Drug Traceability and Quality Control in Pharmaceuticals
Social Justice & Development
- PYQs5
- Articles1
Background
This concept is crucial for UPSC as it involves public health, India's global pharmaceutical standing, regulatory mechanisms, challenges for MSMEs, digital governance, and international trade implications. It reflects the government's efforts to ensure drug safety and quality.
India's pharmaceutical industry is a global supplier, but faces challenges related to counterfeit drugs, quality control, and supply chain integrity, impacting public health and international reputation. Robust regulatory frameworks are crucial to ensure the authenticity and quality of medicines reaching consumers.
Facts & tables
- Schedule H2
- Mandates barcode or QR code on drug packs for authenticity verification, expanded from specific brands to entire therapeutic classes.
- Purpose
- Combats counterfeit drugs, addresses antimicrobial resistance, and prevents leakage of controlled substances into illicit markets.
- International Concerns
- Aims to address recurring quality control issues raised by bodies like US FDA, European Medicines Agency, and U.S. Trade Representative.
- Implementation Challenges
- Requires state-managed real-time databases, interoperable software, scanning infrastructure, and robust digital governance for sensitive data.
| Type | Reference |
|---|---|
| Conceptual area | Public Health |
| Conceptual area | Governance & Regulation |
| Body | Role |
|---|---|
| Health Ministry | Implements |
| WHO | Flags issues |
| US FDA | Raises concerns |
Prelims angle
Prelims angle: Multi-statement analysis
Prelims angle: Policy measures
- Schedule H2 mandates QR codes for drug authenticity.
- Aims to combat counterfeit drugs, AMR, and illicit substance leakage.
- Addresses international quality control concerns.
- Implementation challenges include database, IT integration, MSME burden.
- Impacts India's pharmaceutical reputation and public health.
| Year | Framing tags |
|---|---|
| 2023 | Multi-statement analysis, Policy measures |
| 2022 | Multi-statement analysis, Factual recall |
| 2018 | Multi-statement analysis, Policy measures |
| 2018 | Multi-statement analysis, Conceptual understanding |
| 2016 | Multi-statement analysis, Policy measures |
Timeline
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Public Health
Conceptual area
-
Governance & Regulation
Conceptual area
-
Prelims 2016
Multi-statement analysis, Policy measures
-
Prelims 2018
Multi-statement analysis, Policy measures
-
Prelims 2018
Multi-statement analysis, Conceptual understanding
-
Prelims 2022
Multi-statement analysis, Factual recall
-
Prelims 2023
Multi-statement analysis, Policy measures
-
Buyer Beware: The Hindu Editorial on the QR code-based drug traceability framework
A government initiative to enhance drug authenticity and quality control through a QR code-based traceability system, addressing counterfeit drugs, antimicrobial resistance, and international concerns, while facing significant implementation challenges related to digital infrastructure and compliance.
See also
Past papers
2016–2023 · 5 questions
In the news
Buyer Beware: The Hindu Editorial on the QR code-based drug traceability framework
A government initiative to enhance drug authenticity and quality control through a QR code-based traceability system, addressing counterfeit drugs, antimicrobial resistance, and international concerns, while facing significant implementation challenges related to digital infrastructure and compliance.
Try these PYQs
With reference to ‘Initiative for Nutritional Security through Intensive Millets Promotion’, which of the following statements is/are correct?
1. This initiative aims to demonstrate the improved production and post-harvest technologies and to demonstrate value addition techniques, in an integrated manner, with a cluster approach.
2. Poor, small, marginal and tribal farmers have a larger stake in this scheme.
3. An important objective of the scheme is to encourage farmers of commercial crops to shift to millet cultivation by offering them free kits of critical inputs of nutrients and micro-irrigation equipment.
Select the correct answer using the code given below.
Statement 1 is correct. The Initiative for Nutritional Security through Intensive Millets Promotion aims to demonstrate improved production and post-harvest technologies in an integrated manner with a cluster approach. Statement 2 is also correct. Millets are mainly grown in regions of low annual rainfall and poor arid soil. It is inadequate, small, marginal and tribal farmers, who cannot afford costly irrigation practices, depend on the cultivation of millets. Hence these farmers benefit from the scheme and have a larger stake in this scheme. Statement 3 is not correct. There is no such provision to encourage commercial crop farmers to shift to millet cultivation.
Consider the following statements in relation to Janani Suraksha Yojana:
1. It is safe motherhood intervention of the State Health Departments.
2. Its objective is to reduce maternal and neonatal mortality among poor pregnant women.
3. It aims to promote institutional delivery among poor pregnant women.
4. Its objective includes providing public health facilities to sick infants up to one year of age.
How many of the statements given above are correct?
Statement 1 is incorrect: Janani Suraksha Yojana (JSY) is a 100% Centrally Sponsored Scheme under the National Health Mission (NHM). It is a central intervention implemented by states, not an intervention of the State Health Departments. Statement 2 is correct: The primary objective is to reduce maternal and neonatal mortality by encouraging safe, institutional births. Statement 3 is correct: The scheme provides a cash incentive to mothers to promote institutional delivery, particularly among those from BPL, SC, and ST households. Statement 4 is incorrect: While care for sick infants is a priority under the National Health Mission, the provision of free facilities for sick infants up to one year of age is specifically a feature of the Janani Shishu Suraksha Karyakram (JSSK) launched in 2011. JSY, launched in 2005, is primarily a conditional cash transfer scheme for delivery.
Which of the following is/are the aim/aims of "Digital India" Plan of the Government of India?
1. Formation of India's own Internet companies like China did.
2. Establish a policy framework to encourage overseas multinational corporations that collect Big Data to build their large data centres within our national geographical boundaries.
3. Connect many of our villages to the Internet and bring Wi-Fi to many of our school, public places and major tourist centres
Select the correct answer using the code given below
* Statement 1 is not correct: The formation of India’s own internet companies, similar to China’s approach, is not an aim of the Digital India programme. The initiative focuses on creating digital infrastructure, providing digital services, and promoting digital literacy — not establishing government-backed internet firms. * Statement 2 is not correct: The Digital India plan does not include any policy framework to attract foreign multinational corporations to build data centres in India. While data localisation and data centre policies have emerged later under different frameworks, they are not part of the original Digital India objectives. * Statement 3 is correct: One of the key aims of Digital India is to connect villages through broadband and to provide Wi-Fi access in schools, public places, and tourist centres. This is part of its core pillars like Broadband Highways, Public Internet Access Programme, and Early Harvest Programmes.
With reference to Pradhan Mantri Kaushal Vikas Yojana, consider the following statements
1. It is the flagship scheme of the Ministry of Labour and Employment.
2. It, among other things, will also impart training in soft skills, entrepreneurship, financial and digital literacy.
3. It aims to align the competencies of the unregulated workforce of the country to the National Skill Qualification Framework.
Which of the statements given above is/are correct?
Statement 1 is Incorrect. The Ministry of Skill Development and Entrepreneurship (MSDE) is responsible for PMKVY, not the Ministry of Labour and Employment. Statement 2 is Correct. PMKVY goes beyond technical skills training and incorporates soft skills, entrepreneurship, financial literacy, and digital literacy to make participants more employable. Statement 3 is Correct. A core objective of PMKVY is to bridge the gap between the skills of the unregulated workforce and industry requirements by aligning them with the National Skill Qualification Framework (NSQF). This standardization helps ensure a minimum level of competency and improves employment opportunities.
With reference to Ayushman Bharat Digital Mission, consider the following statements:
1. Private and public hospitals must adopt it.
2. As it aims to achieve universal health coverage, every citizen of India should be part of it ultimately.
3. It has seamless portability across the country.
Which of the statements given above is/are correct?
Ayushman Bharat Digital Mission aims to provide digital health IDs for all Indian citizens to help hospitals, insurance firms, and citizens access health records electronically when required. Statement 1 is incorrect. Ayushman Bharat Digital Mission (ABDM) has not made it mandatory for adoption by private and public hospitals. Its adoption so far would be voluntary. Participation in ABDM is voluntary including for citizens. Participation of a healthcare facility or an institution is also voluntary and shall be taken by the respective management (government or private management). Statement 2 is incorrect. The aim of the Ayushman Bharat Digital Mission is to facilitate the ease of access to medical records and it is not been mandated to have every citizen as its part though the facility is available to every citizen on a consent basis. Statement 3 is correct. ABDM will have a national footprint and will enable seamless portability across the country through a Health ID Personal Health Identifier.