger regulatory oversight at both the central and state levels. This includes increasing the frequency and scope of inspections and ensuring that all states report data on drug quality regularly.
2. Enhanced Testing Facilities: Investing in modern testing facilities and technologies can help regulatory authorities detect substandard drugs more efficiently and accurately.
3. Industry Accountability: Pharmaceutical companies must adhere to good manufacturing practices (GMP) and implement stringent quality control measures throughout the production process. Transparent reporting of quality issues and prompt action to recall substandard products are also crucial.
4. Public Awareness: Educating the public about the risks associated with substandard drugs and encouraging them to report adverse drug reactions can help regulatory authorities take timely action.
5. International Collaboration: Given the global nature of the pharmaceutical supply chain, international collaboration on quality standards and regulatory practices can help improve drug safety and efficacy.

 FAQs about the CDSCO’s Drug Alert and Substandard Drugs

1. What does “not of standard quality” mean in the context of drugs?

“Not of standard quality” (NSQ) refers to drugs that fail to meet the quality standards specified by regulatory authorities, such as the Indian Pharmacopoeia (IP). This could mean that the drug contains incorrect levels of active ingredients, has impurities, or does not dissolve properly, among other issues.

2. How often does the CDSCO release drug alerts?

The CDSCO releases drug alerts on a monthly basis to inform the public and healthcare professionals about drugs that have been found to be of substandard quality.

3. What should I do if I have taken a drug listed in the CDSCO’s alert?

If you have taken a drug listed in the CDSCO’s alert and are experiencing adverse effects or if the drug is not working as expected, you should consult your healthcare provider immediately. They can provide guidance on alternative treatments and report the issue to the relevant authorities

4. Why is it important to monitor the quality of drugs?

Monitoring the quality of drugs is essential to ensure their safety and efficacy. Substandard drugs can lead to therapeutic failure, adverse reactions, and contribute to drug resistance, posing serious risks to public health.

5. What actions does the CDSCO take against companies that produce substandard drugs?

When a drug is found to be of substandard quality, the CDSCO can take various actions, including recalling the affected batches, suspending the manufacturer’s license, and imposing penalties. In severe cases, criminal proceedings may be initiated against the responsible parties.

6. How can I check if a drug is of standard quality?

Patients can check the CDSCO’s monthly drug alerts, which are available on their official website. They can also consult with their healthcare provider or pharmacist for guidance.

7. What is the government doing to improve the quality of drugs in India?

The government is working to strengthen regulatory oversight, improve testing facilities, and enforce stricter penalties for non-compliance. Efforts are also being made to enhance coordination between central and state drug regulatory authorities.

8. How can pharmaceutical companies ensure the quality of their products?

Pharmaceutical companies must adhere to good manufacturing practices (GMP), conduct regular quality checks throughout the production process, and ensure compliance with all regulatory requirements. Transparency in reporting and prompt corrective actions are also crucial.

 Conclusion

The recent findings by the CDSCO highlighting over 50 drugs as “not of standard quality” underscore the ongoing challenges in ensuring drug safety and efficacy in India. As the country continues to play a pivotal role in the global pharmaceutical supply chain, it is imperative that regulatory authorities, industry stakeholders, and the public work together to uphold the highest standards of drug quality. Strengthening regulatory oversight, improving testing capabilities, and fostering a culture of accountability and transparency within the pharmaceutical industry are essential steps to safeguard public health.

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